Date/Time of Define-XML document generation: 2021-04-27T08:02:54Z
Define-XML version: 2.0.0
Stylesheet version: 2018-11-21
Datasets
| Dataset | Description | Class | Structure | Purpose | Keys | Documentation | Location |
|---|---|---|---|---|---|---|---|
| ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | One record per subject | Analysis | STUDYID, USUBJID | adsl.xpt | |
| ADC19EF | Covid-19 Efficacy Analysis | BASIC DATA STRUCTURE | One record or multiple records per subject per analysis parameter per analysis timepoint | Analysis | STUDYID, USUBJID, PARAMCD, ADT | adc19ef.xpt | |
| ADFACEVD | Diary and Non-event Analysis Dataset | BASIC DATA STRUCTURE | One record or multiple records per subject per analysis parameter per analysis timepoint | Analysis | STUDYID, USUBJID, PARAMCD, ATPT | adfacevd.xpt | |
| ADSYMPT | Covid-19 Signs and Symptoms | BASIC DATA STRUCTURE | One record or multiple records per subject per analysis parameter per analysis timepoint | Analysis | STUDYID, USUBJID, PARAMCD, ADT | adsympt.xpt | |
| ADVA | Immunogenicity Analysis Dataset | BASIC DATA STRUCTURE | One record or multiple records per subject per analysis parameter per analysis visit | Analysis | STUDYID, USUBJID, PARAMCD, AVISIT | adva.xpt | |
| ADAE | Adverse Events Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record or multiple records per subject per adverse event per event start date | Analysis | STUDYID, USUBJID, AEDECOD, AESTDTC | adae.xpt | |
| ADCEVD | Diary and CRF Event Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record or multiple records per subject per clinical event | Analysis | STUDYID, USUBJID, CETERM | adcevd.xpt | |
| ADCM | Concomitant Medications Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record or multiple records per subject per recorded medication occurrence or constant-dosing interval | Analysis | STUDYID, USUBJID, CMDECOD, CMSTDTC | adcm.xpt | |
| ADDS | Disposition Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record or multiple records per subject per disposition status or protocol milestone | Analysis | STUDYID, USUBJID, DSDECOD | adds.xpt | |
| ADDV | Protocol Deviation Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record or multiple records per subject per protocol deviation per event start date | Analysis | STUDYID, USUBJID, DVTERM, DVSTDTC | addv.xpt | |
| ADMH | Medical History Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record or multiple records per subject per medical history event | Analysis | STUDYID, USUBJID, MHTERM | admh.xpt |
Go to the top of the Define-XML document
Subject-Level Analysis Dataset (ADSL)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: DM.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: DM.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: DM.SUBJID | |
| SITEID | Study Site Identifier | text | 4 | Predecessor: DM.SITEID | |
| AGE | Age | integer | 8 | Predecessor: DM.AGE | |
| AGEU | Age Units | text | 5 | Age Unit
| Predecessor: DM.AGEU |
| SEX | Sex | text | 1 | Sex
| Predecessor: DM.SEX |
| SEXN | Sex (N) | integer | 8 | Numeric Code of Sex
| Assigned Numeric Code of the DM.SEX. Equals 1 if SEX="M", Equals 2 if SEX="F". |
| RACE | Race | text | 41 | Race [7 Terms] | Predecessor: DM.RACE |
| RACEN | Race (N) | integer | 8 | Numeric Code of Race [7 Terms] | Assigned Numeric Code of the DM.RACE. 1 if RACE="WHITE"; 2 if RACE="BLACK OR AFRICAN AMERICAN"; 3 if RACE="AMERICAN INDIAN OR ALASKA NATIVE"; 4 if RACE="ASIAN"; 5 if RACE="NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER"; 6 if RACE="MULTIPLE"; 7 if RACE="NOT REPORTED"; |
| ETHNIC | Ethnicity | text | 22 | Ethnic Group
| Predecessor: DM.ETHNIC |
| ETHNICN | Ethnicity (N) | integer | 8 | Numeric Code of Ethnic Group
| Assigned Numeric Code of the DM.ETHNIC. 1 if ETHNIC="HISPANIC OR LATINO"; 2 if ETHNIC="NOT HISPANIC OR LATINO"; 3 if ETHNIC="NOT REPORTED". |
| RACIALD | Racial Designation | text | 8 | RACIALD
| Predecessor: SUPPDM.QVAL where SUPPDM.QNAM="RACIALD" |
| RACIALDN | Racial Designation (N) | integer | 8 | Numeric Code of RACIALD
| Assigned Numeric Code of RACIALD 5 if RACIALD="JAPANESE" 999 if RACIALDN="OTHER" |
| COUNTRY | Country | text | ISO 3166 | Predecessor: DM.COUNTRY | |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Derived If RANDFL='Y' and (VAX101DT ne . or VAX102DT ne . ) and (index(SUPPDV.QNAM.CAPE, "POP1")=0 for subjects's all DV records) then SAFFL='Y', else SAFFL='N' |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response
| Derived Assign 'Y' for participants who are assigned a randomization number and with non-missing randomization date. |
| ENRLFL | Enrolled Population Flag | text | 1 | Y
| Derived Assign 'Y' for participants who have a signed ICD. |
| DTHFL | Subject Death Flag | text | 1 | Y
| Predecessor: DM.DTHFL |
| ARM | Description of Planned Arm | text | 29 | Description of Planned Arm [11 Terms] | Derived if armcd="B1_10" then arm="BNT162b1 Phase 1 (10 mcg)"
if armcd="B1_100" then arm="BNT162b1 Phase 1 (100/10 mcg)"
if armcd="B1_20" then arm="BNT162b1 Phase 1 (20 mcg)"
if armcd="B1_30" then arm="BNT162b1 Phase 1 (30 mcg)"
if armcd="B2_10" then arm="BNT162b2 Phase 1 (10 mcg)"
if armcd="B2_20" then arm="BNT162b2 Phase 1 (20 mcg)"
if armcd="B2_30" then arm="BNT162b2 Phase 1 (30 mcg)"
if armcd="B2_P23_30" then arm="BNT162b2 Phase 2/3 (30 mcg)"
if armcd="NOTASSGN" then arm="NOT ASSIGNED"
if armcd="NOTTRT" then arm="Not Treated"
if armcd="PLACEBO" then arm="Placebo"
if armcd="SCRNFAIL" then arm="SCREEN FAILURE" |
| ARMCD | Planned Arm Code | text | 9 | Planned Arm Code [11 Terms] | Predecessor: DM.ARMCD |
| ACTARM | Description of Actual Arm | text | 29 | Description of Actual Arm [12 Terms] | Derived Based on the actual vaccinations taken by subjects. Same as ARM if no medication error for the vaccinated subjects
ACTARM=' NOT ASSIGNED ' for not assigned subjects;
ACTARM=' SCREEN FAILURE ' for screen failure subjects;
ACTARM='Not Treated' for not treated subjets or subjects without determined treatment; |
| ACTARMCD | Actual Arm Code | text | 9 | Actual Arm Code [12 Terms] | Derived Based on the actual vaccinations taken by subjects. Same as ARMCD if no medication error for the vaccinated subjects.
ACTARM=' NOTASSGN ' for not assigned subjects;
ACTARM=' SCRNFAIL ' for screen failure subjects;
ACTARMCD='NOTTRT' for not treated subjets or subjects without determined treatment; |
| TRT01P | Planned Treatment for Period 01 | text | 29 | TRT01P [9 Terms] | Derived Obtained from DM.ARM directly. |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | TRT01PN [9 Terms] | Assigned BNT162b1 Phase 1 (10 mcg)=1; BNT162b1 Phase 1 (20 mcg)=2; BNT162b1 Phase 1 (30 mcg)=3; BNT162b1 Phase 1 (100/10 mcg)=4; BNT162b2 Phase 1 (10 mcg)=5; BNT162b2 Phase 1 (20 mcg)=6; BNT162b2 Phase 1 (30 mcg)=7; BNT162b2 Phase 2/3 (30 mcg)=8; Placebo=9 |
| TRT02P | Planned Treatment for Period 02 | text | 27 | TRT02P
| Derived assign as "BNT162b2 Phase 1 (30 mcg)" for Phase 1 subjects and "BNT162b2 Phase 2/3 (30 mcg)" for Phase 2/3 subjects if EX.EXDOSE and EX.EXSTDTC are not missing when EX.EXTPTREF='VACCINATION 3' or 'VACCINATION 4' |
| TRT02PN | Planned Treatment for Period 02 (N) | integer | 8 | TRT02PN
| Assigned BNT162b2 Phase 1 (30 mcg)=7; BNT162b2 Phase 2/3 (30 mcg)=8 |
| TRT01A | Actual Treatment for Period 01 | text | 29 | TRT01A [9 Terms] | Derived Derived from DM.ACTARM. If subject received any of doses as BNT162b2, then the subject will be assigned as 'BNT162b2 Phase 1 (30 mcg)' for phase 1 subject and 'BNT162b2 Phase 2/3 (30 mcg)' for phase 2/3 subject. If the subject received 1 or 2 doses of placebo and no BNT, the subject will be assigned as "Placebo". If subject with all indeterminate vaccinations, set TRT01A to missing. |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | TRT01AN [9 Terms] | Assigned BNT162b1 Phase 1 (10 mcg)=1; BNT162b1 Phase 1 (20 mcg)=2; BNT162b1 Phase 1 (30 mcg)=3; BNT162b1 Phase 1 (100/10 mcg)=4; BNT162b2 Phase 1 (10 mcg)=5; BNT162b2 Phase 1 (20 mcg)=6; BNT162b2 Phase 1 (30 mcg)=7; BNT162b2 Phase 2/3 (30 mcg)=8; Placebo=9 |
| TRT02A | Actual Treatment for Period 02 | text | 27 | TRT02A
| Derived Derived from EX.EXTRT where EXTPTREF in ("Vaccination 3" "Vaccination 4"). If subject received any of these 2 doses as BNT162b2, then the subject will be assigned as 'BNT162b2 Phase 1 (30 mcg)' for phase 1 subject and 'BNT162b2 Phase 2/3 (30 mcg)' for phase 2/3 subject. If subject with all indeterminate vaccinations, set TRT02A to missing. |
| TRT02AN | Actual Treatment for Period 02 (N) | integer | 8 | TRT02AN
| Assigned BNT162b2 Phase 1 (30 mcg)=7; BNT162b2 Phase 2/3 (30 mcg)=8; |
| TRTSEQP | Planned Sequence of Treatments | text | 38 | Derived combination of TRT01P and TRT02P for randomized subject | |
| TRTSEQA | Actual Sequence of Treatments | text | 38 | Derived combination of TRT01A and TRT02A for treated subject | |
| BRTHDT | Date of Birth | integer | DATE9 | Derived Datepart of DM.BRTHDTC
Imputation of Partial Dates:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year. | |
| BRTHDTF | Date of Birth Imput. Flag | text | 1 | Date Imputation Flag
| Derived BRTHDTF = 'M' if Month and Day are imputed in BRTHDT
BRTHDTF = 'D' if only Day is imputed in BRTHDT |
| DTHDTC | Date/Time of Death | date | ISO 8601 | ISO 8601 | Predecessor: DM.DTHDTC |
| DTHDT | Date of Death | integer | DATE9 | Derived If DM.DTHDTC is not missing and not partial then DTHDT=Datepart of DM.DTHDTC;
Else if DM.DTHDTC is partial then impute DTHDT using imputation START rules.
Partial Death Dates Imputation Rules:
If day (DD) and month (MMM) are missing in DM.DTHDTC, then use first day (01) and first month (JAN) for DD and MMM respectively.
If day (DD) missing then use first day (01) of the month for DD.
It is recommended that the database be designed to mandate a complete death date. If there is a record for death, but the date is missing or is partial, it will be imputed based on the last contact date.
If the entire death date DM.DTHDTC is missing OR If imputed Death Date (DTHDT) is ON or PRIOR to Last Know Alive Date then reset DTHDT=(Last Known Alive Date) +1 | |
| DTHDTF | Date of Death Imputation Flag | text | 1 | Date Imputation Flag
| Derived If DTHDT was imputed, DTHDTF must be populated and is required.
DTHDTF = 'Y' if Year is imputed
DTHDTF = 'M' if Year is present and Month is imputed
DTHDTF = 'D' if only day is imputed |
| RANDDT | Date of Randomization | integer | DATE9 | Derived [Protocol]
Randomization Date is defined usually those who have been randomized the study. (For study design where subject gets randomized multiple time then RANDDT will be derive based on 1st Randomization Date)
RANDDT = MIN of DS.DSSTDTC where DS.DSDECOD = "RANDOMIZED" | |
| RANDNO | Randomization Number | text | 6 | Predecessor: DS.DSREFID where DS.DSDECOD = "RANDOMIZED" | |
| RFSTDT | Subject Reference Start Date | integer | DATE9 | Derived Datepart of DM.RFSTDTC | |
| RFSTTM | Subject Reference Start Time | integer | TIME8 | Derived Timepart of DM.RFSTDTC | |
| RFENDT | Subject Reference End Date | integer | DATE9 | Derived Datepart of DM.RFENDTC | |
| RFENTM | Subject Reference End Time | integer | TIME8 | Derived Timepart of DM.RFENDTC | |
| RFPENDT | Date of End of Participation | integer | DATE9 | Predecessor: DM.RFPENDTC | |
| RFICDT | Date of Informed Consent | integer | DATE9 | Predecessor: DM.RFICDTC | |
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Derived Datepart of min(EX.EXSTDTC) by subject level | |
| TRTSTM | Time of First Exposure to Treatment | integer | TIME8 | Derived Timepart of min(EX.EXSTDTC) by subject level | |
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Derived Datepart of max(EX.EXENDTC) by subject level | |
| TRTETM | Time of Last Exposure to Treatment | integer | TIME8 | Derived Timepart of max(EX.EXENDTC) by subject level | |
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Derived Datepart of EX.EXSTDTC for Vaccination 1 | |
| TR01STM | Time of First Exposure in Period 01 | integer | TIME8 | Derived Timepart of EX.EXSTDTC for Vaccination 1 | |
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Derived Datepart of EX.EXENDTC for last vaccination of double blinded period. The last vaccination is defined as latest vaccination for subjects without Vaccination 3 or as last vaccination before Vaccination 3. | |
| TR01ETM | Time of Last Exposure in Period 01 | integer | TIME8 | Derived Timepart of EX.EXENDTC for last vaccination of double blinded period. The last vaccination is defined as latest vaccination for subjects without Vaccination 3 or as last vaccination before Vaccination 3. | |
| TR02SDT | Date of First Exposure in Period 02 | integer | DATE9 | Derived Datepart of EX.EXSTDTC for the first Vaccination for subjects with Vaccination 3/4. | |
| TR02STM | Time of First Exposure in Period 02 | integer | TIME8 | Derived Timepart of EX.EXSTDTC for the first Vaccination for subjects with Vaccination 3/4. | |
| TR02EDT | Date of Last Exposure in Period 02 | integer | DATE9 | Derived Datepart of EX.EXENDTC for last vaccination for subjects with Vaccination 3/4. | |
| TR02ETM | Time of Last Exposure in Period 02 | integer | TIME8 | Derived Timepart of EX.EXENDTC for last vaccination for subjects with Vaccination 3/4. | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Derived Min (EX.EXSTDTC) by subject level | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Derived Max (EX.EXSTDTC) by subject level | |
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Derived Datetime of EX.EXSTDTC for Vaccination 1 | |
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Derived Datetime of EX.EXENDTC for last vaccination of double blinded period. The last vaccination is defined as latest vaccination for subjects without Vaccination 3 or as last vaccination before Vaccination 3. | |
| TR02SDTM | Datetime of First Exposure in Period 02 | integer | DATETIME20 | Derived Datetime of EX.EXSTDTC for the first Vaccination for subjects with Vaccination 3/4. | |
| TR02EDTM | Datetime of Last Exposure in Period 02 | integer | DATETIME20 | Derived Datetime of EX.EXENDTC for last vaccination for subjects with Vaccination 3/4. | |
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Derived Date of the vaccination 1 (first vaccination date) | |
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Derived Date of the vaccination 2 (2nd vaccination date) | |
| VAX201DT | Vaccination Date 03 | integer | DATE9 | Derived Date of the vaccination at Visit 101 (3rd vaccination date), Datepart of EX.EXSTDTC where EX.VISIT in ('V101_VAX3' 'V8A_VAX3'). | |
| VAX202DT | Vaccination Date 04 | integer | DATE9 | Derived Date of the vaccination at Visit 102 (4th vaccination date), Datepart of EX.EXSTDTC where EX.VISIT='V102_VAX4'. | |
| AGETR01 | Age at Vaccination 01 | integer | 8 | Derived Derive AGETR01 from BIRTHDT (after applying imputation for partial date) and date of vaccination1. For participants who were randomized but not vaccinated, the randomization date will be used in place of the date of vaccination at Dose 1 for the age calculation. If the randomization date is also missing, then the informed consent date will be used for the age calculation.
Note: For example: If the vaccination 1 date is one day before the subject's 19th birthday, the subject is 18 years old. | |
| AGETRU01 | Age Units at Vaccination 01 | text | 5 | Age Unit
| Assigned AGETRU01='YEARS' for non-missing AGETR01. |
| AGETR03 | Age at Vaccination 03 | integer | 8 | Derived Derive AGETR03 from BIRTHDT (after applying imputation for partial date) and date of first dose of crossover period.
Note: For example: If dose 3 date is one day before the subject's 19th birthday, the subject is 18 years old. | |
| AGETRU03 | Age Units at Vaccination 03 | text | 5 | Age Unit
| Assigned AGETRU01='YEARS' for non-missing AGETR03. |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Derived Derived using following derivations:
if 12<=agetr01<=15 then AGEGR1='12-15 Years';(Phase 2/3 cohort)
if 18<=agetr01<=55 then AGEGR1='18-55 Years';(Phase 1 cohort)
if 16<=agetr01<=55 then AGEGR1='16-55 Years';(Phase 2/3 cohort)
if 65<=agetr01 then AGEGR1='65-85 Years'; (Phase 1 cohort)
if 56<=agetr01 then AGEGR1='>55 Years'; (Phase 2/3 cohort) |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Numeric Code of Pooled Age Group 1
| Assigned Numeric Code of AGEGR1. 1='12-15 Years'; (Phase 2/3 cohort) 2='16-55 Years'; (Phase 2/3 cohort) 3='18-55 Years'; (Phase 1 cohort) 4='65-85 Years'; (Phase 1 cohort) 5='>55 Years'; (Phase 2/3 cohort) |
| ARACE | Analysis Race | text | 41 | Analysis Race [7 Terms] | Derived if RACEN=1 then ARACE='WHITE';
if RACEN=2 then ARACE='BLACK OR AFRICAN AMERICAN';
if RACEN=3 then ARACE='AMERICAN INDIAN OR ALASKA NATIVE';
if RACEN=4 then ARACE='ASIAN';
if RACEN=5 then ARACE='NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER';
if RACEN=6 then ARACE='MULTIRACIAL';
if RACEN=7 then ARACE='NOT REPORTED'; |
| ARACEN | Analysis Race (N) | integer | 8 | Numeric Code of Analysis Race [7 Terms] | Assigned Numeric Code of ARACE Same as RACEN |
| RACEGR1 | Pooled Race Group 1 | text | 25 | Pooled Race Group 1
| Derived if RACE='WHITE' then RACEGR1="WHITE";
else if RACE='BLACK OR AFRICAN AMERICAN' then RACEGR1="BLACK OR AFRICAN AMERICAN";
else RACEGR1="ALL OTHERS" |
| RACEGR1N | Pooled Race Group 1 (N) | integer | 8 | Numeric Code of Pooled Race Group 1
| Assigned Numeric Code of the DM.RACEGR1. 1 if RACEGR1="WHITE"; 2 if RACEGR1="BLACK OR AFRICAN AMERICAN"; 3 if RACEGR1="ALL OTHERS" |
| EOSDCDT | End Of Study Discontinuation Date | integer | DATE9 | Derived EOSDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and DSPHASE="FOLLOW-UP" and DS.DSDECOD^=“COMPLETED” | |
| EOSDCRS | End Of Study Discontinuation Reason | text | 49 | Derived EOSDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and DSPHASE="FOLLOW-UP" and DS.DSDECOD^=“COMPLETED” | |
| EOTDCDT | End Of Treatment Discontinuation Date | integer | DATE9 | Derived EOTDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and index(SUPPDS.QNAM.DSPHASE, "VACCINATION")>0 and DS.DSDECOD^=“COMPLETED” | |
| EOTDCRS | End Of Treatment Discontinuation Reason | text | 49 | Derived EOTDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and SUPPDS.QNAM.DSPHASE="VACCINATION" and DS.DSDECOD^=“COMPLETED” | |
| INVID | Investigator Identifier | text | 7 | Predecessor: DM.INVID | |
| INVNAM | Investigator Name | text | 37 | Predecessor: DM.INVNAM | |
| DOSALVL | Actual Dosing Level | text | 52 | Actual Dosing Level
| Derived For Phase 1 only:
Assign actual dose level. eg: 10 ug, 20 ug, 30 ug, 100 ug/10 ug
For Placebo: Assign 'Placebo' |
| DOSPLVL | Planned Dosing Level | text | 52 | Planned Dosing Level
| Derived For Phase 1 only:
Assign planned dose level. eg: 10 ug, 20 ug, 30 ug,100 ug/10 ug
For Placebo: Assign 'Placebo' |
| DOSPLVLN | Planned Dosing Level (N) | integer | 8 | Numeric Code of Planned Dosing Level
| Assigned For Phase 1 only: Numeric Code of DOSPLVL 1=10 ug, 2=20 ug, 3=30 ug, 5=100/10 ug, 6=Placebo |
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Numeric Code of Actual Dosing Level
| Assigned For Phase 1 only: Numeric Code of DOSALVL 1=10 ug, 2=20 ug, 3=30 ug, 5=100/10 ug, 6=Placebo |
| CDECASE | Clinical disease endpoint case flag | text | 1 | Predecessor: SUPPDM.QVAL where SUPPDM.QNAM="CDECASE" | |
| REACTOFL | Reactogenicity Population Flag | text | 1 | No Yes Response
| Predecessor: SUPPDM.QVAL where SUPPDM.QNAM="REACTOFL" |
| VAX10UDT | Vaccination Date Unplanned | integer | DATE9 | Derived Date of the unplanned vaccination 2 (3rd vaccination date in the first period) | |
| VAX20UDT | Vaccination Date Unplanned in Period 02 | integer | DATE9 | Derived Date of the unplanned vaccination 1 in open label period. | |
| COHORT | Cohort Group | text | 75 | Cohort [13 Terms] | Derived For Phase 1 only: SUPPDS.QVAL where SUPPDS.QNAM=’ DSRANGRP’ |
| COHORTN | Cohort Group (N) | float | 8 | Numeric Code of Cohort [13 Terms] | Assigned For Phase 1 only: Numeric Code of COHORT, See details in Cohort List. |
| PHASEN | Study Phase (N) | integer | 8 | Numeric Code of Study Phase
| Assigned 1 for subjects from Phase 1; 2 for subjects from Phase 2; 3 for subjects from Phase 3 and included in DS6000; 4 for other subjects from Phase 3 |
| PHASE | Study Phase | text | 20 | Study Phase
| Derived "Phase 1" for subjects from Phase 1, who were picked from an external excel file: c4591001-phase-1-subjects-from-dmw.xlsx;
"Phase 2_ds360/ds6000" for subjects from Phase 2, who were picked from an external excel file: first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsx;
"Phase 3_ds6000" for subjects from Phase 3 and included in DS6000, who were picked from an external excel file: newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsx;
"Phase 3" for other subjects from Phase 3 |
| AGEGR2 | Pooled Age Group 2 | text | 10 | Pooled Age Group 2
| Derived Derived using following derivations:
if 65<=agetr01 then AGEGR2='>=65 Years';
if agetr01<65 then AGEGR2='<65 Years'; |
| AGEGR3 | Pooled Age Group 3 | text | 11 | Pooled Age Group 3
| Derived Derived using following derivations:
if 16<=agetr01<=17 then AGEGR3='16-17 Years';
if 18<=agetr01<=55 then AGEGR3='18-55 Years';
if 55<agetr01 then AGEGR3='>55 Years'; |
| AGEGR4 | Pooled Age Group 4 | text | 11 | Pooled Age Group 4
| Derived Derived using following derivations for Phase 3 subjects only:
if 12<=agetr01<=15 then AGEGR4='12-15 Years';
if 16<=agetr01<=25 then AGEGR4='16-25 Years'; |
| AGEGR4N | Pooled Age Group 4 (N) | integer | 8 | Numeric Code of Pooled Age Group 4
| Assigned Numeric Code of AGEGR4. 1='12-15 Years'; 2='16-25 Years'; |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Numeric Code of Pooled Age Group 2
| Assigned Numeric Code of AGEGR2. 1='<65 Years'; 2='>=65 Years'; |
| AGEGR3N | Pooled Age Group 3 (N) | integer | 8 | Numeric Code of Pooled Age Group 3
| Assigned Numeric Code of AGEGR3. 1='16-17 Years'; 2='18-55 Years'; 3='>55 Years'; |
| AGETGR3 | Age Group at Vaccination 03 | text | 11 | Age Group at Vaccination 03
| Derived Derived using following derivations:
if 16<=agetr03<=55 then AGETGR3='16-55 Years';
if 56<=agetr03 then AGETGR3='>55 Years'; |
| AGETGR3N | Age Group at Vaccination 03 (N) | integer | 8 | Numeric Code of Age Group at Vaccination 03
| Assigned Numeric Code of AGETGR3. 1='16-55 Years'; 2='>55 Years'; |
| VAX101 | Vaccination 01 | text | 37 | Derived Dose 1: combined form the vaccination at dose 1 and the corresponding dosage; set to missing if the dose is INDETERMINATE. | |
| VAX102 | Vaccination 02 | text | 36 | Derived Dose 2: combined form the vaccination at dose 2 and the corresponding dosage; set to missing if the dose is INDETERMINATE. | |
| VAX201 | Vaccination 03 | text | 36 | Derived If EX.EXTRT='BNT162b2' when EX.VISIT in ('V101_VAX3' 'V8A_VAX3'), then VAX201='BNT162b2 (30 (*ESC*){unicode 03BC}g)'; set to missing if the dose is INDETERMINATE. | |
| VAX202 | Vaccination 04 | text | 36 | Derived If EX.EXTRT='BNT162b2' when EX.VISIT='V102_VAX4', then VAX202='BNT162b2 (30 (*ESC*){unicode 03BC}g)'; set to missing if the dose is INDETERMINATE. | |
| VAX10U | Vaccination Unplanned | text | 36 | Derived Unplanned Dose 2: combined form the vaccination at unplanned dose 2 and the corresponding dosage; set to missing if the dose is INDETERMINATE. | |
| VAX20U | Vaccination Unplanned in Period 02 | text | 1 | Derived Unplanned Dose in open label period: combined form the vaccination at unplanned dose after the first dose after crossover period and the corresponding dosage; set to missing if the dose is INDETERMINATE. | |
| VAX101TM | Vaccination Time 01 | integer | TIME8 | Derived Time of the vaccination 1 (first vaccination date) | |
| VAX102TM | Vaccination Time 02 | integer | TIME8 | Derived Time of the vaccination 2 (2nd vaccination date) | |
| VAX201TM | Vaccination Time 03 | integer | TIME8 | Derived Time of the vaccination at Visit 101 (3rd vaccination date), timepart of EX.EXSTDTC where EX.VISIT in ('V101_VAX3' 'V8A_VAX3'). | |
| VAX202TM | Vaccination Time 04 | integer | TIME8 | Derived Time of the vaccination at Visit 102 (4th vaccination date), timepart of EX.EXSTDTC where EX.VISIT='V102_VAX4'. | |
| VAX10UTM | Vaccination Time Unplanned | integer | TIME8 | Derived Time of the unplanned vaccination 2 (3rd vaccination date in the first period) | |
| VAX20UTM | Vaccination Time Unplanned in Period 02 | integer | TIME8 | Derived Time of the unplanned vaccination 1 in open label period. | |
| UNBLNDDT | Treatment Unblinded Date | integer | DATE9 | Derived DS.DSSTDTC when DSDECOD="TREATMENT UNBLINDED" | |
| REVXICDT | Re-vax Informed Consent Date | integer | DATE9 | Derived DS.DSSTDTC for Re-vax Informed Consent. | |
| EOTXDCDT | End Of Open Label Treatment D/C Date | integer | DATE9 | Derived EOTXDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and SUPPDS.QNAM='DSPHASE' and SUPPDS.QVAL="OPEN LABEL TREATMENT" and DS.DSDECOD^=“COMPLETED” | |
| EOTXDCRS | End Of Open Label Treatment D/C Reason | text | 21 | Derived EOTXDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and SUPPDS.QNAM='DSPHASE' and SUPPDS.QVAL="OPEN LABEL TREATMENT" and DS.DSDECOD^=“COMPLETED” | |
| BMICAT | Baseline BMI Category | text | 13 | BMI Category
| Derived Carry BMI from SDTM.VS where index(visit, "V1_DAY1") and vstestcd="BMI" and vsdy<=1
if .<vsstresn<18.5 then BMICAT="Underweight";
else if 18.5<=vsstresn<=24.9 then BMICAT="Normal weight";
else if 25<=vsstresn<=29.9 then BMICAT="Overweight";
else if 30<=vsstresn then BMICAT="Obese";
if vsstresn=. then BMICAT="Missing"; |
| BMICATN | Baseline BMI Category (N) | integer | 8 | Numeric Code of BMI Category
| Assigned if BMICAT="Underweight" then BMICATN=1; else if BMICAT="Normal weight" then BMICATN=2; else if BMICAT="Overweight" then BMICATN=3; else if BMICAT="Obese" then BMICATN=4; else if BMICAT="Missing" then BMICATN=5; |
| OBESEFL | Obese Flag for Adolescent | text | 1 | No Yes Response
| Derived "Y" if adolescent with enrolled age 12-15 meets the BMI cut off for obesity with age/sex groups. The standard for obesity is provided in an external file bmi-12-15-scale.xlsx. |
| COMBODFL | Flag for Comorbodities | text | 1 | No Yes Response
| Derived "Y" if subject with Medical History With Comorbodities. Terms were defined in 19 external excel files whose filename contains 'report-cci'. |
| NIGV1FL | N-binding Antibody Neg at Visit 1 Flag | text | 1 | No Yes Response
| Derived Derived from is.istest='N-binding antibody'
if is.isorres="NEG" and index(visit,"V1_DAY1_") and is.isdy<=1 then NIGV1FL="Y";
else if is.isorres="POS" and index(visit,"V1_DAY1_") and is.isdy<=1 then NIGV1FL="N";
Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. |
| NAATNFL | NAAT Negative at Visit 1 Flag | text | 1 | No Yes Response
| Derived if index(mb.visit,"V1_DAY1_") and mb.mbtestcd='RTCOV2NS' and mb.mborres="NEG" and mb.mbdy<=1 then NAATNFL="Y";
else if index(mb.visit,"V1_DAY1_") and mb.mbtestcd='RTCOV2NS' and mb.mborres="POS" and mb.mbdy<=1 then NAATNFL="N"; |
| COVBLST | Baseline SARS-CoV-2 Status | text | 3 | Baseline SARS-CoV-2 Status
| Derived Subjects are considered with COVID-19 history if MH.MHDECOD in ("Asymptomatic COVID-19" "COVID-19" "COVID-19 pneumonia" "COVID-19 treatment" "Suspected COVID-19" "SARS-CoV-2 antibody test positive" "SARS-CoV-2 carrier" "SARS-CoV-2 sepsis" "SARS-CoV-2 test positive" "SARS-CoV-2 viraemia" "Multisystem inflammatory syndrome in children").
if subjects with COVID-19 history or NIGV1FL="N" or NAATNFL="N" then COVBLST="POS";
if subjects without COVID-19 history and NIGV1FL="Y" and NAATNFL="Y" then COVBLST="NEG"; |
| V01DT | Date of Unblinding or Visit at 1MPD2 | integer | DATE9 | Derived Derived BE1DT from CO.CODTC from Visit 7 after second dose for phase 1 and from visit 3 for phase 2/3
Derived BE1DT2 from SV.SVSTDTC from visit 7 after second dose for phase 1 and from visit 3 for phase 2/3
V01DT=COALESCE(VAX10UDT+35, BE1DT, BE1DT2, VAX102DT+35, VAX101DT+58);
Then, for unblinded subjects, compare V01DT with the day before treatment unblinding, set V01DT=min(V01DT,UNBLNDDT-1)
Note: used for AE summary tables to cutoff AEs within 1 month after vax2 | |
| V02DT | Date of Unblinding or Visit at 6MPD2 | integer | DATE9 | Derived Derived BE2DT from CO.CODTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
Derived BE2DT2 from SV.SVSTDTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
V02DT=COALESCE(VAX10UDT+189, BE2DT, BE2DT2, VAX102DT+189, VAX101DT+189+23);
Then, for unblinded subjects, compare V02DT with the day before treatment unblinding, set V02DT=min(V02DT,UNBLNDDT-1)
Note: used for AE summary tables to cutoff AEs within 6 month after vax2. | |
| V02OBDT | Date of Dose 3 or Visit at 6MPD2 | integer | DATE9 | Derived Derived BE2DT from CO.CODTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
Derived BE2DT2 from SV.SVSTDTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
V02DT=COALESCE(VAX10UDT+189, BE2DT, BE2DT2, VAX102DT+189, VAX101DT+189+23);
Then, for subjects took dose 3, compare V02DT with the day before dose 3, set V02DT=min(V02DT, TR02SDT-1)
Note: used for AE summary tables to cutoff AEs within 6 month after vax2 regardless unblinding. | |
| V03DT | Date of Visit at 1M after Vax4 | integer | DATE9 | Derived Derived BE3DT2 from SV.SVSTDTC from 1 month after second dose in open label period visit
V03DT=COALESCE(BE3DT2, VAX202DT+35, VAX201DT+58)
Note: used for AE summary tables to cutoff AEs within 1 month after vax 4 in open label period | |
| V04DT | Date of Visit at 6M after Vax4 | integer | DATE9 | Derived Derived BE4DT2 from SV.SVSTDTC from 6 months after second dose in open label period visit
V04DT=COALESCE(BE4DT2, VAX202DT+189, VAX201DT+189+23)
Note: used for AE summary tables to cutoff AEs within 6 month after vax 4 in open label period | |
| V3C19NIG | C19NIG Result at Visit 3 | text | 3 | Derived The value of N-binding test at 1 Month after Vax 2 Visit. For subjects had Visit 3 recorded as not done, and if there is a convalescent visit or vax3 visit that happened within 28-42 days post dose 2, the convalescent visit/vax3 visit will be used to replace this one. If there are two records fall in the window, the record closed to 30 days after dose 2 will be chosen. | |
| DVSTDT | Start Date of Important PD | integer | DATE9 | Derived The earliest date of important PD | |
| BLDV1FL | Blood Sample Drawn before Vax 1 | text | 1 | No Yes Response
| Derived If non missing blood draw date at Vax 1 Visit then bldv1fl = 'Y''; else bldv1fl = 'N'. |
| BLDV2FL | Blood Sample Drawn 1 Week after Vax 1 | text | 1 | No Yes Response
| Derived If non missing blood draw date at 1 Week after Vax 1 Visit then bldv2fl = 'Y''; else bldv2fl = 'N'. |
| BLDV3FL | Blood Sample Drawn before Vax 2 | text | 1 | No Yes Response
| Derived If non missing blood draw date at Vax 2 Visit then bldv3fl = 'Y''; else bldv3fl = 'N'. |
| BLDV4FL | Blood Sample Drawn 1 Week after Vax 2 | text | 1 | No Yes Response
| Derived If non missing blood draw date at 1 Week after Vax 2 Visit then bldv4fl = 'Y''; else bldv4fl = 'N'. |
| BLDV5FL | Blood Sample Drawn 2 Weeks after Vax 2 | text | 1 | No Yes Response
| Derived If non missing blood draw date at 2 Weeks after Vax 2 Visit then bldv5fl = 'Y''; else bldv5fl = 'N'. |
| BLDV6FL | Blood Sample Drawn 1 Month after Vax 2 | text | 1 | No Yes Response
| Derived If non missing blood draw date at 1 Month after Vax 2 Visit then bldv6fl = 'Y''; else bldv6fl = 'N'. (Only apply to Phase 2/3 to serology: For subjects had Visit 3 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened within 28-42 days post dose 2, the convalescent visit will be used to replace this one, and bldv6fl will be set to "Y".) |
| BLDV7FL | Blood Sample Drawn 6 Months after Vax 2 | text | 1 | No Yes Response
| Derived If non missing blood draw date at 6 Months after Vax 2 Visit then bldv7fl = 'Y''; else bldv7fl = 'N'. (Only apply to Phase 2/3 to serology: For subjects had Visit 4 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened after 42 days post dose 2, the convalescent visit will be used to replace this one, and bldv7fl will be set to "Y".) |
| BLDV1DT | Blood Sample Date before Vax 1 | integer | DATE9 | Derived Blood draw date at Vax 1 Visit | |
| BLDV2DT | Blood Sample Date 1 Week after Vax 1 | integer | DATE9 | Derived Blood draw date at 1 Week after Vax 1 Visit | |
| BLDV3ADT | Additional Bld Sample Date 3W after Vax1 | integer | DATE9 | Derived For 100 ug only, blood draw date at 3 weeks after Vax 1 Visit | |
| BLDV4ADT | Additional Bld Sample Date 4W after Vax1 | integer | DATE9 | Derived For 100 ug only, blood draw date at 4 weeks after Vax 1 Visit | |
| BLDV5ADT | Additional Bld Sample Date 5W after Vax1 | integer | DATE9 | Derived For 100 ug only, blood draw date at 5 weeks after Vax 1 Visit | |
| BLDV6ADT | Additional Bld Sample Date 7W after Vax1 | integer | DATE9 | Derived For 100 ug only, blood draw date at 3 weeks + 1 month after Vax 1 Visit | |
| BLDV3DT | Blood Sample Date before Vax 2 | integer | DATE9 | Derived Blood draw date at Vax 2 Visit | |
| BLDV4DT | Blood Sample Date 1 Week after Vax 2 | integer | DATE9 | Derived Blood draw date at 1 Week after Vax 2 Visit | |
| BLDV5DT | Blood Sample Date 2 Weeks after Vax 2 | integer | DATE9 | Derived Blood draw date at 2 Weeks after Vax 2 Visit | |
| BLDV6DT | Blood Sample Date 1 Month after Vax 2 | integer | DATE9 | Derived Blood draw date at 1 Month after Vax 2 Visit. (Only apply to Phase 2/3 to serology: For subjects had Visit 3 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened within 28-42 days post dose 2, the convalescent visit will be used to replace this one, and bldv6dt will be set to the date of the convalescent visit. If multiple records fall into such window, the one closed to 30 days post dose 2 will be chosen. If multiple records at the same day, the one with available immunogenicity results will be chosen.) | |
| BLDV7DT | Blood Sample Date 6 Months after Vax 2 | integer | DATE9 | Derived Blood draw date at 6 Months after Vax 2 Visit. (Only apply to Phase 2/3 to serology: For subjects had Visit 4 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened after 42 days post dose 2, the convalescent visit will be used to replace this one, and bldv7dt will be set to the date of the convalescent visit. If multiple records fall into such window, the one closed to 190 days post dose 2 will be chosen. If multiple records at the same day, the one with available immunogenicity results will be chosen.) | |
| INCL1FL | Are eligible for the study at rand | text | 1 | No Yes Response
| Derived Assign value 'Y' if meet following criteria; Else Assign value 'N';
1. Signed IC;
2. Randomized;
3. Not screen failure;
4. Meets all inclusion criteria and meets no exclusion criteria; |
| INCL2FL | Have received Vax 1 as randomized | text | 1 | No Yes Response
| Derived Receive the first dose of vaccine to which they are randomly assigned |
| INCL3FL | Have valid and DTM immuno result 1 | text | 1 | No Yes Response
| Derived Will apply to Phase 1 only. Have at least 1 valid and determinate immunogenicity result after Dose 1 but before Dose 2
Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. N-binding is diagnostic assay and not considered as valid and determinate immunogenicity result. |
| INCL4FL | Have valid and DTM immuno result 2 | text | 1 | No Yes Response
| Derived Will apply to Phase 1 only. Have at least 1 valid and determinate immunogenicity result 21 days after Dose 1.
Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. |
| INCL5FL | Have BD within the timeframe 1 | text | 1 | No Yes Response
| Derived Will apply to Phase 1 only. Have blood collection within an appropriate window after Dose 1, with visit window 19-23 days after dose 1. |
| INCL6FL | No important PD determined by clinician | text | 1 | No Yes Response
| Derived Derive from SUPPDV.QNAM.CAPE. 'Y' if the subjects with all records of SUPPDV.QNAM.CAPE is "NO" or missing or CAPE indicates "POP2" only and this date of PD is earlier that VAX102DT+14 |
| INCL7FL | Received 2 doses as rand within window | text | 1 | No Yes Response
| Derived Receive 2 randomized vaccinations within the pre-defined window
Vaccination window – can be 19-42 days after dose 1:
if 19<=VAX102DT-VAX101DT<=42 and ARM ne "" and
((index(upcase(vax102),"BNT162B2") and index(upcase(arm),"BNT162B2")) or (index(upcase(vax102),"PLACEBO") and index(upcase(arm),"PLACEBO")))
and vax101=vax102 then INCL7FL="Y"; else INCL7FL="N"; |
| INCL8FL | Have valid and DTM immuno result 3 | text | 1 | No Yes Response
| Derived Have at least 1 valid and determinate immunogenicity result after Dose 2
Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. N-binding is diagnostic assay and not considered as valid and determinate immunogenicity result. |
| INCL9FL | Have BD within the timeframe 2 | text | 1 | No Yes Response
| Derived Have blood collection within an appropriate window after Dose 2.
Phase 1 – with visit window 6-8 days after dose 2
Phase 2/3 – 28-42 days after dose 2 |
| INCL10FL | Unblinded after 1M post Dose 2 visit | text | 1 | No Yes Response
| Derived "Y" If unblinding date after the visit date of 1 month post dose 2. else "N" for non-missing unblinding date.
Note: not populated for subjects unblnding beyond 14 days after dose 2 but missing both BLDV6DT and SV.V3. ; not populated for missing dose 2. |
| EXCL1FL | Exclusion Flag 1 | text | 1 | Y
| Derived if INCL1FL="N" then EXCL1FL="Y" |
| EXCRIT1 | Exclusion Criterion 1 | text | 43 | Assigned Assign to "not eligible for the study at randomization" when EXCL1FL="Y" | |
| EXCL2FL | Exclusion Flag 2 | text | 1 | Y
| Derived if EXCL1FL ne "Y" and INCL2FL="N" then EXCL2FL="Y" |
| EXCRIT2 | Exclusion Criterion 2 | text | 36 | Assigned Assign to "did not receive Dose 1 as randomized" when EXCL2FL="Y" | |
| EXCL3FL | Exclusion Flag 3 | text | 1 | Y
| Derived Will apply to Phase 1 only. if (VAX101DT>. or vax102dt>.) and INCL3FL="N" then EXCL3FL="Y" |
| EXCRIT3 | Exclusion Criterion 3 | text | 1 | Assigned Will apply to Phase 1 only. Assign to "did not have at least 1 valid and determinate immunogenicity result after Dose 1 but before Dose 2" when EXCL3FL="Y" | |
| EXCL4FL | Exclusion Flag 4 | text | 1 | Y
| Derived Will apply to Phase 1 only. if EXCL2FL ne "Y" and INCL4FL="N" then EXCL4FL="Y" |
| EXCRIT4 | Exclusion Criterion 4 | text | 1 | Assigned Will apply to Phase 1 only. Assign to "did not have at least 1 valid and determinate immunogenicity result 21 days after Dose 1" when EXCL4FL="Y" | |
| EXCL5FL | Exclusion Flag 5 | text | 1 | Y
| Derived Will apply to Phase 1 only. if EXCL2FL ne "Y" and INCL5FL="N" then EXCL5FL="Y" |
| EXCRIT5 | Exclusion Criterion 5 | text | 1 | Assigned Will apply to Phase 1 only. Assign to "did not have blood collection within 19-23 days after Dose 1" when EXCL5FL="Y" | |
| EXCL6FL | Exclusion Flag 6 | text | 1 | Y
| Derived if INCL6FL="N" then EXCL6FL="Y" |
| EXCRIT6 | Exclusion Criterion 6 | text | 149 | Assigned Assign to "had important protocol deviation(s) as determined by the clinician for XXX population(s)" when EXCL6FL="Y" as specified in SUPPDV. POP1=Safety, POP2=Efficacy (within 7 days post Dose 2) if pd start date is before vax102dt +7, POP2=Efficacy (between 7-14 days post Dose 2) if pd start date is on or after vax102dt +7 but before vax102dt+14, POP2=Efficacy (between 14 days - 1 month post Dose 2) if pd start date is on or after vax102dt +14 but before visit 3 date, POP3=Immunogenicity. For visit 3 date, it will be obtained from non-missing BLDV6DT or derived from SV.SVSTDTC from visit 7 after second dose for phase 1 and from visit 3 for phase 2/3 if BLDV6DT is missing. Note: not populated for subjects missing BLDV6DT/SV.V3 | |
| RSEXSAF | Reason for Exclusion from Safety Pop | text | 43 | Derived DV.DVTERM where SUPPDV.QNAM.CAPE contain 'POP5' then RSEXSAF="Unreliable data due to lack of PI oversight"; else if only 'POP1' then RSEXSAF="Did not provide informed consent"; | |
| EXCL7FL | Exclusion Flag 7 | text | 1 | Y
| Derived if EXCL2FL ne "Y" and INCL7FL="N" then EXCL7FL="Y" |
| EXCRIT7 | Exclusion Criterion 7 | text | 129 | Assigned Assign to "did not receive all vaccination(s) as randomized or did not receive Dose 2 within the predefined window (19-42 days after Dose 1)" when EXCL7FL="Y" | |
| EXCL8FL | Exclusion Flag 8 | text | 1 | Y
| Derived if VAX102DT ne . and INCL8FL="N" then EXCL8FL="Y" |
| EXCRIT8 | Exclusion Criterion 8 | text | 80 | Assigned Assign to "did not have at least 1 valid and determinate immunogenicity result after Dose 2" when EXCL8FL="Y" | |
| EXCL9FL | Exclusion Flag 9 | text | 1 | Y
| Derived if VAX102DT ne . and EXCL2FL ne "Y" and INCL9FL="N" then EXCL9FL="Y" |
| EXCRIT9 | Exclusion Criterion 9 | text | 60 | Assigned Assign to "did not have blood collection within 6-8 days after Dose 2" for Phase 1 when EXCL9FL="Y"; assign to "did not have blood collection within 28-42 days after Dose 2" for Phase 2/3 when EXCL9FL="Y" | |
| EXCL10FL | Exclusion Flag 10 | text | 1 | Y
| Derived "Y" if INCL10FL="N" |
| EXCRIT10 | Exclusion Criterion 10 | text | 73 | Derived for INCL10FL="N" and vax102dt not missing:
assign to "unblinded prior to 7 days post Dose 2" for UNBLNDDT<VAX102DT+7;
assign to "unblinded on or after 7 days but prior to 14 days post Dose 2" for VAX102DT+7<=UNBLNDDT<VAX102DT+14;
assign to "unblinded on or after 14 days but no later than 1 month post Dose 2 visit" for VAX102DT+14<=UNBLNDDT<=V3 date; | |
| EVAL01FL | Dose 1 evaluable Immun Popu Flag | text | 1 | No Yes Response
| Derived Will apply to Phase 1 only. If INCL1fl="Y" and INCL2fl="Y" and INCL4fl="Y" and INCL5fl="Y" and (index(SUPPDV.QNAM.CAPE, "POP3")=0 for subjects's all DV records) then EVAL01FL="Y"; else EVAL01FL="N"; |
| EVAL02FL | Dose 2 evaluable Immun Popu Flag | text | 1 | No Yes Response
| Derived If INCL1fl="Y" and INCL2fl="Y" and (INCL7fl="Y" and vax10udt=.) and INCL8fl="Y" and INCL9fl="Y" and (index(SUPPDV.QNAM.CAPE, "POP3")=0 for subjects's all DV records) then EVAL02FL="Y"; else EVAL02FL="N"; |
| AAI01FL | Dose 1 all-available Immun Popu Flag | text | 1 | No Yes Response
| Derived Will apply to Phase 1 only. If SAFFL="Y" and randfl="Y" and (vax101dt>. or vax102dt>.) and INCL3fl="Y" and not (index(SUPPDV.QNAM.CAPE, "POP3") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI01FL="Y"; else AAI01FL="N"; |
| AAI02FL | Dose 2 all-available Immun Popu Flag | text | 1 | No Yes Response
| Derived If SAFFL="Y" and randfl="Y" and vax102dt>. and INCL8fl="Y" and not ((index(SUPPDV.QNAM.CAPE, "POP3") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI02FL="Y"; else AAI02FL="N"; |
| EVALEFFL | Evaluable Efficacy Popu Flag | text | 1 | No Yes Response
| Derived If SAFFL="Y" and RFICDT>. and RANDFL="Y" and ARM ne "SCREEN FAILURE" and INCL1FL="Y" and INCL2fl="Y" and (INCL7fl="Y" and (vax10udt=. or (vax10udt>vax102dt>. and vax10udt>=vax102dt+7))) and VAX102DT>. and (UNBLNDDT=. or (UNBLNDDT>=vax102dt+7>.)) and (index(SUPPDV.QNAM.CAPE, "POP2")=0 for subjects's all DV records or any records with DV date 7 days after Dose 2 and index(SUPPDV.QNAM.CAPE, "POP2")>0 ) and (index(SUPPDV.QNAM.CAPE, "POP3")=0 and index(SUPPDV.QNAM.CAPE, "POP5")=0 for subjects's all DV records)then EVALEFFL="Y"; else EVALEFFL="N"; |
| AAI1EFFL | Dose 1 all-available Efficacy Popu Flag | text | 1 | No Yes Response
| Derived If SAFFL="Y" and randfl="Y" and (vax101dt>. or vax102dt>.) and not((index(SUPPDV.QNAM.CAPE, "POP2") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI1EFFL="Y"; else AAI1EFFL="N"; |
| AAI2EFFL | Dose 2 all-available Efficacy Popu Flag | text | 1 | No Yes Response
| Derived If SAFFL="Y" and randfl="Y" and vax101dt>. and vax102dt>. and (UNBLNDDT=. or (UNBLNDDT>=vax102dt+7>.)) and not((index(SUPPDV.QNAM.CAPE, "POP2") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI2EFFL="Y"; else AAI2EFFL="N"; |
| SCREEN | Screening | text | 1 | Y
| Derived If RFICDT ne . then SCREEN='Y'; |
| DS3KFL | Phase 3 3000 Subjects Flag | text | 1 | No Yes Response
| Derived "Y" for phase 2/3 subjects had follow up 168 days after Dose 2 at the point of EOS or data cutoff and reiceved 2 planned doses of BNT162b2; else "N". |
| DS30KFL | Phase 3 30k Subjects Flag | text | 1 | No Yes Response
| Derived "Y" for non-phase 1 subjects that are randomized on or before 9Oct2020 and obtained IC on or after 27Jul2020. |
| OPBOUFL | Subjects Received Placebo & unblinded | text | 1 | No Yes Response
| Derived “Y” if (tr02sdt>. or UNBLNDDT>.) and actarm in ("Placebo"); else "N" |
| JPNFL | Japanese Subject Flag | text | 1 | No Yes Response
| Derived "Y" if SUPPDM.QNAM = 'RACIALD' and SUPPDM.QVAL = 'JAPANESE' |
| MULENRFL | Multiply Enrolled Subjects | text | 1 | Y
| Derived "Y" for subjects that were multiply enrolled subjests. |
| PEDREAFL | Phase 2/3 Pop for 12-25 Reacto Subset | text | 1 | No Yes Response
| Derived if reactofl="Y" and phasen ne 1 and agegr4n in (1 2) then PEDREAFL="Y"; |
| PEDIMMFL | Pop for Non-inferiority Assessement | text | 1 | No Yes Response
| Derived PEDIMMFL was derived from an external excel file: c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsx (there are 660 subjects in total who are based on an random selection of 280 active+50 placebo from each of the age groups). |
| HIVFL | HIV Positive Subjects Flag | text | 1 | No Yes Response
| Derived "Y" if subject with HIV positive, subjects with HIV were determined by their medical history, HIV related term were defined in an external file: 201114-hiv-preferred-terms.xlsx |
| EV1MD2FL | Subject without Evidence 1MPD2 | text | 1 | No Yes Response
| Derived Subjects will be set to “N” if any of the following conditions are met:
•N-Binding is POS at visit 3.
•Convalescent visit with POS result in the absence of visit 3 and is within 28-42 days PD2.
•Convalescent N-Binding result is POS and is before Visit 3 date or up to 7 days after Visit 3 date.
•Subjects without symptoms and have unscheduled POS swab results within 1MPD2 .
•Subjects with POS swab results at Dose 1/Dose 2 or POS for N-Binding at Dose 1.
•Subjects with presence of symptoms on or after Dose 1 and within 1MPD2 that are without valid NEG swab results.
Else "Y". |
| BDCSRDT | Double Blinded Follow-up Censor Date | integer | DATE9 | Derived if randfl="Y" then do;
if (tr02sdt>. or UNBLNDDT>. ) and boostfl ne "Y" then do;
if .<tr02sdt-1<"&cutoff2"d then BDCSRDT=tr02sdt-1;
else BDCSRDT="&cutoff2"d;
if .<UNBLNDDT-1<=BDCSRDT then BDCSRDT=UNBLNDDT-1;
end;
else do;
if .<UNBLNDDT-1<="&cutoff2"d then BDCSRDT=UNBLNDDT-1;
else BDCSRDT="&cutoff2"d;
if .<eosdcdt<=BDCSRDT then BDCSRDT=eosdcdt;
end;
end;
Note: &cutoff2 will be the data cutoff date which specified in the table footnote. | |
| X1CSRDT | Crossover Dose1 Censor Date | integer | DATE9 | Derived X1CSRDT=min(eosdcdt, "&cutoff2"d) for subjects with ranfl="Y" and non-missing tr02sdt or non-missing UNBLNDDT and boostfl ne "Y" | |
| STCSRDT | Study Censor Date | integer | DATE9 | Derived STCSRDT=min(eosdcdt, "&cutoff2"d) for subjects with ranfl="Y" | |
| FUP2CUT | PD2 FU Time in Days: to Cutoff | integer | 8 | Derived if randfl="Y" then do;
if vax102dt=. then FUP2CUT=0;
else if not missing(eosdcdt) then do;
FUP2CUT=eosdcdt-vax102dt+1;
if vax10udt>. then FUP2CUT=eosdcdt-vax10udt+1;
end;
else do;
FUP2CUT="&cutoff2"d-vax102dt+1;
if vax10udt>. then FUP2CUT="&cutoff2"d-vax10udt+1;
end;
end; | |
| FUP2UNB | PD2 FU Time in Days: to Unblinding | integer | 8 | Derived if randfl="Y" then do;
if vax102dt=. then FUP2UNB=0;
else if not missing(BDCSRDT) then do;
FUP2UNB=BDCSRDT-vax102dt+1;
if vax10udt>. then FUP2UNB=BDCSRDT-vax10udt+1;
end;
end; | |
| FPX1CUT | Post Xover D1 FUTM in Days: to Cutoff | integer | 8 | Derived if (UNBLNDDT>. or tr02sdt>. ) and boostfl ne "Y" then do;
if tr02sdt=. then FPX1CUT=0;
else if not missing(eosdcdt) and eosdcdt>=tr02sdt then FPX1CUT=eosdcdt-tr02sdt+1;
else FPX1CUT="&cutoff2"d-tr02sdt+1;
end;
Note: only populate for subjects unblinded or received cross over doses | |
| FUNBCUT | Unblinding FUTM in Days: to Cutoff | integer | 8 | Derived if (UNBLNDDT>. or tr02sdt>. ) and boostfl ne "Y" then do;
if UNBLNDDT=. then FUNBCUT=0;
else if not missing(eosdcdt) then FUNBCUT=eosdcdt-UNBLNDDT+1;
else FUNBCUT="&cutoff2"d-UNBLNDDT+1;
end; | |
| FUP1CUT | PD1 FU Time in Days: to Cutoff | integer | 8 | Derived if randfl="Y" then do;
if vax101dt=. then FUP1CUT=0;
else if not missing(eosdcdt) then FUP1CUT=eosdcdt-vax101dt+1;
else FUP1CUT="&cutoff2"d-vax101dt+1;
end; | |
| FUP1UNB | PD1 FU Time in Days: to Unblinding | integer | 8 | Derived if randfl="Y" then do;
if vax101dt=. then FUP1UNB=0;
else if not missing(BDCSRDT) then FUP1UNB=BDCSRDT-vax101dt+1;
end; | |
| FUP2CAT1 | PD2 FU Time Cat 1: to Cutoff | text | 12 | FUP2CAT1 [11 Terms] | Derived "0-1 Month" for FUP2CA1N=1;
"1-2 Months" for FUP2CA1N=2;
"2-3 Months" for FUP2CA1N=3;
"3-4 Months" for FUP2CA1N=4;
etc. |
| FUP2CA1N | PD2 FU Time Cat 1 (N): to Cutoff | integer | 8 | FUP2CA1N [11 Terms] | Derived 1 for 0<=FUP2CUT/28<1;
2 for 1<=FUP2CUT/28<2;
3 for 2<=FUP2CUT/28<3;
4 for 3<=FUP2CUT/28<4;
etc. |
| FUP2CAT2 | PD2 FU Time Cat 2: to Unblinding | text | 11 | FUP2CAT2 [10 Terms] | Derived "0-1 Month" for FUP2CA2N=1;
"1-2 Months" for FUP2CA2N=2;
"2-3 Months" for FUP2CA2N=3;
"3-4 Months" for FUP2CA2N=4;
etc. |
| FUP2CA2N | PD2 FU Time Cat 2 (N): to Unblinding | integer | 8 | FUP2CA2N [10 Terms] | Derived 1 for 0<=FUP2UNB/28<1;
2 for 1<=FUP2UNB/28<2;
3 for 2<=FUP2UNB/28<3;
4 for 3<=FUP2UNB/28<4;
etc." |
| FPX1CAT1 | Post Xover D1 FUTM Cat 1: to Cutoff | text | 10 | FPX1CAT1
| Derived "0-1 Month" for FPX1CA1N=1;
"1-2 Months" for FPX1CA1N=2;
"2-3 Months" for FPX1CA1N=3;
"3-4 Months" for FPX1CA1N=4;
etc. |
| FPX1CA1N | Post Xover D1 FUTM Cat 1 (N): to Cutoff | integer | 8 | FPX1CA1N
| Derived 1 for 0<=FPX1CUT/28<1;
2 for 1<=FPX1CUT/28<2;
3 for 2<=FPX1CUT/28<3;
4 for 3<=FPX1CUT/28<4;
etc. |
| FUP1CAT1 | PD1 FU Time Cat 1: to Cutoff | text | 12 | FUP1CAT1 [12 Terms] | Derived "0-1 Month" for FUP1CA1N=1;
"1-2 Months" for FUP1CA1N=2;
"2-3 Months" for FUP1CA1N=3;
"3-4 Months" for FUP1CA1N=4;
etc. |
| FUP1CA1N | PD1 FU Time Cat 1 (N): to Cutoff | integer | 8 | FUP1CA1N [12 Terms] | Derived 1 for 0<=FUP1CUT/28<1;
2 for 1<=FUP1CUT/28<2;
3 for 2<=FUP1CUT/28<3;
4 for 3<=FUP1CUT/28<4;
etc. |
| RNACAT | HIV RNA Category | text | 4 | RNACAT
| Derived Derived numeric value from LB.LBORRES where LB.LBTESTCD="HIVR_US". Assigned as "<50" if subject's LBORRES does not contain any numeric value and not equal to positive. If derived numeric value is less than 50 then assigned as "<50"; if derived numeric value is equal to or greater than 50 then assigned as ">=50". |
| RNACATN | HIV RNA Category (N) | integer | 8 | RNACATN
| Derived 1="<50"
2=">=50" |
| CD4CAT | CD4 Category for HIV-positive | text | 7 | CD4CAT
| Derived if .<LB.LBSTRESN*1000<200 then assigned as "<200"; else if 200<=LB.LBSTRESN*1000<=500 then assigned as "200-500"; else if LB.LBSTRESN*1000>500 then assigned as ">500"; where LB.LBTESTCD="CD4" and LBSTRESU="10^9/L" and LB.LBSTAT ne "NOT DONE" and index(visit, "V1_DAY1_VAX1") and LBDY<=1 |
| CD4CATN | CD4 Category for HIV-positive (N) | integer | 8 | CD4CATN
| Derived 1="<200"
2="200-500"
3=">500" |
| SAF1FL | Safety - excld Multi-Enrolloer&HIV&IND | text | 1 | No Yes Response
| Derived if SAFFL="Y" and MULENRFL^="Y" and HIVFL^="Y" and trt01a ne "" then SAF1FL="Y"; else SAF1FL="N"; |
| SAF2FL | Safety - exclude Multi-Enrolloer&IND | text | 1 | No Yes Response
| Derived if SAFFL="Y" and MULENRFL^="Y" and trt01a ne "" then SAF2FL="Y"; else SAF2FL="N"; |
| RAND1FL | Random - exclude Multi-Enrolloer | text | 1 | No Yes Response
| Derived if RANDFL="Y" and MULENRFL^="Y" and then RAND1FL="Y"; else RAND1FL="N"; |
Go to the top of the Define-XML document
Covid-19 Efficacy Analysis (ADC19EF)
| Variable | Where Condition | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: ADSL.STUDYID | ||
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: ADSL.USUBJID | ||
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | ||
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | ||
| BRTHDT | Date of Birth | integer | DATE9 | Predecessor: ADSL.BRTHDT | ||
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Numeric Code of Pooled Age Group 1
| Predecessor: ADSL.AGEGR1N | |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 | |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
| RACE | Race | text | 41 | Race [7 Terms] | Predecessor: ADSL.RACE | |
| ETHNIC | Ethnicity | text | 22 | Ethnic Group
| Predecessor: ADSL.ETHNIC | |
| ARMCD | Planned Arm Code | text | 9 | Planned Arm Code [11 Terms] | Predecessor: ADSL.ARMCD | |
| ARM | Description of Planned Arm | text | 27 | Description of Planned Arm [11 Terms] | Predecessor: ADSL.ARM | |
| ACTARMCD | Actual Arm Code | text | 9 | Actual Arm Code [12 Terms] | Predecessor: ADSL.ACTARMCD | |
| ACTARM | Description of Actual Arm | text | 27 | Description of Actual Arm [12 Terms] | Predecessor: ADSL.ACTARM | |
| PARAMN | Parameter (N) | integer | 8 | ADC19EF.PARAMN [63 Terms] | Assigned Numeric code for PARAM Please refer to codelist ADC19EF.PARAMN. | |
| PARAMCD | Parameter Code | text | 8 | ADC19EF.PARAMCD [63 Terms] | Assigned Character code for PARAM Please refer to codelist ADC19EF.PARAMCD. Algorithm for picking params/records only upto UNBLNDDT as below: If protocol-defined and CDC-defined symptoms start after unblinding date (ADSL.UNBLNDDT), then all records for that illness visit (unscheduled) are dropped. For protocol-defined and CDC-defined symptoms that start on/before UNBLNDDT: 1. Keep records even if lab results, severe symptoms, collapsed visit symptoms within that illness visit goes beyond UNBLNDDT. 2. Any scheduled visits (non-illness) with ADT/ASTDT after UNBLNDDT are dropped. | |
| PARAM | Parameter | text | 109 | ADC19EF.PARAM [63 Terms] | Derived if PARAMCD in ("C19NIG" "HCUHSP" "RTCOV2NS" "HCUICU" "SARSCOV2" "PRCDTH" "SECDTH") then set to ADSYMPT.PARAM
if PARAMCD= “DTHODC19” then set to “DEATH OCCURRED DUE TO COVID-19 ILLNESS?”
if PARAMCD= “PRPDSAD” then set to “PRESENCE OF PROTOCOL DEFINED SYMPTOMS AFTER DOSE”
if paramcd= “PRCDCSAD” then set to “PRESENCE OF CDC DEFINED SYMPTOMS AFTER DOSE”
if paramcd= “SEVCVS” then set to “SEVERE COVID-19 SYMPTOMS - VITAL SIGNS”
if paramcd=”SEVCRF” then set to “SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE”
if paramcd= “SEVCVSPR” then set to “SEVERE COVID-19 SYMPTOMS - USE OF VASOPRESSORS”
if paramcd= “SEVCRHN” then set to “SEVERE COVID-19 SYMPTOMS - SIGNIFICANT ACUTE RENAL, HEPATIC, OR NEUROLOGIC DYSFUNCTION”
if paramcd = “PRSVCSAD” then set to “PRESENCE OF PROTOCOL DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE”
if paramcd=”PRSCDCAD” then set to “PRESENCE OF CDC DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE”
if paramcd=”NAATRAD” then set to “COVID-19 NAAT RESULT AFTER DOSE”
if paramcd = “C19ONST” then set to “PROTOCOL DEFINED COVID-19 ILLNESS ONSET”
if paramcd = “CDCONST” then set to “CDC DEFINED COVID-19 ILLNESS ONSET”
if paramcd = “SEVCONST” then set to “PROTOCOL DEFINED SEVERE COVID-19 ILLNESS ONSET”
if paramcd = “CDCSONST” then set to “CDC DEFINED SEVERE COVID-19 ILLNESS ONSET”
if paramcd = ”ST1PD” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS”
if paramcd=“ST17PD” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS”
if paramcd=“ST2PD” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS”
if paramcd=“ST27PD” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS”
if paramcd=“ST214PD” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS”
if paramcd=“ST1CD” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS”
if paramcd=“ST17CD” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS”
if paramcd=“ST2CD” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS”
if paramcd=“ST27CD” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS”
if paramcd=“ST214CD” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS”
if paramcd=“ST1SE” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“ST17SE” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“ST2SE” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“ST27SE” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“ST214SE” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“STC1SE” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“STC17SE” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“STC2SE” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“STC27SE” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“STC214SE” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“ST1PDA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST17PDA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST2PDA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST27PDA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST214PDA” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST1CDA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST17CDA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST2CDA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST27CDA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST214CDA” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST1SEA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST17SEA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST2SEA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST27SEA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST214SEA” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“STC1SA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“STC17SA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“STC2SA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“STC27SA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“STC214SA” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST1PDX” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS – CROSSOVER”
if paramcd=“STC1SX” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS – CROSSOVER” | |
| PARCAT1 | Parameter Category 1 | text | 44 | ADC19EF.PARCAT1 [15 Terms] | Derived if index (PARAM, "SURVEILLANCE")>0 then set to "SURVEILLANCE TIME".
if PARAMCD in ("C19NIG" "RTCOV2NS" "SARSCOV2" "PRCDTH" "SECDTH" “PRPDSAD” “PRCDCSAD” “SEVCRF” “SEVCVSPR” “SEVCRHN”) then set to ADSYMPT.PARCAT1
if paramcd in (”HCUHSP” “HCUICU”) then set to “HOSPITALIZATION STATUS”
if paramcd = “DTHODC19” then set to "DEATH STATUS".
If paramcd = “PRSVCSAD” then set to "SEVERE COVID-19 SYMPTOMS".
If paramcd=”PRSCDCAD”“ then Set to "SEVERE COVID-19 SYMPTOMS".
If paramcd=”NAATRAD” then Set to "CENTRAL/LOCAL NAAT RESULTS".
If paramcd=”C19ONST” then Set to "ILLNESS ONSET".
If paramcd=“CDCONST” then Set to "ILLNESS ONSET".
If paramcd=”SEVCONST” then Set to "ILLNESS ONSET".
If paramcd=”CDCSONST” then Set to "ILLNESS ONSET". | |
| AVALVLM | Analysis Value | integer | 8 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST1PD" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST17PD" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST2PD" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST27PD" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST214PD" (SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST1CD" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST17CD" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST2CD" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST27CD" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST214CD" (SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST1SE" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST17SE" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST2SE" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST27SE" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST214SE" (SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "STC1SE" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "STC17SE" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "STC2SE" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "STC27SE" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "STC214SE" (SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST1PDA" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST17PDA" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST2PDA" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST27PDA" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST214PDA" (SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST1CDA" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST17CDA" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST2CDA" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST27CDA" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST214CDA" (SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST1SEA" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST17SEA" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST2SEA" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST27SEA" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST214SEA" (SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "STC1SA" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "STC17SA" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "STC2SA" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "STC27SA" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "STC214SA" (SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "ST1PDX" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - CROSSOVER) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - CROSSOVER | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| PARAMCD = "STC1SX" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - CROSSOVER) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - CROSSOVER | integer | 3 | Derived if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null | ||
| AVALCVLM | Analysis Value (C) | text | 37 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "RTCOV2NS" (CEPHEID RT-PCR ASSAY FOR SARS-COV-2) | CEPHEID RT-PCR ASSAY FOR SARS-COV-2 | text | 3 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "C19NIG" (N-BINDING ANTIBODY) | N-BINDING ANTIBODY | text | 3 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "PRPDSAD" (PRESENCE OF PROTOCOL DEFINED SYMPTOMS AFTER DOSE) | PRESENCE OF PROTOCOL DEFINED SYMPTOMS AFTER DOSE | text | 1 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "PRCDCSAD" (PRESENCE OF CDC DEFINED SYMPTOMS AFTER DOSE) | PRESENCE OF CDC DEFINED SYMPTOMS AFTER DOSE | text | 1 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "C19ONST" (PROTOCOL DEFINED COVID-19 ILLNESS ONSET) | PROTOCOL DEFINED COVID-19 ILLNESS ONSET | text | 3 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "CDCONST" (CDC DEFINED COVID-19 ILLNESS ONSET) | CDC DEFINED COVID-19 ILLNESS ONSET | text | 3 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "SARSCOV2" (SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2) | SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 | text | 3 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "NAATRAD" (COVID-19 NAAT RESULT AFTER DOSE) | COVID-19 NAAT RESULT AFTER DOSE | text | 3 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "HCUHSP" (HOSPITALIZED DUE TO COVID-19 ILLNESS?) | HOSPITALIZED DUE TO COVID-19 ILLNESS? | text | 1 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "PRSCDCAD" (PRESENCE OF CDC DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE) | PRESENCE OF CDC DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE | text | 1 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "CDCSONST" (CDC DEFINED SEVERE COVID-19 ILLNESS ONSET) | CDC DEFINED SEVERE COVID-19 ILLNESS ONSET | text | 3 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "SEVCVS" (SEVERE COVID-19 SYMPTOMS - VITAL SIGNS) | SEVERE COVID-19 SYMPTOMS - VITAL SIGNS | text | 1 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "PRSVCSAD" (PRESENCE OF PROTOCOL DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE) | PRESENCE OF PROTOCOL DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE | text | 1 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "SEVCONST" (PROTOCOL DEFINED SEVERE COVID-19 ILLNESS ONSET) | PROTOCOL DEFINED SEVERE COVID-19 ILLNESS ONSET | text | 3 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "HCUICU" (SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS) | SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS | text | 1 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "SEVCRF" (SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE) | SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE | text | 1 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "PRCDTH" (PRIMARY CAUSE OF DEATH) | PRIMARY CAUSE OF DEATH | text | 37 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "DTHODC19" (DEATH OCCURRED DUE TO COVID-19 ILLNESS?) | DEATH OCCURRED DUE TO COVID-19 ILLNESS? | text | 1 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "SECDTH" (SECONDARY CAUSE OF DEATH) | SECONDARY CAUSE OF DEATH | text | 27 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "SEVCRHN" (SEVERE COVID-19 SYMPTOMS - SIGNIFICANT ACUTE RENAL, HEPATIC, OR NEUROLOGIC DYSFUNCTION) | SEVERE COVID-19 SYMPTOMS - SIGNIFICANT ACUTE RENAL, HEPATIC, OR NEUROLOGIC DYSFUNCTION | text | 1 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| PARAMCD = "SEVCVSPR" (SEVERE COVID-19 SYMPTOMS - USE OF VASOPRESSORS) | SEVERE COVID-19 SYMPTOMS - USE OF VASOPRESSORS | text | 1 | Derived if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. | ||
| VISITNUM | Visit Number | integer | 8 | Predecessor: ADSYMPT.VISITNUM from ADSYMPT.VISITNUM for all records except for derived records for surveillance time. | ||
| VISIT | Visit Name | text | 20 | Predecessor: ADSYMPT.VISIT from ADSYMPT.VISIT for all records except for derived records for surveillance time. | ||
| AVISITN | Analysis Visit (N) | integer | 8 | ADC19EF.AVISITN [13 Terms] | Derived 1. Set to ADSYMPT.AVISITN for all other parameters except for derived records for surveillance time.
2. For PARAMCD="DTHODC19", the AVISITN is populated if death occurred after an illness visit. This last illness visit AVISITN is assigned to the record.
3. If derived parameters for surveillance time, the set to null. | |
| AVISIT | Analysis Visit | text | 20 | ADC19EF.AVISIT [13 Terms] | Derived 1. Set to ADSYMPT.AVISIT for all other parameters except for derived records for surveillance time.
2. For PARAMCD="DTHODC19", the AVISIT is populated if death occurred after an illness visit. This last illness visit AVISIT is assigned to the record.
3. If derived parameters for surveillance time, the set to null. | |
| ADT | Analysis Date | integer | DATE9 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "PRCDTH" "SECDTH" ) then set to ADSYMPT.ADT
if paramcd = "SEVCVS" then set to the earliest date from ADSYMPT.ADT when condition/s are present.
if paramcd = "NAATRAD" then set from ADSYMPT.ADT of concluded NAAT result based on specifications in AVALC of this record.
If both local and central results are missing/invalid, set this to null.
if paramcd = "C19ONST" then set to ASTDT where PARAMCD = "PRPDSAD"
if paramcd = "CDCONST" then set to ASTDT where PARAMCD = "PRCDCSAD"
if paramcd = "SEVCONST" then set to ASTDT where PARAMCD = "PRSVCSAD"
if paramcd = "CDCSONST" then set to ASTDT where PARAMCD = "PRSCDCAD"
if paramcd="DTHODC19" then set to ADT where PARAMCD is "PRCDTH" or "SECDTH"
if paramcd in ("HCUICU" "HCUHSP" "PRPDSAD” “PRCDCSAD” “SEVCRF” “SEVCVSPR” “SEVCRHN” “PRSVCSAD” “PRSCDCAD” “ST1PD” “ST17PD” “ST2PD” “ST27PD” “ST214PD” “ST1CD” “ST17CD” “ST2CD” “ST27CD” “ST214CD” “ST1SE” “ST17SE” “ST2SE” “ST27SE” “ST214SE” “STC1SE” “STC17SE” “STC2SE” “STC27SE” “STC214SE” “ST1PDA” “ST17PDA” “ST2PDA” “ST27PDA” “ST214PDA” “ST1CDA” “ST17CDA” “ST2CDA” “ST27CDA” “ST214CDA” “ST1SEA” “ST17SEA” “ST2SEA” “ST27SEA” “ST214SEA” “STC1SA” “STC17SA” “STC2SA” “STC27SA” “STC214SA” “ST1PDX” “STC1SX”)
then set to null. | ||
| ADY | Analysis Relative Day | integer | 8 | Derived Set as following:
ADY = ADT - TRTSDT.
If ADT >= TRTSDT, ADY = ADT - TRTSDT + 1. | ||
| ASTDT | Analysis Start Date | integer | DATE9 | Derived if paramcd in ("HCUICU" "HCUHSP") then set to ADSYMPT.ASTDT.
if paramcd in ("PRPDSAD" "PRCDCSAD") then set to the earliest date from ADSYMPT.ASTDT when condition/s are present.
if paramcdin ("SEVCRF" "SEVCRHN" "SEVCVSPR") then set to the earliest date from ADSYMPT.ASTDT when condition/s are present and end dates of all contributing records are reported.
if paramcd in ("PRSVCSAD" "PRSCDCAD") then set to the earliest date from ADT/ASTDT when condition/s are present.
if paramcd in (“ST1PD” “ST1CD” “ST1SE” “STC1SE” “ST1PDA” “ST1CDA” “ST1SEA” “STC1SA” “ST1PDX” “STC1SX” ) then set as Dose 1 when Dose 1 date is not missing.
if paramcd in (“ST17PD” “ST17CD” “ST17SE” “STC17SE” “ST17PDA” “ST17CDA” “ST17SEA” “STC17SA”) then set as Dose 1 + 7 when Dose 1 date is not missing.
if paramcd in (“ST214PD” “ST214CD” “ST214SE” “STC214SE” “ST214PDA” “ST214CDA” “ST214SEA” “STC214SA”) then set as Dose 2 + 14 when Dose 2 date is not missing.
if paramcd in (“ST27PD” “ST27CD” “ST27SE” “STC27SE” “ST27PDA” “ST27CDA” “ST27SEA” “STC27SA” ) then set as Dose 2 + 7 when Dose 2 date is not missing.
if paramcd in (“ST2PD” “ST2CD” “ST2SE” “STC2SE” “ST2PDA” “ST2CDA” “ST2SEA” “STC2SA” ) then set as Dose 2 when Dose 2 date is not missing. | ||
| ASTDY | Analysis Start Relative Day | integer | 8 | Derived Set as following:
ASTDY = ASTDT - TRTSDT.
If ASTDT >= TRTSDT, ASTDY = ASTDT - TRTSDT + 1. | ||
| AENDT | Analysis End Date | integer | DATE9 | Derived if paramcd in ("HCUICU" "HCUHSP") then set to ADSYMPT.AENDT.
if paramcd in ("PRPDSAD" "PRCDCSAD") then set to the latest date from ADSYMPT.AENDT when condition/s are present.
if paramcdin ("SEVCRF" "SEVCRHN" "SEVCVSPR") then set to the latest date from ADSYMPT.AENDT when condition/s are present and end dates of all contributing records are reported.
if paramcd in ("PRSVCSAD" "PRSCDCAD") then set to the latest date from AENDT when condition/s are present and contributing end dates except from vital signs are present/populated.
If there is a death and this record is part of last illness visit, set to date of death.
if paramcd in ("ST1PD" "ST17PD" "ST2PD" "ST27PD" "ST214PD" ) then set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd in ("ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA" "ST1PDX") then set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd in ("ST1CD" "ST17CD" "ST2CD" "ST27CD" "ST214CD" ) then set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "CDCONST".
if paramcd in ("ST1CDA" "ST17CDA" "ST2CDA" "ST27CDA" "ST214CDA") then set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "CDCONST".
if paramcd in ("ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE") then set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "SEVCONST".
if paramcd in ("ST1SEA" "ST17SEA" "ST2SEA" "ST27SEA" "ST214SEA") then set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "SEVCONST".
else if none of the above PARAMCDs, set to null. | ||
| AENDY | Analysis End Relative Day | integer | 8 | Derived Set as following:
AENDY = AENDT - TRTSDT.
If AENDT >= TRTSDT, AENDY = AENDT - TRTSDT + 1. | ||
| DCODT | Data Cutoff Date | integer | DATE9 | Assigned Assign as data cutoff date | ||
| RANDDT | Date of Randomization | integer | DATE9 | Predecessor: ADSL.RANDDT | ||
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | ||
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | ||
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Predecessor: ADSL.VAX101DT | ||
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Predecessor: ADSL.VAX102DT | ||
| DVSTDT | Start Date of Important PD | integer | DATE9 | Predecessor: ADSL.DVSTDT | ||
| UNBLNDDT | Treatment Unblinded Date | integer | DATE9 | Predecessor: ADSL.UNBLNDDT | ||
| DTHDT | Date of Death | integer | DATE9 | Predecessor: ADSL.DTHDT | ||
| EOTDCDT | End Of Treatment Discontinuation Date | integer | DATE9 | Predecessor: ADSL.EOTDCDT | ||
| EOSDCDT | End Of Study Discontinuation Date | integer | DATE9 | Predecessor: ADSL.EOSDCDT | ||
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.RANDFL | |
| EVALEFFL | Evaluable Efficacy Popu Flag | text | 1 | No Yes Response
| Predecessor: ADSL.EVALEFFL | |
| AAI1EFFL | Dose 1 all-available Efficacy Popu Flag | text | 1 | No Yes Response
| Predecessor: ADSL.AAI1EFFL | |
| AAI2EFFL | Dose 2 all-available Efficacy Popu Flag | text | 1 | No Yes Response
| Predecessor: ADSL.AAI2EFFL | |
| DTHFL | Subject Death Flag | text | 1 | Y
| Predecessor: ADSL.DTHFL | |
| C19ILHFL | Prior Covid-19 Illness History Flag | text | 1 | Y
| Predecessor: ADSYMPT.C19ILHFL | |
| CNCRSLFL | Consider Result for Analysis Flag | text | 1 | Y
| Derived Set for records where PARAMCD is "SARSCOV2" or "RTCOV2NS" or "C19NIG" as following:
If only one result is present per PARAMCD within a given visit set to "Y'.
For unplanned results, set "Y" if result date is up to 4 days before, on/after the symptom start date and symptom end date is missing. If the symptom end date is present, the result date must be within 4 days after the end date.
If multiple unplanned results qualify above condition, set to "Y" based on the result as POS > IND > NEG > UNK/missing. | |
| VRBLNGFL | NVA Baseline Result Negative Flag | text | 1 | No Yes Response
| Derived Set for all records of a subject based on following:
If NVA result date is on or before Dose 1 date and AVAC = "NEG" when PARAMCD = "C19NIG", set to "Y".
If NVA result date is on or before Dose 1 date and AVAC = "POS" when PARAMCD = "C19NIG", set to "N".
Otherwise, set to null. | |
| CRD1NGFL | NAAT Result At Dose 1 Negative Flag | text | 1 | No Yes Response
| Derived Set for all records of a subject based on following:
If NAAT result date is on or before Dose 1 date and AVAC = "NEG" when PARAMCD = "RTCOV2NS", set to "Y".
If NAAT result date is on or before Dose 1 date and AVAC = "POS" when PARAMCD = "RTCOV2NS", set to "N".
Otherwise, set to null. | |
| CRD2NGFL | NAAT Result At Dose 2 Negative Flag | text | 1 | No Yes Response
| Derived Set for all records of a subject based on following:
If NAAT result date is on or before Dose 2 date and AVAC = "NEG" when PARAMCD = "RTCOV2NS", set to "Y".
If NAAT result date is on or before Dose 2 date and AVAC = "POS" when PARAMCD = "RTCOV2NS", set to "N".
Otherwise, set to null. | |
| PDSYMFL | Protocol Defined SYMP Present Flag | text | 1 | No Yes Response
| Derived Set for all records of a subject as following:
If a subject has any record with AVALC = "Y" when PARAMCD = "PRPDSAD", set to "Y".
Otherwise set to "N". | |
| PDSDMFL | Protocol Defined SYMP Date Missing Flag | text | 1 | No Yes Response
| Derived Set for all records of a subject as following:
If PDSYMFL = "Y" and symptom start date is missing, set to "Y".
Otherwise set to "N". | |
| CDCSYMFL | CDC Defined SYMP Present Flag | text | 1 | No Yes Response
| Derived Set for all records of a subject as following:
If a subject has any record with AVALC = "Y" when PARAMCD = "PRCDCSAD", set to "Y".
Otherwise set to "N". | |
| SEVSYMFL | Severe Covid PD SYMP Present Flag | text | 1 | No Yes Response
| Derived Set for all records of a subject as following:
If a subject has any record with AVALC = "Y" when PARAMCD = "PRSVCSAD", set to "Y".
Otherwise set to "N". | |
| SEVCDCFL | Severe Covid CDC SYMP Present Flag | text | 1 | No Yes Response
| Derived Set for all records of a subject as following:
If a subject has any record with AVALC = "Y" when PARAMCD = "PRSCDCAD", set to "Y".
Otherwise set to "N". | |
| ILD1FL | Illness Occur After Dose 1 Flag | text | 1 | No Yes Response
| Derived Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" and AVALC is "POS" as following:
If illness onset date is greater then Dose 1 date, set to "Y". Otherwise set to "N". | |
| ILD17FL | Illness Occur 7 Days After Dose 1 Flag | text | 1 | No Yes Response
| Derived Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" and AVALC is "POS" as following:
If illness onset date is greater then 7 days post Dose 1 date, set to "Y". Otherwise set to "N". | |
| ILD2FL | Illness Occur After Dose 2 Flag | text | 1 | No Yes Response
| Derived Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" and AVALC is "POS" as following:
If illness onset date is greater then Dose 2 date, set to "Y". Otherwise set to "N". | |
| ILD27FL | Illness Occur 7 Days After Dose 2 Flag | text | 1 | No Yes Response
| Derived Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" and AVALC is "POS" as following:
If illness onset date is greater then 7 days post Dose 2 date, set to "Y". Otherwise set to "N". | |
| ILD214FL | Illness Occur 14 Days After Dose 2 Flag | text | 1 | No Yes Response
| Derived Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" and AVALC is "POS" as following:
If illness onset date is greater then 14 days post Dose 2 date, set to "Y". Otherwise set to "N". | |
| FILOCRFL | First Illness Occurrence Flag | text | 1 | Y
| Derived Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" as following:
if AVALC = "POS" and is the first onset of illness after dose, set to "Y". | |
| PDRMUFL | PD SYMP Result Missing or Unknown Flag | text | 1 | No Yes Response
| Derived Set to "Y" for all records of a subject, if protocol defined symptom/s are present and test result from local and/or central lab concluded as indeterminate, missing or unknown and symptom/s start date is before a first positive(PARAMCD is "C19ONST") case.
Otherwise set to "N" for all records of a subject. Also set as "N" for subjects who did not report any protocol defined symptoms.
Note: If a subject has reported these symptom/s more than once at different visits, set to "Y" if any of the test results are concluded as indeterminate, missing or unknown. | |
| PDRMUPFL | PD SYMP Rslt Miss/UNK With POS Rslt Flag | text | 1 | No Yes Response
| Derived Set to "Y" for all records of a subject, if protocol defined symptom/s are present and test result from local and/or central lab concluded as indeterminate, missing or unknown and not followed by a confirmed positive case where PARAMCD is "C19ONST".
Otherwise set to "N" for all records of a subject. Also set as "N" for subjects who did not report any protocol defined symptoms.
Note: If a subject has reported these symptom/s more than once at different visits, set to "Y" if any of the test results are concluded as indeterminate, missing or unknown. | |
| CDCRMUFL | CDC SYMP Result Missing or Unknown Flag | text | 1 | No Yes Response
| Derived Set to "Y" for all records of a subject, if CDC defined symptom/s are present and test result from local and/or central lab concluded as indeterminate, missing or unknown and symptom/s start date is before a first positive(PARAMCD is "CDCONST") case.
Otherwise set to "N" for all records of a subject. Also set to "N" for subjects who did not report any CDC defined symptoms.
Note: If a subject has reported these symptom/s more than once at different visits, set to "Y" if any of the test results are concluded as indeterminate, missing or unknown. | |
| CDRMUPFL | CD SYMP Rslt Miss/UNK With POS Rslt Flag | text | 1 | No Yes Response
| Derived Set to "Y" for all records of a subject, if CDC defined symptom/s are present and test result from local and/or central lab concluded as indeterminate, missing or unknown and not followed by a confirmed positive case where PARAMCD is "CDCONST".
Otherwise set to "N" for all records of a subject. Also set to "N" for subjects who did not report any CDC defined symptoms.
Note: If a subject has reported these symptom/s more than once at different visits, set to "Y" if any of the test results are concluded as indeterminate, missing or unknown. | |
| PDP1FL | VE Prot Def Pop Incl Post D1 Flag | text | 1 | No Yes Response
| Derived Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date.
2. Otherwise set to "N".
If subject reports protocol define symptoms and/or has , the following condition/s may overwrite the previous value.
3. If there is an unscheduled NAAT test on or before Dose 1 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptoms and start date of symptom is missing, on or after Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. | |
| PDP17FL | VE Prot Def Pop Incl 7D Post D1 Flag | text | 1 | No Yes Response
| Derived Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date.
2. Otherwise set to "N".
If subject reports protocol define symptoms, the following condition/s may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 1 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptom and start date of symptom is missing, on or after Dose 1 and within 7 days post Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. | |
| PDP27FL | VE Prot Def Pop Incl 7D Post D2 Flag | text | 1 | No Yes Response
| Derived Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates.
2. Otherwise set to "N".
If subject reports protocol define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 2 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptom and start date of symptom is missing, on or after Dose 1 and within 7 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. | |
| PDP214FL | VE Prot Def Pop Incl 14D Post D2 Flag | text | 1 | No Yes Response
| Derived Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates.
2. Otherwise set to "N".
If subject reports protocol define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 14 days after Dose 2 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptom and start date of symptom is missing, on or after Dose 1 and within 14 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. | |
| CDP1FL | VE CDC Def Pop Incl Post Dose 1 Flag | text | 1 | No Yes Response
| Derived Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date.
2. Otherwise set to "N".
If subject reports CDC define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. | |
| CDP17FL | VE CDC Def Pop Incl 7D Post Dose 1 Flag | text | 1 | No Yes Response
| Derived Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date.
2. Otherwise set to "N".
If subject reports CDC define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 1 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and within 7 days post Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. | |
| CDP27FL | VE CDC Def Pop Incl 7D Post Dose 2 Flag | text | 1 | No Yes Response
| Derived Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates.
2. Otherwise set to "N".
If subject reports CDC define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 2 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and within 7 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. | |
| CDP214FL | VE CDC Def Pop Incl 14D Post Dose 2 Flag | text | 1 | No Yes Response
| Derived Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates.
2. Otherwise set to "N".
If subject reports CDC define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 14 days after Dose 2 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and within 14 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. | |
| NMPDOCFL | No Major Protocol Deviation Occur Flag | text | 1 | Y
| Derived Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" as following:
if DVSTDT is null, set to "Y".
Also set to "Y" if DVSTDT occurs after the ADT of PARAMCDs specified above. |
Go to the top of the Define-XML document
Diary and Non-event Analysis Dataset (ADFACEVD)
| Variable | Where Condition | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: FACE.STUDYID or VS.STUDYID | ||
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: FACE.USUBJID or VS.USUBJID | ||
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | ||
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | ||
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | ||
| AGEU | Age Units | text | 5 | Age Unit
| Predecessor: ADSL.AGEU | |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
| SEXN | Sex (N) | integer | 8 | Numeric Code of Sex
| Predecessor: ADSL.SEXN | |
| RACE | Race | text | 41 | Race [7 Terms] | Predecessor: ADSL.RACE | |
| RACEN | Race (N) | integer | 8 | Numeric Code of Race [7 Terms] | Predecessor: ADSL.RACEN | |
| ARACE | Analysis Race | text | 41 | Analysis Race [7 Terms] | Predecessor: ADSL.ARACE | |
| ARACEN | Analysis Race (N) | integer | 8 | Numeric Code of Analysis Race [7 Terms] | Predecessor: ADSL.ARACEN | |
| ETHNIC | Ethnicity | text | 22 | Ethnic Group
| Predecessor: ADSL.ETHNIC | |
| ETHNICN | Ethnicity (N) | integer | 8 | Numeric Code of Ethnic Group
| Predecessor: ADSL.ETHNICN | |
| COUNTRY | Country | text | ISO 3166 | Predecessor: ADSL.COUNTRY | ||
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFFL | |
| ARM | Description of Planned Arm | text | 29 | Description of Planned Arm [11 Terms] | Predecessor: ADSL.ARM | |
| ARMCD | Planned Arm Code | text | 9 | Planned Arm Code [11 Terms] | Predecessor: ADSL.ARMCD | |
| ACTARM | Description of Actual Arm | text | 29 | Description of Actual Arm [12 Terms] | Predecessor: ADSL.ACTARM | |
| ACTARMCD | Actual Arm Code | text | 9 | Actual Arm Code [12 Terms] | Predecessor: ADSL.ACTARMCD | |
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | ||
| TRTSTM | Time of First Exposure to Treatment | integer | TIME8 | Predecessor: ADSL.TRTSTM | ||
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | ||
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | ||
| TRTETM | Time of Last Exposure to Treatment | integer | TIME8 | Predecessor: ADSL.TRTETM | ||
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | ||
| TRT01A | Actual Treatment for Period 01 | text | 29 | TRT01A [9 Terms] | Predecessor: ADSL.TRT01A | |
| TRT02A | Actual Treatment for Period 02 | text | 27 | TRT02A
| Predecessor: ADSL.TRT02A | |
| TRT02AN | Actual Treatment for Period 02 (N) | integer | 8 | TRT02AN
| Predecessor: ADSL.TRT02AN | |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | TRT01AN [9 Terms] | Predecessor: ADSL.TRT01AN | |
| TRT01P | Planned Treatment for Period 01 | text | 29 | TRT01P [9 Terms] | Predecessor: ADSL.TRT01P | |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | TRT01PN [9 Terms] | Predecessor: ADSL.TRT01PN | |
| TRT02P | Planned Treatment for Period 02 | text | 27 | TRT02P
| Predecessor: ADSL.TRT02P | |
| TRT02PN | Planned Treatment for Period 02 (N) | integer | 8 | TRT02PN
| Predecessor: ADSL.TRT02PN | |
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | ||
| TR01STM | Time of First Exposure in Period 01 | integer | TIME8 | Predecessor: ADSL.TR01STM | ||
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | ||
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | ||
| TR01ETM | Time of Last Exposure in Period 01 | integer | TIME8 | Predecessor: ADSL.TR01ETM | ||
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | ||
| TR02SDT | Date of First Exposure in Period 02 | integer | DATE9 | Predecessor: ADSL.TR02SDT | ||
| TR02STM | Time of First Exposure in Period 02 | integer | TIME8 | Predecessor: ADSL.TR02STM | ||
| TR02SDTM | Datetime of First Exposure in Period 02 | integer | DATETIME20 | Predecessor: ADSL.TR02SDTM | ||
| TR02EDT | Date of Last Exposure in Period 02 | integer | DATE9 | Predecessor: ADSL.TR02EDT | ||
| TR02ETM | Time of Last Exposure in Period 02 | integer | TIME8 | Predecessor: ADSL.TR02ETM | ||
| TR02EDTM | Datetime of Last Exposure in Period 02 | integer | DATETIME20 | Predecessor: ADSL.TR02EDTM | ||
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Predecessor: ADSL.VAX101DT | ||
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Predecessor: ADSL.VAX102DT | ||
| COHORT | Cohort Group | text | 75 | Cohort [13 Terms] | Predecessor: ADSL.COHORT | |
| COHORTN | Cohort Group (N) | float | 8 | Numeric Code of Cohort [13 Terms] | Predecessor: ADSL.COHORTN | |
| PHASE | Study Phase | text | 20 | Study Phase
| Predecessor: ADSL.PHASE | |
| PHASEN | Study Phase (N) | integer | 8 | Numeric Code of Study Phase
| Predecessor: ADSL.PHASEN | |
| DOSPLVL | Planned Dosing Level | text | 52 | Planned Dosing Level
| Predecessor: ADSL.DOSPLVL | |
| DOSPLVLN | Planned Dosing Level (N) | integer | 8 | Numeric Code of Planned Dosing Level
| Predecessor: ADSL.DOSPLVLN | |
| DOSALVL | Actual Dosing Level | text | 52 | Actual Dosing Level
| Predecessor: ADSL.DOSALVL | |
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Numeric Code of Actual Dosing Level
| Predecessor: ADSL.DOSALVLN | |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 | |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Numeric Code of Pooled Age Group 1
| Predecessor: ADSL.AGEGR1N | |
| AGEGR2 | Pooled Age Group 2 | text | 10 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 | |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Numeric Code of Pooled Age Group 2
| Predecessor: ADSL.AGEGR2N | |
| AGEGR4 | Pooled Age Group 4 | text | 11 | Pooled Age Group 4
| Predecessor: ADSL.AGEGR4 | |
| AGEGR4N | Pooled Age Group 4 (N) | integer | 8 | Numeric Code of Pooled Age Group 4
| Predecessor: ADSL.AGEGR4N | |
| RACEGR1 | Pooled Race Group 1 | text | 25 | Pooled Race Group 1
| Predecessor: ADSL.RACEGR1 | |
| RACEGR1N | Pooled Race Group 1 (N) | integer | 8 | Numeric Code of Pooled Race Group 1
| Predecessor: ADSL.RACEGR1N | |
| VAX101 | Vaccination 01 | text | 37 | Predecessor: ADSL.VAX101 | ||
| VAX102 | Vaccination 02 | text | 36 | Predecessor: ADSL.VAX102 | ||
| DS30KFL | Phase 3 30k Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DS30KFL | |
| COVBLST | Baseline SARS-CoV-2 Status | text | 3 | Baseline SARS-CoV-2 Status
| Predecessor: ADSL.COVBLST | |
| MULENRFL | Multiply Enrolled Subjects | text | 1 | Y
| Predecessor: ADSL.MULENRFL | |
| HIVFL | HIV Positive Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.HIVFL | |
| PEDREAFL | Phase 2/3 Pop for 12-25 Reacto Subset | text | 1 | No Yes Response
| Predecessor: ADSL.PEDREAFL | |
| UNBLNDDT | Treatment Unblinded Date | integer | DATE9 | Predecessor: ADSL.UNBLNDDT | ||
| DS3KFL | Phase 3 3000 Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DS3KFL | |
| REACTOFL | Reactogenicity Population Flag | text | 1 | Y
| Predecessor: ADSL.REACTOFL | |
| AGETR01 | Age at Vaccination 01 | integer | 8 | Predecessor: ADSL.AGETR01 | ||
| VAX10U | Vaccination Unplanned | text | 36 | Predecessor: ADSL.VAX10U | ||
| VAX10UDT | Vaccination Date Unplanned | integer | DATE9 | Predecessor: ADSL.VAX10UDT | ||
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.RANDFL | |
| RAND1FL | Random - exclude Multi-Enrolloer | text | 1 | No Yes Response
| Predecessor: ADSL.RAND1FL | |
| SAF1FL | Safety - excld Multi-Enrolloer&HIV&IND | text | 1 | No Yes Response
| Predecessor: ADSL.SAF1FL | |
| SAF2FL | Safety - exclude Multi-Enrolloer&IND | text | 1 | No Yes Response
| Predecessor: ADSL.SAF2FL | |
| SRCDOM | Source Data | text | 2 | Predecessor: FACE.DOMAIN or VS.DOMAIN | ||
| SRCSEQ | Source Sequence Number | integer | 8 | Assigned 1) FACE.FASEQ or VS.VSSEQ. 2) Set to missing for those derived parameters: where FATEST in ('Maximum Severity', 'Maximum Diameter', 'Maximum Temperature'). | ||
| FAGRPID | Group ID | text | 33 | Derived FACE.FAGRPID or FAGRPID=concatenate (VS.VSTPTREF, VS.VSSCAT) separated by hyphen "-". | ||
| FALNKID | Link ID | text | 77 | Derived 1) FACE.FALNKID; 2) VS.VSLNKID;
3) Set to missing where FATEST in ('Maximum Severity', 'Maximum Diameter', 'Maximum Temperature'). | ||
| FALNKGRP | Link Group ID | text | 71 | Predecessor: FACE.FALNKGRP or VS.VSLNKGRP | ||
| FATEST | Findings About Test Name | text | 40 | Derived ADFACEVD includes:
1) the records from FACE domain: set to FACE.FATEST. For unplanned readings, only clinical assessments within 7 days after each vaccination are invovled.
2) the fever records from VS domain: FATEST="Occurrence Indicator";
3) the parameters derived in ADFACEVD, their values of FATEST have 'Severity/Intensity', 'Maximum Severity', 'Maximum Diameter' or 'Maximum Temperature'. See the algorithms of AVALC for detailed derivation. | ||
| FATESTCD | Findings About Test Short Name | text | 8 | Derived 1) FACE.FATESTCD. 2) Set to 'SEV', 'MAXSEV', 'MAXDIAM', 'MAXTEMP where FATEST in ('Severity/Intensity', 'Maximum Severity', 'Maximum Diameter', 'Maximum Temperature'). | ||
| PARAM | Parameter | text | 57 | ADFACEVD.PARAM [53 Terms] | Derived If upcase(FATESTCD) = "DIAMETER" then PARAM = concatenate (FAOBJ, FATEST, "cm") separated by a blank space; else if upcase(FATESTCD) ^= "DIAMETER and FATEST ne missing then PARAM = concatenate (FAOBJ, FATEST) separated by a blank space; else if FAOBJ="MEDICATIONS" and FATEST eq missing then PARAM='Medications duration'. See the algorithms of AVALC for detailed derivation.
Note: Use sentence case for param values. | |
| PARAMCD | Parameter Code | text | 8 | ADFACEVD.PARAMCD [53 Terms] | Assigned Join FACE and VS with data by PARAM then set PARAMCD per value level. | |
| PARAMN | Parameter (N) | integer | 8 | ADFACEVD.PARAMN [53 Terms] | Assigned Join FACE and VS with data generated then assigned based on PARAM. | |
| FAOBJ | Object of the Observation | text | 36 | Derived FACE.FAOBJ or set to ‘FEVER’ for fever related parameters | ||
| PARCAT1 | Parameter Category 1 | text | 14 | ADFACEVD.PARCAT1
| Derived Set to 'REACTOGENICITY' if index(FACAT, 'REACTOGENICITY') or index(VSCAT, 'REACTOGENICITY'). | |
| PARCAT2 | Parameter Category 2 | text | 19 | ADFACEVD.PARCAT2
| Predecessor: FACE.FASCAT or VS.VSSCAT | |
| AVALCVLM | Analysis Value (C) | text | 10 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "MSPIS" (Pain at injection site maximum severity) | Pain at injection site maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCPIS" (Pain at injection site occurrence indicator) | Pain at injection site occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "SEVPIS" (Pain at injection site severity/intensity) | Pain at injection site severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCISR" (Redness occurrence indicator) | Redness occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCINS" (Swelling occurrence indicator) | Swelling occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "MEDTFVPN" (Medications medication to treat fever or pain) | Medications medication to treat fever or pain | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCCHILLS" (Chills occurrence indicator) | Chills occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCDIAR" (Diarrhea occurrence indicator) | Diarrhea occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "MAXSFAT" (Fatigue maximum severity) | Fatigue maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCFATIG" (Fatigue occurrence indicator) | Fatigue occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "SEVFATI" (Fatigue severity/intensity) | Fatigue severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCFEVER" (Fever occurrence indicator) | Fever occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "MAXSHEA" (Headache maximum severity) | Headache maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCHEAD" (Headache occurrence indicator) | Headache occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "SEVHEAD" (Headache severity/intensity) | Headache severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "MAXSJP" (Joint pain maximum severity) | Joint pain maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCJOPAIN" (Joint pain occurrence indicator) | Joint pain occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "SEVJOIN" (Joint pain severity/intensity) | Joint pain severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCMPNIS" (Muscle pain occurrence indicator) | Muscle pain occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCVOMI" (Vomiting occurrence indicator) | Vomiting occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "DIARE" (Redness diameter cm) | Redness diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "MSERE" (Redness maximum severity) | Redness maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "SEVREDN" (Redness severity/intensity) | Redness severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "MAXDIAR" (Diarrhea maximum severity) | Diarrhea maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "SEVDIAR" (Diarrhea severity/intensity) | Diarrhea severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "MAXCHIL" (Chills maximum severity) | Chills maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "SEVCHIL" (Chills severity/intensity) | Chills severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCHOFA" (Hospitalized for tiredness (fatigue) occurrence indicator) | Hospitalized for tiredness (fatigue) occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "MAXSMP" (Muscle pain maximum severity) | Muscle pain maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "SEVMUSP" (Muscle pain severity/intensity) | Muscle pain severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "DIASW" (Swelling diameter cm) | Swelling diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "MSESW" (Swelling maximum severity) | Swelling maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "SEVSWEL" (Swelling severity/intensity) | Swelling severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCHIS" (Hospitalized for injection site pain occurrence indicator) | Hospitalized for injection site pain occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCHOHE" (Hospitalized for headache occurrence indicator) | Hospitalized for headache occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCHOMP" (Hospitalized for muscle pain occurrence indicator) | Hospitalized for muscle pain occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "STPDMEDP" (Medications stop date meds given to trt/pnt symptoms) | Medications stop date meds given to trt/pnt symptoms | text | 10 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCHOJP" (Hospitalized for joint pain occurrence indicator) | Hospitalized for joint pain occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCHODI" (Hospitalized for diarrhea occurrence indicator) | Hospitalized for diarrhea occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "MAXSVOM" (Vomiting maximum severity) | Vomiting maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "SEVVOMI" (Vomiting severity/intensity) | Vomiting severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCHOCHIL" (Hospitalized for chills occurrence indicator) | Hospitalized for chills occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "MEDDUR" (Medications duration) | Medications duration | text | 7 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "G4CRR" (Redness grade 4 criteria met) | Redness grade 4 criteria met | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "MADRE" (Redness maximum diameter cm) | Redness maximum diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "MIDRE" (Redness minimum diameter cm) | Redness minimum diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "G4CRS" (Swelling grade 4 criteria met) | Swelling grade 4 criteria met | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "MADSW" (Swelling maximum diameter cm) | Swelling maximum diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "MIDSW" (Swelling minimum diameter cm) | Swelling minimum diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| PARAMCD = "OCHOVO" (Hospitalized for vomiting occurrence indicator) | Hospitalized for vomiting occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". | ||
| AVALVLM | Analysis Value | float | 8 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MSPIS" (Pain at injection site maximum severity) | Pain at injection site maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVPIS" (Pain at injection site severity/intensity) | Pain at injection site severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MEDDUR" (Medications duration) | Medications duration | integer | 2 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MAXSFAT" (Fatigue maximum severity) | Fatigue maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVFATI" (Fatigue severity/intensity) | Fatigue severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MAXTEMP" (Fever maximum temperature) | Fever maximum temperature | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MAXSHEA" (Headache maximum severity) | Headache maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVHEAD" (Headache severity/intensity) | Headache severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MAXSJP" (Joint pain maximum severity) | Joint pain maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVJOIN" (Joint pain severity/intensity) | Joint pain severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "DIARE" (Redness diameter cm) | Redness diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MDIRE" (Redness maximum diameter) | Redness maximum diameter | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MSERE" (Redness maximum severity) | Redness maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVREDN" (Redness severity/intensity) | Redness severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MAXDIAR" (Diarrhea maximum severity) | Diarrhea maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVDIAR" (Diarrhea severity/intensity) | Diarrhea severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MAXCHIL" (Chills maximum severity) | Chills maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVCHIL" (Chills severity/intensity) | Chills severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MAXSMP" (Muscle pain maximum severity) | Muscle pain maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVMUSP" (Muscle pain severity/intensity) | Muscle pain severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "DIASW" (Swelling diameter cm) | Swelling diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MDISW" (Swelling maximum diameter) | Swelling maximum diameter | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MSESW" (Swelling maximum severity) | Swelling maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVSWEL" (Swelling severity/intensity) | Swelling severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MAXSVOM" (Vomiting maximum severity) | Vomiting maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVVOMI" (Vomiting severity/intensity) | Vomiting severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MADRE" (Redness maximum diameter cm) | Redness maximum diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MIDRE" (Redness minimum diameter cm) | Redness minimum diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MADSW" (Swelling maximum diameter cm) | Swelling maximum diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MIDSW" (Swelling minimum diameter cm) | Swelling minimum diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| AVALCAT1 | Analysis Value Category 1 | text | 9 | AVALCAT1
| Derived Create AVALCAT1 if FATESTCD in ("DIAMETER" "MAXDIAM") and aval > 0:
if 0 < AVAL <= 2.0 then AVALCAT1=">0-2.0"
if 2 < AVAL <= 5.0 then AVALCAT1=">2.0-5.0"
if 5 < AVAL <= 10.0 then AVALCAT1=">5.0-10.0"
if AVAL > 10.0 then AVALCAT1=">10.0" | |
| AVALCA1N | Analysis Value Category 1 (N) | integer | 8 | AVALCA1N
| Assigned Numeric Code of AVALCAT1 0='>0-2.0'; 1='>2.0-5.0'; 2='>5.0-10.0'; 3='>10.0'; | |
| FASTAT | Completion Status | text | 8 | Not Done
| Predecessor: FACE.FASTAT or VS.VSSTAT | |
| FAREASND | Reason Not Performed | text | 41 | Predecessor: FACE.FAREASND or VS.VSREASND | ||
| FAEVAL | Evaluator | text | 13 | Evaluator
| Predecessor: FACE.FAEVAL or VS.VSEVAL | |
| AVISITN | Analysis Visit (N) | float | 8 | ADFACEVD.AVISITN [18 Terms] | Predecessor: FACE.VISITNUM or VS.VISITNUM | |
| AVISIT | Analysis Visit | text | 25 | ADFACEVD.AVISIT [18 Terms] | Derived 1) FACE.VISIT or VS.VISIT. 2) For unplanned readings, AVISIT=concatenate ('UNPLANNED VISIT', AVISITN) separated by a blank space. | |
| ADT | Analysis Date | integer | DATE9 | Derived date part of FACE.FADTC or date part of VS.VSDTC | ||
| ADTM | Analysis Datetime | integer | DATETIME | Derived Datetime format of FACE.FADTC or VS.VSDTC | ||
| ADY | Analysis Relative Day | integer | 8 | Predecessor: FACE.FADY or VS.VSDY | ||
| ATPT | Analysis Timepoint | text | 5 | Analysis Timepoint [7 Terms] | Derived 1) FACE.FATPT or VS.VSTPT; 2) For unplanned readings, ATPT is populated with DAY <#> for relative day: # = FADTC/VSDTC - date of last vaccination + 1; 3) Set to missing where FATEST in ('Maximum Severity', 'Maximum Temperature', 'Maximum Diameter'). | |
| ATPTN | Analysis Timepoint (N) | integer | 8 | Numeric Code of Analysis Timepoint [7 Terms] | Assigned Numeric Part of ATPT | |
| ATPTREF | Analysis Timepoint Reference | text | 13 | Predecessor: FACE.FATPTREF or VS.VSTPTREF | ||
| FAEVINTX | Evaluation Interval Text | text | 17 | Predecessor: FACE.FAEVINTX or VS.VSEVINTX | ||
| DTYPE | Derivation Type | text | 7 | ADFACEVD.DTYPE
| Derived Set to "MAXIMUM" if FATEST in ('Maximum Severity', 'Maximum Temperature', 'Maximum Diameter') | |
| FASTINT | Evaluation Interval Start | text | 3 | Derived Set to 'P0H' if FATEST in ('Maximum Severity', 'Maximum Temperature', 'Maximum Diameter') | ||
| FAENINT | Evaluation Interval End | text | 3 | Derived Set to "7D" if FATEST in ('Maximum Severity', 'Maximum Temperature', 'Maximum Diameter') | ||
| EXDOSE | Dose | float | 8 | Predecessor: EX.EXDOSE Carried over from EX.EXDOSE. Detailed algorithm as below: For local reaction merge FACE with EX by USUBJID and FATPTREF equals EXTPTREF For systemic events merge FACE with EX by USUBJID and FATPTREF equals EXTPTREF Create ADFACEVD by setting local reactions and systemic events from above step keeping from EX EXDOSE , EXTRT, EXDOSU, EXSTDTC, EXENDTC. | ||
| EXTRT | Name of Treatment | text | 13 | Predecessor: EX.EXTRT | ||
| EXDOSU | Dose Units | text | 3 | Predecessor: EX.EXDOSU | ||
| EXSTDTC | Start Date/Time of Treatment | datetime | ISO 8601 | ISO 8601 | Predecessor: EX.EXSTDTC | |
| EXENDTC | End Date/Time of Treatment | datetime | ISO 8601 | ISO 8601 | Predecessor: EX.EXENDTC | |
| CLTYP | Collection Type | text | 10 | Predecessor: SUPPFACE.QVAL where SUPPFACE.QNAM='CLTYP' or SUPPVS.QVAL where SUPPVSE.QNAM='CLTYP' | ||
| VSORRES | Result or Finding in Original Units | text | 5 | Predecessor: VS.VSORRES where index(VS.VSTESTCD,”TEMP”) and CLTYP in ('DIARY CARD' 'CRF') | ||
| VSORRESU | Original Units | text | 1 | Predecessor: VS.VSORRESU where index(VS.VSTESTCD,”TEMP”) and CLTYP in ('DIARY CARD' 'CRF') | ||
| VSSTRESN | Numeric Result/Finding in Standard Units | float | 8 | Predecessor: VS.VSSTRESN where index(VS.VSTESTCD,”TEMP”) and CLTYP in ('DIARY CARD' 'CRF') | ||
| VSSTRESU | Standard Units | text | 1 | Units for Vital Signs Results
| Predecessor: VS.VSSTRESU where index(VS.VSTESTCD,”TEMP”) and CLTYP in ('DIARY CARD' 'CRF') | |
| FTEMCAT | Fever Temperature Category | text | 17 | FTEMCAT [6 Terms] | Derived Derived only for FAOBJ='FEVER'.
For VSORRESU='F':
if .<input(VS.VSORRES,best.)<100.4 then "<38.0 C";
else if 100.4<=input(VS.VSORRES,best.)<=101.1 then "38.0 C to 38.4 C" ;
else if 101.2<=input(VS.VSORRES,best.)<=102.0 then ">38.4 C to 38.9 C" ;
else if 102.1<=input(VS.VSORRES,best.)<=104.0 then ">38.9 C to 40.0 C";
else if input(VS.VSORRES,best.)>104.0 and VSSTRESN<=42.0 then ">40.0 C".
else if VSSTRESN>42 then 'Missing'.
For VSORRESU='C':
if .<input(VS.VSORRES,best.)<38.0 then "<38.0 C";
else if 38.0<=input(VS.VSORRES,best.)<=38.4 then "38.0 C to 38.4 C" ;
else if 38.5<=input(VS.VSORRES,best.)<=38.9 then ">38.4 C to 38.9 C" ;
else if 39.0<=input(VS.VSORRES,best.)<=40.0 then ">38.9 C to 40.0 C";
else if input(VS.VSORRES,best.)>40 and VSSTRESN<=42.0 then ">40.0 C".
else if VSSTRESN>42 then 'Missing'. | |
| FTEMCATN | Fever Temperature Category (N) | integer | 8 | FTEMCATN
| Derived Numerive Code of FTEMCAT
.="Missing"
0="<38.0 C"
1="38.0 C to 38.4 C"
2= ">38.4 C to 38.9 C"
3=">38.9 C to 40.0 C"
4=">40.0 C" | |
| KNOWVFL | Known Value Flag | text | 1 | No Yes Response
| Derived This flag is derived at USUBJID/FATPTREF/FAOBJ level:
Set to "Y" for a reaction or an event if a subject had a valid record where AVALC in ('Y' 'N') at any day from day 1 to day 7 after each dose.
else set to 'N'. | |
| EVENTFL | Event Value Flag | text | 1 | No Yes Response
| Derived This flag is derived at USUBJID/FATPTREF/FAOBJ level:
For FAOBJ in ('REDNESS' 'SWELLING'): Set to 'Y' if a subject had a record (diameter>=2.5 cm) at any day from day 1 to day 7; else set to 'N'.
For FAOBJ='MEDICATIONS': Set to 'Y' if a subject had a record (avalc='Y') at any day after each dose; else set to 'N'.
For FAOBJ='FEVER' : Set to 'Y' if a subject had a record (38.0 °C <=aval<=42.0 °C) at any day after each dose; else set to 'N'. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
For FAOBJ not in ('REDNESS' 'SWELLING' 'MEDICATIONS' 'FEVER'): Set to 'Y' for an reaction or an event if a subject had a record (avalc in ('MILD', 'MODERATE','SEVER','GRADE 4')) at any day after each dose; else set to 'N'. | |
| KNOWVDFL | Day Known Value Flag | text | 1 | No Yes Response
| Derived This flag is derived at SUBJECT/FATPTREF/FAOBJ/FATEST/FATPT level:
Set to "Y" if a subject had a valid record (where the event was reported regardless if it occurred or not) at that day from day 1 to day 7 within FATPTREF/FAOBJ/FATEST/FATPT level, else set to 'N'. | |
| EVENTDFL | Day Event Value Flag | text | 1 | No Yes Response
| Derived This flag is derived at SUBJECT/FATPTREF/FAOBJ/FATEST/FATPT level:
For FATEST in ('Occurrence Indicator') and FAOBJ in ('REDNESS' 'SWELLING'): Set to 'Y' if a subject had a event (avalc='Y' and diameter>=2.5 cm) on the day within FATPTREF/FAOBJ/FATEST level; else set to 'N'.
For (FATEST in ('Occurrence Indicator') and FAOBJ not in ('REDNESS' 'SWELLING')) or (FATESTCD='MEDTFVPN' and FAOBJ='MEDICATIONS'): Set to 'Y' if a subject had a event (avalc='Y') on the day within FATPTREF/FAOBJ/FATEST/FATPT level; else set to 'N'.
For FATEST in ('Severity/Intensity', 'Maximum Severity') : Set to 'Y' if a subject had a event (avalc in ('MILD', 'MODERATE', 'SEVERE', 'GRADE4')) on the day within FATPTREF/FAOBJ/FATEST/FATPT level; else set to 'N'.
For FATEST in ('Diameter', 'Maximum Diameter') : Set to 'Y' if a subject had a event (aval>=2.5 cm) on the day within FATPTREF/FAOBJ/FATPT level; else set to 'N'.
For FATEST in ('Maximum Temperature') : Set to 'Y' if a subject had a event (38.0 °C <=aval<=42.0 °C) on the day within FATPTREF/FAOBJ/FATPT level; else set to 'N'. | |
| CUTUNBFL | Cut after Unblinding Date Flag | text | 1 | Y
| Derived if FADTC/VSDTC>=UNBLNDDT. Then CUTUNBFL="Y" | |
| EVENTOCC | Occurences of Event | integer | 8 | Derived This variable is derived at SUBJECT/FATPTREF/FAOBJ level.
EVENTOCC is the number of events. When a subject reported an event at least 1 day (with EVENTDF='Y'), then EVENTOCC=1; If the occurrence is consecutive >=2 days, it should be still counted once. But if the event recurred after one or more day’s disappearance, then EVENTOCC+1.
For example, subject A had redness (diameter>=2.5cm) on Day 1, 2, 4, 5, 6.
The symptom on Day 1-2 and Day 4-6 is counted once respectively , so EVENTOCC is 2 for subject A. | ||
| TRTA | Actual Treatment | text | 29 | TRTA [9 Terms] | Derived if (VAX101='Placebo' and ATPTREF="VACCINATION 1") or (VAX102='Placebo' and ATPTREF="VACCINATION 2") then TRTA='Placebo';
else ADSL.TRT01A. | |
| TRTAN | Actual Treatment (N) | integer | 8 | TRTAN [9 Terms] | Derived if (VAX101='Placebo' and ATPTREF="VACCINATION 1") or (VAX102='Placebo' and ATPTREF="VACCINATION 2") then TRTAN=9';
else ADSL.TRT01AN. | |
| TRTP | Planned Treatment | text | 29 | TRTP [9 Terms] | Predecessor: ADSL.TRT01P | |
| TRTPN | Planned Treatment (N) | integer | 8 | TRTPN [9 Terms] | Predecessor: ADSL.TRT01PN |
Go to the top of the Define-XML document
Covid-19 Signs and Symptoms (ADSYMPT)
| Variable | Where Condition | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: ADSL.STUDYID | ||
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: ADSL.USUBJID | ||
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | ||
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | ||
| BRTHDT | Date of Birth | integer | DATE9 | Predecessor: ADSL.BRTHDT | ||
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Numeric Code of Pooled Age Group 1
| Predecessor: ADSL.AGEGR1N | |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 | |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
| RACE | Race | text | 41 | Race [7 Terms] | Predecessor: ADSL.RACE | |
| ETHNIC | Ethnicity | text | 22 | Ethnic Group
| Predecessor: ADSL.ETHNIC | |
| ARMCD | Planned Arm Code | text | 9 | Planned Arm Code [11 Terms] | Predecessor: ADSL.ARMCD | |
| ARM | Description of Planned Arm | text | 27 | Description of Planned Arm [11 Terms] | Predecessor: ADSL.ARM | |
| ACTARMCD | Actual Arm Code | text | 9 | Actual Arm Code [12 Terms] | Predecessor: ADSL.ACTARMCD | |
| ACTARM | Description of Actual Arm | text | 27 | Description of Actual Arm [12 Terms] | Predecessor: ADSL.ACTARM | |
| PARAMN | Parameter (N) | integer | 8 | ADSYMPT.PARAMN [36 Terms] | Assigned Numeric code for PARAM Please refer to codelist ADSYMPT.PARAMN. | |
| PARAMCD | Parameter Code | text | 8 | ADSYMPT.PARAMCD [36 Terms] | Assigned Character code for PARAM Please refer to codelist ADSYMPT.PARAMCD. | |
| PARAM | Parameter | text | 48 | ADSYMPT.PARAM [36 Terms] | Derived Set to FA.FAOBJ when upcase(FA.FAOBJ) = "CHILLS" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "DIARRHEA" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "FEVER" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW LOSS OF TASTE OR SMELL" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED COUGH" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED MUSCLE PAIN" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED SHORTNESS OF BREATH" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED SORE THROAT" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "VOMITING" and FA.FACAT = "EFFICACY" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to "NEW OR INCREASED NASAL CONGESTION" when upcase(FA.FAOBJ) = "NEW OR INCREASED NASAL CONGESTION" or "NASAL CONGESTION" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to "NEW OR INCREASED WHEEZING" when upcase(FA.FAOBJ) = "NEW OR INCREASED WHEEZING" or upcase(FA.FAOBJ) = "WHEEZING" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "FATIGUE" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "HEADACHE" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to "RHINORRHOEA" when upcase(FA.FAOBJ) contains "RUNNY NOSE" or upcase(FA.FAOBJ) = "RHINORRHOEA" and FA.FAOBJ ^= "NEW OR INCREASED NASAL DISCHARGE" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NAUSEA" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to CE.CESCAT when CE.CESCAT = "SIGNIFICANT ACUTE RENAL DYSFUNCTION".
Set to CE.CESCAT when CE.CESCAT = "SIGNIFICANT ACUTE HEPATIC DYSFUNCTION".
Set to CE.CESCAT when CE.CESCAT = "SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION".
Set to MB.MBTEST when upcase(MB.MBTESTCD) = "SARSCOV2" and MB.MBMETHOD = "IMMUNOCHROMATOGRAPHY".
Set to MB.MBTEST when upcase(MB.MBTESTCD) = "RTCOV2NS" and MB.MBMETHOD = "REVERSE TRANSCRIPTASE PCR".
Set to VS.VSTEST when VS.VSTESTCD = "RESP".
Set to VS.VSTEST when VS.VSTESTCD = "HR".
Set to VS.VSTEST when VS.VSTESTCD = "OXYSAT"
Set to VS.VSTEST when VS.VSTESTCD = "DIABP".
Set to VS.VSTEST when VS.VSTESTCD = "SYSBP".
Set to LB.LBTEST when LB.LBTEST = "PP Arterial O2/Fraction Inspired O2".
Set to PR.PRTRT when upcase(PR.PRTRT) = "INTUBATION".
Set to PR.PRTRT when upcase(PR.PRTRT) = "NON-INVASIVE POSITIVE PRESSURE VENTILATION".
Set to "CONTINUOUS POSITIVE AIRWAY PRESSURE" when upcase(PR.PRTRT) = "CONTINUOUS POSITIVE AIRWAY PRESSURE" or upcase(PR.PRTRT) = "CPAP".
Set to PR.PRTRT when upcase(PR.PRTRT) = "OXYGEN THERAPY"
Set to PR.PRTRT when upcase(PR.PRTRT) = "MECHANICAL VENTILATION".
Set to PR.PRTRT when upcase(PR.PRTRT) = "EXTRACORPOREAL MEMBRANE OXYGENATION".
Set to PR.PRTRT when upcase(PR.PRTRT) = "HIGH FLOW OXYGEN THERAPY".
Set to CM.CMSCAT when CM.CMCAT = "GENERAL CONCOMITANT MEDICATIONS" and CM.CMSCAT = "VASOPRESSORS AGENTS". Keep only one record per subject per CM.CMSTDTC where CM.CMTRT is not missing.
Set to IS.ISTEST when IS.ISTESTCD = "C19NIG"
Set to "SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS" when (HOTERM = "ICU') or (SUPPHO.QNAM = "HCUICU" and QVAL="Y").
Set to "HOSPITALIZED DUE TO COVID-19 ILLNESS?" when SUPPHO.QNAM = "HCUHSP" and QVAL="Y"
Set to DD.DDTEST when DD.DDTESTCD = "PRCDTH". Note: Only bring records when ADSL.DTHDT not null or DD.DDSTRESC is not null.
Set to DD.DDTEST when DD.DDTESTCD = "SECDTH". Note: Only bring records when DD.DDSTRESC is populated.
Set to DS.DSDECOD when DS.DSDECOD = "DEATH". | |
| PARCAT1 | Parameter Category 1 | text | 33 | ADSYMPT.PARCAT1 [13 Terms] | Derived if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to "GENERAL VITAL SIGNS".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to "SIGNS AND SYMPTOMS OF DISEASE".
if paramcd in ("SARDFN" "SAHDFN" "SANDFN") then Set to CE.CECAT.
if paramcd in ("DEATH") then Set to DS.DSCAT.
if paramcd in ("HCUICU" "HCUHSP") then Set to HO.HOCAT.
if paramcd in ("C19NIG") then Set to IS.ISCAT.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBCAT.
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PRCAT.
if paramcd in ("VSOPRES") then Set to CM.CMCAT
if paramcd in ("PO2FIO2") then set to LB.LBCAT
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDCAT | |
| PARCAT2 | Parameter Category 2 | text | 19 | ADSYMPT.PARCAT2
| Derived if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to "RESPIRATORY FAILURE".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASCAT.
if paramcd in ("HCUICU" "HCUHSP" "C19NIG" "SARSCOV2" "RTCOV2NS" "RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "SARDFN" "SAHDFN" "SANDFN" "PRCDTH" "SECDTH" "DEATH") then Set to null.
if paramcd in ("VSOPRES") then Set to CM.CMSCAT
if paramcd in ("PO2FIO2") then set to LB.LBSCAT | |
| AVALVLM | Analysis Value | float | 8 | Derived if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN.
if paramcd in ("PO2FIO2") then set to LB.LBORRES
else Set to null. | ||
| PARAMCD = "RESP" (RESPIRATORY RATE) | RESPIRATORY RATE | integer | 2 | Derived if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN.
if paramcd in ("PO2FIO2") then set to LB.LBORRES
else Set to null. | ||
| PARAMCD = "HR" (HEART RATE) | HEART RATE | integer | 3 | Derived if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN.
if paramcd in ("PO2FIO2") then set to LB.LBORRES
else Set to null. | ||
| PARAMCD = "OXYSAT" (OXYGEN SATURATION) | OXYGEN SATURATION | float | 4 | Derived if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN.
if paramcd in ("PO2FIO2") then set to LB.LBORRES
else Set to null. | ||
| PARAMCD = "DIABP" (DIASTOLIC BLOOD PRESSURE) | DIASTOLIC BLOOD PRESSURE | integer | 3 | Derived if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN.
if paramcd in ("PO2FIO2") then set to LB.LBORRES
else Set to null. | ||
| PARAMCD = "SYSBP" (SYSTOLIC BLOOD PRESSURE) | SYSTOLIC BLOOD PRESSURE | integer | 3 | Derived if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN.
if paramcd in ("PO2FIO2") then set to LB.LBORRES
else Set to null. | ||
| PARAMCD = "PO2FIO2" (PP ARTERIAL O2/FRACTION INSPIRED O2) | PP ARTERIAL O2/FRACTION INSPIRED O2 | float | 5 | Derived if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN.
if paramcd in ("PO2FIO2") then set to LB.LBORRES
else Set to null. | ||
| AVALCVLM | Analysis Value (C) | text | 37 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "RTCOV2NS" (CEPHEID RT-PCR ASSAY FOR SARS-COV-2) | CEPHEID RT-PCR ASSAY FOR SARS-COV-2 | text | 3 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "C19NIG" (N-BINDING ANTIBODY) | N-BINDING ANTIBODY | text | 3 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "CHILLS" (CHILLS) | CHILLS | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "DIARRHEA" (DIARRHEA) | DIARRHEA | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "FEVER" (FEVER) | FEVER | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "NLTSTSML" (NEW LOSS OF TASTE OR SMELL) | NEW LOSS OF TASTE OR SMELL | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "NCOUG" (NEW OR INCREASED COUGH) | NEW OR INCREASED COUGH | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "NMUSPN" (NEW OR INCREASED MUSCLE PAIN) | NEW OR INCREASED MUSCLE PAIN | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "NSTBRTH" (NEW OR INCREASED SHORTNESS OF BREATH) | NEW OR INCREASED SHORTNESS OF BREATH | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "NSRTHROT" (NEW OR INCREASED SORE THROAT) | NEW OR INCREASED SORE THROAT | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "VOMIT" (VOMITING) | VOMITING | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "SARSCOV2" (SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2) | SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 | text | 3 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "FATIGUE" (FATIGUE) | FATIGUE | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "RIHNRA" (RHINORRHOEA) | RHINORRHOEA | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "NNSLCONG" (NEW OR INCREASED NASAL CONGESTION) | NEW OR INCREASED NASAL CONGESTION | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "HEADACHE" (HEADACHE) | HEADACHE | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "NAUSEA" (NAUSEA) | NAUSEA | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "HCUHSP" (HOSPITALIZED DUE TO COVID-19 ILLNESS?) | HOSPITALIZED DUE TO COVID-19 ILLNESS? | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "HCUICU" (SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS) | SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "MCHVENT" (MECHANICAL VENTILATION) | MECHANICAL VENTILATION | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "DEATH" (DEATH) | DEATH | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "PRCDTH" (PRIMARY CAUSE OF DEATH) | PRIMARY CAUSE OF DEATH | text | 37 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "HFOXTHRP" (HIGH FLOW OXYGEN THERAPY) | HIGH FLOW OXYGEN THERAPY | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "SECDTH" (SECONDARY CAUSE OF DEATH) | SECONDARY CAUSE OF DEATH | text | 31 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "WHEEZ" (NEW OR INCREASED WHEEZING) | NEW OR INCREASED WHEEZING | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "NIPPV" (NON-INVASIVE POSITIVE PRESSURE VENTILATION) | NON-INVASIVE POSITIVE PRESSURE VENTILATION | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "SARDFN" (SIGNIFICANT ACUTE RENAL DYSFUNCTION) | SIGNIFICANT ACUTE RENAL DYSFUNCTION | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "SANDFN" (SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION) | SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "SAHDFN" (SIGNIFICANT ACUTE HEPATIC DYSFUNCTION) | SIGNIFICANT ACUTE HEPATIC DYSFUNCTION | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| PARAMCD = "VSOPRES" (VASOPRESSORS AGENTS) | VASOPRESSORS AGENTS | text | 14 | Derived if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. | ||
| VISITNUM | Visit Number | integer | 8 | Predecessor: CE.VISITNUM FACE.VISITNUM HO.VISITNUM IS.VISITNUM MB.VISITNUM MH.VISITNUM PR.VISITNUM VS.VISITNUM VISITNUM will be missing for observations from CM, DS | ||
| VISIT | Visit Name | text | 20 | Predecessor: CE.VISIT FACE.VISIT HO.VISIT IS.VISIT MB.VISIT MH.VISIT PR.VISIT VS.VISIT VISIT will be missing for observations from CM, DS | ||
| AVISITN | Analysis Visit (N) | integer | 8 | ADSYMPT.AVISITN [18 Terms] | Derived Set to VISITNUM of source dataset and for any existing multiple unplanned visits that are at least 4 days apart from the end of previous unplanned visit.
When multiple unplanned visits are present and start of next unplanned visit is within 3 days of end of current unplanned visit, collapse the next unplanned visit into current unplanned visit and assign current VISITNUM to the next unplanned visit. Also set any repeat visits such as "..ARx" back to its main/parent visit. | |
| AVISIT | Analysis Visit | text | 20 | ADSYMPT.AVISIT [18 Terms] | Derived Follow AVISITN specification from below, but assign VISIT from source data instead. | |
| ADT | Analysis Date | integer | DATE9 | Derived if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FADTC.
if paramcd in ("HCUICU" "HCUHSP") then Set to HO.HODTC.
if paramcd in ("C19NIG") then Set to IS.ISDTC.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBDTC.
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PRDTC.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSDTC.
if paramcd in ("PRCDTH" "SECDTH") then ADSL.DTHDT
if paramcd in ("PO2FIO2") then LB.LBDTC
if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "VSOPRES") then Set to null. | ||
| ADY | Analysis Relative Day | integer | 8 | Derived Set as following:
ADY = ADT - TRTSDT.
If ADT >= TRTSDT, ADY = ADT - TRTSDT + 1. | ||
| ASTDT | Analysis Start Date | integer | DATE9 | Derived if paramcd in ("SARDFN" "SAHDFN") then Set to CE.CESTDTC.
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FASTRESC where FA.FATESTCD = "FSYMDATE" and FA.FACAT = "EFFICACY" and FASCAT = "RESPIRATORY ILLNESS" within a matching FA.VISIT of a subject.
if paramcd in ("HCUICU" "HCUHSP") then Set to HO.HOSTDTC.
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PRSTDTC.
if paramcd in ("VSOPRES") then set to CM.CMSTDTC
if paramcd in ("SARSCOV2" "RTCOV2NS" "RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "C19NIG" "DEATH" "PRCDTH" "SECDTH" "PO2FIO2") then Set to null. | ||
| ASTDY | Analysis Start Relative Day | integer | 8 | Derived Set as following:
ASTDY = ASTDT - TRTSDT.
If ASTDT >= TRTSDT, ASTDY = ASTDT - TRTSDT + 1. | ||
| AENDT | Analysis End Date | integer | DATE9 | Derived if paramcd in ("SARDFN" "SAHDFN") then Set to CE.CEENDTC.
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FASTRESC where FA.FATESTCD = "LSYMDATE" and FA.FACAT = "EFFICACY" and FASCAT = "RESPIRATORY ILLNESS" within a matching FA.VISIT of a subject..
if paramcd in ("HCUICU" "HCUHSP") then Set to HO.HOENDTC.
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PRENDTC.
if paramcd in ("VSOPRES") then set to CM.CMENDTC
if paramcd in ("SARSCOV2" "RTCOV2NS" "RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "C19NIG" "DEATH" "PRCDTH" "SECDTH" "PO2FIO2") then Set to null. | ||
| AENDY | Analysis End Relative Day | integer | 8 | Derived Set as following:
AENDY = AENDT - TRTSDT.
If AENDT >= TRTSDT, AENDY = AENDT - TRTSDT + 1. | ||
| ISSPEC | IS Specimen Type | text | 5 | Specimen Type
| Predecessor: IS.ISSPEC where IS.ISTESTCD = "C19NIG" | |
| ISMETHOD | IS Method of Test or Examination | text | 24 | Predecessor: IS.ISMETHOD where IS.ISTESTCD = "C19NIG" | ||
| MBLOC | Specimen Collection Location | text | 24 | Predecessor: MB.MBLOC when PARAMCD in ("SARSCOV2" "RTCOV2NS") | ||
| MBSPEC | MB Specimen Type | text | 22 | Predecessor: MB.MBSPEC when PARAMCD in ("SARSCOV2" "RTCOV2NS") | ||
| MBMETHOD | MB Method of Test or Examination | text | 25 | Predecessor: MB.MBMETHOD when PARAMCD in ("SARSCOV2" "RTCOV2NS") | ||
| PRPRESP | Pre-specified | text | 1 | Y
| Predecessor: PR.PRPRESP when PARAMCD in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") | |
| VSSTRESU | Standard Units | text | 11 | Units for Vital Signs Results
| Predecessor: VS.VSSTRESU when PARAMCD in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") | |
| RANDDT | Date of Randomization | integer | DATE9 | Predecessor: ADSL.RANDDT | ||
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | ||
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | ||
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Predecessor: ADSL.VAX101DT | ||
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Predecessor: ADSL.VAX102DT | ||
| ENRLFL | Enrolled Population Flag | text | 1 | Y
| Predecessor: ADSL.ENRLFL | |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.RANDFL | |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFFL | |
| EVALEFFL | Evaluable Efficacy Popu Flag | text | 1 | No Yes Response
| Predecessor: ADSL.EVALEFFL | |
| AAI1EFFL | Dose 1 all-available Efficacy Popu Flag | text | 1 | No Yes Response
| Predecessor: ADSL.AAI1EFFL | |
| AAI2EFFL | Dose 2 all-available Efficacy Popu Flag | text | 1 | No Yes Response
| Predecessor: ADSL.AAI2EFFL | |
| C19ILHFL | Prior Covid-19 Illness History Flag | text | 1 | Y
| Derived Set this to "Y", if subject reported any of the following terms in MH.MHDECOD .
"Asymptomatic COVID-19"
"COVID-19"
"COVID-19 pneumonia"
"COVID-19 treatment"
"Suspected COVID-19"
"SARS-CoV-2 antibody test positive"
"SARS-CoV-2 carrier"
"SARS-CoV-2 sepsis"
"SARS-CoV-2 test positive"
"SARS-CoV-2 viraemia"
"Multisystem inflammatory syndrome in children" |
Go to the top of the Define-XML document
Immunogenicity Analysis Dataset (ADVA)
| Variable | Where Condition | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: IS.STUDYID | ||
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: IS.USUBJID | ||
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | ||
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | ||
| TRTP | Planned Treatment | text | 29 | TRTP [9 Terms] | Derived TRT01P for Period 1; TRT02P for Period 2 | |
| TRTPN | Planned Treatment (N) | integer | 8 | TRTPN [9 Terms] | Derived TRT01PN for Period 1; TRT02PN for Period 2 | |
| TRTA | Actual Treatment | text | 29 | TRTA [9 Terms] | Derived TRT01A for Period 1; TRT02A for Period 2 | |
| TRTAN | Actual Treatment (N) | integer | 8 | TRTAN [9 Terms] | Derived TRT01AN for Period 1; TRT02AN for Period 2 | |
| ISDTC | Date/Time of Collection | date | ISO 8601 | ISO 8601 | Predecessor: IS.ISDTC | |
| ADT | Analysis Date | integer | DATE9 | Derived date part of IS.ISDTC | ||
| ADY | Analysis Relative Day | integer | 8 | Predecessor: IS.ISDY | ||
| AVISIT | Analysis Visit | text | 39 | ADVA.AVISIT [11 Terms] | Derived Derive AVISIT based on IS.Visit/Visitnum for records with non-missing value (AVAL ne .)
Note: For phase 1 BNTb2 30 ug subjects, repeat test results are used in Vist 1/4/7/8, so AVISITN is set to missing for original results.
Note: set AVISIT='' for ISTESTCD='C19NIG' as no need to report this test. | |
| AVISITN | Analysis Visit (N) | float | 8 | ADVA.AVISITN [11 Terms] | Assigned Numeric Code of the AVISIT. 1 if AVISIT= "Before Vaccination 1"; 2 if AVISIT= "1 Week after Vaccination 1"; 3 if AVISIT= "3 Weeks after Vaccination 1" (Note: This is the visit before vaccination 2); 3.1 if AVISIT= "4 Weeks after Vaccination 1" (Note: For 100ug only); 3.2 if AVISIT= "5 Weeks after Vaccination 1" (Note: For 100ug only); 3.3 if AVISIT= "1 Month and 3 weeks after Vaccination 1" (Note: For 100ug only); 3.9 if AVISIT= "Before Vaccination 2" (Note: For 100ug only); 4 if AVISIT= "1 Week after Vaccination 2"; 5 if AVISIT= "2 Weeks after Vaccination 2"; 6 if AVISIT= "1 Month after Vaccination 2"; 7 if AVISIT= "6 Months after Vaccination 2"; 8 if AVISIT= "12 Months after Vaccination 2"; 9 if AVISIT= "24 Months after Vaccination 2"; | |
| VISIT | Visit Name | text | 21 | Predecessor: IS.VISIT | ||
| VISITNUM | Visit Number | integer | 8 | Predecessor: IS.VISITNUM | ||
| PARCAT1 | Parameter Category 1 | text | 8 | ADVA.PARCAT1
| Predecessor: IS.ISCAT | |
| PARCAT1N | Parameter Category 1 (N) | integer | 8 | ADVA.PARCAT1N
| Assigned Numeric Code from PARCAT1. 1 if PARCAT1="SEROLOGY". | |
| PARAM | Parameter | text | 75 | ADVA.PARAM [7 Terms] | Derived trim(left(IS.ISTEST)) || '(' || trim(left(IS.ISSTRESU)) || ')' || ' - ' || trim(left(IS.ISMETHOD)) | |
| PARAMN | Parameter (N) | integer | 8 | ADVA.PARAMN [7 Terms] | Assigned Assigned based on PARAMCD: PARAMN=1 when PARAMCD="C2NGNT50" PARAMN=2 when PARAMCD="C2NGNT90" PARAMN=3 when PARAMCD="C19S1IGG" PARAMN=4 when PARAMCD="C19RBDIG" PARAMN=5 when PARAMCD="C19NIG" PARAMN=11 when PARAMCD="NT50_S1" PARAMN=12 when PARAMCD="NT90_S1" PARAMN=13 when PARAMCD="NT50_RB" PARAMN=14 when PARAMCD="NT90_RB" | |
| PARAMCD | Parameter Code | text | 8 | ADVA.PARAMCD [7 Terms] | Assigned IS.ISTESTCD | |
| AVALVLM | Analysis Value | float | 8 | Derived If ISSTRESC in (' ', 'IND', 'QNS') then set to missing;
if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ;
else set to IS.ISSTRESN.
*LLoQ equals the value of ISLLOQ.
For N-binding antibody test, 0 for negative and 1 for positive.
For parameter with paramn equal 11 and 12:
AVAL is the ratio of the corresponding parameters specified in PARAM
eg: For PARAMN=11 (PARAM='COV2_MNG_SERUM_NT50 to Covid 19 S1 IGG), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| PARAMCD = "C19RBDIG" (COVID-19 RBD IgG (U/mL) - Luminex Immunoassay) | COVID-19 RBD IgG (U/mL) - Luminex Immunoassay | float | 10 | Derived If ISSTRESC in (' ', 'IND', 'QNS') then set to missing;
if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ;
else set to IS.ISSTRESN.
*LLoQ equals the value of ISLLOQ.
For N-binding antibody test, 0 for negative and 1 for positive.
For parameter with paramn equal 11 and 12:
AVAL is the ratio of the corresponding parameters specified in PARAM
eg: For PARAMN=11 (PARAM='COV2_MNG_SERUM_NT50 to Covid 19 S1 IGG), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| PARAMCD = "C19S1IGG" (COVID-19 S1 IgG (U/mL) - Luminex Immunoassay) | COVID-19 S1 IgG (U/mL) - Luminex Immunoassay | float | 10 | Derived If ISSTRESC in (' ', 'IND', 'QNS') then set to missing;
if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ;
else set to IS.ISSTRESN.
*LLoQ equals the value of ISLLOQ.
For N-binding antibody test, 0 for negative and 1 for positive.
For parameter with paramn equal 11 and 12:
AVAL is the ratio of the corresponding parameters specified in PARAM
eg: For PARAMN=11 (PARAM='COV2_MNG_SERUM_NT50 to Covid 19 S1 IGG), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| PARAMCD = "C19NIG" (N-binding antibody - N-binding Antibody Assay) | N-binding antibody - N-binding Antibody Assay | integer | 1 | Derived If ISSTRESC in (' ', 'IND', 'QNS') then set to missing;
if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ;
else set to IS.ISSTRESN.
*LLoQ equals the value of ISLLOQ.
For N-binding antibody test, 0 for negative and 1 for positive.
For parameter with paramn equal 11 and 12:
AVAL is the ratio of the corresponding parameters specified in PARAM
eg: For PARAMN=11 (PARAM='COV2_MNG_SERUM_NT50 to Covid 19 S1 IGG), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| PARAMCD = "C2NGNT50" (SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay) | SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay | float | 13 | Derived If ISSTRESC in (' ', 'IND', 'QNS') then set to missing;
if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ;
else set to IS.ISSTRESN.
*LLoQ equals the value of ISLLOQ.
For N-binding antibody test, 0 for negative and 1 for positive.
For parameter with paramn equal 11 and 12:
AVAL is the ratio of the corresponding parameters specified in PARAM
eg: For PARAMN=11 (PARAM='COV2_MNG_SERUM_NT50 to Covid 19 S1 IGG), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| PARAMCD = "NT50_S1" (SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG) | SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG | float | 7 | Derived If ISSTRESC in (' ', 'IND', 'QNS') then set to missing;
if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ;
else set to IS.ISSTRESN.
*LLoQ equals the value of ISLLOQ.
For N-binding antibody test, 0 for negative and 1 for positive.
For parameter with paramn equal 11 and 12:
AVAL is the ratio of the corresponding parameters specified in PARAM
eg: For PARAMN=11 (PARAM='COV2_MNG_SERUM_NT50 to Covid 19 S1 IGG), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| PARAMCD = "C2NGNT90" (SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay) | SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay | float | 12 | Derived If ISSTRESC in (' ', 'IND', 'QNS') then set to missing;
if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ;
else set to IS.ISSTRESN.
*LLoQ equals the value of ISLLOQ.
For N-binding antibody test, 0 for negative and 1 for positive.
For parameter with paramn equal 11 and 12:
AVAL is the ratio of the corresponding parameters specified in PARAM
eg: For PARAMN=11 (PARAM='COV2_MNG_SERUM_NT50 to Covid 19 S1 IGG), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| PARAMCD = "NT90_S1" (SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG) | SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG | float | 7 | Derived If ISSTRESC in (' ', 'IND', 'QNS') then set to missing;
if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ;
else set to IS.ISSTRESN.
*LLoQ equals the value of ISLLOQ.
For N-binding antibody test, 0 for negative and 1 for positive.
For parameter with paramn equal 11 and 12:
AVAL is the ratio of the corresponding parameters specified in PARAM
eg: For PARAMN=11 (PARAM='COV2_MNG_SERUM_NT50 to Covid 19 S1 IGG), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| AVALCVLM | Analysis Value (C) | text | 11 | Derived Character value for AVAL | ||
| PARAMCD = "C19RBDIG" (COVID-19 RBD IgG (U/mL) - Luminex Immunoassay) | COVID-19 RBD IgG (U/mL) - Luminex Immunoassay | float | 10 | Derived Character value for AVAL | ||
| PARAMCD = "C19S1IGG" (COVID-19 S1 IgG (U/mL) - Luminex Immunoassay) | COVID-19 S1 IgG (U/mL) - Luminex Immunoassay | float | 10 | Derived Character value for AVAL | ||
| PARAMCD = "C19NIG" (N-binding antibody - N-binding Antibody Assay) | N-binding antibody - N-binding Antibody Assay | text | 3 | Derived Character value for AVAL | ||
| PARAMCD = "C2NGNT50" (SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay) | SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay | float | 13 | Derived Character value for AVAL | ||
| PARAMCD = "NT50_S1" (SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG) | SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG | float | 7 | Derived Character value for AVAL | ||
| PARAMCD = "C2NGNT90" (SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay) | SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay | float | 12 | Derived Character value for AVAL | ||
| PARAMCD = "NT90_S1" (SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG) | SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG | float | 7 | Derived Character value for AVAL | ||
| BASE | Baseline Value | float | 8 | Derived AVAL from the record with ABLFL="Y" at USUBJID/PARAM level | ||
| BASEC | Baseline Value (C) | text | 8 | Derived AVALC from the record with ABLFL="Y" at USUBJID/PARAM level | ||
| BASETYPE | Baseline Type | text | 15 | Derived trim(left("Study"))||' ('||trim(left(dtype))||')'; | ||
| ABLFL | Baseline Record Flag | text | 1 | Y
| Derived Set to 'Y' for a valid result (AVAL ne .) where collected before vax1.
Note: For phase 1 BNTb2 30 ug subjects, repeat test results are used in Vist 1/4/7/8, so only repeated V1 results are used to derive ABLFL | |
| APSBLFL | Post Baseline Record Flag | text | 1 | Y
| Derived Set to 'Y' for a post-baseline result where collected after vax1 | |
| ABLPBLFL | Baseline and post-baseline flag | text | 1 | No Yes Response
| Derived Set to 'Y' if a subject has results both at baseline and post-baseline.
Set to 'N' if a subject only has baseline or post-baseline results. | |
| DTYPE | Derivation Type | text | 7 | ADVA.DTYPE
| Assigned Set to 'LLOQIMP' for imputed records. Set to 'Derived' for parameters for ratios. | |
| R2BASE | Ratio to Baseline | float | 8 | Derived R2BASE = AVAL/BASE for post baseline readings | ||
| SRCDOM | Source Data | text | 2 | Assigned Set to "IS" when DTYPE ne 'Derived'. | ||
| SRCVAR | Source Variable | text | 8 | Assigned Set to "ISSTRESN" when DTYPE ne 'Derived'. | ||
| SRCSEQ | Source Sequence Number | integer | 8 | Derived IS.ISSEQ when DTYPE ne 'Derived'. | ||
| ANL01FL | Analysis Record Flag 01:Window Record | text | 1 | Y
| Derived Flag the record that is selected based on Windowing
1. AVISIT ne missing;
2. Vax 1 date ne missing;
3. For Visit 1, visit date should no later than Vax 1 date;
4. For Visit 3, visit date should no later than Vax 3 (re-vax) date;
Note: For phase 1 BNTb2 30 ug subjects, repeat test results are used in Vist 1/4/7/8, so ANL01FL is set to missing for original results. | |
| ANL03FL | Analysis Flag 03:valid value | text | 1 | Y
| Derived Flag the record with non-missing result (AVAL ne . ) and ISSTRESC not in ('IND', 'QNS') | |
| ANL04FL | Analysis Flag 04:ge LLoQ | text | 1 | Y
| Derived Flag the record with non-missing AVAL and AVAL ge LLoQ. | |
| ISLLOQ | Lower Limit of Quantitation | float | 8 | Predecessor: IS.ISLLOQ | ||
| ISSTRESC | Result or Finding in Standard Format | text | 11 | Predecessor: IS.ISSTRESC | ||
| EVIMMFL | Evaluable Immunogenicity Record Flag | text | 1 | No Yes Response
| Derived For Phase 1:
if avisitn<4 then do; /*related to dose 1 evaluable immunogenicity population*/
if eval01fl="Y" then EVIMMFL="Y";
else EVIMMFL="N";
end;
else if avisitn>=4 then do; /*related to dose 2 evaluable immunogenicity population*/
if eval02fl="Y" then EVIMMFL="Y";
else EVIMMFL="N";
end;
For Phase 2/3:
if eval02fl="Y" then EVIMMFL="Y";
else EVIMMFL="N"; | |
| AAIMMFL | All-available Immunogenicity Record Flag | text | 1 | No Yes Response
| Derived For Phase 1:
if avisitn<4 then do; /*related to dose 1 all-available immunogenicity population*/
if aai01fl="Y" then AAIMMFL="Y";
else AAIMMFL="N";
end;
else if avisitn>=4 then do;/*related to dose 2 all-available immunogenicity population*/
if aai02fl="Y" then AAIMMFL="Y";
else AAIMMFL="N";
end;
For Phase 2/3:
if aai02fl="Y" then AAIMMFL="Y";
else AAIMMFL="N"; | |
| BSSERON | Baseline serostatus (N) | integer | 8 | Numeric Code of Baseline serostatus
| Assigned if BSSEROC="Missing" then BSSERON=0; if BSSEROC="< LLOQ" then BSSERON=1; if BSSEROC=">= LLOQ" then BSSERON=2; | |
| BSSEROC | Baseline serostatus | text | 7 | Baseline serostatus
| Derived if base<islloq then BSSEROC="< LLOQ";
if base>=islloq then BSSEROC=">= LLOQ";
if missing baseline then BSSEROC="Missing" | |
| APERIOD | Period | integer | 8 | Period
| Derived if adt<TR02SDT or without TR02SDT or (adt=TR02SDT and index(visit, "V3_MONTH1_POSTVAX2")) then APERIOD=1;
if adt>TR02SDT or (adt=TR02SDT and index(visit, "V101_VAX3")) then APERIOD=2;
null if not dosed. | |
| APERIODC | Period (C) | text | 9 | Period (C)
| Assigned "Period x" where x is APERIOD | |
| APERSDTM | Period Start Datetime | integer | DATETIME20 | Derived TR01SDTM for Period 1; TR02SDTM for Period 2, | ||
| APEREDTM | Period End Datetime | integer | DATETIME20 | Derived For Period 1, min(TR01EDTM + 365days ,TR02SDTM) for subjects with TR02SDTM, TR01EDTM + 365 days for subjects without TR02SDTM; TR02EDTM + 365 days for Period 2 | ||
| BASE4F | Baseline Value for 4 Fold Rise | float | 8 | Derived AVAL from the record with ABLFL="Y" at USUBJID/PARAM level; if BASE<islloq or BASEC="BLQ" then BASE4F=islloq | ||
| R2BASE4F | Ratio to baseline for 4 Fold Rise | float | 8 | Derived R2BASE4F = AVAL/BASE4F for post baseline readings | ||
| FOLD4FL | Achieve 4-Fold Rise Flag | text | 1 | Y
| Derived if r2base4f ge 4 then fold4fl="Y" | |
| ISTSTDTL | Measurement, Test or Examination Detail | text | 11 | Predecessor: IS.ISTSTDTL | ||
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | ||
| AGEU | Age Units | text | 5 | Age Unit
| Predecessor: ADSL.AGEU | |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
| SEXN | Sex (N) | integer | 8 | Numeric Code of Sex
| Predecessor: ADSL.SEXN | |
| RACE | Race | text | 41 | Race [7 Terms] | Predecessor: ADSL.RACE | |
| RACEN | Race (N) | integer | 8 | Numeric Code of Race [7 Terms] | Predecessor: ADSL.RACEN | |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.RANDFL | |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFFL | |
| ARM | Description of Planned Arm | text | 29 | Description of Planned Arm [11 Terms] | Predecessor: ADSL.ARM | |
| ARMCD | Planned Arm Code | text | 9 | Planned Arm Code [11 Terms] | Predecessor: ADSL.ARMCD | |
| ACTARM | Description of Actual Arm | text | 29 | Description of Actual Arm [12 Terms] | Predecessor: ADSL.ACTARM | |
| ACTARMCD | Actual Arm Code | text | 9 | Actual Arm Code [12 Terms] | Predecessor: ADSL.ACTARMCD | |
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | ||
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | ||
| TRTSTM | Time of First Exposure to Treatment | integer | TIME8 | Predecessor: ADSL.TRTSTM | ||
| TRTETM | Time of Last Exposure to Treatment | integer | TIME8 | Predecessor: ADSL.TRTETM | ||
| TRT01A | Actual Treatment for Period 01 | text | 29 | TRT01A [9 Terms] | Predecessor: ADSL.TRT01A | |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | TRT01AN [9 Terms] | Predecessor: ADSL.TRT01AN | |
| TRT02A | Actual Treatment for Period 02 | text | 27 | TRT02A
| Predecessor: ADSL.TRT02A | |
| TRT02AN | Actual Treatment for Period 02 (N) | integer | 8 | TRT02AN
| Predecessor: ADSL.TRT02AN | |
| TRT01P | Planned Treatment for Period 01 | text | 29 | TRT01P [9 Terms] | Predecessor: ADSL.TRT01P | |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | TRT01PN [9 Terms] | Predecessor: ADSL.TRT01PN | |
| TRT02P | Planned Treatment for Period 02 | text | 27 | TRT02P
| Predecessor: ADSL.TRT02P | |
| TRT02PN | Planned Treatment for Period 02 (N) | integer | 8 | TRT02PN
| Predecessor: ADSL.TRT02PN | |
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | ||
| TR01STM | Time of First Exposure in Period 01 | integer | TIME8 | Predecessor: ADSL.TR01STM | ||
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | ||
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | ||
| TR01ETM | Time of Last Exposure in Period 01 | integer | TIME8 | Predecessor: ADSL.TR01ETM | ||
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | ||
| TR02SDT | Date of First Exposure in Period 02 | integer | DATE9 | Predecessor: ADSL.TR02SDT | ||
| TR02STM | Time of First Exposure in Period 02 | integer | TIME8 | Predecessor: ADSL.TR02STM | ||
| TR02SDTM | Datetime of First Exposure in Period 02 | integer | DATETIME20 | Predecessor: ADSL.TR02SDTM | ||
| TR02EDT | Date of Last Exposure in Period 02 | integer | DATE9 | Predecessor: ADSL.TR02EDT | ||
| TR02ETM | Time of Last Exposure in Period 02 | integer | TIME8 | Predecessor: ADSL.TR02ETM | ||
| TR02EDTM | Datetime of Last Exposure in Period 02 | integer | DATETIME20 | Predecessor: ADSL.TR02EDTM | ||
| COHORTN | Cohort Group (N) | float | 8 | Numeric Code of Cohort [13 Terms] | Predecessor: ADSL.COHORTN | |
| COHORT | Cohort Group | text | 75 | Cohort [13 Terms] | Predecessor: ADSL.COHORT | |
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Predecessor: ADSL.VAX101DT | ||
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Predecessor: ADSL.VAX102DT | ||
| VAX10UDT | Vaccination Date Unplanned | integer | DATE9 | Predecessor: ADSL.VAX10UDT | ||
| VAX201DT | Vaccination Date 03 | integer | DATE9 | Predecessor: ADSL.VAX201DT | ||
| VAX202DT | Vaccination Date 04 | integer | DATE9 | Predecessor: ADSL.VAX202DT | ||
| AAI01FL | Dose 1 all-available Immun Popu Flag | text | 1 | No Yes Response
| Predecessor: ADSL.AAI01FL | |
| EVAL02FL | Dose 2 evaluable Immun Popu Flag | text | 1 | No Yes Response
| Predecessor: ADSL.EVAL02FL | |
| AAI02FL | Dose 2 all-available Immun Popu Flag | text | 1 | No Yes Response
| Predecessor: ADSL.AAI02FL | |
| EVAL01FL | Dose 1 evaluable Immun Popu Flag | text | 1 | No Yes Response
| Predecessor: ADSL.EVAL01FL | |
| DOSALVL | Actual Dosing Level | text | 52 | Actual Dosing Level
| Predecessor: ADSL.DOSALVL | |
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Numeric Code of Actual Dosing Level
| Predecessor: ADSL.DOSALVLN | |
| DOSPLVL | Planned Dosing Level | text | 52 | Planned Dosing Level
| Predecessor: ADSL.DOSPLVL | |
| DOSPLVLN | Planned Dosing Level (N) | integer | 8 | Numeric Code of Planned Dosing Level
| Predecessor: ADSL.DOSPLVLN | |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 | |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Numeric Code of Pooled Age Group 1
| Predecessor: ADSL.AGEGR1N | |
| AGEGR2 | Pooled Age Group 2 | text | 10 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 | |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Numeric Code of Pooled Age Group 2
| Predecessor: ADSL.AGEGR2N | |
| AGEGR4 | Pooled Age Group 4 | text | 11 | Pooled Age Group 4
| Predecessor: ADSL.AGEGR4 | |
| AGEGR4N | Pooled Age Group 4 (N) | integer | 8 | Numeric Code of Pooled Age Group 4
| Predecessor: ADSL.AGEGR4N | |
| PHASE | Study Phase | text | 20 | Study Phase
| Predecessor: ADSL.PHASE | |
| PHASEN | Study Phase (N) | integer | 8 | Numeric Code of Study Phase
| Predecessor: ADSL.PHASEN | |
| COVBLST | Baseline SARS-CoV-2 Status | text | 3 | Baseline SARS-CoV-2 Status
| Predecessor: ADSL.COVBLST | |
| HIVFL | HIV Positive Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.HIVFL | |
| PEDIMMFL | Pop for Non-inferiority Assessement | text | 1 | No Yes Response
| Predecessor: ADSL.PEDIMMFL | |
| EV1MD2FL | Subject without Evidence 1MPD2 | text | 1 | No Yes Response
| Predecessor: ADSL.EV1MD2FL | |
| AGETR01 | Age at Vaccination 01 | integer | 8 | Predecessor: ADSL.AGETR01 | ||
| VAX101 | Vaccination 01 | text | 37 | Predecessor: ADSL.VAX101 | ||
| VAX102 | Vaccination 02 | text | 36 | Predecessor: ADSL.VAX102 | ||
| VAX10U | Vaccination Unplanned | text | 36 | Predecessor: ADSL.VAX10U | ||
| VAX201 | Vaccination 03 | text | 36 | Predecessor: ADSL.VAX201 | ||
| VAX202 | Vaccination 04 | text | 36 | Predecessor: ADSL.VAX202 | ||
| VAX20U | Vaccination Unplanned in Period 02 | text | 1 | Predecessor: ADSL.VAX20U | ||
| VAX20UDT | Vaccination Date Unplanned in Period 02 | integer | DATE9 | Predecessor: ADSL.VAX20UDT | ||
| UNBLNDDT | Treatment Unblinded Date | integer | DATE9 | Predecessor: ADSL.UNBLNDDT | ||
| MULENRFL | Multiply Enrolled Subjects | text | 1 | Y
| Predecessor: ADSL.MULENRFL | |
| RAND1FL | Random - exclude Multi-Enrolloer | text | 1 | No Yes Response
| Predecessor: ADSL.RAND1FL | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | ||
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM |
Go to the top of the Define-XML document
Adverse Events Analysis Dataset (ADAE)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | |
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | |
| ARM | Description of Planned Arm | text | 29 | Description of Planned Arm [11 Terms] | Predecessor: ADSL.ARM |
| ARMCD | Planned Arm Code | text | 9 | Planned Arm Code [11 Terms] | Predecessor: ADSL.ARMCD |
| ACTARM | Description of Actual Arm | text | 29 | Description of Actual Arm [12 Terms] | Predecessor: ADSL.ACTARM |
| ACTARMCD | Actual Arm Code | text | 9 | Actual Arm Code [12 Terms] | Predecessor: ADSL.ACTARMCD |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | Age Unit
| Predecessor: ADSL.AGEU |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Numeric Code of Pooled Age Group 1
| Predecessor: ADSL.AGEGR1N |
| AGEGR2 | Pooled Age Group 2 | text | 10 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Numeric Code of Pooled Age Group 2
| Predecessor: ADSL.AGEGR2N |
| AGEGR3 | Pooled Age Group 3 | text | 11 | Pooled Age Group 3
| Predecessor: ADSL.AGEGR3 |
| AGEGR3N | Pooled Age Group 3 (N) | integer | 8 | Numeric Code of Pooled Age Group 3
| Predecessor: ADSL.AGEGR3N |
| AGEGR4 | Pooled Age Group 4 | text | 11 | Pooled Age Group 4
| Predecessor: ADSL.AGEGR4 |
| AGEGR4N | Pooled Age Group 4 (N) | integer | 8 | Numeric Code of Pooled Age Group 4
| Predecessor: ADSL.AGEGR4N |
| RACE | Race | text | 41 | Race [7 Terms] | Predecessor: ADSL.RACE |
| RACEN | Race (N) | integer | 8 | Numeric Code of Race [7 Terms] | Predecessor: ADSL.RACEN |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX |
| SEXN | Sex (N) | integer | 8 | Numeric Code of Sex
| Predecessor: ADSL.SEXN |
| ETHNIC | Ethnicity | text | 22 | Ethnic Group
| Predecessor: ADSL.ETHNIC |
| ETHNICN | Ethnicity (N) | integer | 8 | Numeric Code of Ethnic Group
| Predecessor: ADSL.ETHNICN |
| COUNTRY | Country | text | ISO 3166 | Predecessor: ADSL.COUNTRY | |
| ARACE | Analysis Race | text | 41 | Analysis Race [7 Terms] | Predecessor: ADSL.ARACE |
| ARACEN | Analysis Race (N) | integer | 8 | Numeric Code of Analysis Race [7 Terms] | Predecessor: ADSL.ARACEN |
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | |
| TRTSTM | Time of First Exposure to Treatment | integer | TIME8 | Predecessor: ADSL.TRTSTM | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | |
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | |
| TRTETM | Time of Last Exposure to Treatment | integer | TIME8 | Predecessor: ADSL.TRTETM | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | |
| TRT01A | Actual Treatment for Period 01 | text | 29 | TRT01A [9 Terms] | Predecessor: ADSL.TRT01A |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | TRT01AN [9 Terms] | Predecessor: ADSL.TRT01AN |
| TRT01P | Planned Treatment for Period 01 | text | 29 | TRT01P [9 Terms] | Predecessor: ADSL.TRT01P |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | TRT01PN [9 Terms] | Predecessor: ADSL.TRT01PN |
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Predecessor: ADSL.VAX101DT | |
| VAX101TM | Vaccination Time 01 | integer | TIME8 | Predecessor: ADSL.VAX101TM | |
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Predecessor: ADSL.VAX102DT | |
| VAX102TM | Vaccination Time 02 | integer | TIME8 | Predecessor: ADSL.VAX102TM | |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFFL |
| COHORT | Cohort Group | text | 75 | Cohort [13 Terms] | Predecessor: ADSL.COHORT |
| COHORTN | Cohort Group (N) | float | 8 | Numeric Code of Cohort [13 Terms] | Predecessor: ADSL.COHORTN |
| DOSALVL | Actual Dosing Level | text | 52 | Actual Dosing Level
| Predecessor: ADSL.DOSALVL |
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Numeric Code of Actual Dosing Level
| Predecessor: ADSL.DOSALVLN |
| DOSPLVL | Planned Dosing Level | text | 52 | Planned Dosing Level
| Predecessor: ADSL.DOSPLVL |
| DOSPLVLN | Planned Dosing Level (N) | integer | 8 | Numeric Code of Planned Dosing Level
| Predecessor: ADSL.DOSPLVLN |
| VAX101 | Vaccination 01 | text | 37 | Predecessor: ADSL.VAX101 | |
| VAX102 | Vaccination 02 | text | 36 | Predecessor: ADSL.VAX102 | |
| V01DT | Date of Unblinding or Visit at 1MPD2 | integer | DATE9 | Predecessor: ADSL.V01DT | |
| V02DT | Date of Unblinding or Visit at 6MPD2 | integer | DATE9 | Predecessor: ADSL.V02DT | |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.RANDFL |
| PHASE | Study Phase | text | 20 | Study Phase
| Predecessor: ADSL.PHASE |
| PHASEN | Study Phase (N) | integer | 8 | Numeric Code of Study Phase
| Predecessor: ADSL.PHASEN |
| DS30KFL | Phase 3 30k Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DS30KFL |
| COVBLST | Baseline SARS-CoV-2 Status | text | 3 | Baseline SARS-CoV-2 Status
| Predecessor: ADSL.COVBLST |
| MULENRFL | Multiply Enrolled Subjects | text | 1 | Y
| Predecessor: ADSL.MULENRFL |
| UNBLNDDT | Treatment Unblinded Date | integer | DATE9 | Predecessor: ADSL.UNBLNDDT | |
| VAX10U | Vaccination Unplanned | text | 36 | Predecessor: ADSL.VAX10U | |
| VAX201 | Vaccination 03 | text | 36 | Predecessor: ADSL.VAX201 | |
| VAX202 | Vaccination 04 | text | 36 | Predecessor: ADSL.VAX202 | |
| VAX10UDT | Vaccination Date Unplanned | integer | DATE9 | Predecessor: ADSL.VAX10UDT | |
| VAX10UTM | Vaccination Time Unplanned | integer | TIME8 | Predecessor: ADSL.VAX10UTM | |
| VAX201DT | Vaccination Date 03 | integer | DATE9 | Predecessor: ADSL.VAX201DT | |
| VAX202DT | Vaccination Date 04 | integer | DATE9 | Predecessor: ADSL.VAX202DT | |
| VAX201TM | Vaccination Time 03 | integer | TIME8 | Predecessor: ADSL.VAX201TM | |
| VAX202TM | Vaccination Time 04 | integer | TIME8 | Predecessor: ADSL.VAX202TM | |
| V03DT | Date of Visit at 1M after Vax4 | integer | DATE9 | Predecessor: ADSL.V03DT | |
| V04DT | Date of Visit at 6M after Vax4 | integer | DATE9 | Predecessor: ADSL.V04DT | |
| TRT02A | Actual Treatment for Period 02 | text | 27 | TRT02A
| Predecessor: ADSL.TRT02A |
| TRT02AN | Actual Treatment for Period 02 (N) | integer | 8 | TRT02AN
| Predecessor: ADSL.TRT02AN |
| TRT02P | Planned Treatment for Period 02 | text | 27 | TRT02P
| Predecessor: ADSL.TRT02P |
| TRT02PN | Planned Treatment for Period 02 (N) | integer | 8 | TRT02PN
| Predecessor: ADSL.TRT02PN |
| HIVFL | HIV Positive Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.HIVFL |
| DS3KFL | Phase 3 3000 Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DS3KFL |
| EOTXDCDT | End Of Open Label Treatment D/C Date | integer | DATE9 | Predecessor: ADSL.EOTXDCDT | |
| BDCSRDT | Double Blinded Follow-up Censor Date | integer | DATE9 | Predecessor: ADSL.BDCSRDT | |
| X1CSRDT | Crossover Dose1 Censor Date | integer | DATE9 | Predecessor: ADSL.X1CSRDT | |
| FUP1UNB | PD1 FU Time in Days: to Unblinding | integer | 8 | Predecessor: ADSL.FUP1UNB | |
| FPX1CUT | Post Xover D1 FUTM in Days: to Cutoff | integer | 8 | Predecessor: ADSL.FPX1CUT | |
| FUNBCUT | Unblinding FUTM in Days: to Cutoff | integer | 8 | Predecessor: ADSL.FUNBCUT | |
| FUP1CUT | PD1 FU Time in Days: to Cutoff | integer | 8 | Predecessor: ADSL.FUP1CUT | |
| AGETR01 | Age at Vaccination 01 | integer | 8 | Predecessor: ADSL.AGETR01 | |
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | |
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | |
| TR02SDTM | Datetime of First Exposure in Period 02 | integer | DATETIME20 | Predecessor: ADSL.TR02SDTM | |
| TR02EDTM | Datetime of Last Exposure in Period 02 | integer | DATETIME20 | Predecessor: ADSL.TR02EDTM | |
| VAX20U | Vaccination Unplanned in Period 02 | text | 1 | Predecessor: ADSL.VAX20U | |
| VAX20UDT | Vaccination Date Unplanned in Period 02 | integer | DATE9 | Predecessor: ADSL.VAX20UDT | |
| RAND1FL | Random - exclude Multi-Enrolloer | text | 1 | No Yes Response
| Predecessor: ADSL.RAND1FL |
| SAF1FL | Safety - excld Multi-Enrolloer&HIV&IND | text | 1 | No Yes Response
| Predecessor: ADSL.SAF1FL |
| SAF2FL | Safety - exclude Multi-Enrolloer&IND | text | 1 | No Yes Response
| Predecessor: ADSL.SAF2FL |
| STUDYID | Study Identifier | text | 8 | Predecessor: AE.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: AE.USUBJID | |
| AESEQ | Sequence Number | integer | 8 | Predecessor: AE.AESEQ | |
| AECAT | Category for Adverse Event | text | 16 | Category for Adverse Event
| Predecessor: AE.AECAT |
| AESPID | Sponsor-Defined Identifier | text | 2 | Predecessor: AE.AESPID | |
| AETERM | Reported Term for the Adverse Event | text | 100 | Predecessor: AE.AETERM | |
| AEDECOD | Dictionary-Derived Term | text | 51 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Derived AE.AEDECOD
if AE.AEDECOD eq '' and not missing(AE.AETERM))) then AEDECOD=upcase(strip(AE.AETERM)) || "@@" |
| AEBDSYCD | Body System or Organ Class Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: AE.AEBDSYCD |
| AEBODSYS | Body System or Organ Class | text | 67 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: AE.AEBODSYS |
| AELLT | Lowest Level Term | text | 60 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: AE.AELLT |
| AELLTCD | Lowest Level Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: AE.AELLTCD |
| AEPTCD | Preferred Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: AE.AEPTCD |
| AEHLT | High Level Term | text | 79 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: AE.AEHLT |
| AEHLTCD | High Level Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: AE.AEHLTCD |
| AEHLGT | High Level Group Term | text | 86 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: AE.AEHLGT |
| AEHLGTCD | High Level Group Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: AE.AEHLGTCD |
| AESOC | Primary System Organ Class | text | 67 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: AE.AESOC |
| AESOCCD | Primary System Organ Class Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: AE.AESOCCD |
| AESTDTC | Start Date/Time of Adverse Event | datetime | ISO 8601 | ISO 8601 | Predecessor: AE.AESTDTC |
| AESTDY | Study Day of Start of Adverse Event | integer | 8 | Predecessor: AE.AESTDY | |
| AEENDTC | End Date/Time of Adverse Event | datetime | ISO 8601 | ISO 8601 | Predecessor: AE.AEENDTC |
| AEENDY | Study Day of End of Adverse Event | integer | 8 | Predecessor: AE.AEENDY | |
| AEENRTPT | End Relative to Reference Time Point | text | 7 | Relation to Reference Period
| Predecessor: AE.AEENRTPT |
| AEENTPT | End Reference Time Point | text | 22 | Predecessor: AE.AEENTPT | |
| AETOXGR | Standard Toxicity Grade | text | 1 | Standard Toxicity Grade
| Predecessor: AE.AETOXGR |
| DICTVER | Dictionary Name and Version | text | 12 | Predecessor: SUPPAE.QVAL where SUPPAE.QNAM='DICTVER' | |
| ADESFL | Discontinued due to AE | text | 1 | No Yes Response
| Derived If (index (upcase(AEACN),'DRUG WITHDRAWN') > 0 or AESUBJDC='Y') then ADESFL=”Y” else ADESFL=N. |
| ASTDT | Analysis Start Date | integer | DATE9 | Derived Convert imputed AESTDTC to DATE9 format.
Imputate partial start date per Vaccine Rule Book.
Firstly:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year.
no imputation for complete missing start date.
Secondly:
If day is missing, and at the same year and month of the vaccination, impute to the first vaccination date of that month.
if month is missing, and at the same year of the vaccination, impute to the first vaccination date of that year. | |
| ASTDTF | Analysis Start Date Imputation Flag | text | 1 | Date Imputation Flag
| Derived = "D" if day is imputed.
= "M" if month and day are imputed.
= "Y" if month, day and year are imputed |
| ASTDY | Analysis Start Relative Day | integer | 8 | Derived if (ASTDT<ADSL.VAX101DT) then ASTDY= ASTDT – ADSL.VAX101DT;
else ASTDY= ASTDT – most recent dosing date before the AE + 1
Note: Use relative vaccination date (Last vaccination date prior to the onset of the AE) to calculate ASTDY. | |
| ASTTM | Analysis Start Time | integer | TIME8 | Derived Timepart of AE.AESTDTC | |
| ASTDTM | Analysis Start Date/Time | integer | DATETIME20 | Derived Convert AESTDTC to IS8601 format. | |
| AENDT | Analysis End Date | integer | DATE9 | Derived Convert AEENDTC to DATE9 format
Note: No imputation for AENDT, all imputing will be based on pfizer standards. | |
| AENDY | Analysis End Relative Day | integer | 8 | Derived For AEs without time collected:
if (ASTDT<ADSL.VAX101DT) then AENDY= AENDT – ADSL.VAX101DT;
if (ASTDT>= ADSL.VAX101DT and ADSL.VAX101DT>.) and (ASTDT<ADSL.VAX102DT or ADSL.VAX102DT=.) then AENDY= AENDT – ADSL.VAX101DT + 1;
if (ASTDT>= ADSL.VAX102DT and ADSL.VAX102DT>.) and (ASTDT<ADSL.VAX201DT or ADSL.VAX201DT=.) then AENDY= AENDT – ADSL.VAX102DT + 1;
if (ASTDT>=ADSL.VAX201DT and ADSL.VAX201DT>.) and (ASTDT<ADSL.VAX202DT or ADSL.VAX202DT=. ) then AENDY= AENDT – ADSL.VAX201DT + 1;
if (ASTDT>=ADSL.VAX202DT and ADSL.VAX202DT>.) then AENDY= AENDT – ADSL.VAX202DT + 1;
For AEs with time collected:
Similar logic as AEs without time, but need to compare the AE happened time with the exact time of vaccination. eg: For AE happend on the same day of the vaccination 2, if AE start time is collected, then the AE start time need to be compared with the time of vaccination 2. If AE happened before the time of vaccination 2, AENDY=AENDT-ADSL.VAX101DT+1. Otherwise if AE happened after the time of vacciantion 2 then AENDY=AENDT- ADSL.VAX102DT+1;
Note: Use relative vaccination date (Last vaccination date prior to the onset of the AE) to calculate AENDY. | |
| AENTM | Analysis End Time | integer | TIME8 | Derived Timepart of AE.AEENDTC | |
| AENDTM | Analysis End Date/Time | integer | DATETIME20 | Derived Convert AEENDTC to IS8601 format. | |
| ADURN | Analysis Duration (N) | integer | 8 | Derived ADURN in Days: ADURN= AENDT - ASTDT+1 and ADURU =’DAYS’ | |
| ADURU | Analysis Duration Units | text | 4 | Unit
| Assigned Assign value 'DAYS' if ADURN is not missing |
| AESER | Serious Event | text | 1 | No Yes Response
| Predecessor: AE.AESER |
| AESCONG | Congenital Anomaly or Birth Defect | text | 1 | No Yes Response
| Predecessor: AE.AESCONG |
| AESDISAB | Persist or Signif Disability/Incapacity | text | 1 | No Yes Response
| Predecessor: AE.AESDISAB |
| AESDTH | Results in Death | text | 1 | No Yes Response
| Predecessor: AE.AESDTH |
| AESHOSP | Requires or Prolongs Hospitalization | text | 1 | No Yes Response
| Predecessor: AE.AESHOSP |
| AESLIFE | Is Life Threatening | text | 1 | No Yes Response
| Predecessor: AE.AESLIFE |
| AESMIE | Other Medically Important Serious Event | text | 1 | No Yes Response
| Predecessor: AE.AESMIE |
| AEMERES | Is AE a Result of a Medication Error | text | 1 | No Yes Response
| Predecessor: SUPPAE.QVAL where SUPPAE.QNAM='AEMERES' |
| AEREL | Causality | text | 11 | Causality
| Predecessor: AE.AEREL |
| AERELNST | Relationship to Non-Study Treatment | text | 30 | Predecessor: AE.AERELNST | |
| AERELTXT | Event Due to Other Specify | text | 80 | Predecessor: SUPPAE.QVAL where SUPPAE.QNAM='AERELTXT' | |
| AEACN | Action Taken with Study Treatment | text | 16 | Predecessor: AE.AEACN | |
| AECMGIV | Concomitant Medication Given | text | 1 | No Yes Response
| Predecessor: SUPPAE.QVAL where SUPPAE.QNAM='AECMGIV' |
| AENDGIV | Was a Non-Drug Treatment given | text | 1 | No Yes Response
| Predecessor: SUPPAE.QVAL where SUPPAE.QNAM='AENDGIV' |
| AEOUT | Outcome of Adverse Event | text | 32 | Outcome of Event [6 Terms] | Predecessor: AE.AEOUT |
| AESUBJDC | Discontinued because of this AE | text | 1 | No Yes Response
| Predecessor: SUPPAE.QVAL where SUPPAE.QNAM='AESUBJDC' |
| AEREFID | Reference ID | text | 10 | Predecessor: AE.AEREFID | |
| AERELN | Causality (N) | integer | 8 | Numeric Code of Causality
| Assigned Numeric Code of AEREL: AERELN=1 for RELATED; ARRELN=3 for NOT RELATED |
| AREL | Analysis Causality | text | 11 | Analysis Causality
| Predecessor: AE.AEREL |
| ARELN | Analysis Causality (N) | integer | 8 | Numeric Code of Analysis Causality
| Assigned Numeric Code of AREL: If AREL = RELATED then ARELN=1; else If AREL = NOT RELATED then ARELN=3; |
| AETOXGRN | Standard Toxicity Grade (N) | integer | 8 | Numeric Code of Standard Toxicity Grade
| Assigned Numeric Code of AE.AETOXGR 1=Grade 1; 2=Grade 2; 3=Grade 3; 4=Grade 4 |
| ATOXGR | Analysis Toxicity Grade | text | 7 | Analysis Toxicity Grade
| Derived ATOXGR="GRADE "|| strip(AETOXGR) |
| ATOXGRN | Analysis Toxicity Grade (N) | integer | 8 | Numeric Code of Analysis Toxicity Grade
| Assigned Numeric Code of AE.ATOXGR 1=Grade 1; 2=Grade 2; 3=Grade 3; 4=Grade 4 |
| AEMEFL | Medication Error Associated With AE | text | 1 | No Yes Response
| Predecessor: SUPPAE.QVAL where SUPPAE.QNAM='AEMEFL' |
| AETPDOS | Time Post Dose | integer | 8 | Derived If ( ASTDTM >ADSL.TRTSDTM ) and select the record with minimum positive value of ASTDTM-EX.EXSTDTC then set AETPDOS = round((ASTDTM - EX.EXSTDTM)/60,1.).
if (ASTDTM < ADSL.TRTSDTM and ASTDTM is not missing then AETPDOS = round((ASTDTM - ADSL.TRTSDTM)/60,1.). | |
| AEIMMFL | Vaccine Studies AE Immediate flag | text | 1 | Y
| Derived If 0<=AETPDOS < = 30 mins (0.5 hours) then AEIMMFL=”Y” else null
Note: Immediate AE is defined as AEs happened within 30 mins after corresponding vaccination |
| APERIOD | Period | integer | 8 | Period
| Derived Numeric Code of aperiodc
1 for AEs happened before ADSL.TR02SDTM or VAX3 is missing
2 for AEs happened after or on ADSL.TR02SDTM |
| APERIODC | Period (C) | text | 9 | Period (C)
| Assigned aperiodc='Period 01' when APERIOD=1 aperiodc='Period 02' when APERIOD=2 |
| APERSDT | Period Start Date | integer | DATE9 | Derived Datepart(APERSDTM) | |
| APERSTM | Period Start Time | integer | TIME8 | Derived Timepart(APERSDTM) | |
| APERSDTM | Period Start Date/Time | integer | DATETIME20 | Derived for APERIOD=1, APERSDTM = datetime of (ADSL.TRTSDTM)
for APERIOD=2, APERSDTM = datetime of (ADSL.TR02SDTM) | |
| APEREDT | Period End Date | integer | DATE9 | Derived Datepart(APEREDTM) | |
| APERETM | Period End Time | integer | TIME8 | Derived Timepart(APEREDTM) | |
| APEREDTM | Period End Date/Time | integer | DATETIME20 | Derived for APERIOD=1,
APEREDTM = ADSL.TR02SDTM -1 ;
if VAX3 is missing then APEREDTM =ADSL.TR01EDTM +365 days;
for APERIOD=2,
APEREDTM =ADSL.TR02EDTM +365 days | |
| VPHASE | Vaccine Phase | text | 41 | ADAE.VPHASE [9 Terms] | Derived If AE happened before vax 1 then VPHASE='Pre-Vaccination'; (Note: AE start time is collected per CRF)
If AE happened on or after vax1 and (before vax2 or vax2 is missing) then VPHASE='Vaccination 1';
if AE happened on or after vax2 and before or on the same day ADSL.V01DT then VPHASE='Vaccination 2';
if AE happened after of ADSL.V01DT and before or on the same day ADSL.V02DT then VPHASE='Follow Up 1';
if AE happened after of ADSL.V02DT then VPHASE='Follow Up 2';
if AE happened on or after unblinded date and (before vax3 or vax3 is missing) then VPHASE='After unblinding and before Vaccination 3';
If AE happened on or after vax3 and (before vax4 or vax4 is missing) then VPHASE='Vaccination 3';
if AE happened on or after vax4 and before or on the same day ADSL.V03DT then VPHASE='Vaccination 4';
if AE happened after ADSL.V03DT and before or on the same day ADSL.V04DT then VPHASE='Follow Up 3';
if AE happened after ADSL.V04DT then VPHASE='Follow Up 4'; |
| VPHASEN | Vaccine Phase(N) | integer | 8 | ADAE.VPHASEN [9 Terms] | Assigned VPHASEN=0 when VPHASE='Pre-Vaccination'; VPHASEN=1 when VPHASE='Vaccination 1'; VPHASEN=2 when VPHASE='Vaccination 2; VPHASEN=3 when VPHASE='Follow Up 1'; VPHASEN=99 when VPHASE='Follow Up 2'; VPHASEN=4 when VPHASE='After unblinding and before Vaccination 3'; VPHASEN=5 when VPHASE='Vaccination 3'; VPHASEN=6 when VPHASE='Vaccination 4; VPHASEN=7 when VPHASE='Follow Up 3'; VPHASEN=100 when VPHASE='Follow Up 4'; |
| INWDFL | Within Reporting Window Flag | text | 1 | Y
| Derived if VPHASEN ne . and VPHASEN not in (0, 99, 4, 100) then INWDFL = "Y" |
| PREFL | Pre-treatment Flag | text | 1 | Y
| Derived ASTDTM<TRTSDTM then PREFL="Y" |
| VAXNO | AE Occured after Which Vaccination | integer | 8 | Derived the number of last vaccine before AE occurred.
if AE happened in VPHASE 'After unblinding and before Vaccination 3', then set VAXNO to most latest Dose before the AE. | |
| V02OBDT | Date of Dose 3 or Visit at 6MPD2 | integer | DATE9 | Predecessor: ADSL.V02OBDT | |
| RACEGR1 | Pooled Race Group 1 | text | 25 | Pooled Race Group 1
| Predecessor: ADSL.RACEGR1 |
| RACEGR1N | Pooled Race Group 1 (N) | integer | 8 | Numeric Code of Pooled Race Group 1
| Predecessor: ADSL.RACEGR1N |
Go to the top of the Define-XML document
Diary and CRF Event Analysis Dataset (ADCEVD)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: CE.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: CE.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | |
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | Age Unit
| Predecessor: ADSL.AGEU |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX |
| SEXN | Sex (N) | integer | 8 | Numeric Code of Sex
| Predecessor: ADSL.SEXN |
| RACE | Race | text | 41 | Race [7 Terms] | Predecessor: ADSL.RACE |
| RACEN | Race (N) | integer | 8 | Numeric Code of Race [7 Terms] | Predecessor: ADSL.RACEN |
| ARACE | Analysis Race | text | 41 | Analysis Race [7 Terms] | Predecessor: ADSL.ARACE |
| ARACEN | Analysis Race (N) | integer | 8 | Numeric Code of Analysis Race [7 Terms] | Predecessor: ADSL.ARACEN |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFFL |
| ARM | Description of Planned Arm | text | 29 | Description of Planned Arm [11 Terms] | Predecessor: ADSL.ARM |
| ARMCD | Planned Arm Code | text | 9 | Planned Arm Code [11 Terms] | Predecessor: ADSL.ARMCD |
| ACTARM | Description of Actual Arm | text | 29 | Description of Actual Arm [12 Terms] | Predecessor: ADSL.ACTARM |
| ACTARMCD | Actual Arm Code | text | 9 | Actual Arm Code [12 Terms] | Predecessor: ADSL.ACTARMCD |
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | |
| TRTSTM | Time of First Exposure to Treatment | integer | TIME8 | Predecessor: ADSL.TRTSTM | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | |
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | |
| TRTETM | Time of Last Exposure to Treatment | integer | TIME8 | Predecessor: ADSL.TRTETM | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | |
| TRT01A | Actual Treatment for Period 01 | text | 29 | TRT01A [9 Terms] | Predecessor: ADSL.TRT01A |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | TRT01AN [9 Terms] | Predecessor: ADSL.TRT01AN |
| TRT02A | Actual Treatment for Period 02 | text | 27 | TRT02A
| Predecessor: ADSL.TRT02A |
| TRT02AN | Actual Treatment for Period 02 (N) | integer | 8 | TRT02AN
| Predecessor: ADSL.TRT02AN |
| TRT01P | Planned Treatment for Period 01 | text | 29 | TRT01P [9 Terms] | Predecessor: ADSL.TRT01P |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | TRT01PN [9 Terms] | Predecessor: ADSL.TRT01PN |
| TRT02P | Planned Treatment for Period 02 | text | 27 | TRT02P
| Predecessor: ADSL.TRT02P |
| TRT02PN | Planned Treatment for Period 02 (N) | integer | 8 | TRT02PN
| Predecessor: ADSL.TRT02PN |
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | |
| TR01STM | Time of First Exposure in Period 01 | integer | TIME8 | Predecessor: ADSL.TR01STM | |
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | |
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | |
| TR01ETM | Time of Last Exposure in Period 01 | integer | TIME8 | Predecessor: ADSL.TR01ETM | |
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | |
| TR02SDT | Date of First Exposure in Period 02 | integer | DATE9 | Predecessor: ADSL.TR02SDT | |
| TR02STM | Time of First Exposure in Period 02 | integer | TIME8 | Predecessor: ADSL.TR02STM | |
| TR02SDTM | Datetime of First Exposure in Period 02 | integer | DATETIME20 | Predecessor: ADSL.TR02SDTM | |
| TR02EDT | Date of Last Exposure in Period 02 | integer | DATE9 | Predecessor: ADSL.TR02EDT | |
| TR02ETM | Time of Last Exposure in Period 02 | integer | TIME8 | Predecessor: ADSL.TR02ETM | |
| TR02EDTM | Datetime of Last Exposure in Period 02 | integer | DATETIME20 | Predecessor: ADSL.TR02EDTM | |
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Predecessor: ADSL.VAX101DT | |
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Predecessor: ADSL.VAX102DT | |
| COHORT | Cohort Group | text | 75 | Cohort [13 Terms] | Predecessor: ADSL.COHORT |
| COHORTN | Cohort Group (N) | float | 8 | Numeric Code of Cohort [13 Terms] | Predecessor: ADSL.COHORTN |
| PHASE | Study Phase | text | 20 | Study Phase
| Predecessor: ADSL.PHASE |
| PHASEN | Study Phase (N) | integer | 8 | Numeric Code of Study Phase
| Predecessor: ADSL.PHASEN |
| DOSPLVL | Planned Dosing Level | text | 52 | Planned Dosing Level
| Predecessor: ADSL.DOSPLVL |
| DOSPLVLN | Planned Dosing Level (N) | integer | 8 | Numeric Code of Planned Dosing Level
| Predecessor: ADSL.DOSPLVLN |
| DOSALVL | Actual Dosing Level | text | 52 | Actual Dosing Level
| Predecessor: ADSL.DOSALVL |
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Numeric Code of Actual Dosing Level
| Predecessor: ADSL.DOSALVLN |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Numeric Code of Pooled Age Group 1
| Predecessor: ADSL.AGEGR1N |
| AGEGR2 | Pooled Age Group 2 | text | 10 | Pooled Age Group 2
| Predecessor: ADSL.AGEGR2 |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Numeric Code of Pooled Age Group 2
| Predecessor: ADSL.AGEGR2N |
| AGEGR4 | Pooled Age Group 4 | text | 11 | Pooled Age Group 4
| Predecessor: ADSL.AGEGR4 |
| AGEGR4N | Pooled Age Group 4 (N) | integer | 8 | Numeric Code of Pooled Age Group 4
| Predecessor: ADSL.AGEGR4N |
| VAX101 | Vaccination 01 | text | 37 | Predecessor: ADSL.VAX101 | |
| VAX102 | Vaccination 02 | text | 36 | Predecessor: ADSL.VAX102 | |
| DS30KFL | Phase 3 30k Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DS30KFL |
| COVBLST | Baseline SARS-CoV-2 Status | text | 3 | Baseline SARS-CoV-2 Status
| Predecessor: ADSL.COVBLST |
| MULENRFL | Multiply Enrolled Subjects | text | 1 | Y
| Predecessor: ADSL.MULENRFL |
| HIVFL | HIV Positive Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.HIVFL |
| PEDREAFL | Phase 2/3 Pop for 12-25 Reacto Subset | text | 1 | No Yes Response
| Predecessor: ADSL.PEDREAFL |
| UNBLNDDT | Treatment Unblinded Date | integer | DATE9 | Predecessor: ADSL.UNBLNDDT | |
| DS3KFL | Phase 3 3000 Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DS3KFL |
| REACTOFL | Reactogenicity Population Flag | text | 1 | Y
| Predecessor: ADSL.REACTOFL |
| AGETR01 | Age at Vaccination 01 | integer | 8 | Predecessor: ADSL.AGETR01 | |
| VAX10U | Vaccination Unplanned | text | 36 | Predecessor: ADSL.VAX10U | |
| VAX10UDT | Vaccination Date Unplanned | integer | DATE9 | Predecessor: ADSL.VAX10UDT | |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.RANDFL |
| RAND1FL | Random - exclude Multi-Enrolloer | text | 1 | No Yes Response
| Predecessor: ADSL.RAND1FL |
| SAF1FL | Safety - excld Multi-Enrolloer&HIV&IND | text | 1 | No Yes Response
| Predecessor: ADSL.SAF1FL |
| SAF2FL | Safety - exclude Multi-Enrolloer&IND | text | 1 | No Yes Response
| Predecessor: ADSL.SAF2FL |
| TRTA | Actual Treatment | text | 29 | TRTA [9 Terms] | Derived if (VAX101='Placebo' and CETPTREF="VACCINATION 1") or (VAX102='Placebo' and CETPTREF="VACCINATION 2") then TRTA='Placebo';
else ADSL.TRT01A. |
| TRTAN | Actual Treatment (N) | integer | 8 | TRTAN [9 Terms] | Derived if (VAX101='Placebo' and CETPTREF="VACCINATION 1") or (VAX102='Placebo' and CETPTREF="VACCINATION 2") then TRTAN=9';
else ADSL.TRT01AN. |
| TRTP | Planned Treatment | text | 29 | TRTP [9 Terms] | Predecessor: ADSL.TRT01P |
| TRTPN | Planned Treatment (N) | integer | 8 | TRTPN [9 Terms] | Predecessor: ADSL.TRT01PN |
| SRCDOM | Source Data | text | 2 | Predecessor: CE.DOMAIN | |
| SRCSEQ | Source Sequence Number | integer | 8 | Predecessor: CE.CESEQ | |
| CEGRPID | Group ID | text | 33 | Predecessor: CE.CEGRPID | |
| CELNKGRP | Link Group ID | text | 57 | Predecessor: CE.CELNKGRP | |
| CETERM | Reported Term for the Clinical Event | text | 22 | Predecessor: CE.CETERM | |
| CELLT | Lowest Level Term | text | 19 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: CE.CELLT |
| CEDECOD | Dictionary-Derived Term | text | 19 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: CE.CEDECOD |
| CEPTCD | Preferred Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: CE.CEPTCD |
| CEBODSYS | Body System or Organ Class | text | 52 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: CE.CEBODSYS |
| CEBDSYCD | Body System or Organ Class Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: CE.CEBDSYCD |
| CECAT | Category for Clinical Event | text | 14 | Clinical Events Category
| Predecessor: CE.CECAT |
| CESCAT | Subcategory for Clinical Event | text | 19 | Subcategory for Clinical Event
| Predecessor: CE.CESCAT |
| CEPRESP | Clinical Event Pre-Specified | text | 1 | No Yes Response
| Predecessor: CE.CEPRESP |
| CEOCCUR | Clinical Event Occurrence | text | 1 | No Yes Response
| Predecessor: CE.CEOCCUR |
| CESTAT | Completion Status | text | 1 | Not Done
| Predecessor: CE.CESTAT |
| CEREASND | Reason Clinical Event Not Collected | text | 1 | Predecessor: CE.CEREASND | |
| ASEV | Analysis Severity/Intensity | text | 6 | Derived Set to 'Severe' for cases in FACE: 1) where FACE.FADTC is within 7 days after each vaccination and (FACE.FATESTCD in ('DIAMETER' 'MINDIAM' 'MAXDIAM') and FACE.FASTRESN>=10.5 and FACE.FAOBJ in ('REDNESS' 'SWELLING')); | |
| CESEV | Severity/Intensity | text | 28 | Predecessor: CE.CESEV | |
| CELOC | Location of Event | text | 14 | Anatomical Location
| Predecessor: CE.CELOC |
| CELAT | Laterality | text | 5 | Laterality
| Predecessor: CE.CELAT |
| CESTDTC | Start Date/Time of Clinical Event | date | ISO 8601 | ISO 8601 | Predecessor: CE.CESTDTC |
| CEENDTC | End Date/Time of Clinical Event | datetime | ISO 8601 | ISO 8601 | Predecessor: CE.CEENDTC |
| CESTDY | Study Day of Start of Observation | integer | 8 | Predecessor: CE.CESTDY | |
| CEENDY | Study Day of End of Observation | integer | 8 | Predecessor: CE.CEENDY | |
| CEENRTPT | End Relative to Reference Time Point | text | 7 | Relation to Reference Period
| Predecessor: CE.CEENRTPT |
| CEENTPT | End Reference Time Point | text | 5 | Predecessor: CE.CEENTPT | |
| CETPT | Planned Time Point Name | text | 5 | Predecessor: CE.CETPT | |
| CETPTREF | Time Point Reference | text | 13 | Predecessor: CE.CETPTREF | |
| EXDOSE | Dose | float | 8 | Predecessor: EX.EXDOSE Carried over from EX.EXDOSE. Detailed algorithm as below: Merge local reaction records (CE.CESCAT =”ADMINISTRATION SITE” ) with EX by USUBJID and (CE.CETPTREF equals EX.EXTPTREF) Merge Systemic events (CE.CESCAT =”SYSTEMIC” ) with EX by USUBJID and (CE.CETPTREF = EX.EXTPTREF) Create ADCEVD by setting local reactions and systemic events from above step keeping from EX EXDOSE , EXTRT, EXDOSU, EXSTDTC, EXENDTC. | |
| EXTRT | Name of Treatment | text | 13 | Predecessor: EX.EXTRT | |
| EXDOSU | Dose Units | text | 3 | Predecessor: EX.EXDOSU | |
| EXSTDTC | Start Date/Time of Treatment | datetime | ISO 8601 | ISO 8601 | Predecessor: EX.EXSTDTC |
| EXENDTC | End Date/Time of Treatment | datetime | ISO 8601 | ISO 8601 | Predecessor: EX.EXENDTC |
| ASTDT | Analysis Start Date | integer | DATE9 | Derived Exclude FADTC/VSDTC>=UNBLNDDT.
ASTDT is the first day of the reactions/events within USUBJID/FATPTREF/FAOBJ level.
If first.FACE.FAOBJ then set ASTDT to datepart of FACE.FADTC when FACE.FAOBJ not in ('REDNESS' 'SWELLING' 'MEDICATIONS') and FACE.FASTRESC=”Y” and FACE.FATESTCD=”OCCUR”.
If first.FACE.FAOBJ then set ASTDT to datepart of FACE.FADTC when FACE.FAOBJ in ('REDNESS' 'SWELLING') and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FACE.FASTRESN>=2.5.
For CETERM='FEVER', if first.VSTESTCD then set ASTDT to datepart of VS.VSDTC where VS.VSCAT='REACTOGENICITY' and index(VS.VSTESTCD,'TEMP') and 38.0<=VS.VSSTRESN<=42.0 within USUBJID/VSTPTREF/VSTESTCD level.
Similar algorithm for readings with ASEV='Severe' (To derive start date for subjects with severe redness or swelling)
where FACE.FADTC is not missing and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FACE.FASTRESN>10 and FACE.FAOBJ in ('REDNESS' 'SWELLING'); | |
| AENDT | Analysis End Date | integer | DATE9 | Derived Exclude FADTC/VSDTC>=UNBLNDDT.
AENDT is the resolution date of the reactions/events within USUBJID/FATPTREF/FAOBJ level.
1) if a reaction/event resolved before or on the last diary day:
If last.FACE.FAOBJ then set AENDT to datepart of FACE.FADTC where FACE.FAOBJ not in ('REDNESS' 'SWELLING' 'MEDICATIONS') and FACE.FASTRESC=”Y” and FACE.FATESTCD=”OCCUR”.
If last.FACE.FAOBJ then set AENDT to datepart of FACE.FADTC where FACE.FAOBJ in ('REDNESS' 'SWELLING') and FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FASTRESN>=2.5.
For CETERM='FEVER', if last.VSTESTCD then set AENDT to datepart of VS.VSDTC where VS.VSCAT='REACTOGENICITY' and index(VS.VSTESTCD,'TEMP') and 38.0<=VS.VSSTRESN<=42.0 within USUBJID/VSTPTREF/VSTESTCD level.
2) if a reaction/event still happend on the last diary day
AENDT was derived as missing if SUPPCE.ONGNXVIS='Y' and SUPPCE.RCENDTC is missing.
AENDT was derived as numeric value of CE.CEENDTC if CE.CEENDTC is captured and not partial.
If CETPTREF='VACCINATION 1' and ADSL.VAX102DT ne . and (numeric value of SUPPCE.RCENDTC>VAX102DT or SUPPCE.ONGNXVIS='Y'), set AENDT to VAX102DT.
Similar algorithm for readings with ASEV='Severe' (To derive start date for subjects with severe redness or swelling):
where FACE.FADTC is not missing and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FACE.FASTRESN>10 and FACE.FAOBJ in ('REDNESS' 'SWELLING'); | |
| ADURU | Analysis Duration Units | text | 4 | Unit
| Assigned Set to ”Days” if ADURN is not missing. |
| ADURN | Analysis Duration (N) | integer | 8 | Derived ADURN=AENDT - ASTDT+1. | |
| KNOWVFL | Known Value Flag | text | 1 | No Yes Response
| Derived Exclude FADTC/VSDTC>=UNBLNDDT.
This flag is derived at SUBJECT/FATPTREF/FAOBJ level:
Set to "Y" for a reaction or an event if a subject had a vaild record (where FACE.FASTRESC or VS.VSORRES ne missing) at any day from day 1 to day 7 after each dose for any local reacaction or systemic event, else set to 'N'. |
| EVENTFL | Event Value Flag | text | 1 | No Yes Response
| Derived Exclude FADTC/VSDTC>=UNBLNDDT.
This flag is derived at SUBJECT/FATPTREF/FAOBJ level:
For CE.CETERM in ('REDNESS' 'SWELLING'): Set to 'Y' if a subject had a reaction (FACE.FASTRESN >=2.5 and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') ) at any day from day 1 to day 7 after each dose; else set to 'N'.
For CE.CETERM not in ('REDNESS' 'SWELLING' 'FEVER'): Set to 'Y' if a subject had a reaction or an event (FACE.FATESTCD='SEV' and FACE.FASTRESC in ('MILD', 'MODERATE','SEVER', 'GRADE 4')) at any day from day 1 to day 7 after each dose; else set to 'N'.
For CE.CETERM="FEVER", set to 'Y' if a subject had a record (38.0<=VS.VSSTRESN<=42.0) at any day from day 1 to day 7 after each dose within USUBJID/VSTPTREF/VSTESTCD level; else set to 'N'. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
Note: The unplanned assessments beyond 7 days after each vaccination are excluded when deriving ADCEVD. |
Go to the top of the Define-XML document
Concomitant Medications Analysis Dataset (ADCM)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: CM.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: CM.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | |
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | |
| CMSEQ | Sequence Number | integer | 8 | Predecessor: CM.CMSEQ | |
| CMCAT | Category for Medication | text | 37 | Category for Medication
| Predecessor: CM.CMCAT |
| CMSCAT | Subcategory for Medication | text | 19 | Subcategory for Medication
| Predecessor: CM.CMSCAT |
| CMSTDTC | Start Date/Time of Medication | datetime | ISO 8601 | ISO 8601 | Predecessor: CM.CMSTDTC |
| CMENDTC | End Date/Time of Medication | datetime | ISO 8601 | ISO 8601 | Predecessor: CM.CMENDTC |
| CMTRT | Reported Name of Drug, Med, or Therapy | text | 100 | Predecessor: CM.CMTRT | |
| CMDECOD | Standardized Medication Name | text | 100 | Drug Dictionary WHO DDE v202003 | Predecessor: CM.CMDECOD |
| CMCODE | Standardized Medication Code | text | 11 | Predecessor: CM.CMCODE | |
| PREFL | Pre-treatment Flag | text | 1 | Y
| Derived if ASTDT < TR01SDT then PREFL='Y' |
| ONPERFL | On-Period Flag | text | 1 | Y
| Derived If ONTR01FL or ONTR02FL= ‘Y’ then ONPERFL=’Y’ |
| ONTR01FL | On-Period 01 Flag | text | 1 | Y
| Derived If NOT LAST PERIOD then
if (ASTDT <= (TR[xx]EDT + G_PRT_PERIOD_LAG) > . and ((AENDT >=TRXXSDT) or (upcase(CMENRTPT)='ONGOING'))) or (ASTDT >= TR[xx]SDT and ASTDT <= (TR[xx]EDT + G_PRT_PERIOD_LAG)) then ONTRxxFL = 'Y' ;
If LAST PERIOD then
if (ASTDT <= (TR[xx]EDT + G_PRT_LASTPERIOD_LAG) > . and ((AENDT >=TRXXSDT) or (upcase(CMENRTPT)='ONGOING')) ) or (ASTDT >= TR[xx]SDT and ASTDT <= (TR[xx]EDT + G_PRT_LASTPERIOD_LAG)) then ONTRxxFL = 'Y' ;
[xx] will replaced by 01 and 02 in the code, G_PRT_PERIOD_LAG is set as 365
if cm happend after unblinding but before vax 3 and vax 3 is not missing, then set to missing |
| ONTR02FL | On-Period 02 Flag | text | 1 | Y
| Derived If NOT LAST PERIOD then
if (ASTDT <= (TR[xx]EDT + G_PRT_PERIOD_LAG) > . and ((AENDT >=TRXXSDT) or (upcase(CMENRTPT)='ONGOING'))) or (ASTDT >= TR[xx]SDT and ASTDT <= (TR[xx]EDT + G_PRT_PERIOD_LAG)) then ONTRxxFL = 'Y' ;
If LAST PERIOD then
if (ASTDT <= (TR[xx]EDT + G_PRT_LASTPERIOD_LAG) > . and ((AENDT >=TRXXSDT) or (upcase(CMENRTPT)='ONGOING')) ) or (ASTDT >= TR[xx]SDT and ASTDT <= (TR[xx]EDT + G_PRT_LASTPERIOD_LAG)) then ONTRxxFL = 'Y' ;
[xx] will replaced by 01 and 02 in the code, G_PRT_PERIOD_LAG is set as 365
if cm happend after unblinding but before vax 3 and vax 3 is not missing, then set to missing |
| ASTDT | Analysis Start Date | integer | DATE9 | Derived DATEPART of (CM.CMSTDTC) | |
| ASTDTF | Analysis Start Date Imputation Flag | text | 1 | Date Imputation Flag
| Derived ASTDTF = 'Y' if Year is imputed
ASTDTF = 'M' if Year is present and Month is imputed
ASTDTF = 'D' if only day is imputed |
| ASTDY | Analysis Start Relative Day | integer | 8 | Derived ASTDT – ADSL.TRTSDT + 1 if ASTDT >= TRTSDT, else ASTDT – ADSL.TRTSDT if ASTDT< TRTSDT | |
| AENDT | Analysis End Date | integer | DATE9 | Derived DATEPART of (CM.CMENDTC) | |
| AENDTF | Analysis End Date Imputation Flag | text | 1 | Date Imputation Flag
| Derived AENDTF = 'Y' if Year is imputed
AENDTF = 'M' if Year is present and Month is imputed
AENDTF = 'D' if only day is imputed |
| AENDY | Analysis End Relative Day | integer | 8 | Derived AENDT – ADSL.TRTSDT + 1 if AENDT >= TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT | |
| CMCLAS | Medication Class | text | 66 | Drug Dictionary WHO DDE v202003 | Predecessor: CM.CMCLAS |
| CMCLASCD | Medication Class Code | text | 8 | Drug Dictionary WHO DDE v202003 | Predecessor: CM.CMCLASCD |
| DRUGNAME | WHODrug preferred name | text | 190 | Drug Dictionary WHO DDE v202003 | Derived Derived from WHODrug Dictionary |
| DRGNAME1 | WHODrug preferred name1 | text | 109 | Derived if length of DRUGNAME gt 200, then put letters gt 200 in DRGNAME1 | |
| ATC1CD | ATC Level 1 Code | text | 1 | Drug Dictionary WHO DDE v202003 | Derived Derived from WHODrug Dictionary |
| ATC1T | ATC Level 1 Text | text | 63 | Drug Dictionary WHO DDE v202003 | Derived Derived from WHODrug Dictionary |
| ATC2CD | ATC Level 2 Code | text | 3 | Drug Dictionary WHO DDE v202003 | Derived Derived from WHODrug Dictionary |
| ATC2T | ATC Level 2 Text | text | 64 | Drug Dictionary WHO DDE v202003 | Derived Derived from WHODrug Dictionary |
| ATC3CD | ATC Level 3 Code | text | 4 | Drug Dictionary WHO DDE v202003 | Derived Derived from WHODrug Dictionary |
| ATC3T | ATC Level 3 Text | text | 71 | Drug Dictionary WHO DDE v202003 | Derived Derived from WHODrug Dictionary |
| ATC4CD | ATC Level 4 Code | text | 5 | Drug Dictionary WHO DDE v202003 | Derived Derived from WHODrug Dictionary |
| ATC4T | ATC Level 4 Text | text | 75 | Drug Dictionary WHO DDE v202003 | Derived Derived from WHODrug Dictionary |
| ATC5CD | ATC Level 5 Code | text | 7 | Drug Dictionary WHO DDE v202003 | Derived Derived from WHODrug Dictionary |
| ATC5T | ATC Level 5 Text | text | 84 | Drug Dictionary WHO DDE v202003 | Derived Derived from WHODrug Dictionary |
| CMSTDY | Study Day of Start of Medication | integer | 8 | Predecessor: CM.CMSTDY | |
| CMENDY | Study Day of End of Medication | integer | 8 | Predecessor: CM.CMENDY | |
| CMDOSE | Dose per Administration | float | 8 | Predecessor: CM.CMDOSE | |
| CMROUTE | Route of Administration | text | 24 | Predecessor: CM.CMROUTE | |
| CMDOSTXT | Dose Description | text | 19 | Predecessor: CM.CMDOSTXT | |
| CMDOSU | Dose Units | text | 6 | Predecessor: CM.CMDOSU | |
| CMDOSFRQ | Dosing Frequency per Interval | text | 10 | Predecessor: CM.CMDOSFRQ | |
| CMENRTPT | End Relative to Reference Time Point | text | 7 | Relation to Reference Period
| Predecessor: CM.CMENRTPT |
| CMENTPT | End Reference Time Point | text | 22 | Predecessor: CM.CMENTPT | |
| EPOCH | Epoch | text | 20 | EPOCH [6 Terms] | Predecessor: CM.EPOCH |
| DICTVER | Dictionary Name and Version | text | 15 | Predecessor: SUPPCM.QVAL where SUPPCM.QNAM="DICTVER" | |
| CMCLAS1 | Medication Class 1 | text | 51 | Predecessor: SUPPCM.QVAL where SUPPCM.QNAM="CMCLAS1" | |
| CMCLAS2 | Medication Class 2 | text | 75 | Predecessor: SUPPCM.QVAL where SUPPCM.QNAM="CMCLAS2" | |
| CMCLSCD1 | Medication Class Code 1 | text | 5 | Predecessor: SUPPCM.QVAL where SUPPCM.QNAM="CMCLSCD1" | |
| CMCLSCD2 | Medication Class Code 2 | text | 5 | Predecessor: SUPPCM.QVAL where SUPPCM.QNAM="CMCLSCD2" | |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | Age Unit
| Predecessor: ADSL.AGEU |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX |
| SEXN | Sex (N) | integer | 8 | Numeric Code of Sex
| Predecessor: ADSL.SEXN |
| RACE | Race | text | 41 | Race [7 Terms] | Predecessor: ADSL.RACE |
| RACEN | Race (N) | integer | 8 | Numeric Code of Race [7 Terms] | Predecessor: ADSL.RACEN |
| ARACE | Analysis Race | text | 41 | Analysis Race [7 Terms] | Predecessor: ADSL.ARACE |
| ARACEN | Analysis Race (N) | integer | 8 | Numeric Code of Analysis Race [7 Terms] | Predecessor: ADSL.ARACEN |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFFL |
| ARM | Description of Planned Arm | text | 29 | Description of Planned Arm [11 Terms] | Predecessor: ADSL.ARM |
| ARMCD | Planned Arm Code | text | 9 | Planned Arm Code [11 Terms] | Predecessor: ADSL.ARMCD |
| ACTARM | Description of Actual Arm | text | 29 | Description of Actual Arm [12 Terms] | Predecessor: ADSL.ACTARM |
| ACTARMCD | Actual Arm Code | text | 9 | Actual Arm Code [12 Terms] | Predecessor: ADSL.ACTARMCD |
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | |
| TRTSTM | Time of First Exposure to Treatment | integer | TIME8 | Predecessor: ADSL.TRTSTM | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | |
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | |
| TRTETM | Time of Last Exposure to Treatment | integer | TIME8 | Predecessor: ADSL.TRTETM | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | |
| V01DT | Date of Unblinding or Visit at 1MPD2 | integer | DATE9 | Predecessor: ADSL.V01DT | |
| V02DT | Date of Unblinding or Visit at 6MPD2 | integer | DATE9 | Predecessor: ADSL.V02DT | |
| V03DT | Date of Visit at 1M after Vax4 | integer | DATE9 | Predecessor: ADSL.V03DT | |
| V04DT | Date of Visit at 6M after Vax4 | integer | DATE9 | Predecessor: ADSL.V04DT | |
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Predecessor: ADSL.VAX101DT | |
| VAX10UDT | Vaccination Date Unplanned | integer | DATE9 | Predecessor: ADSL.VAX10UDT | |
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Predecessor: ADSL.VAX102DT | |
| VAX201DT | Vaccination Date 03 | integer | DATE9 | Predecessor: ADSL.VAX201DT | |
| VAX202DT | Vaccination Date 04 | integer | DATE9 | Predecessor: ADSL.VAX202DT | |
| COHORTN | Cohort Group (N) | float | 8 | Numeric Code of Cohort [13 Terms] | Predecessor: ADSL.COHORTN |
| COHORT | Cohort Group | text | 75 | Cohort [13 Terms] | Predecessor: ADSL.COHORT |
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Numeric Code of Actual Dosing Level
| Predecessor: ADSL.DOSALVLN |
| DOSALVL | Actual Dosing Level | text | 52 | Actual Dosing Level
| Predecessor: ADSL.DOSALVL |
| DOSPLVLN | Planned Dosing Level (N) | integer | 8 | Numeric Code of Planned Dosing Level
| Predecessor: ADSL.DOSPLVLN |
| DOSPLVL | Planned Dosing Level | text | 52 | Planned Dosing Level
| Predecessor: ADSL.DOSPLVL |
| PHASEN | Study Phase (N) | integer | 8 | Numeric Code of Study Phase
| Predecessor: ADSL.PHASEN |
| PHASE | Study Phase | text | 20 | Study Phase
| Predecessor: ADSL.PHASE |
| UNBLNDDT | Treatment Unblinded Date | integer | DATE9 | Predecessor: ADSL.UNBLNDDT | |
| MULENRFL | Multiply Enrolled Subjects | text | 1 | Y
| Predecessor: ADSL.MULENRFL |
| DS30KFL | Phase 3 30k Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DS30KFL |
| HIVFL | HIV Positive Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.HIVFL |
| AGETR01 | Age at Vaccination 01 | integer | 8 | Predecessor: ADSL.AGETR01 | |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Numeric Code of Pooled Age Group 1
| Predecessor: ADSL.AGEGR1N |
| AGEGR4 | Pooled Age Group 4 | text | 11 | Pooled Age Group 4
| Predecessor: ADSL.AGEGR4 |
| AGEGR4N | Pooled Age Group 4 (N) | integer | 8 | Numeric Code of Pooled Age Group 4
| Predecessor: ADSL.AGEGR4N |
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | |
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | |
| TR02SDTM | Datetime of First Exposure in Period 02 | integer | DATETIME20 | Predecessor: ADSL.TR02SDTM | |
| TR02EDTM | Datetime of Last Exposure in Period 02 | integer | DATETIME20 | Predecessor: ADSL.TR02EDTM | |
| TRT01A | Actual Treatment for Period 01 | text | 29 | TRT01A [9 Terms] | Predecessor: ADSL.TRT01A |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | TRT01AN [9 Terms] | Predecessor: ADSL.TRT01AN |
| TRT01P | Planned Treatment for Period 01 | text | 29 | TRT01P [9 Terms] | Predecessor: ADSL.TRT01P |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | TRT01PN [9 Terms] | Predecessor: ADSL.TRT01PN |
| TRT02A | Actual Treatment for Period 02 | text | 27 | TRT02A
| Predecessor: ADSL.TRT02A |
| TRT02AN | Actual Treatment for Period 02 (N) | integer | 8 | TRT02AN
| Predecessor: ADSL.TRT02AN |
| TRT02P | Planned Treatment for Period 02 | text | 27 | TRT02P
| Predecessor: ADSL.TRT02P |
| TRT02PN | Planned Treatment for Period 02 (N) | integer | 8 | TRT02PN
| Predecessor: ADSL.TRT02PN |
| VAX101 | Vaccination 01 | text | 37 | Predecessor: ADSL.VAX101 | |
| VAX102 | Vaccination 02 | text | 36 | Predecessor: ADSL.VAX102 | |
| VAX10U | Vaccination Unplanned | text | 36 | Predecessor: ADSL.VAX10U | |
| VAX201 | Vaccination 03 | text | 36 | Predecessor: ADSL.VAX201 | |
| VAX202 | Vaccination 04 | text | 36 | Predecessor: ADSL.VAX202 | |
| VAX20U | Vaccination Unplanned in Period 02 | text | 1 | Predecessor: ADSL.VAX20U | |
| VAX20UDT | Vaccination Date Unplanned in Period 02 | integer | DATE9 | Predecessor: ADSL.VAX20UDT | |
| DS3KFL | Phase 3 3000 Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DS3KFL |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.RANDFL |
| RAND1FL | Random - exclude Multi-Enrolloer | text | 1 | No Yes Response
| Predecessor: ADSL.RAND1FL |
| SAF1FL | Safety - excld Multi-Enrolloer&HIV&IND | text | 1 | No Yes Response
| Predecessor: ADSL.SAF1FL |
| SAF2FL | Safety - exclude Multi-Enrolloer&IND | text | 1 | No Yes Response
| Predecessor: ADSL.SAF2FL |
| VPHASE | Vaccine Phase | text | 41 | ADCM.VPHASE [9 Terms] | Derived 1. if CM happend before adsl.UNBLNDDT and VAX3 or both adsl.UNBLNDDT and VAX3 are missing;
If CM happend before vax 1 then VPHASE='Pre-Vaccination'; (Note: CM start time is collected per CRF)
If CM happend on or after vax1 and (before vax2 or vax2 is missing) then VPHASE='Vaccination 1';
if CM happend on or after vax2 and before or on the same day of ADSL.V01DT then VPHASE='Vaccination 2';
if CM happend after ADSL.V01DT and before or on the same day of ADSL.V02DT then VPHASE='Follow Up 1';
if CM happend after ADSL.V02DT then VPHASE='Follow Up 2';
2. if CM happend after or on adsl.UNBLNDDT;
If CM happend after or on adsl.UNBLNDDT and (before vax3 or vax3 is missing) then VPHASE=''After unblinding and before Vaccination 3';
If CM happend after or on vax3 and (before vax4 or vax4 is missing) then VPHASE='Vaccination 3';
if CM happend after or on vax4 and before or on the same day of ADSL.V03DT then VPHASE='Vaccination 4';
if CM happend after ADSL.V03DT and before or on the same day of ADSL.V04DT then VPHASE='Follow Up 3';
if CM happend after ADSL.V04DT then VPHASE='Follow Up 4'; |
| VPHASEN | Vaccine Phase(N) | integer | 8 | ADCM.VPHASEN [9 Terms] | Assigned VPHASEN=0 when VPHASE='Pre-Vaccination'; VPHASEN=1 when VPHASE='Vaccination 1'; VPHASEN=2 when VPHASE='Vaccination 2; VPHASEN=3 when VPHASE='Follow Up 1'; VPHASEN=99 when VPHASE='Follow Up 2'; VPHASEN=4 when VPHASE=''After unblinding and before Vaccination 3'; VPHASEN=5 when VPHASE='Vaccination 3'; VPHASEN=6 when VPHASE='Vaccination 4; VPHASEN=7 when VPHASE='Follow Up 3'; VPHASEN=100 when VPHASE='Follow Up 4'; |
| VAXNO | CM Occured after Which Vaccination | integer | 8 | Derived the number of last vaccine before CM occurred
if CM happened in VPHASE 'After unblinding and before Vaccination 3', then set VAXNO to most latest Dose before the CM. |
Go to the top of the Define-XML document
Disposition Analysis Dataset (ADDS)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: DS.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: DS.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | |
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | |
| ADT | Analysis Date | integer | DATE9 | Derived Datepart( numeric value of DS.DSDTC)
Imputation of Partial Dates:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year. | |
| ASTDT | Analysis Start Date | integer | DATE9 | Derived Datepart(numeric value of DS.DSSTDTC) | |
| ASTDY | Analysis Start Relative Day | integer | 8 | Derived if ASTDT >= ADSL.TRTSDT then ASTDY = ASTDT - ADSL.TRTSDT + 1
otherwise ASTDY = ASTDT – ADSL.TRTSDT | |
| DSPHASE | Disposition Phase | text | 20 | Disposition Phase
| Predecessor: SUPPDS.QVAL where SUPPDS.QNAM="DSPHASE" |
| DSPHASEN | Disposition Phase Code (N) | integer | 8 | Numeric Code of Disposition Phase
| Assigned Numeric code for DSPHASE: 1="SCREENING" 7="OPEN LABEL TREATMENT" 26="VACCINATION" 31="FOLLOW-UP" 101="REPEAT SCREENING 1" |
| DSCAT | Category for Disposition Event | text | 17 | Category for Disposition Event
| Predecessor: DS.DSCAT where DSCAT='DISPOSITION EVENT' |
| DSDECOD | Standardized Disposition Term | text | 49 | Completion/Reason for Non-Completion [14 Terms] | Predecessor: DS.DSDECOD |
| DSDECODN | Standardized Disposition Term (N) | integer | 8 | Numeric Code of Completion/Reason for Non-Completion [14 Terms] | Assigned Numeric code for DS.DSDECOD .Numeric code populated for only discontinued reasons: 2=COMPLETED; 13=SCREEN FAILURE; 1=ADVERSE EVENT; 3=DEATH; 5=LOST TO FOLLOW-UP; 7=OTHER; 8=PHYSICIAN DECISION; 9=PREGNANCY; 11=PROTOCOL DEVIATION; 14=STUDY TERMINATED BY SPONSOR; 16=WITHDRAWAL BY SUBJECT; 17=MEDICATION ERROR WITHOUT ASSOCIATED ADVERSE EVENT; 18=NO LONGER MEETS ELIGIBILITY CRITERIA; 25=REFUSED FURTHER STUDY PROCEDURES; 26=WITHDRAWAL BY PARENT/GUARDIAN |
| DSTERM | Reported Term for the Disposition Event | text | 100 | Predecessor: DS.DSTERM | |
| M1PD2DT | 1 Month Post Dose 2 Visit Date | integer | DATE9 | Derived Derived from SV.svstdtc where SV.visit contains 'MONTH1_POSTVAX2' or 'V7_MONTH1_S' or ('V7_MONTH1_S_R' for cohortn=1.16)；
if null SV.SVSTDTC then derived from ADSL.BLDV6DT | |
| M6PD2DT | 6 Months Post Dose 2 Visit Date | integer | DATE9 | Derived Derived from SV.svstdtc where SV.visit contains 'V4_MONTH6_L' or 'V8_MONTH6_S'；
if null SV.SVSTDTC then derived from ADSL.BLDV7DT； | |
| M1PX2DT | 1 Month Post Dose 4 Visit Date | integer | DATE9 | Derived Derived from SV.svstdtc where SV.visit contains 'V103_MONTH1' | |
| M1P2CUT | 1 Month PD2 Cutoff Date for Disposition | integer | DATE9 | Derived 1. find date for V3: non-missing value for ADSL.BLDV6DT, and ADDS.M1PD2DT, if both these 2 variables have values, then choose the bigger one.
2. if missing V3, and EOT=EOS and not missing, then EOT date;
3. if EOT not eq to EOS, then the later of Dose2 date or unplanned dose date +42 days
4. if only one dose, then Dose1+42+42 days.
5. cutoff to the day before not null Xover Dose1 date | |
| M1P2EXC | Excluded from 1 Month Post Dose 2 | text | 1 | Y
| Derived For DSPHASE not equal to 'SCREENING' or 'VACCINATION' or "REPEAT SCREENING 1"
if ASTDT>M1P2CUT, then 'Y'
if missing M1P2CUT, and subject have open label period activity, then 'Y'. |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | Age Unit
| Predecessor: ADSL.AGEU |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX |
| SEXN | Sex (N) | integer | 8 | Numeric Code of Sex
| Predecessor: ADSL.SEXN |
| RACE | Race | text | 41 | Race [7 Terms] | Predecessor: ADSL.RACE |
| RACEN | Race (N) | integer | 8 | Numeric Code of Race [7 Terms] | Predecessor: ADSL.RACEN |
| ARACE | Analysis Race | text | 41 | Analysis Race [7 Terms] | Predecessor: ADSL.ARACE |
| ARACEN | Analysis Race (N) | integer | 8 | Numeric Code of Analysis Race [7 Terms] | Predecessor: ADSL.ARACEN |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.RANDFL |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFFL |
| ARM | Description of Planned Arm | text | 29 | Description of Planned Arm [11 Terms] | Predecessor: ADSL.ARM |
| ARMCD | Planned Arm Code | text | 9 | Planned Arm Code [11 Terms] | Predecessor: ADSL.ARMCD |
| ACTARM | Description of Actual Arm | text | 29 | Description of Actual Arm [12 Terms] | Predecessor: ADSL.ACTARM |
| ACTARMCD | Actual Arm Code | text | 9 | Actual Arm Code [12 Terms] | Predecessor: ADSL.ACTARMCD |
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | |
| TRTSTM | Time of First Exposure to Treatment | integer | TIME8 | Predecessor: ADSL.TRTSTM | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | |
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | |
| TRTETM | Time of Last Exposure to Treatment | integer | TIME8 | Predecessor: ADSL.TRTETM | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | |
| TRTSEQP | Planned Sequence of Treatments | text | 38 | Predecessor: ADSL.TRTSEQP | |
| TRTSEQA | Actual Sequence of Treatments | text | 38 | Predecessor: ADSL.TRTSEQA | |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Numeric Code of Pooled Age Group 1
| Predecessor: ADSL.AGEGR1N |
| COHORT | Cohort Group | text | 75 | Cohort [13 Terms] | Predecessor: ADSL.COHORT |
| COHORTN | Cohort Group (N) | float | 8 | Numeric Code of Cohort [13 Terms] | Predecessor: ADSL.COHORTN |
| DOSALVL | Actual Dosing Level | text | 52 | Actual Dosing Level
| Predecessor: ADSL.DOSALVL |
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Numeric Code of Actual Dosing Level
| Predecessor: ADSL.DOSALVLN |
| DOSPLVL | Planned Dosing Level | text | 52 | Planned Dosing Level
| Predecessor: ADSL.DOSPLVL |
| DOSPLVLN | Planned Dosing Level (N) | integer | 8 | Numeric Code of Planned Dosing Level
| Predecessor: ADSL.DOSPLVLN |
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Predecessor: ADSL.VAX101DT | |
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Predecessor: ADSL.VAX102DT | |
| VAX10UDT | Vaccination Date Unplanned | integer | DATE9 | Predecessor: ADSL.VAX10UDT | |
| VAX201DT | Vaccination Date 03 | integer | DATE9 | Predecessor: ADSL.VAX201DT | |
| VAX202DT | Vaccination Date 04 | integer | DATE9 | Predecessor: ADSL.VAX202DT | |
| VAX20UDT | Vaccination Date Unplanned in Period 02 | integer | DATE9 | Predecessor: ADSL.VAX20UDT | |
| UNBLNDDT | Treatment Unblinded Date | integer | DATE9 | Predecessor: ADSL.UNBLNDDT | |
| VAX101 | Vaccination 01 | text | 37 | Predecessor: ADSL.VAX101 | |
| VAX102 | Vaccination 02 | text | 36 | Predecessor: ADSL.VAX102 | |
| VAX10U | Vaccination Unplanned | text | 36 | Predecessor: ADSL.VAX10U | |
| VAX201 | Vaccination 03 | text | 36 | Predecessor: ADSL.VAX201 | |
| VAX202 | Vaccination 04 | text | 36 | Predecessor: ADSL.VAX202 | |
| VAX20U | Vaccination Unplanned in Period 02 | text | 1 | Predecessor: ADSL.VAX20U | |
| TRT01A | Actual Treatment for Period 01 | text | 29 | TRT01A [9 Terms] | Predecessor: ADSL.TRT01A |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | TRT01AN [9 Terms] | Predecessor: ADSL.TRT01AN |
| TRT02A | Actual Treatment for Period 02 | text | 27 | TRT02A
| Predecessor: ADSL.TRT02A |
| TRT02AN | Actual Treatment for Period 02 (N) | integer | 8 | TRT02AN
| Predecessor: ADSL.TRT02AN |
| TRT01P | Planned Treatment for Period 01 | text | 29 | TRT01P [9 Terms] | Predecessor: ADSL.TRT01P |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | TRT01PN [9 Terms] | Predecessor: ADSL.TRT01PN |
| TRT02P | Planned Treatment for Period 02 | text | 27 | TRT02P
| Predecessor: ADSL.TRT02P |
| TRT02PN | Planned Treatment for Period 02 (N) | integer | 8 | TRT02PN
| Predecessor: ADSL.TRT02PN |
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | |
| TR01STM | Time of First Exposure in Period 01 | integer | TIME8 | Predecessor: ADSL.TR01STM | |
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | |
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | |
| TR01ETM | Time of Last Exposure in Period 01 | integer | TIME8 | Predecessor: ADSL.TR01ETM | |
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | |
| TR02SDT | Date of First Exposure in Period 02 | integer | DATE9 | Predecessor: ADSL.TR02SDT | |
| TR02STM | Time of First Exposure in Period 02 | integer | TIME8 | Predecessor: ADSL.TR02STM | |
| TR02SDTM | Datetime of First Exposure in Period 02 | integer | DATETIME20 | Predecessor: ADSL.TR02SDTM | |
| TR02EDT | Date of Last Exposure in Period 02 | integer | DATE9 | Predecessor: ADSL.TR02EDT | |
| TR02ETM | Time of Last Exposure in Period 02 | integer | TIME8 | Predecessor: ADSL.TR02ETM | |
| TR02EDTM | Datetime of Last Exposure in Period 02 | integer | DATETIME20 | Predecessor: ADSL.TR02EDTM | |
| PHASE | Study Phase | text | 20 | Study Phase
| Predecessor: ADSL.PHASE |
| PHASEN | Study Phase (N) | integer | 8 | Numeric Code of Study Phase
| Predecessor: ADSL.PHASEN |
| EOSDCDT | End Of Study Discontinuation Date | integer | DATE9 | Predecessor: ADSL.EOSDCDT | |
| EOTDCDT | End Of Treatment Discontinuation Date | integer | DATE9 | Predecessor: ADSL.EOTDCDT | |
| BLDV6DT | Blood Sample Date 1 Month after Vax 2 | integer | DATE9 | Predecessor: ADSL.BLDV6DT | |
| BLDV7DT | Blood Sample Date 6 Months after Vax 2 | integer | DATE9 | Predecessor: ADSL.BLDV7DT | |
| AGEGR4 | Pooled Age Group 4 | text | 11 | Pooled Age Group 4
| Predecessor: ADSL.AGEGR4 |
| AGEGR4N | Pooled Age Group 4 (N) | integer | 8 | Numeric Code of Pooled Age Group 4
| Predecessor: ADSL.AGEGR4N |
| PEDIMMFL | Pop for Non-inferiority Assessement | text | 1 | No Yes Response
| Predecessor: ADSL.PEDIMMFL |
| MULENRFL | Multiply Enrolled Subjects | text | 1 | Y
| Predecessor: ADSL.MULENRFL |
| PEDREAFL | Phase 2/3 Pop for 12-25 Reacto Subset | text | 1 | No Yes Response
| Predecessor: ADSL.PEDREAFL |
| HIVFL | HIV Positive Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.HIVFL |
| DS3KFL | Phase 3 3000 Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DS3KFL |
| EOTXDCDT | End Of Open Label Treatment D/C Date | integer | DATE9 | Predecessor: ADSL.EOTXDCDT | |
| EOTXDCRS | End Of Open Label Treatment D/C Reason | text | 21 | Predecessor: ADSL.EOTXDCRS | |
| BDCSRDT | Double Blinded Follow-up Censor Date | integer | DATE9 | Predecessor: ADSL.BDCSRDT | |
| X1CSRDT | Crossover Dose1 Censor Date | integer | DATE9 | Predecessor: ADSL.X1CSRDT | |
| STCSRDT | Study Censor Date | integer | DATE9 | Predecessor: ADSL.STCSRDT | |
| AGETR01 | Age at Vaccination 01 | integer | 8 | Predecessor: ADSL.AGETR01 | |
| AGETRU01 | Age Units at Vaccination 01 | text | 5 | Age Unit
| Predecessor: ADSL.AGETRU01 |
| RAND1FL | Random - exclude Multi-Enrolloer | text | 1 | No Yes Response
| Predecessor: ADSL.RAND1FL |
| SAF1FL | Safety - excld Multi-Enrolloer&HIV&IND | text | 1 | No Yes Response
| Predecessor: ADSL.SAF1FL |
| SAF2FL | Safety - exclude Multi-Enrolloer&IND | text | 1 | No Yes Response
| Predecessor: ADSL.SAF2FL |
| DOMAIN | Domain Abbreviation | text | 2 | Assigned DS.DOMAIN | |
| DSSEQ | Sequence Number | integer | 8 | Predecessor: DS.DSSEQ |
Go to the top of the Define-XML document
Protocol Deviation Analysis Dataset (ADDV)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: DV.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: DV.USUBJID | |
| DOMAIN | Domain Abbreviation | text | 2 | Assigned DV.DOMAIN | |
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | |
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX |
| RACE | Race | text | 41 | Race [7 Terms] | Predecessor: ADSL.RACE |
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | |
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | |
| ARM | Description of Planned Arm | text | 29 | Description of Planned Arm [11 Terms] | Predecessor: ADSL.ARM |
| ARMCD | Planned Arm Code | text | 9 | Planned Arm Code [11 Terms] | Predecessor: ADSL.ARMCD |
| ACTARM | Description of Actual Arm | text | 29 | Description of Actual Arm [12 Terms] | Predecessor: ADSL.ACTARM |
| ACTARMCD | Actual Arm Code | text | 9 | Actual Arm Code [12 Terms] | Predecessor: ADSL.ACTARMCD |
| TRT01P | Planned Treatment for Period 01 | text | 29 | TRT01P [9 Terms] | Predecessor: ADSL.TRT01P |
| TRT01A | Actual Treatment for Period 01 | text | 29 | TRT01A [9 Terms] | Predecessor: ADSL.TRT01A |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | TRT01PN [9 Terms] | Predecessor: ADSL.TRT01PN |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | TRT01AN [9 Terms] | Predecessor: ADSL.TRT01AN |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Numeric Code of Pooled Age Group 1
| Predecessor: ADSL.AGEGR1N |
| DVSEQ | Sequence Number | integer | 8 | Predecessor: DV.DVSEQ | |
| DVSPID | Sponsor-Defined Identifier | text | 9 | Predecessor: DV.DVSPID | |
| DVTERM | Protocol Deviation Term | text | 200 | Predecessor: DV.DVTERM | |
| DVTERM1 | Protocol Deviation Term 1 | text | 50 | Predecessor: SUPPDV.QVAL where SUPPDV.QNAM='DVTERM1' | |
| DVDECOD | Protocol Deviation Coded Term | text | 23 | Predecessor: DV.DVDECOD | |
| EPOCH | Epoch | text | 20 | EPOCH [6 Terms] | Predecessor: DV.EPOCH |
| ACTSITE | Actual Site of Deviation Occurrence | text | 4 | Predecessor: SUPPDV.QVAL where SUPPDV.QNAM='ACTSITE' | |
| DESGTOR | Visit Designator | text | 33 | Predecessor: SUPPDV.QVAL where SUPPDV.QNAM='DESGTOR' | |
| CAPE | Confirmed Analysis Population Exclusion | text | 35 | Predecessor: SUPPDV.QVAL where SUPPDV.QNAM='CAPE' | |
| DVCAT | Category for Protocol Deviation | text | 13 | Category for Protocol Deviation
| Predecessor: DV.DVCAT |
| DVSTDTC | Start Date/Time of Deviation | date | ISO 8601 | ISO 8601 | Predecessor: DV.DVSTDTC |
| DVSTDY | Study Day of Start of Deviation | integer | 8 | Predecessor: DV.DVSTDY | |
| ASTDT | Analysis Start Date | integer | DATE9 | Derived Convert DV.DVSTDTC to numeric format | |
| PREFL | Pre-treatment Flag | text | 1 | Y
| Derived If ASTDT < ADSL.TRTSDT then PREFL='Y' |
| TRPFL | On Treatment Flag | text | 1 | No Yes Response
| Derived if (ASTDTM >= APHASDTM and substr(APHASE,1,9) = 'TREATMENT' then TRPFL='Y' else TRPFL = 'N' |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.RANDFL |
| PHASE | Study Phase | text | 20 | Study Phase
| Predecessor: ADSL.PHASE |
| PHASEN | Study Phase (N) | integer | 8 | Numeric Code of Study Phase
| Predecessor: ADSL.PHASEN |
| COHORT | Cohort Group | text | 75 | Cohort [13 Terms] | Predecessor: ADSL.COHORT |
| COHORTN | Cohort Group (N) | float | 8 | Numeric Code of Cohort [13 Terms] | Predecessor: ADSL.COHORTN |
| DOSALVL | Actual Dosing Level | text | 52 | Actual Dosing Level
| Predecessor: ADSL.DOSALVL |
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Numeric Code of Actual Dosing Level
| Predecessor: ADSL.DOSALVLN |
| DOSPLVL | Planned Dosing Level | text | 52 | Planned Dosing Level
| Predecessor: ADSL.DOSPLVL |
| DOSPLVLN | Planned Dosing Level (N) | integer | 8 | Numeric Code of Planned Dosing Level
| Predecessor: ADSL.DOSPLVLN |
| DS3KFL | Phase 3 3000 Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DS3KFL |
| AGEGR3N | Pooled Age Group 3 (N) | integer | 8 | Numeric Code of Pooled Age Group 3
| Predecessor: ADSL.AGEGR3N |
| AGEGR3 | Pooled Age Group 3 | text | 11 | Pooled Age Group 3
| Predecessor: ADSL.AGEGR3 |
| AGEGR4N | Pooled Age Group 4 (N) | integer | 8 | Numeric Code of Pooled Age Group 4
| Predecessor: ADSL.AGEGR4N |
| AGEGR4 | Pooled Age Group 4 | text | 11 | Pooled Age Group 4
| Predecessor: ADSL.AGEGR4 |
| HIVFL | HIV Positive Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.HIVFL |
| AGETR01 | Age at Vaccination 01 | integer | 8 | Predecessor: ADSL.AGETR01 | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | |
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | |
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | |
| TR02SDTM | Datetime of First Exposure in Period 02 | integer | DATETIME20 | Predecessor: ADSL.TR02SDTM | |
| TR02EDTM | Datetime of Last Exposure in Period 02 | integer | DATETIME20 | Predecessor: ADSL.TR02EDTM | |
| VAX101 | Vaccination 01 | text | 37 | Predecessor: ADSL.VAX101 | |
| VAX102 | Vaccination 02 | text | 36 | Predecessor: ADSL.VAX102 | |
| VAX10U | Vaccination Unplanned | text | 36 | Predecessor: ADSL.VAX10U | |
| VAX201 | Vaccination 03 | text | 36 | Predecessor: ADSL.VAX201 | |
| VAX202 | Vaccination 04 | text | 36 | Predecessor: ADSL.VAX202 | |
| VAX20U | Vaccination Unplanned in Period 02 | text | 1 | Predecessor: ADSL.VAX20U | |
| VAX20UDT | Vaccination Date Unplanned in Period 02 | integer | DATE9 | Predecessor: ADSL.VAX20UDT | |
| UNBLNDDT | Treatment Unblinded Date | integer | DATE9 | Predecessor: ADSL.UNBLNDDT | |
| MULENRFL | Multiply Enrolled Subjects | text | 1 | Y
| Predecessor: ADSL.MULENRFL |
| RAND1FL | Random - exclude Multi-Enrolloer | text | 1 | No Yes Response
| Predecessor: ADSL.RAND1FL |
Go to the top of the Define-XML document
Medical History Analysis Dataset (ADMH)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: MH.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: MH.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | |
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | |
| MHSEQ | Sequence Number | integer | 8 | Predecessor: MH.MHSEQ | |
| MHTERM | Reported Term for the Medical History | text | 100 | Predecessor: MH.MHTERM | |
| MHDECOD | Dictionary-Derived Term | text | 88 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHDECOD |
| MHPTCD | Preferred Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHPTCD |
| MHBODSYS | Body System or Organ Class | text | 67 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHBODSYS |
| MHBDSYCD | Body System or Organ Class Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHBDSYCD |
| MHLLT | Lowest Level Term | text | 87 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHLLT |
| MHLLTCD | Lowest Level Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHLLTCD |
| MHHLT | High Level Term | text | 82 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHHLT |
| MHHLTCD | High Level Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHHLTCD |
| MHHLGT | High Level Group Term | text | 86 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHHLGT |
| MHHLGTCD | High Level Group Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHHLGTCD |
| MHSOC | Primary System Organ Class | text | 67 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHSOC |
| MHSOCCD | Primary System Organ Class Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHSOCCD |
| MHCAT | Category for Medical History | text | 23 | Category for Medical History
| Predecessor: MH.MHCAT |
| MHSTDTC | Start Date/Time of Medical History Event | datetime | ISO 8601 | ISO 8601 | Predecessor: MH.MHSTDTC |
| MHENDTC | End Date/Time of Medical History Event | datetime | ISO 8601 | ISO 8601 | Predecessor: MH.MHENDTC |
| MHENRTPT | End Relative to Reference Time Point | text | 7 | Relation to Reference Period
| Predecessor: MH.MHENRTPT |
| MHENTPT | End Reference Time Point | text | 22 | Predecessor: MH.MHENTPT | |
| DICTVER | Dictionary Name and Version | text | 12 | Predecessor: SUPPMH.QVAL where SUPPMH.QNAM='DICTVER' | |
| MHSPID | Sponsor-Defined Identifier | text | 2 | Predecessor: MH.MHSPID | |
| ASTDT | Analysis Start Date | integer | DATE9 | Derived ASTDT = date part of MH.MHSTDTC
Imputation of Partial Dates:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year. | |
| ASTDTF | Analysis Start Date Imputation Flag | text | 1 | Date Imputation Flag
| Derived = "D" if day is imputed.
= "M" if month and day are imputed.
= "Y" if month, day and year are imputed.ADMH |
| ASTDY | Analysis Start Relative Day | integer | 8 | Derived if ASTDT >= TRTSDT then ASTDT – ADSL.TRTSDT + 1;
else if ASTDT< TRTSDT then ASTDT – ADSL.TRTSDT; | |
| AENDT | Analysis End Date | integer | DATE9 | Derived AENDT = date part of MH.MHENDTC
Imputation of Partial Dates:
If Day is missing, last day of Month
If Month is missing, last month of Year. | |
| AENDTF | Analysis End Date Imputation Flag | text | 1 | Date Imputation Flag
| Derived = "D" if day is imputed.
= "M" if month and day are imputed.
= "Y" if month, day and year are imputed. |
| AENDY | Analysis End Relative Day | integer | 8 | Derived AENDT – ADSL.TRTSDT + 1 if AENDT >= TRTSDT,
else AENDT – ADSL.TRTSDT if AENDT < TRTSDT | |
| COMORBFL | Comorbidity Flag | text | 1 | No Yes Response
| Derived "Y" if mhterm with Comorbidities. |
| CAT1 | Charlson Comorbidity Index Category 1 | text | 37 | Assigned Comorbidity category assigned by external source according to comorbidity-categories.xlsx, CAT1='AIDS/HIV' was assigned if the term was included in external excel file - report-cci-aids-hiv.xlsx; CAT1='Any Malignancy' was assigned if the term was included in external excel file - report-cci-any-malignancy.xlsx; CAT1='Cerebrovascular Disease' was assigned if the term was included in external excel file - report-cci-cerebrovascular.xlsx; CAT1='Congestive Heart Failure' was assigned if the term was included in external excel file - report-cci-chf.xlsx; CAT1='Dementia' was assigned if the term was included in external excel file - report-cci-dementia.xlsx; CAT1='Diabetes With Chronic Complication' was assigned if the term was included in external excel file - report-cci-diabetes-with-comp.xlsx; CAT1='Diabetes Without Chronic Complication' was assigned if the term was included in external excel file - report-cci-diabetes-without-comp.xlsx; CAT1='Hemiplegia or Paraplegia' was assigned if the term was included in external excel file - report-cci-hemiplegia.xlsx; CAT1='Leukemia' was derived if the term was assigned in external excel file - report-cci-leukemia.xlsx; CAT1='Lymphoma' was derived if the term was assigned in external excel file - report-cci-lymphoma.xlsx; CAT1='Metastatic Solid Tumor' was assigned if the term was included in external excel file - report-cci-metastatic-tumour.xlsx; CAT1='Myocardial Infarction' was assigned if the term was included in external excel file - report-cci-mi.xlsx; CAT1='Mild Liver Disease' was assigned if the term was included in external excel file - report-cci-mild-liver.xlsx; CAT1='Moderate or Severe Liver Disease' was assigned if the term was included in external excel file - report-cci-mod-sev-liver.xlsx; CAT1='Peptic Ulcer Disease' was derived if the term was included in external excel file - report-cci-peptic-ulcer.xlsx; CAT1='Peripheral Vascular Disease' was assigned if the term was included in external excel file - report-cci-periph-vasc.xlsx; CAT1='Chronic Pulmonary Disease' was assigned if the term was included in external excel file - report-cci-pulmonary.xlsx; CAT1='Renal Disease' was derived if the term was assigned in external excel file - report-cci-renal.xlsx; CAT1='Rheumatic Disease' was derived if the term was assigned in external excel file - report-cci-rheumatic.xlsx | |
| CAT2 | Charlson Comorbidity Index Category 2 | text | 27 | Assigned Comorbidity category assigned by external source if the term meets the second category, assigned rule following with CAT1. e.g. If a patient meets two comorbidity categories, then the first category will be assigned in CAT1 and the second one goes to CAT2 | |
| ADT | Analysis Date | integer | DATE9 | Derived ADT = date part of MH.MHDTC
Imputation of Partial Dates:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year. | |
| ADTF | Analysis Date Imputation Flag | text | 1 | Date Imputation Flag
| Derived = "D" if day is imputed.
= "M" if month and day are imputed.
= "Y" if month, day and year are imputed.ADMH |
| ADURN | Analysis Duration (N) | float | 8 | Derived if MH.MHDUR exists then calculate ADURN in years and round it to 2 decimals. | |
| ADURU | Analysis Duration Units | text | 5 | Unit
| Assigned if adurn ne . then ADURU= 'YEARS' |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | Age Unit
| Predecessor: ADSL.AGEU |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Numeric Code of Pooled Age Group 1
| Predecessor: ADSL.AGEGR1N |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX |
| SEXN | Sex (N) | integer | 8 | Numeric Code of Sex
| Predecessor: ADSL.SEXN |
| RACE | Race | text | 41 | Race [7 Terms] | Predecessor: ADSL.RACE |
| RACEN | Race (N) | integer | 8 | Numeric Code of Race [7 Terms] | Predecessor: ADSL.RACEN |
| ARACE | Analysis Race | text | 41 | Analysis Race [7 Terms] | Predecessor: ADSL.ARACE |
| ARACEN | Analysis Race (N) | integer | 8 | Numeric Code of Analysis Race [7 Terms] | Predecessor: ADSL.ARACEN |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.RANDFL |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Predecessor: ADSL.SAFFL |
| ARM | Description of Planned Arm | text | 29 | Description of Planned Arm [11 Terms] | Predecessor: ADSL.ARM |
| ARMCD | Planned Arm Code | text | 9 | Planned Arm Code [11 Terms] | Predecessor: ADSL.ARMCD |
| ACTARM | Description of Actual Arm | text | 29 | Description of Actual Arm [12 Terms] | Predecessor: ADSL.ACTARM |
| ACTARMCD | Actual Arm Code | text | 9 | Actual Arm Code [12 Terms] | Predecessor: ADSL.ACTARMCD |
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | |
| TRTSTM | Time of First Exposure to Treatment | integer | TIME8 | Predecessor: ADSL.TRTSTM | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTSDTM | |
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | |
| TRTETM | Time of Last Exposure to Treatment | integer | TIME8 | Predecessor: ADSL.TRTETM | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Predecessor: ADSL.TRTEDTM | |
| TRT01A | Actual Treatment for Period 01 | text | 29 | TRT01A [9 Terms] | Predecessor: ADSL.TRT01A |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | TRT01AN [9 Terms] | Predecessor: ADSL.TRT01AN |
| TRT02A | Actual Treatment for Period 02 | text | 27 | TRT02A
| Predecessor: ADSL.TRT02A |
| TRT02AN | Actual Treatment for Period 02 (N) | integer | 8 | TRT02AN
| Predecessor: ADSL.TRT02AN |
| TRT01P | Planned Treatment for Period 01 | text | 29 | TRT01P [9 Terms] | Predecessor: ADSL.TRT01P |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | TRT01PN [9 Terms] | Predecessor: ADSL.TRT01PN |
| TRT02P | Planned Treatment for Period 02 | text | 27 | TRT02P
| Predecessor: ADSL.TRT02P |
| TRT02PN | Planned Treatment for Period 02 (N) | integer | 8 | TRT02PN
| Predecessor: ADSL.TRT02PN |
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01SDT | |
| TR01STM | Time of First Exposure in Period 01 | integer | TIME8 | Predecessor: ADSL.TR01STM | |
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01SDTM | |
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Predecessor: ADSL.TR01EDT | |
| TR01ETM | Time of Last Exposure in Period 01 | integer | TIME8 | Predecessor: ADSL.TR01ETM | |
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Predecessor: ADSL.TR01EDTM | |
| TR02SDT | Date of First Exposure in Period 02 | integer | DATE9 | Predecessor: ADSL.TR02SDT | |
| TR02STM | Time of First Exposure in Period 02 | integer | TIME8 | Predecessor: ADSL.TR02STM | |
| TR02SDTM | Datetime of First Exposure in Period 02 | integer | DATETIME20 | Predecessor: ADSL.TR02SDTM | |
| TR02EDT | Date of Last Exposure in Period 02 | integer | DATE9 | Predecessor: ADSL.TR02EDT | |
| TR02ETM | Time of Last Exposure in Period 02 | integer | TIME8 | Predecessor: ADSL.TR02ETM | |
| TR02EDTM | Datetime of Last Exposure in Period 02 | integer | DATETIME20 | Predecessor: ADSL.TR02EDTM | |
| VAX101 | Vaccination 01 | text | 37 | Predecessor: ADSL.VAX101 | |
| VAX102 | Vaccination 02 | text | 36 | Predecessor: ADSL.VAX102 | |
| VAX10U | Vaccination Unplanned | text | 36 | Predecessor: ADSL.VAX10U | |
| VAX201 | Vaccination 03 | text | 36 | Predecessor: ADSL.VAX201 | |
| VAX202 | Vaccination 04 | text | 36 | Predecessor: ADSL.VAX202 | |
| VAX20U | Vaccination Unplanned in Period 02 | text | 1 | Predecessor: ADSL.VAX20U | |
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Predecessor: ADSL.VAX101DT | |
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Predecessor: ADSL.VAX102DT | |
| VAX10UDT | Vaccination Date Unplanned | integer | DATE9 | Predecessor: ADSL.VAX10UDT | |
| VAX201DT | Vaccination Date 03 | integer | DATE9 | Predecessor: ADSL.VAX201DT | |
| VAX202DT | Vaccination Date 04 | integer | DATE9 | Predecessor: ADSL.VAX202DT | |
| VAX20UDT | Vaccination Date Unplanned in Period 02 | integer | DATE9 | Predecessor: ADSL.VAX20UDT | |
| UNBLNDDT | Treatment Unblinded Date | integer | DATE9 | Predecessor: ADSL.UNBLNDDT | |
| RANDDT | Date of Randomization | integer | DATE9 | Predecessor: ADSL.RANDDT | |
| COHORT | Cohort Group | text | 75 | Cohort [13 Terms] | Predecessor: ADSL.COHORT |
| COHORTN | Cohort Group (N) | float | 8 | Numeric Code of Cohort [13 Terms] | Predecessor: ADSL.COHORTN |
| DOSALVL | Actual Dosing Level | text | 52 | Actual Dosing Level
| Predecessor: ADSL.DOSALVL |
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Numeric Code of Actual Dosing Level
| Predecessor: ADSL.DOSALVLN |
| DOSPLVL | Planned Dosing Level | text | 52 | Planned Dosing Level
| Predecessor: ADSL.DOSPLVL |
| DOSPLVLN | Planned Dosing Level (N) | integer | 8 | Numeric Code of Planned Dosing Level
| Predecessor: ADSL.DOSPLVLN |
| DS30KFL | Phase 3 30k Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DS30KFL |
| PHASE | Study Phase | text | 20 | Study Phase
| Predecessor: ADSL.PHASE |
| PHASEN | Study Phase (N) | integer | 8 | Numeric Code of Study Phase
| Predecessor: ADSL.PHASEN |
| AGEGR4 | Pooled Age Group 4 | text | 11 | Pooled Age Group 4
| Predecessor: ADSL.AGEGR4 |
| AGEGR4N | Pooled Age Group 4 (N) | integer | 8 | Numeric Code of Pooled Age Group 4
| Predecessor: ADSL.AGEGR4N |
| HIVFL | HIV Positive Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.HIVFL |
| PEDIMMFL | Pop for Non-inferiority Assessement | text | 1 | No Yes Response
| Predecessor: ADSL.PEDIMMFL |
| MULENRFL | Multiply Enrolled Subjects | text | 1 | Y
| Predecessor: ADSL.MULENRFL |
| PEDREAFL | Phase 2/3 Pop for 12-25 Reacto Subset | text | 1 | No Yes Response
| Predecessor: ADSL.PEDREAFL |
| DS3KFL | Phase 3 3000 Subjects Flag | text | 1 | No Yes Response
| Predecessor: ADSL.DS3KFL |
| AGETR01 | Age at Vaccination 01 | integer | 8 | Predecessor: ADSL.AGETR01 | |
| AGETRU01 | Age Units at Vaccination 01 | text | 5 | Age Unit
| Predecessor: ADSL.AGETRU01 |
| RAND1FL | Random - exclude Multi-Enrolloer | text | 1 | No Yes Response
| Predecessor: ADSL.RAND1FL |
| SAF1FL | Safety - excld Multi-Enrolloer&HIV&IND | text | 1 | No Yes Response
| Predecessor: ADSL.SAF1FL |
| SAF2FL | Safety - exclude Multi-Enrolloer&IND | text | 1 | No Yes Response
| Predecessor: ADSL.SAF2FL |
Go to the top of the Define-XML document
CodeLists
Description of Actual Arm
| Permitted Value (Code) |
|---|
| BNT162b1 Phase 1 (10 mcg) |
| BNT162b1 Phase 1 (20 mcg) |
| BNT162b1 Phase 1 (30 mcg) |
| BNT162b1 Phase 1 (100/10 mcg) |
| BNT162b2 Phase 1 (10 mcg) |
| BNT162b2 Phase 1 (20 mcg) |
| BNT162b2 Phase 1 (30 mcg) |
| BNT162b2 Phase 2/3 (30 mcg) |
| NOT ASSIGNED |
| Not Treated |
| Placebo |
| SCREEN FAILURE |
Actual Arm Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| B1_10 | BNT162b1 Phase 1 (10 mcg) |
| B1_20 | BNT162b1 Phase 1 (20 mcg) |
| B1_30 | BNT162b1 Phase 1 (30 mcg) |
| B1_100 | BNT162b1 Phase 1 (100/10 mcg) |
| B2_10 | BNT162b2 Phase 1 (10 mcg) |
| B2_20 | BNT162b2 Phase 1 (20 mcg) |
| B2_30 | BNT162b2 Phase 1 (30 mcg) |
| B2_P23_30 | BNT162b2 Phase 2/3 (30 mcg) |
| NOTASSGN | NOT ASSIGNED |
| NOTTRT | Not Treated |
| PLACEBO | Placebo |
| SCRNFAIL | SCREEN FAILURE |
ADAE.VPHASE
| Permitted Value (Code) |
|---|
| Pre-Vaccination |
| Vaccination 1 |
| Vaccination 2 |
| Follow Up 1 |
| After unblinding and before Vaccination 3 |
| Vaccination 3 |
| Vaccination 4 |
| Follow Up 3 |
| Follow Up 2 |
ADAE.VPHASEN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 0 | Pre-Vaccination |
| 1 | Vaccination 1 |
| 2 | Vaccination 2 |
| 3 | Follow Up 1 |
| 4 | After unblinding and before Vaccination 3 |
| 5 | Vaccination 3 |
| 6 | Vaccination 4 |
| 7 | Follow Up 3 |
| 99 | Follow Up 2 |
ADC19EF.AVISIT
| Permitted Value (Code) |
|---|
| COVID_A |
| COVID_B |
| COVID_C |
| COVID_D |
| COVID_E |
| COVID_F |
| SSWAB_WEEK2 |
| SSWAB_WEEK4 |
| SSWAB_WEEK6 |
| SSWAB_WEEK8 |
| V1_DAY1_VAX1_L |
| V201_SURVEIL_CONSENT |
| V2_VAX2_L |
ADC19EF.AVISITN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | COVID_A |
| 2 | COVID_B |
| 3 | COVID_C |
| 4 | COVID_D |
| 5 | COVID_E |
| 6 | COVID_F |
| 20202 | SSWAB_WEEK2 |
| 20204 | SSWAB_WEEK4 |
| 20206 | SSWAB_WEEK6 |
| 20208 | SSWAB_WEEK8 |
| 60765 | V1_DAY1_VAX1_L |
| 60766 | V2_VAX2_L |
| 56985855 | V201_SURVEIL_CONSENT |
ADC19EF.PARAM
| Permitted Value (Code) |
|---|
| CDC DEFINED COVID-19 ILLNESS ONSET |
| CDC DEFINED SEVERE COVID-19 ILLNESS ONSET |
| CEPHEID RT-PCR ASSAY FOR SARS-COV-2 |
| COVID-19 NAAT RESULT AFTER DOSE |
| DEATH OCCURRED DUE TO COVID-19 ILLNESS? |
| HOSPITALIZED DUE TO COVID-19 ILLNESS? |
| N-BINDING ANTIBODY |
| PRESENCE OF CDC DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE |
| PRESENCE OF CDC DEFINED SYMPTOMS AFTER DOSE |
| PRESENCE OF PROTOCOL DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE |
| PRESENCE OF PROTOCOL DEFINED SYMPTOMS AFTER DOSE |
| PRIMARY CAUSE OF DEATH |
| PROTOCOL DEFINED COVID-19 ILLNESS ONSET |
| PROTOCOL DEFINED SEVERE COVID-19 ILLNESS ONSET |
| SECONDARY CAUSE OF DEATH |
| SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 |
| SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE |
| SEVERE COVID-19 SYMPTOMS - SIGNIFICANT ACUTE RENAL, HEPATIC, OR NEUROLOGIC DYSFUNCTION |
| SEVERE COVID-19 SYMPTOMS - USE OF VASOPRESSORS |
| SEVERE COVID-19 SYMPTOMS - VITAL SIGNS |
| SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS |
| SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - CROSSOVER |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - CROSSOVER |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
ADC19EF.PARAMCD
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| CDCONST | CDC DEFINED COVID-19 ILLNESS ONSET |
| CDCSONST | CDC DEFINED SEVERE COVID-19 ILLNESS ONSET |
| RTCOV2NS | CEPHEID RT-PCR ASSAY FOR SARS-COV-2 |
| NAATRAD | COVID-19 NAAT RESULT AFTER DOSE |
| DTHODC19 | DEATH OCCURRED DUE TO COVID-19 ILLNESS? |
| HCUHSP | HOSPITALIZED DUE TO COVID-19 ILLNESS? |
| C19NIG | N-BINDING ANTIBODY |
| PRSCDCAD | PRESENCE OF CDC DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE |
| PRCDCSAD | PRESENCE OF CDC DEFINED SYMPTOMS AFTER DOSE |
| PRSVCSAD | PRESENCE OF PROTOCOL DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE |
| PRPDSAD | PRESENCE OF PROTOCOL DEFINED SYMPTOMS AFTER DOSE |
| PRCDTH | PRIMARY CAUSE OF DEATH |
| C19ONST | PROTOCOL DEFINED COVID-19 ILLNESS ONSET |
| SEVCONST | PROTOCOL DEFINED SEVERE COVID-19 ILLNESS ONSET |
| SECDTH | SECONDARY CAUSE OF DEATH |
| SARSCOV2 | SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 |
| SEVCRF | SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE |
| SEVCRHN | SEVERE COVID-19 SYMPTOMS - SIGNIFICANT ACUTE RENAL, HEPATIC, OR NEUROLOGIC DYSFUNCTION |
| SEVCVSPR | SEVERE COVID-19 SYMPTOMS - USE OF VASOPRESSORS |
| SEVCVS | SEVERE COVID-19 SYMPTOMS - VITAL SIGNS |
| HCUICU | SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS |
| ST214CD | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS |
| ST214CDA | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| STC214SE | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS |
| STC214SA | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| ST214PD | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS |
| ST214PDA | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| ST214SE | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS |
| ST214SEA | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| ST17CD | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS |
| ST17CDA | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| STC17SE | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS |
| STC17SA | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| ST17PD | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS |
| ST17PDA | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| ST17SE | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS |
| ST17SEA | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| ST27CD | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS |
| ST27CDA | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| STC27SE | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS |
| STC27SA | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| ST27PD | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS |
| ST27PDA | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| ST27SE | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS |
| ST27SEA | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| ST1CD | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS |
| ST1CDA | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| STC1SE | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS |
| STC1SA | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| STC1SX | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - CROSSOVER |
| ST1PD | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS |
| ST1PDA | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| ST1PDX | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - CROSSOVER |
| ST1SE | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS |
| ST1SEA | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| ST2CD | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS |
| ST2CDA | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| STC2SE | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS |
| STC2SA | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| ST2PD | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS |
| ST2PDA | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| ST2SE | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS |
| ST2SEA | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
ADC19EF.PARAMN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 40 | SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 |
| 41 | CEPHEID RT-PCR ASSAY FOR SARS-COV-2 |
| 90 | N-BINDING ANTIBODY |
| 91 | SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS |
| 92 | HOSPITALIZED DUE TO COVID-19 ILLNESS? |
| 95 | PRIMARY CAUSE OF DEATH |
| 96 | SECONDARY CAUSE OF DEATH |
| 100 | DEATH OCCURRED DUE TO COVID-19 ILLNESS? |
| 101 | PRESENCE OF PROTOCOL DEFINED SYMPTOMS AFTER DOSE |
| 102 | PRESENCE OF CDC DEFINED SYMPTOMS AFTER DOSE |
| 103 | SEVERE COVID-19 SYMPTOMS - VITAL SIGNS |
| 104 | SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE |
| 105 | SEVERE COVID-19 SYMPTOMS - USE OF VASOPRESSORS |
| 106 | SEVERE COVID-19 SYMPTOMS - SIGNIFICANT ACUTE RENAL, HEPATIC, OR NEUROLOGIC DYSFUNCTION |
| 107 | PRESENCE OF PROTOCOL DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE |
| 108 | PRESENCE OF CDC DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE |
| 110 | COVID-19 NAAT RESULT AFTER DOSE |
| 120 | PROTOCOL DEFINED COVID-19 ILLNESS ONSET |
| 125 | CDC DEFINED COVID-19 ILLNESS ONSET |
| 130 | PROTOCOL DEFINED SEVERE COVID-19 ILLNESS ONSET |
| 135 | CDC DEFINED SEVERE COVID-19 ILLNESS ONSET |
| 141 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS |
| 142 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS |
| 143 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS |
| 144 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS |
| 145 | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS |
| 151 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS |
| 152 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS |
| 153 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS |
| 154 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS |
| 155 | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS |
| 161 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS |
| 162 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS |
| 163 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS |
| 164 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS |
| 165 | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS |
| 171 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS |
| 172 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS |
| 173 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS |
| 174 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS |
| 175 | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS |
| 201 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| 202 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| 203 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| 204 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| 205 | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| 211 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| 212 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| 213 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| 214 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| 215 | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE |
| 221 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| 222 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| 223 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| 224 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| 225 | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| 231 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| 232 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| 233 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| 234 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| 235 | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE |
| 301 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - CROSSOVER |
| 331 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - CROSSOVER |
ADC19EF.PARCAT1
| Permitted Value (Code) |
|---|
| CENTRAL/LOCAL NAAT RESULTS |
| CONFIRMATION OF INFECTION |
| DEATH DETAILS CODED |
| DEATH STATUS |
| GENERAL CONCOMITANT MEDICATIONS |
| GENERAL NON-DRUG TREATMENT |
| GENERAL VITAL SIGNS & OXYGENATION PARAMETERS |
| HOSPITALIZATION STATUS |
| ILLNESS ONSET |
| SEROLOGY |
| SEVERE COVID-19 ILLNESS |
| SEVERE COVID-19 SYMPTOMS |
| SIGNS AND SYMPTOMS OF DISEASE |
| SURVEILLANCE TIME |
| VIROLOGY |
ADCM.VPHASE
| Permitted Value (Code) |
|---|
| Pre-Vaccination |
| Vaccination 1 |
| Vaccination 2 |
| Follow Up 1 |
| After unblinding and before Vaccination 3 |
| Vaccination 3 |
| Vaccination 4 |
| Follow Up 3 |
| Follow Up 2 |
ADCM.VPHASEN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 0 | Pre-Vaccination |
| 1 | Vaccination 1 |
| 2 | Vaccination 2 |
| 3 | Follow Up 1 |
| 4 | After unblinding and before Vaccination 3 |
| 5 | Vaccination 3 |
| 6 | Vaccination 4 |
| 7 | Follow Up 3 |
| 99 | Follow Up 2 |
ADFACEVD.AVISIT
| Permitted Value (Code) |
|---|
| UNPLANNED VISIT 0.001 |
| UNPLANNED VISIT 1.001 |
| V1_DAY1_VAX1_S |
| UNPLANNED VISIT 60748.001 |
| UNPLANNED VISIT 60749.001 |
| UNPLANNED VISIT 60750.001 |
| V4_WEEK3_VAX2_S |
| V6_WEEK2_POSTVAX2_S |
| V1_DAY1_VAX1_L |
| UNPLANNED VISIT 60765.001 |
| UNPLANNED VISIT 60765.002 |
| UNPLANNED VISIT 60765.003 |
| V2_VAX2_L |
| UNPLANNED VISIT 60766.001 |
| UNPLANNED VISIT 60766.002 |
| V3_MONTH1_POSTVAX2_L |
| V4_WEEK3_VAX2_S_R |
| V6_WEEK2_POSTVAX2_S_R |
ADFACEVD.AVISITN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 0.001 | UNPLANNED VISIT 0.001 |
| 1.001 | UNPLANNED VISIT 1.001 |
| 60748 | V1_DAY1_VAX1_S |
| 60748.001 | UNPLANNED VISIT 60748.001 |
| 60749.001 | UNPLANNED VISIT 60749.001 |
| 60750.001 | UNPLANNED VISIT 60750.001 |
| 60751 | V4_WEEK3_VAX2_S |
| 60753 | V6_WEEK2_POSTVAX2_S |
| 60765 | V1_DAY1_VAX1_L |
| 60765.001 | UNPLANNED VISIT 60765.001 |
| 60765.002 | UNPLANNED VISIT 60765.002 |
| 60765.003 | UNPLANNED VISIT 60765.003 |
| 60766 | V2_VAX2_L |
| 60766.001 | UNPLANNED VISIT 60766.001 |
| 60766.002 | UNPLANNED VISIT 60766.002 |
| 60767 | V3_MONTH1_POSTVAX2_L |
| 1165454 | V4_WEEK3_VAX2_S_R |
| 1165456 | V6_WEEK2_POSTVAX2_S_R |
ADFACEVD.DTYPE [C81224]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| MAXIMUM [C82868] | Maximum Value Derivation Technique |
ADFACEVD.PARAM
| Permitted Value (Code) |
|---|
| Chills maximum severity |
| Chills occurrence indicator |
| Chills severity/intensity |
| Diarrhea maximum severity |
| Diarrhea occurrence indicator |
| Diarrhea severity/intensity |
| Fatigue maximum severity |
| Fatigue occurrence indicator |
| Fatigue severity/intensity |
| Fever maximum temperature |
| Fever occurrence indicator |
| Headache maximum severity |
| Headache occurrence indicator |
| Headache severity/intensity |
| Hospitalized for chills occurrence indicator |
| Hospitalized for diarrhea occurrence indicator |
| Hospitalized for headache occurrence indicator |
| Hospitalized for injection site pain occurrence indicator |
| Hospitalized for joint pain occurrence indicator |
| Hospitalized for muscle pain occurrence indicator |
| Hospitalized for tiredness (fatigue) occurrence indicator |
| Hospitalized for vomiting occurrence indicator |
| Joint pain maximum severity |
| Joint pain occurrence indicator |
| Joint pain severity/intensity |
| Medications duration |
| Medications medication to treat fever or pain |
| Medications stop date meds given to trt/pnt symptoms |
| Muscle pain maximum severity |
| Muscle pain occurrence indicator |
| Muscle pain severity/intensity |
| Pain at injection site maximum severity |
| Pain at injection site occurrence indicator |
| Pain at injection site severity/intensity |
| Redness diameter cm |
| Redness grade 4 criteria met |
| Redness maximum diameter |
| Redness maximum diameter cm |
| Redness maximum severity |
| Redness minimum diameter cm |
| Redness occurrence indicator |
| Redness severity/intensity |
| Swelling diameter cm |
| Swelling grade 4 criteria met |
| Swelling maximum diameter |
| Swelling maximum diameter cm |
| Swelling maximum severity |
| Swelling minimum diameter cm |
| Swelling occurrence indicator |
| Swelling severity/intensity |
| Vomiting maximum severity |
| Vomiting occurrence indicator |
| Vomiting severity/intensity |
ADFACEVD.PARAMCD
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| DIARE | Redness diameter cm |
| DIASW | Swelling diameter cm |
| G4CRR | Redness grade 4 criteria met |
| G4CRS | Swelling grade 4 criteria met |
| MADRE | Redness maximum diameter cm |
| MADSW | Swelling maximum diameter cm |
| MAXCHIL | Chills maximum severity |
| MAXDIAR | Diarrhea maximum severity |
| MAXSFAT | Fatigue maximum severity |
| MAXSHEA | Headache maximum severity |
| MAXSJP | Joint pain maximum severity |
| MAXSMP | Muscle pain maximum severity |
| MAXSVOM | Vomiting maximum severity |
| MAXTEMP | Fever maximum temperature |
| MDIRE | Redness maximum diameter |
| MDISW | Swelling maximum diameter |
| MEDDUR | Medications duration |
| MEDTFVPN | Medications medication to treat fever or pain |
| MIDRE | Redness minimum diameter cm |
| MIDSW | Swelling minimum diameter cm |
| MSERE | Redness maximum severity |
| MSESW | Swelling maximum severity |
| MSPIS | Pain at injection site maximum severity |
| OCCHILLS | Chills occurrence indicator |
| OCDIAR | Diarrhea occurrence indicator |
| OCFATIG | Fatigue occurrence indicator |
| OCFEVER | Fever occurrence indicator |
| OCHEAD | Headache occurrence indicator |
| OCHIS | Hospitalized for injection site pain occurrence indicator |
| OCHOCHIL | Hospitalized for chills occurrence indicator |
| OCHODI | Hospitalized for diarrhea occurrence indicator |
| OCHOFA | Hospitalized for tiredness (fatigue) occurrence indicator |
| OCHOHE | Hospitalized for headache occurrence indicator |
| OCHOJP | Hospitalized for joint pain occurrence indicator |
| OCHOMP | Hospitalized for muscle pain occurrence indicator |
| OCHOVO | Hospitalized for vomiting occurrence indicator |
| OCINS | Swelling occurrence indicator |
| OCISR | Redness occurrence indicator |
| OCJOPAIN | Joint pain occurrence indicator |
| OCMPNIS | Muscle pain occurrence indicator |
| OCPIS | Pain at injection site occurrence indicator |
| OCVOMI | Vomiting occurrence indicator |
| SEVCHIL | Chills severity/intensity |
| SEVDIAR | Diarrhea severity/intensity |
| SEVFATI | Fatigue severity/intensity |
| SEVHEAD | Headache severity/intensity |
| SEVJOIN | Joint pain severity/intensity |
| SEVMUSP | Muscle pain severity/intensity |
| SEVPIS | Pain at injection site severity/intensity |
| SEVREDN | Redness severity/intensity |
| SEVSWEL | Swelling severity/intensity |
| SEVVOMI | Vomiting severity/intensity |
| STPDMEDP | Medications stop date meds given to trt/pnt symptoms |
ADFACEVD.PARAMN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | Redness severity/intensity |
| 2 | Redness maximum severity |
| 3 | Redness grade 4 criteria met |
| 4 | Redness diameter cm |
| 5 | Redness minimum diameter cm |
| 6 | Redness maximum diameter |
| 7 | Redness occurrence indicator |
| 9 | Redness maximum diameter cm |
| 30 | Swelling severity/intensity |
| 31 | Swelling maximum severity |
| 32 | Swelling grade 4 criteria met |
| 33 | Swelling diameter cm |
| 34 | Swelling minimum diameter cm |
| 35 | Swelling maximum diameter |
| 36 | Swelling occurrence indicator |
| 38 | Swelling maximum diameter cm |
| 50 | Pain at injection site occurrence indicator |
| 51 | Pain at injection site severity/intensity |
| 52 | Pain at injection site maximum severity |
| 70 | Fever maximum temperature |
| 71 | Fever occurrence indicator |
| 80 | Fatigue severity/intensity |
| 81 | Fatigue maximum severity |
| 82 | Fatigue occurrence indicator |
| 90 | Headache severity/intensity |
| 91 | Headache maximum severity |
| 92 | Headache occurrence indicator |
| 100 | Chills severity/intensity |
| 101 | Chills maximum severity |
| 102 | Chills occurrence indicator |
| 182 | Medications medication to treat fever or pain |
| 189 | Medications stop date meds given to trt/pnt symptoms |
| 195 | Medications duration |
| 270 | Diarrhea occurrence indicator |
| 271 | Diarrhea severity/intensity |
| 272 | Diarrhea maximum severity |
| 310 | Muscle pain occurrence indicator |
| 311 | Muscle pain severity/intensity |
| 312 | Muscle pain maximum severity |
| 390 | Joint pain occurrence indicator |
| 391 | Joint pain severity/intensity |
| 392 | Joint pain maximum severity |
| 400 | Vomiting occurrence indicator |
| 401 | Vomiting severity/intensity |
| 402 | Vomiting maximum severity |
| 410 | Hospitalized for diarrhea occurrence indicator |
| 415 | Hospitalized for headache occurrence indicator |
| 420 | Hospitalized for injection site pain occurrence indicator |
| 425 | Hospitalized for joint pain occurrence indicator |
| 430 | Hospitalized for tiredness (fatigue) occurrence indicator |
| 440 | Hospitalized for vomiting occurrence indicator |
| 445 | Hospitalized for muscle pain occurrence indicator |
| 455 | Hospitalized for chills occurrence indicator |
ADFACEVD.PARCAT1
| Permitted Value (Code) |
|---|
| REACTOGENICITY |
| REACTOGENICITY - ADVERSE EVENT |
ADFACEVD.PARCAT2
| Permitted Value (Code) |
|---|
| ADMINISTRATION SITE |
| MEDICATIONS GIVEN |
| SYSTEMIC |
ADSYMPT.AVISIT
| Permitted Value (Code) |
|---|
| COVID_A |
| COVID_B |
| COVID_C |
| COVID_D |
| COVID_E |
| COVID_F |
| COVID_A1 |
| COVID_B1 |
| SSWAB_WEEK2 |
| SSWAB_WEEK4 |
| SSWAB_WEEK6 |
| SSWAB_WEEK8 |
| V1_DAY1_VAX1_L |
| V2_VAX2_L |
| V3_MONTH1_POSTVAX2_L |
| V4_MONTH6_L |
| V101_VAX3 |
| V201_SURVEIL_CONSENT |
ADSYMPT.AVISITN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | COVID_A |
| 2 | COVID_B |
| 3 | COVID_C |
| 4 | COVID_D |
| 5 | COVID_E |
| 6 | COVID_F |
| 200 | COVID_A1 |
| 201 | COVID_B1 |
| 20202 | SSWAB_WEEK2 |
| 20204 | SSWAB_WEEK4 |
| 20206 | SSWAB_WEEK6 |
| 20208 | SSWAB_WEEK8 |
| 60765 | V1_DAY1_VAX1_L |
| 60766 | V2_VAX2_L |
| 60767 | V3_MONTH1_POSTVAX2_L |
| 60768 | V4_MONTH6_L |
| 51231793 | V101_VAX3 |
| 56985855 | V201_SURVEIL_CONSENT |
ADSYMPT.PARAM
| Permitted Value (Code) |
|---|
| CHILLS |
| DIARRHEA |
| FEVER |
| NEW LOSS OF TASTE OR SMELL |
| NEW OR INCREASED COUGH |
| NEW OR INCREASED MUSCLE PAIN |
| NEW OR INCREASED SHORTNESS OF BREATH |
| NEW OR INCREASED SORE THROAT |
| VOMITING |
| NEW OR INCREASED NASAL CONGESTION |
| NEW OR INCREASED WHEEZING |
| FATIGUE |
| HEADACHE |
| RHINORRHOEA |
| NAUSEA |
| SIGNIFICANT ACUTE RENAL DYSFUNCTION |
| SIGNIFICANT ACUTE HEPATIC DYSFUNCTION |
| SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION |
| SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 |
| CEPHEID RT-PCR ASSAY FOR SARS-COV-2 |
| RESPIRATORY RATE |
| HEART RATE |
| OXYGEN SATURATION |
| DIASTOLIC BLOOD PRESSURE |
| SYSTOLIC BLOOD PRESSURE |
| PP ARTERIAL O2/FRACTION INSPIRED O2 |
| NON-INVASIVE POSITIVE PRESSURE VENTILATION |
| MECHANICAL VENTILATION |
| HIGH FLOW OXYGEN THERAPY |
| VASOPRESSORS AGENTS |
| N-BINDING ANTIBODY |
| SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS |
| HOSPITALIZED DUE TO COVID-19 ILLNESS? |
| PRIMARY CAUSE OF DEATH |
| SECONDARY CAUSE OF DEATH |
| DEATH |
ADSYMPT.PARAMCD
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| CHILLS | CHILLS |
| DIARRHEA | DIARRHEA |
| FEVER | FEVER |
| NLTSTSML | NEW LOSS OF TASTE OR SMELL |
| NCOUG | NEW OR INCREASED COUGH |
| NMUSPN | NEW OR INCREASED MUSCLE PAIN |
| NSTBRTH | NEW OR INCREASED SHORTNESS OF BREATH |
| NSRTHROT | NEW OR INCREASED SORE THROAT |
| VOMIT | VOMITING |
| NNSLCONG | NEW OR INCREASED NASAL CONGESTION |
| WHEEZ | NEW OR INCREASED WHEEZING |
| FATIGUE | FATIGUE |
| HEADACHE | HEADACHE |
| RIHNRA | RHINORRHOEA |
| NAUSEA | NAUSEA |
| SARDFN | SIGNIFICANT ACUTE RENAL DYSFUNCTION |
| SAHDFN | SIGNIFICANT ACUTE HEPATIC DYSFUNCTION |
| SANDFN | SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION |
| SARSCOV2 | SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 |
| RTCOV2NS | CEPHEID RT-PCR ASSAY FOR SARS-COV-2 |
| RESP | RESPIRATORY RATE |
| HR | HEART RATE |
| OXYSAT | OXYGEN SATURATION |
| DIABP | DIASTOLIC BLOOD PRESSURE |
| SYSBP | SYSTOLIC BLOOD PRESSURE |
| PO2FIO2 | PP ARTERIAL O2/FRACTION INSPIRED O2 |
| NIPPV | NON-INVASIVE POSITIVE PRESSURE VENTILATION |
| MCHVENT | MECHANICAL VENTILATION |
| HFOXTHRP | HIGH FLOW OXYGEN THERAPY |
| VSOPRES | VASOPRESSORS AGENTS |
| C19NIG | N-BINDING ANTIBODY |
| HCUICU | SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS |
| HCUHSP | HOSPITALIZED DUE TO COVID-19 ILLNESS? |
| PRCDTH | PRIMARY CAUSE OF DEATH |
| SECDTH | SECONDARY CAUSE OF DEATH |
| DEATH | DEATH |
ADSYMPT.PARAMN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | CHILLS |
| 2 | DIARRHEA |
| 3 | FEVER |
| 4 | NEW LOSS OF TASTE OR SMELL |
| 5 | NEW OR INCREASED COUGH |
| 6 | NEW OR INCREASED MUSCLE PAIN |
| 7 | NEW OR INCREASED SHORTNESS OF BREATH |
| 8 | NEW OR INCREASED SORE THROAT |
| 9 | VOMITING |
| 11 | NEW OR INCREASED NASAL CONGESTION |
| 14 | NEW OR INCREASED WHEEZING |
| 15 | FATIGUE |
| 16 | HEADACHE |
| 17 | RHINORRHOEA |
| 18 | NAUSEA |
| 25 | SIGNIFICANT ACUTE RENAL DYSFUNCTION |
| 30 | SIGNIFICANT ACUTE HEPATIC DYSFUNCTION |
| 35 | SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION |
| 40 | SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 |
| 41 | CEPHEID RT-PCR ASSAY FOR SARS-COV-2 |
| 50 | RESPIRATORY RATE |
| 51 | HEART RATE |
| 52 | OXYGEN SATURATION |
| 53 | DIASTOLIC BLOOD PRESSURE |
| 54 | SYSTOLIC BLOOD PRESSURE |
| 60 | PP ARTERIAL O2/FRACTION INSPIRED O2 |
| 71 | NON-INVASIVE POSITIVE PRESSURE VENTILATION |
| 74 | MECHANICAL VENTILATION |
| 76 | HIGH FLOW OXYGEN THERAPY |
| 80 | VASOPRESSORS AGENTS |
| 90 | N-BINDING ANTIBODY |
| 91 | SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS |
| 92 | HOSPITALIZED DUE TO COVID-19 ILLNESS? |
| 95 | PRIMARY CAUSE OF DEATH |
| 96 | SECONDARY CAUSE OF DEATH |
| 99 | DEATH |
ADSYMPT.PARCAT1
| Permitted Value (Code) |
|---|
| CONFIRMATION OF INFECTION |
| DEATH DETAILS CODED |
| DISPOSITION EVENT |
| GENERAL CONCOMITANT MEDICATIONS |
| GENERAL NON-DRUG TREATMENT |
| GENERAL VITAL SIGNS |
| HEALTHCARE UTILIZATION ASSESSMENT |
| HOSPITALIZATION STATUS |
| OXYGENATION PARAMETERS |
| SEROLOGY |
| SEVERE COVID-19 ILLNESS |
| SIGNS AND SYMPTOMS OF DISEASE |
| VIROLOGY |
ADSYMPT.PARCAT2
| Permitted Value (Code) |
|---|
| BLOOD CHEMISTRY |
| RESPIRATORY FAILURE |
| RESPIRATORY ILLNESS |
| VASOPRESSORS AGENTS |
ADVA.AVISIT
| Permitted Value (Code) |
|---|
| Before Vaccination 1 |
| 1 Week after Vaccination 1 |
| 3 Weeks after Vaccination 1 |
| 4 Weeks after Vaccination 1 |
| 5 Weeks after Vaccination 1 |
| 1 Month and 3 weeks after Vaccination 1 |
| Before Vaccination 2 |
| 1 Week after Vaccination 2 |
| 2 Weeks after Vaccination 2 |
| 1 Month after Vaccination 2 |
| 6 Months after Vaccination 2 |
ADVA.AVISITN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | Before Vaccination 1 |
| 2 | 1 Week after Vaccination 1 |
| 3 | 3 Weeks after Vaccination 1 |
| 3.1 | 4 Weeks after Vaccination 1 |
| 3.2 | 5 Weeks after Vaccination 1 |
| 3.3 | 1 Month and 3 weeks after Vaccination 1 |
| 3.9 | Before Vaccination 2 |
| 4 | 1 Week after Vaccination 2 |
| 5 | 2 Weeks after Vaccination 2 |
| 6 | 1 Month after Vaccination 2 |
| 7 | 6 Months after Vaccination 2 |
ADVA.DTYPE [C81224]
| Permitted Value (Code) |
|---|
| LLOQIMP [*] |
| Derived [*] |
* Extended Value
ADVA.PARAM
| Permitted Value (Code) |
|---|
| SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay |
| SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay |
| COVID-19 S1 IgG (U/mL) - Luminex Immunoassay |
| COVID-19 RBD IgG (U/mL) - Luminex Immunoassay |
| N-binding antibody - N-binding Antibody Assay |
| SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG |
| SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG |
ADVA.PARAMCD
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| C2NGNT50 | SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay |
| C2NGNT90 | SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay |
| C19S1IGG | COVID-19 S1 IgG (U/mL) - Luminex Immunoassay |
| C19RBDIG | COVID-19 RBD IgG (U/mL) - Luminex Immunoassay |
| C19NIG | N-binding antibody - N-binding Antibody Assay |
| NT50_S1 | SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG |
| NT90_S1 | SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG |
ADVA.PARAMN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay |
| 2 | SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay |
| 3 | COVID-19 S1 IgG (U/mL) - Luminex Immunoassay |
| 4 | COVID-19 RBD IgG (U/mL) - Luminex Immunoassay |
| 5 | N-binding antibody - N-binding Antibody Assay |
| 11 | SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG |
| 12 | SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG |
ADVA.PARCAT1
| Permitted Value (Code) |
|---|
| SEROLOGY |
ADVA.PARCAT1N
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | SEROLOGY |
Category for Adverse Event
| Permitted Value (Code) |
|---|
| ADVERSE EVENT |
| MEDICATION ERROR |
Causality
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| RELATED | RELATED |
| NOT RELATED | NOT RELATED |
Numeric Code of Causality
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | RELATED |
| 3 | NOT RELATED |
Standard Toxicity Grade
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | GRADE 1 |
| 2 | GRADE 2 |
| 3 | GRADE 3 |
| 4 | GRADE 4 |
Numeric Code of Standard Toxicity Grade
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | GRADE 1 |
| 2 | GRADE 2 |
| 3 | GRADE 3 |
| 4 | GRADE 4 |
Pooled Age Group 1
| Permitted Value (Code) |
|---|
| 12-15 Years |
| 16-55 Years |
| 18-55 Years |
| 65-85 Years |
| >55 Years |
Numeric Code of Pooled Age Group 1
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 12-15 Years |
| 2 | 16-55 Years |
| 3 | 18-55 Years |
| 4 | 65-85 Years |
| 5 | >55 Years |
Pooled Age Group 2
| Permitted Value (Code) |
|---|
| <65 Years |
| >=65 Years |
Numeric Code of Pooled Age Group 2
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | <65 Years |
| 2 | >=65 Years |
Pooled Age Group 3
| Permitted Value (Code) |
|---|
| 16-17 Years |
| 18-55 Years |
| >55 Years |
Numeric Code of Pooled Age Group 3
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 16-17 Years |
| 2 | 18-55 Years |
| 3 | >55 Years |
Pooled Age Group 4
| Permitted Value (Code) |
|---|
| 12-15 Years |
| 16-25 Years |
Numeric Code of Pooled Age Group 4
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 12-15 Years |
| 2 | 16-25 Years |
Age Group at Vaccination 03
| Permitted Value (Code) |
|---|
| 16-55 Years |
| >55 Years |
Numeric Code of Age Group at Vaccination 03
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 16-55 Years |
| 2 | >55 Years |
Age Unit [C66781]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| YEARS [C29848] | Year |
Period
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | Period 01 |
| 2 | Period 02 |
Period (C)
| Permitted Value (Code) |
|---|
| Period 01 |
| Period 02 |
Analysis Race
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| WHITE [C41261] | White |
| BLACK OR AFRICAN AMERICAN [C16352] | Black or african american |
| AMERICAN INDIAN OR ALASKA NATIVE [C41259] | American indian or alaska native |
| ASIAN [C41260] | Asian |
| NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER [C41219] | Native hawaiian or other pacific islander |
| MULTIRACIAL | Multiple |
| NOT REPORTED [C43234] | Not reported |
Numeric Code of Analysis Race
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | WHITE |
| 2 | BLACK OR AFRICAN AMERICAN |
| 3 | AMERICAN INDIAN OR ALASKA NATIVE |
| 4 | ASIAN |
| 5 | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER |
| 6 | MULTIRACIAL |
| 7 | NOT REPORTED |
Analysis Causality
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| RELATED | RELATED |
| NOT RELATED | NOT RELATED |
Numeric Code of Analysis Causality
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | RELATED |
| 3 | NOT RELATED |
Description of Planned Arm
| Permitted Value (Code) |
|---|
| BNT162b1 Phase 1 (10 mcg) |
| BNT162b1 Phase 1 (20 mcg) |
| BNT162b1 Phase 1 (30 mcg) |
| BNT162b1 Phase 1 (100/10 mcg) |
| BNT162b2 Phase 1 (10 mcg) |
| BNT162b2 Phase 1 (20 mcg) |
| BNT162b2 Phase 1 (30 mcg) |
| BNT162b2 Phase 2/3 (30 mcg) |
| NOT ASSIGNED |
| Placebo |
| SCREEN FAILURE |
Planned Arm Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| B1_10 | BNT162b1 Phase 1 (10 mcg) |
| B1_20 | BNT162b1 Phase 1 (20 mcg) |
| B1_30 | BNT162b1 Phase 1 (30 mcg) |
| B1_100 | BNT162b1 Phase 1 (100/10 mcg) |
| B2_10 | BNT162b2 Phase 1 (10 mcg) |
| B2_20 | BNT162b2 Phase 1 (20 mcg) |
| B2_30 | BNT162b2 Phase 1 (30 mcg) |
| B2_P23_30 | BNT162b2 Phase 2/3 (30 mcg) |
| NOTASSGN | NOT ASSIGNED |
| PLACEBO | Placebo |
| SCRNFAIL | SCREEN FAILURE |
Analysis Toxicity Grade
| Permitted Value (Code) |
|---|
| GRADE 1 |
| GRADE 2 |
| GRADE 3 |
| GRADE 4 |
Numeric Code of Analysis Toxicity Grade
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | GRADE 1 |
| 2 | GRADE 2 |
| 3 | GRADE 3 |
| 4 | GRADE 4 |
Analysis Timepoint
| Permitted Value (Code) |
|---|
| DAY 1 |
| DAY 2 |
| DAY 3 |
| DAY 4 |
| DAY 5 |
| DAY 6 |
| DAY 7 |
Numeric Code of Analysis Timepoint
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | DAY 1 |
| 2 | DAY 2 |
| 3 | DAY 3 |
| 4 | DAY 4 |
| 5 | DAY 5 |
| 6 | DAY 6 |
| 7 | DAY 7 |
AVALCA1N
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 0 | >0-2.0 |
| 1 | >2.0-5.0 |
| 2 | >5.0-10.0 |
| 3 | >10.0 |
AVALCAT1
| Permitted Value (Code) |
|---|
| >0-2.0 |
| >2.0-5.0 |
| >5.0-10.0 |
| >10.0 |
BMI Category
| Permitted Value (Code) |
|---|
| Underweight |
| Normal weight |
| Overweight |
| Obese |
| Missing |
Numeric Code of BMI Category
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | Underweight |
| 2 | Normal weight |
| 3 | Overweight |
| 4 | Obese |
| 5 | Missing |
Baseline serostatus
| Permitted Value (Code) |
|---|
| Missing |
| < LLOQ |
| >= LLOQ |
Numeric Code of Baseline serostatus
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 0 | Missing |
| 1 | < LLOQ |
| 2 | >= LLOQ |
CD4CAT
| Permitted Value (Code) |
|---|
| <200 |
| 200-500 |
| >500 |
CD4CATN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | <200 |
| 2 | 200-500 |
| 3 | >500 |
Clinical Events Category
| Permitted Value (Code) |
|---|
| REACTOGENICITY |
Subcategory for Clinical Event
| Permitted Value (Code) |
|---|
| SYSTEMIC |
| ADMINISTRATION SITE |
Category for Medication
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| CONCOMITANT IMMUNOSUPPRESSIVE THERAPY | CONCOMITANT IMMUNOSUPPRESSIVE THERAPY |
| CORTICOSTEROIDS | CORTICOSTEROIDS |
| GENERAL CONCOMITANT MEDICATIONS | GENERAL CONCOMITANT MEDICATIONS |
| VACCINATIONS | VACCINATIONS |
| IMMUNOGLOBULINS | IMMUNOGLOBULINS |
Subcategory for Medication
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| VASOPRESSORS AGENTS | VASOPRESSORS AGENTS |
Cohort
| Permitted Value (Code) |
|---|
| Stage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) |
| Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO) |
| Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) |
| Stage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) |
| Stage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) |
| Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO) |
| Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) |
| Stage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) |
| Stage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO) |
| Stage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) |
| Stage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) |
| Stage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO) |
| Stage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) |
Numeric Code of Cohort
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1.14 | Stage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) |
| 1.145 | Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO) |
| 1.15 | Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) |
| 1.16 | Stage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) |
| 1.17 | Stage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) |
| 1.175 | Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO) |
| 1.18 | Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) |
| 1.34 | Stage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) |
| 1.345 | Stage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO) |
| 1.35 | Stage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) |
| 1.37 | Stage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) |
| 1.375 | Stage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO) |
| 1.38 | Stage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) |
Baseline SARS-CoV-2 Status
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| NEG | Negative |
| POS | Positive |
Date Imputation Flag [C81223]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| D [C81212] | Day Imputed |
| M [C81211] | Month Day Imputed |
Actual Dosing Level
| Permitted Value (Code) |
|---|
| 10 (*ESC*){unicode 03BC}g |
| 20 (*ESC*){unicode 03BC}g |
| 30 (*ESC*){unicode 03BC}g |
| 100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}g |
| Placebo |
Numeric Code of Actual Dosing Level
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 10 (*ESC*){unicode 03BC}g |
| 2 | 20 (*ESC*){unicode 03BC}g |
| 3 | 30 (*ESC*){unicode 03BC}g |
| 5 | 100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}g |
| 6 | Placebo |
Planned Dosing Level
| Permitted Value (Code) |
|---|
| 10 (*ESC*){unicode 03BC}g |
| 20 (*ESC*){unicode 03BC}g |
| 30 (*ESC*){unicode 03BC}g |
| 100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}g |
| Placebo |
Numeric Code of Planned Dosing Level
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 10 (*ESC*){unicode 03BC}g |
| 2 | 20 (*ESC*){unicode 03BC}g |
| 3 | 30 (*ESC*){unicode 03BC}g |
| 5 | 100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}g |
| 6 | Placebo |
Category for Disposition Event [C74558]
| Permitted Value (Code) |
|---|
| DISPOSITION EVENT [C74590] |
Numeric Code of Completion/Reason for Non-Completion
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | ADVERSE EVENT |
| 2 | COMPLETED |
| 3 | DEATH |
| 5 | LOST TO FOLLOW-UP |
| 7 | OTHER |
| 8 | PHYSICIAN DECISION |
| 9 | PREGNANCY |
| 11 | PROTOCOL DEVIATION |
| 13 | SCREEN FAILURE |
| 16 | WITHDRAWAL BY SUBJECT |
| 17 | MEDICATION ERROR WITHOUT ASSOCIATED ADVERSE EVENT |
| 18 | NO LONGER MEETS ELIGIBILITY CRITERIA |
| 25 | REFUSED FURTHER STUDY PROCEDURES |
| 26 | WITHDRAWAL BY PARENT/GUARDIAN |
Disposition Phase
| Permitted Value (Code) |
|---|
| SCREENING |
| REPEAT SCREENING 1 |
| VACCINATION |
| OPEN LABEL TREATMENT |
| FOLLOW-UP |
Numeric Code of Disposition Phase
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | SCREENING |
| 7 | OPEN LABEL TREATMENT |
| 26 | VACCINATION |
| 31 | FOLLOW-UP |
| 101 | REPEAT SCREENING 1 |
Category for Protocol Deviation
| Permitted Value (Code) |
|---|
| Important |
| Non-Important |
EPOCH [C99079]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| FOLLOW-UP [C99158] | FOLLOW-UP |
| SCREENING [C48262] | SCREENING |
| VACCINATION [*] | VACCINATION |
| OPEN LABEL FOLLOW-UP [*] | OPEN LABEL FOLLOW-UP |
| OPEN LABEL TREATMENT [C102256] | OPEN LABEL TREATMENT |
| REPEAT SCREENING 1 [*] | REPEAT SCREENING 1 |
* Extended Value
Ethnic Group [C66790]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| HISPANIC OR LATINO [C17459] | Hispanic or Latino |
| NOT HISPANIC OR LATINO [C41222] | Not Hispanic or Latino |
| NOT REPORTED [C43234] | Not Reported |
Numeric Code of Ethnic Group
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | HISPANIC OR LATINO |
| 2 | NOT HISPANIC OR LATINO |
| 3 | NOT REPORTED |
Evaluator [C78735]
| Permitted Value (Code) |
|---|
| INVESTIGATOR [C25936] |
| STUDY SUBJECT [C41189] |
FPX1CA1N
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 0-1 month |
| 2 | 1-2 months |
| 3 | 2-3 months |
| 4 | 3-4 months |
FPX1CAT1
| Permitted Value (Code) |
|---|
| 0-1 month |
| 1-2 months |
| 2-3 months |
| 3-4 months |
FTEMCAT
| Permitted Value (Code) |
|---|
| <38.0 C |
| 38.0 C to 38.4 C |
| >38.4 C to 38.9 C |
| >38.9 C to 40.0 C |
| >40.0 C |
| Missing |
FTEMCATN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 0 | <38.0 C |
| 1 | 38.0 C to 38.4 C |
| 2 | >38.4 C to 38.9 C |
| 3 | >38.9 C to 40.0 C |
| 4 | >40.0 C |
FUP1CA1N
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 0-1 month |
| 2 | 1-2 months |
| 3 | 2-3 months |
| 4 | 3-4 months |
| 5 | 4-5 months |
| 6 | 5-6 months |
| 7 | 6-7 months |
| 8 | 7-8 months |
| 9 | 8-9 months |
| 10 | 9-10 months |
| 11 | 10-11 months |
| 12 | 11-12 months |
FUP1CAT1
| Permitted Value (Code) |
|---|
| 0-1 month |
| 1-2 months |
| 2-3 months |
| 3-4 months |
| 4-5 months |
| 5-6 months |
| 6-7 months |
| 7-8 months |
| 8-9 months |
| 9-10 months |
| 10-11 months |
| 11-12 months |
FUP2CA1N
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 0-1 month |
| 2 | 1-2 months |
| 3 | 2-3 months |
| 4 | 3-4 months |
| 5 | 4-5 months |
| 6 | 5-6 months |
| 7 | 6-7 months |
| 8 | 7-8 months |
| 9 | 8-9 months |
| 10 | 9-10 months |
| 11 | 10-11 months |
FUP2CA2N
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 0-1 month |
| 2 | 1-2 months |
| 3 | 2-3 months |
| 4 | 3-4 months |
| 5 | 4-5 months |
| 6 | 5-6 months |
| 7 | 6-7 months |
| 8 | 7-8 months |
| 9 | 8-9 months |
| 10 | 9-10 months |
FUP2CAT1
| Permitted Value (Code) |
|---|
| 0-1 month |
| 1-2 months |
| 2-3 months |
| 3-4 months |
| 4-5 months |
| 5-6 months |
| 6-7 months |
| 7-8 months |
| 8-9 months |
| 9-10 months |
| 10-11 months |
FUP2CAT2
| Permitted Value (Code) |
|---|
| 0-1 month |
| 1-2 months |
| 2-3 months |
| 3-4 months |
| 4-5 months |
| 5-6 months |
| 6-7 months |
| 7-8 months |
| 8-9 months |
| 9-10 months |
Laterality [C99073]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| LEFT [C25229] | Left |
| RIGHT [C25228] | Right |
Anatomical Location [C74456]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| DELTOID MUSCLE [C32446] | Deltoid |
Category for Medical History
| Permitted Value (Code) |
|---|
| GENERAL MEDICAL HISTORY |
Completion/Reason for Non-Completion [C66727]
| Permitted Value (Code) |
|---|
| ADVERSE EVENT [C41331] |
| COMPLETED [C25250] |
| DEATH [C28554] |
| LOST TO FOLLOW-UP [C48227] |
| OTHER [C17649] |
| PHYSICIAN DECISION [C48250] |
| PREGNANCY [C25742] |
| PROTOCOL DEVIATION [C50996] |
| SCREEN FAILURE [C49628] |
| WITHDRAWAL BY SUBJECT [C49634] |
| MEDICATION ERROR WITHOUT ASSOCIATED ADVERSE EVENT [*] |
| NO LONGER MEETS ELIGIBILITY CRITERIA [*] |
| REFUSED FURTHER STUDY PROCEDURES [*] |
| WITHDRAWAL BY PARENT/GUARDIAN [C102355] |
* Extended Value
Not Done [C66789]
| Permitted Value (Code) |
|---|
| NOT DONE [C49484] |
No Yes Response [C66742]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| N [C49487] | No |
| Y [C49488] | Yes |
Outcome of Event [C66768]
| Permitted Value (Code) |
|---|
| FATAL [C48275] |
| RECOVERED/RESOLVED [C49498] |
| RECOVERED/RESOLVED WITH SEQUELAE [C49495] |
| RECOVERING/RESOLVING [C49496] |
| NOT RECOVERED/NOT RESOLVED [C49494] |
| UNKNOWN [C17998] |
Study Phase
| Permitted Value (Code) |
|---|
| Phase 1 |
| Phase 2_ds360/ds6000 |
| Phase 3_ds6000 |
| Phase 3 |
Numeric Code of Study Phase
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | Phase 1 |
| 2 | Phase 2_ds360/ds6000 |
| 3 | Phase 3_ds6000 |
| 4 | Phase 3 |
Race [C74457]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| WHITE [C41261] | White |
| BLACK OR AFRICAN AMERICAN [C16352] | Black or african american |
| AMERICAN INDIAN OR ALASKA NATIVE [C41259] | American indian or alaska native |
| ASIAN [C41260] | Asian |
| NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER [C41219] | Native hawaiian or other pacific islander |
| MULTIPLE [*] | Multiple |
| NOT REPORTED [C43234] | Not reported |
* Extended Value
Pooled Race Group 1
| Permitted Value (Code) |
|---|
| WHITE |
| BLACK OR AFRICAN AMERICAN |
| ALL OTHERS |
Numeric Code of Pooled Race Group 1
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | WHITE |
| 2 | BLACK OR AFRICAN AMERICAN |
| 3 | ALL OTHERS |
Numeric Code of Race
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | WHITE |
| 2 | BLACK OR AFRICAN AMERICAN |
| 3 | AMERICAN INDIAN OR ALASKA NATIVE |
| 4 | ASIAN |
| 5 | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER |
| 6 | MULTIPLE |
| 7 | NOT REPORTED |
RACIALD
| Permitted Value (Code) |
|---|
| JAPANESE |
| OTHER |
Numeric Code of RACIALD
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 5 | JAPANESE |
| 999 | OTHER |
RNACAT
| Permitted Value (Code) |
|---|
| <50 |
| >=50 |
RNACATN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | <50 |
| 2 | >=50 |
Sex [C66731]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| F [C16576] | Female |
| M [C20197] | Male |
Numeric Code of Sex
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | M |
| 2 | F |
Specimen Type [C78734]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| SERUM [C13325] | Serum |
Relation to Reference Period [C66728]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| BEFORE [C25629] | Prior |
| ONGOING [C53279] | Continue |
TRT01A
| Permitted Value (Code) |
|---|
| BNT162b1 Phase 1 (10 mcg) |
| BNT162b1 Phase 1 (20 mcg) |
| BNT162b1 Phase 1 (30 mcg) |
| BNT162b1 Phase 1 (100/10 mcg) |
| BNT162b2 Phase 1 (10 mcg) |
| BNT162b2 Phase 1 (20 mcg) |
| BNT162b2 Phase 1 (30 mcg) |
| BNT162b2 Phase 2/3 (30 mcg) |
| Placebo |
TRT01AN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | BNT162b1 Phase 1 (10 mcg) |
| 2 | BNT162b1 Phase 1 (20 mcg) |
| 3 | BNT162b1 Phase 1 (30 mcg) |
| 4 | BNT162b1 Phase 1 (100/10 mcg) |
| 5 | BNT162b2 Phase 1 (10 mcg) |
| 6 | BNT162b2 Phase 1 (20 mcg) |
| 7 | BNT162b2 Phase 1 (30 mcg) |
| 8 | BNT162b2 Phase 2/3 (30 mcg) |
| 9 | Placebo |
TRT01P
| Permitted Value (Code) |
|---|
| BNT162b1 Phase 1 (10 mcg) |
| BNT162b1 Phase 1 (20 mcg) |
| BNT162b1 Phase 1 (30 mcg) |
| BNT162b1 Phase 1 (100/10 mcg) |
| BNT162b2 Phase 1 (10 mcg) |
| BNT162b2 Phase 1 (20 mcg) |
| BNT162b2 Phase 1 (30 mcg) |
| BNT162b2 Phase 2/3 (30 mcg) |
| Placebo |
TRT01PN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | BNT162b1 Phase 1 (10 mcg) |
| 2 | BNT162b1 Phase 1 (20 mcg) |
| 3 | BNT162b1 Phase 1 (30 mcg) |
| 4 | BNT162b1 Phase 1 (100/10 mcg) |
| 5 | BNT162b2 Phase 1 (10 mcg) |
| 6 | BNT162b2 Phase 1 (20 mcg) |
| 7 | BNT162b2 Phase 1 (30 mcg) |
| 8 | BNT162b2 Phase 2/3 (30 mcg) |
| 9 | Placebo |
TRT02A
| Permitted Value (Code) |
|---|
| BNT162b2 Phase 1 (30 mcg) |
| BNT162b2 Phase 2/3 (30 mcg) |
TRT02AN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 7 | BNT162b2 Phase 1 (30 mcg) |
| 8 | BNT162b2 Phase 2/3 (30 mcg) |
TRT02P
| Permitted Value (Code) |
|---|
| BNT162b2 Phase 1 (30 mcg) |
| BNT162b2 Phase 2/3 (30 mcg) |
TRT02PN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 7 | BNT162b2 Phase 1 (30 mcg) |
| 8 | BNT162b2 Phase 2/3 (30 mcg) |
TRTA
| Permitted Value (Code) |
|---|
| BNT162b1 Phase 1 (10 mcg) |
| BNT162b1 Phase 1 (20 mcg) |
| BNT162b1 Phase 1 (30 mcg) |
| BNT162b1 Phase 1 (100/10 mcg) |
| BNT162b2 Phase 1 (10 mcg) |
| BNT162b2 Phase 1 (20 mcg) |
| BNT162b2 Phase 1 (30 mcg) |
| BNT162b2 Phase 2/3 (30 mcg) |
| Placebo |
TRTAN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | BNT162b1 Phase 1 (10 mcg) |
| 2 | BNT162b1 Phase 1 (20 mcg) |
| 3 | BNT162b1 Phase 1 (30 mcg) |
| 4 | BNT162b1 Phase 1 (100/10 mcg) |
| 5 | BNT162b2 Phase 1 (10 mcg) |
| 6 | BNT162b2 Phase 1 (20 mcg) |
| 7 | BNT162b2 Phase 1 (30 mcg) |
| 8 | BNT162b2 Phase 2/3 (30 mcg) |
| 9 | Placebo |
TRTP
| Permitted Value (Code) |
|---|
| BNT162b1 Phase 1 (10 mcg) |
| BNT162b1 Phase 1 (20 mcg) |
| BNT162b1 Phase 1 (30 mcg) |
| BNT162b1 Phase 1 (100/10 mcg) |
| BNT162b2 Phase 1 (10 mcg) |
| BNT162b2 Phase 1 (20 mcg) |
| BNT162b2 Phase 1 (30 mcg) |
| BNT162b2 Phase 2/3 (30 mcg) |
| Placebo |
TRTPN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | BNT162b1 Phase 1 (10 mcg) |
| 2 | BNT162b1 Phase 1 (20 mcg) |
| 3 | BNT162b1 Phase 1 (30 mcg) |
| 4 | BNT162b1 Phase 1 (100/10 mcg) |
| 5 | BNT162b2 Phase 1 (10 mcg) |
| 6 | BNT162b2 Phase 1 (20 mcg) |
| 7 | BNT162b2 Phase 1 (30 mcg) |
| 8 | BNT162b2 Phase 2/3 (30 mcg) |
| 9 | Placebo |
Unit [C71620]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| DAYS [C25301] | Day |
Unit [C71620]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| YEARS [C29848] | Year |
Units for Vital Signs Results [C66770]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| % [C25613] | Percentage |
| beats/min [C49673] | Beats per Minute |
| breaths/min [C49674] | Breaths per Minute |
| mmHg [C49670] | Millimeter of Mercury |
| C [C42559] | Degree Celsius |
Y [C66742]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| Y [C49488] | Yes |
Go to the top of the Define-XML document
External Dictionaries
| Reference Name | External Dictionary | Dictionary Version |
|---|---|---|
| Medical Dictionary for Regulatory Activities | MedDRA | 23.1 |
| Drug Dictionary | WHO DDE | v202003 |
Go to the top of the Define-XML document
Methods
| Method | Type | Description |
|---|---|---|
| Algorithm: ADAE.ADESFL | Computation | If (index (upcase(AEACN),'DRUG WITHDRAWN') > 0 or AESUBJDC='Y') then ADESFL=”Y” else ADESFL=N. |
| Algorithm: ADAE.ADURN | Computation | ADURN in Days: ADURN= AENDT - ASTDT+1 and ADURU =’DAYS’ |
| Algorithm: ADAE.AEDECOD | Computation | AE.AEDECOD
if AE.AEDECOD eq '' and not missing(AE.AETERM))) then AEDECOD=upcase(strip(AE.AETERM)) || "@@" |
| Algorithm: ADAE.AEIMMFL | Computation | If 0<=AETPDOS < = 30 mins (0.5 hours) then AEIMMFL=”Y” else null
Note: Immediate AE is defined as AEs happened within 30 mins after corresponding vaccination |
| Algorithm: ADAE.AENDT | Computation | Convert AEENDTC to DATE9 format
Note: No imputation for AENDT, all imputing will be based on pfizer standards. |
| Algorithm: ADAE.AENDTM | Computation | Convert AEENDTC to IS8601 format. |
| Algorithm: ADAE.AENDY | Computation | For AEs without time collected:
if (ASTDT<ADSL.VAX101DT) then AENDY= AENDT – ADSL.VAX101DT;
if (ASTDT>= ADSL.VAX101DT and ADSL.VAX101DT>.) and (ASTDT<ADSL.VAX102DT or ADSL.VAX102DT=.) then AENDY= AENDT – ADSL.VAX101DT + 1;
if (ASTDT>= ADSL.VAX102DT and ADSL.VAX102DT>.) and (ASTDT<ADSL.VAX201DT or ADSL.VAX201DT=.) then AENDY= AENDT – ADSL.VAX102DT + 1;
if (ASTDT>=ADSL.VAX201DT and ADSL.VAX201DT>.) and (ASTDT<ADSL.VAX202DT or ADSL.VAX202DT=. ) then AENDY= AENDT – ADSL.VAX201DT + 1;
if (ASTDT>=ADSL.VAX202DT and ADSL.VAX202DT>.) then AENDY= AENDT – ADSL.VAX202DT + 1;
For AEs with time collected:
Similar logic as AEs without time, but need to compare the AE happened time with the exact time of vaccination. eg: For AE happend on the same day of the vaccination 2, if AE start time is collected, then the AE start time need to be compared with the time of vaccination 2. If AE happened before the time of vaccination 2, AENDY=AENDT-ADSL.VAX101DT+1. Otherwise if AE happened after the time of vacciantion 2 then AENDY=AENDT- ADSL.VAX102DT+1;
Note: Use relative vaccination date (Last vaccination date prior to the onset of the AE) to calculate AENDY. |
| Algorithm: ADAE.AENTM | Computation | Timepart of AE.AEENDTC |
| Algorithm: ADAE.AETPDOS | Computation | If ( ASTDTM >ADSL.TRTSDTM ) and select the record with minimum positive value of ASTDTM-EX.EXSTDTC then set AETPDOS = round((ASTDTM - EX.EXSTDTM)/60,1.).
if (ASTDTM < ADSL.TRTSDTM and ASTDTM is not missing then AETPDOS = round((ASTDTM - ADSL.TRTSDTM)/60,1.). |
| Algorithm: ADAE.APEREDT | Computation | Datepart(APEREDTM) |
| Algorithm: ADAE.APEREDTM | Computation | for APERIOD=1,
APEREDTM = ADSL.TR02SDTM -1 ;
if VAX3 is missing then APEREDTM =ADSL.TR01EDTM +365 days;
for APERIOD=2,
APEREDTM =ADSL.TR02EDTM +365 days |
| Algorithm: ADAE.APERETM | Computation | Timepart(APEREDTM) |
| Algorithm: ADAE.APERIOD | Computation | Numeric Code of aperiodc
1 for AEs happened before ADSL.TR02SDTM or VAX3 is missing
2 for AEs happened after or on ADSL.TR02SDTM |
| Algorithm: ADAE.APERSDT | Computation | Datepart(APERSDTM) |
| Algorithm: ADAE.APERSDTM | Computation | for APERIOD=1, APERSDTM = datetime of (ADSL.TRTSDTM)
for APERIOD=2, APERSDTM = datetime of (ADSL.TR02SDTM) |
| Algorithm: ADAE.APERSTM | Computation | Timepart(APERSDTM) |
| Algorithm: ADAE.ASTDT | Computation | Convert imputed AESTDTC to DATE9 format.
Imputate partial start date per Vaccine Rule Book.
Firstly:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year.
no imputation for complete missing start date.
Secondly:
If day is missing, and at the same year and month of the vaccination, impute to the first vaccination date of that month.
if month is missing, and at the same year of the vaccination, impute to the first vaccination date of that year. |
| Algorithm: ADAE.ASTDTF | Computation | = "D" if day is imputed.
= "M" if month and day are imputed.
= "Y" if month, day and year are imputed |
| Algorithm: ADAE.ASTDTM | Computation | Convert AESTDTC to IS8601 format. |
| Algorithm: ADAE.ASTDY | Computation | if (ASTDT<ADSL.VAX101DT) then ASTDY= ASTDT – ADSL.VAX101DT;
else ASTDY= ASTDT – most recent dosing date before the AE + 1
Note: Use relative vaccination date (Last vaccination date prior to the onset of the AE) to calculate ASTDY. |
| Algorithm: ADAE.ASTTM | Computation | Timepart of AE.AESTDTC |
| Algorithm: ADAE.ATOXGR | Computation | ATOXGR="GRADE "|| strip(AETOXGR) |
| Algorithm: ADAE.INWDFL | Computation | if VPHASEN ne . and VPHASEN not in (0, 99, 4, 100) then INWDFL = "Y" |
| Algorithm: ADAE.PREFL | Computation | ASTDTM<TRTSDTM then PREFL="Y" |
| Algorithm: ADAE.VAXNO | Computation | the number of last vaccine before AE occurred.
if AE happened in VPHASE 'After unblinding and before Vaccination 3', then set VAXNO to most latest Dose before the AE. |
| Algorithm: ADAE.VPHASE | Computation | If AE happened before vax 1 then VPHASE='Pre-Vaccination'; (Note: AE start time is collected per CRF)
If AE happened on or after vax1 and (before vax2 or vax2 is missing) then VPHASE='Vaccination 1';
if AE happened on or after vax2 and before or on the same day ADSL.V01DT then VPHASE='Vaccination 2';
if AE happened after of ADSL.V01DT and before or on the same day ADSL.V02DT then VPHASE='Follow Up 1';
if AE happened after of ADSL.V02DT then VPHASE='Follow Up 2';
if AE happened on or after unblinded date and (before vax3 or vax3 is missing) then VPHASE='After unblinding and before Vaccination 3';
If AE happened on or after vax3 and (before vax4 or vax4 is missing) then VPHASE='Vaccination 3';
if AE happened on or after vax4 and before or on the same day ADSL.V03DT then VPHASE='Vaccination 4';
if AE happened after ADSL.V03DT and before or on the same day ADSL.V04DT then VPHASE='Follow Up 3';
if AE happened after ADSL.V04DT then VPHASE='Follow Up 4'; |
| Algorithm: ADC19EF.ADT | Computation | if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "PRCDTH" "SECDTH" ) then set to ADSYMPT.ADT
if paramcd = "SEVCVS" then set to the earliest date from ADSYMPT.ADT when condition/s are present.
if paramcd = "NAATRAD" then set from ADSYMPT.ADT of concluded NAAT result based on specifications in AVALC of this record.
If both local and central results are missing/invalid, set this to null.
if paramcd = "C19ONST" then set to ASTDT where PARAMCD = "PRPDSAD"
if paramcd = "CDCONST" then set to ASTDT where PARAMCD = "PRCDCSAD"
if paramcd = "SEVCONST" then set to ASTDT where PARAMCD = "PRSVCSAD"
if paramcd = "CDCSONST" then set to ASTDT where PARAMCD = "PRSCDCAD"
if paramcd="DTHODC19" then set to ADT where PARAMCD is "PRCDTH" or "SECDTH"
if paramcd in ("HCUICU" "HCUHSP" "PRPDSAD” “PRCDCSAD” “SEVCRF” “SEVCVSPR” “SEVCRHN” “PRSVCSAD” “PRSCDCAD” “ST1PD” “ST17PD” “ST2PD” “ST27PD” “ST214PD” “ST1CD” “ST17CD” “ST2CD” “ST27CD” “ST214CD” “ST1SE” “ST17SE” “ST2SE” “ST27SE” “ST214SE” “STC1SE” “STC17SE” “STC2SE” “STC27SE” “STC214SE” “ST1PDA” “ST17PDA” “ST2PDA” “ST27PDA” “ST214PDA” “ST1CDA” “ST17CDA” “ST2CDA” “ST27CDA” “ST214CDA” “ST1SEA” “ST17SEA” “ST2SEA” “ST27SEA” “ST214SEA” “STC1SA” “STC17SA” “STC2SA” “STC27SA” “STC214SA” “ST1PDX” “STC1SX”)
then set to null. |
| Algorithm: ADC19EF.ADY | Computation | Set as following:
ADY = ADT - TRTSDT.
If ADT >= TRTSDT, ADY = ADT - TRTSDT + 1. |
| Algorithm: ADC19EF.AENDT | Computation | if paramcd in ("HCUICU" "HCUHSP") then set to ADSYMPT.AENDT.
if paramcd in ("PRPDSAD" "PRCDCSAD") then set to the latest date from ADSYMPT.AENDT when condition/s are present.
if paramcdin ("SEVCRF" "SEVCRHN" "SEVCVSPR") then set to the latest date from ADSYMPT.AENDT when condition/s are present and end dates of all contributing records are reported.
if paramcd in ("PRSVCSAD" "PRSCDCAD") then set to the latest date from AENDT when condition/s are present and contributing end dates except from vital signs are present/populated.
If there is a death and this record is part of last illness visit, set to date of death.
if paramcd in ("ST1PD" "ST17PD" "ST2PD" "ST27PD" "ST214PD" ) then set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd in ("ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA" "ST1PDX") then set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd in ("ST1CD" "ST17CD" "ST2CD" "ST27CD" "ST214CD" ) then set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "CDCONST".
if paramcd in ("ST1CDA" "ST17CDA" "ST2CDA" "ST27CDA" "ST214CDA") then set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "CDCONST".
if paramcd in ("ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE") then set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "SEVCONST".
if paramcd in ("ST1SEA" "ST17SEA" "ST2SEA" "ST27SEA" "ST214SEA") then set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "SEVCONST".
else if none of the above PARAMCDs, set to null. |
| Algorithm: ADC19EF.AENDY | Computation | Set as following:
AENDY = AENDT - TRTSDT.
If AENDT >= TRTSDT, AENDY = AENDT - TRTSDT + 1. |
| Algorithm: ADC19EF.ASTDT | Computation | if paramcd in ("HCUICU" "HCUHSP") then set to ADSYMPT.ASTDT.
if paramcd in ("PRPDSAD" "PRCDCSAD") then set to the earliest date from ADSYMPT.ASTDT when condition/s are present.
if paramcdin ("SEVCRF" "SEVCRHN" "SEVCVSPR") then set to the earliest date from ADSYMPT.ASTDT when condition/s are present and end dates of all contributing records are reported.
if paramcd in ("PRSVCSAD" "PRSCDCAD") then set to the earliest date from ADT/ASTDT when condition/s are present.
if paramcd in (“ST1PD” “ST1CD” “ST1SE” “STC1SE” “ST1PDA” “ST1CDA” “ST1SEA” “STC1SA” “ST1PDX” “STC1SX” ) then set as Dose 1 when Dose 1 date is not missing.
if paramcd in (“ST17PD” “ST17CD” “ST17SE” “STC17SE” “ST17PDA” “ST17CDA” “ST17SEA” “STC17SA”) then set as Dose 1 + 7 when Dose 1 date is not missing.
if paramcd in (“ST214PD” “ST214CD” “ST214SE” “STC214SE” “ST214PDA” “ST214CDA” “ST214SEA” “STC214SA”) then set as Dose 2 + 14 when Dose 2 date is not missing.
if paramcd in (“ST27PD” “ST27CD” “ST27SE” “STC27SE” “ST27PDA” “ST27CDA” “ST27SEA” “STC27SA” ) then set as Dose 2 + 7 when Dose 2 date is not missing.
if paramcd in (“ST2PD” “ST2CD” “ST2SE” “STC2SE” “ST2PDA” “ST2CDA” “ST2SEA” “STC2SA” ) then set as Dose 2 when Dose 2 date is not missing. |
| Algorithm: ADC19EF.ASTDY | Computation | Set as following:
ASTDY = ASTDT - TRTSDT.
If ASTDT >= TRTSDT, ASTDY = ASTDT - TRTSDT + 1. |
| Algorithm: ADC19EF.AVAL | Computation | if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record).
If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered.
else for other paramcds, set to null |
| Algorithm: ADC19EF.AVALC | Computation | if index (PARAM, "SURVEILLANCE")>0 then set to null.
if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L".
if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP".
if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH".
if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH".
if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit.
if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null.
if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following:
1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following:
1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N".
if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. |
| Algorithm: ADC19EF.AVISIT | Computation | 1. Set to ADSYMPT.AVISIT for all other parameters except for derived records for surveillance time.
2. For PARAMCD="DTHODC19", the AVISIT is populated if death occurred after an illness visit. This last illness visit AVISIT is assigned to the record.
3. If derived parameters for surveillance time, the set to null. |
| Algorithm: ADC19EF.AVISITN | Computation | 1. Set to ADSYMPT.AVISITN for all other parameters except for derived records for surveillance time.
2. For PARAMCD="DTHODC19", the AVISITN is populated if death occurred after an illness visit. This last illness visit AVISITN is assigned to the record.
3. If derived parameters for surveillance time, the set to null. |
| Algorithm: ADC19EF.CDCRMUFL | Computation | Set to "Y" for all records of a subject, if CDC defined symptom/s are present and test result from local and/or central lab concluded as indeterminate, missing or unknown and symptom/s start date is before a first positive(PARAMCD is "CDCONST") case.
Otherwise set to "N" for all records of a subject. Also set to "N" for subjects who did not report any CDC defined symptoms.
Note: If a subject has reported these symptom/s more than once at different visits, set to "Y" if any of the test results are concluded as indeterminate, missing or unknown. |
| Algorithm: ADC19EF.CDCSYMFL | Computation | Set for all records of a subject as following:
If a subject has any record with AVALC = "Y" when PARAMCD = "PRCDCSAD", set to "Y".
Otherwise set to "N". |
| Algorithm: ADC19EF.CDP17FL | Computation | Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date.
2. Otherwise set to "N".
If subject reports CDC define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 1 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and within 7 days post Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. |
| Algorithm: ADC19EF.CDP1FL | Computation | Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date.
2. Otherwise set to "N".
If subject reports CDC define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. |
| Algorithm: ADC19EF.CDP214FL | Computation | Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates.
2. Otherwise set to "N".
If subject reports CDC define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 14 days after Dose 2 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and within 14 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. |
| Algorithm: ADC19EF.CDP27FL | Computation | Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates.
2. Otherwise set to "N".
If subject reports CDC define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 2 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and within 7 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. |
| Algorithm: ADC19EF.CDRMUPFL | Computation | Set to "Y" for all records of a subject, if CDC defined symptom/s are present and test result from local and/or central lab concluded as indeterminate, missing or unknown and not followed by a confirmed positive case where PARAMCD is "CDCONST".
Otherwise set to "N" for all records of a subject. Also set to "N" for subjects who did not report any CDC defined symptoms.
Note: If a subject has reported these symptom/s more than once at different visits, set to "Y" if any of the test results are concluded as indeterminate, missing or unknown. |
| Algorithm: ADC19EF.CNCRSLFL | Computation | Set for records where PARAMCD is "SARSCOV2" or "RTCOV2NS" or "C19NIG" as following:
If only one result is present per PARAMCD within a given visit set to "Y'.
For unplanned results, set "Y" if result date is up to 4 days before, on/after the symptom start date and symptom end date is missing. If the symptom end date is present, the result date must be within 4 days after the end date.
If multiple unplanned results qualify above condition, set to "Y" based on the result as POS > IND > NEG > UNK/missing. |
| Algorithm: ADC19EF.CRD1NGFL | Computation | Set for all records of a subject based on following:
If NAAT result date is on or before Dose 1 date and AVAC = "NEG" when PARAMCD = "RTCOV2NS", set to "Y".
If NAAT result date is on or before Dose 1 date and AVAC = "POS" when PARAMCD = "RTCOV2NS", set to "N".
Otherwise, set to null. |
| Algorithm: ADC19EF.CRD2NGFL | Computation | Set for all records of a subject based on following:
If NAAT result date is on or before Dose 2 date and AVAC = "NEG" when PARAMCD = "RTCOV2NS", set to "Y".
If NAAT result date is on or before Dose 2 date and AVAC = "POS" when PARAMCD = "RTCOV2NS", set to "N".
Otherwise, set to null. |
| Algorithm: ADC19EF.FILOCRFL | Computation | Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" as following:
if AVALC = "POS" and is the first onset of illness after dose, set to "Y". |
| Algorithm: ADC19EF.ILD17FL | Computation | Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" and AVALC is "POS" as following:
If illness onset date is greater then 7 days post Dose 1 date, set to "Y". Otherwise set to "N". |
| Algorithm: ADC19EF.ILD1FL | Computation | Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" and AVALC is "POS" as following:
If illness onset date is greater then Dose 1 date, set to "Y". Otherwise set to "N". |
| Algorithm: ADC19EF.ILD214FL | Computation | Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" and AVALC is "POS" as following:
If illness onset date is greater then 14 days post Dose 2 date, set to "Y". Otherwise set to "N". |
| Algorithm: ADC19EF.ILD27FL | Computation | Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" and AVALC is "POS" as following:
If illness onset date is greater then 7 days post Dose 2 date, set to "Y". Otherwise set to "N". |
| Algorithm: ADC19EF.ILD2FL | Computation | Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" and AVALC is "POS" as following:
If illness onset date is greater then Dose 2 date, set to "Y". Otherwise set to "N". |
| Algorithm: ADC19EF.NMPDOCFL | Computation | Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" as following:
if DVSTDT is null, set to "Y".
Also set to "Y" if DVSTDT occurs after the ADT of PARAMCDs specified above. |
| Algorithm: ADC19EF.PARAM | Computation | if PARAMCD in ("C19NIG" "HCUHSP" "RTCOV2NS" "HCUICU" "SARSCOV2" "PRCDTH" "SECDTH") then set to ADSYMPT.PARAM
if PARAMCD= “DTHODC19” then set to “DEATH OCCURRED DUE TO COVID-19 ILLNESS?”
if PARAMCD= “PRPDSAD” then set to “PRESENCE OF PROTOCOL DEFINED SYMPTOMS AFTER DOSE”
if paramcd= “PRCDCSAD” then set to “PRESENCE OF CDC DEFINED SYMPTOMS AFTER DOSE”
if paramcd= “SEVCVS” then set to “SEVERE COVID-19 SYMPTOMS - VITAL SIGNS”
if paramcd=”SEVCRF” then set to “SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE”
if paramcd= “SEVCVSPR” then set to “SEVERE COVID-19 SYMPTOMS - USE OF VASOPRESSORS”
if paramcd= “SEVCRHN” then set to “SEVERE COVID-19 SYMPTOMS - SIGNIFICANT ACUTE RENAL, HEPATIC, OR NEUROLOGIC DYSFUNCTION”
if paramcd = “PRSVCSAD” then set to “PRESENCE OF PROTOCOL DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE”
if paramcd=”PRSCDCAD” then set to “PRESENCE OF CDC DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE”
if paramcd=”NAATRAD” then set to “COVID-19 NAAT RESULT AFTER DOSE”
if paramcd = “C19ONST” then set to “PROTOCOL DEFINED COVID-19 ILLNESS ONSET”
if paramcd = “CDCONST” then set to “CDC DEFINED COVID-19 ILLNESS ONSET”
if paramcd = “SEVCONST” then set to “PROTOCOL DEFINED SEVERE COVID-19 ILLNESS ONSET”
if paramcd = “CDCSONST” then set to “CDC DEFINED SEVERE COVID-19 ILLNESS ONSET”
if paramcd = ”ST1PD” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS”
if paramcd=“ST17PD” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS”
if paramcd=“ST2PD” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS”
if paramcd=“ST27PD” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS”
if paramcd=“ST214PD” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS”
if paramcd=“ST1CD” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS”
if paramcd=“ST17CD” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS”
if paramcd=“ST2CD” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS”
if paramcd=“ST27CD” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS”
if paramcd=“ST214CD” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS”
if paramcd=“ST1SE” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“ST17SE” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“ST2SE” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“ST27SE” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“ST214SE” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“STC1SE” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“STC17SE” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“STC2SE” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“STC27SE” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“STC214SE” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS”
if paramcd=“ST1PDA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST17PDA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST2PDA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST27PDA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST214PDA” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST1CDA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST17CDA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST2CDA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST27CDA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST214CDA” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST1SEA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST17SEA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST2SEA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST27SEA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST214SEA” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“STC1SA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“STC17SA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“STC2SA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“STC27SA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“STC214SA” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE”
if paramcd=“ST1PDX” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS – CROSSOVER”
if paramcd=“STC1SX” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS – CROSSOVER” |
| Algorithm: ADC19EF.PARCAT1 | Computation | if index (PARAM, "SURVEILLANCE")>0 then set to "SURVEILLANCE TIME".
if PARAMCD in ("C19NIG" "RTCOV2NS" "SARSCOV2" "PRCDTH" "SECDTH" “PRPDSAD” “PRCDCSAD” “SEVCRF” “SEVCVSPR” “SEVCRHN”) then set to ADSYMPT.PARCAT1
if paramcd in (”HCUHSP” “HCUICU”) then set to “HOSPITALIZATION STATUS”
if paramcd = “DTHODC19” then set to "DEATH STATUS".
If paramcd = “PRSVCSAD” then set to "SEVERE COVID-19 SYMPTOMS".
If paramcd=”PRSCDCAD”“ then Set to "SEVERE COVID-19 SYMPTOMS".
If paramcd=”NAATRAD” then Set to "CENTRAL/LOCAL NAAT RESULTS".
If paramcd=”C19ONST” then Set to "ILLNESS ONSET".
If paramcd=“CDCONST” then Set to "ILLNESS ONSET".
If paramcd=”SEVCONST” then Set to "ILLNESS ONSET".
If paramcd=”CDCSONST” then Set to "ILLNESS ONSET". |
| Algorithm: ADC19EF.PDP17FL | Computation | Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date.
2. Otherwise set to "N".
If subject reports protocol define symptoms, the following condition/s may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 1 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptom and start date of symptom is missing, on or after Dose 1 and within 7 days post Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. |
| Algorithm: ADC19EF.PDP1FL | Computation | Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date.
2. Otherwise set to "N".
If subject reports protocol define symptoms and/or has , the following condition/s may overwrite the previous value.
3. If there is an unscheduled NAAT test on or before Dose 1 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptoms and start date of symptom is missing, on or after Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. |
| Algorithm: ADC19EF.PDP214FL | Computation | Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates.
2. Otherwise set to "N".
If subject reports protocol define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 14 days after Dose 2 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptom and start date of symptom is missing, on or after Dose 1 and within 14 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. |
| Algorithm: ADC19EF.PDP27FL | Computation | Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates.
2. Otherwise set to "N".
If subject reports protocol define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 2 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptom and start date of symptom is missing, on or after Dose 1 and within 7 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. |
| Algorithm: ADC19EF.PDRMUFL | Computation | Set to "Y" for all records of a subject, if protocol defined symptom/s are present and test result from local and/or central lab concluded as indeterminate, missing or unknown and symptom/s start date is before a first positive(PARAMCD is "C19ONST") case.
Otherwise set to "N" for all records of a subject. Also set as "N" for subjects who did not report any protocol defined symptoms.
Note: If a subject has reported these symptom/s more than once at different visits, set to "Y" if any of the test results are concluded as indeterminate, missing or unknown. |
| Algorithm: ADC19EF.PDRMUPFL | Computation | Set to "Y" for all records of a subject, if protocol defined symptom/s are present and test result from local and/or central lab concluded as indeterminate, missing or unknown and not followed by a confirmed positive case where PARAMCD is "C19ONST".
Otherwise set to "N" for all records of a subject. Also set as "N" for subjects who did not report any protocol defined symptoms.
Note: If a subject has reported these symptom/s more than once at different visits, set to "Y" if any of the test results are concluded as indeterminate, missing or unknown. |
| Algorithm: ADC19EF.PDSDMFL | Computation | Set for all records of a subject as following:
If PDSYMFL = "Y" and symptom start date is missing, set to "Y".
Otherwise set to "N". |
| Algorithm: ADC19EF.PDSYMFL | Computation | Set for all records of a subject as following:
If a subject has any record with AVALC = "Y" when PARAMCD = "PRPDSAD", set to "Y".
Otherwise set to "N". |
| Algorithm: ADC19EF.SEVCDCFL | Computation | Set for all records of a subject as following:
If a subject has any record with AVALC = "Y" when PARAMCD = "PRSCDCAD", set to "Y".
Otherwise set to "N". |
| Algorithm: ADC19EF.SEVSYMFL | Computation | Set for all records of a subject as following:
If a subject has any record with AVALC = "Y" when PARAMCD = "PRSVCSAD", set to "Y".
Otherwise set to "N". |
| Algorithm: ADC19EF.VRBLNGFL | Computation | Set for all records of a subject based on following:
If NVA result date is on or before Dose 1 date and AVAC = "NEG" when PARAMCD = "C19NIG", set to "Y".
If NVA result date is on or before Dose 1 date and AVAC = "POS" when PARAMCD = "C19NIG", set to "N".
Otherwise, set to null. |
| Algorithm: ADCEVD.ADURN | Computation | ADURN=AENDT - ASTDT+1. |
| Algorithm: ADCEVD.AENDT | Computation | Exclude FADTC/VSDTC>=UNBLNDDT.
AENDT is the resolution date of the reactions/events within USUBJID/FATPTREF/FAOBJ level.
1) if a reaction/event resolved before or on the last diary day:
If last.FACE.FAOBJ then set AENDT to datepart of FACE.FADTC where FACE.FAOBJ not in ('REDNESS' 'SWELLING' 'MEDICATIONS') and FACE.FASTRESC=”Y” and FACE.FATESTCD=”OCCUR”.
If last.FACE.FAOBJ then set AENDT to datepart of FACE.FADTC where FACE.FAOBJ in ('REDNESS' 'SWELLING') and FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FASTRESN>=2.5.
For CETERM='FEVER', if last.VSTESTCD then set AENDT to datepart of VS.VSDTC where VS.VSCAT='REACTOGENICITY' and index(VS.VSTESTCD,'TEMP') and 38.0<=VS.VSSTRESN<=42.0 within USUBJID/VSTPTREF/VSTESTCD level.
2) if a reaction/event still happend on the last diary day
AENDT was derived as missing if SUPPCE.ONGNXVIS='Y' and SUPPCE.RCENDTC is missing.
AENDT was derived as numeric value of CE.CEENDTC if CE.CEENDTC is captured and not partial.
If CETPTREF='VACCINATION 1' and ADSL.VAX102DT ne . and (numeric value of SUPPCE.RCENDTC>VAX102DT or SUPPCE.ONGNXVIS='Y'), set AENDT to VAX102DT.
Similar algorithm for readings with ASEV='Severe' (To derive start date for subjects with severe redness or swelling):
where FACE.FADTC is not missing and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FACE.FASTRESN>10 and FACE.FAOBJ in ('REDNESS' 'SWELLING'); |
| Algorithm: ADCEVD.ASEV | Computation | Set to 'Severe' for cases in FACE: 1) where FACE.FADTC is within 7 days after each vaccination and (FACE.FATESTCD in ('DIAMETER' 'MINDIAM' 'MAXDIAM') and FACE.FASTRESN>=10.5 and FACE.FAOBJ in ('REDNESS' 'SWELLING')); |
| Algorithm: ADCEVD.ASTDT | Computation | Exclude FADTC/VSDTC>=UNBLNDDT.
ASTDT is the first day of the reactions/events within USUBJID/FATPTREF/FAOBJ level.
If first.FACE.FAOBJ then set ASTDT to datepart of FACE.FADTC when FACE.FAOBJ not in ('REDNESS' 'SWELLING' 'MEDICATIONS') and FACE.FASTRESC=”Y” and FACE.FATESTCD=”OCCUR”.
If first.FACE.FAOBJ then set ASTDT to datepart of FACE.FADTC when FACE.FAOBJ in ('REDNESS' 'SWELLING') and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FACE.FASTRESN>=2.5.
For CETERM='FEVER', if first.VSTESTCD then set ASTDT to datepart of VS.VSDTC where VS.VSCAT='REACTOGENICITY' and index(VS.VSTESTCD,'TEMP') and 38.0<=VS.VSSTRESN<=42.0 within USUBJID/VSTPTREF/VSTESTCD level.
Similar algorithm for readings with ASEV='Severe' (To derive start date for subjects with severe redness or swelling)
where FACE.FADTC is not missing and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FACE.FASTRESN>10 and FACE.FAOBJ in ('REDNESS' 'SWELLING'); |
| Algorithm: ADCEVD.EVENTFL | Computation | Exclude FADTC/VSDTC>=UNBLNDDT.
This flag is derived at SUBJECT/FATPTREF/FAOBJ level:
For CE.CETERM in ('REDNESS' 'SWELLING'): Set to 'Y' if a subject had a reaction (FACE.FASTRESN >=2.5 and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') ) at any day from day 1 to day 7 after each dose; else set to 'N'.
For CE.CETERM not in ('REDNESS' 'SWELLING' 'FEVER'): Set to 'Y' if a subject had a reaction or an event (FACE.FATESTCD='SEV' and FACE.FASTRESC in ('MILD', 'MODERATE','SEVER', 'GRADE 4')) at any day from day 1 to day 7 after each dose; else set to 'N'.
For CE.CETERM="FEVER", set to 'Y' if a subject had a record (38.0<=VS.VSSTRESN<=42.0) at any day from day 1 to day 7 after each dose within USUBJID/VSTPTREF/VSTESTCD level; else set to 'N'. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
Note: The unplanned assessments beyond 7 days after each vaccination are excluded when deriving ADCEVD. |
| Algorithm: ADCEVD.KNOWVFL | Computation | Exclude FADTC/VSDTC>=UNBLNDDT.
This flag is derived at SUBJECT/FATPTREF/FAOBJ level:
Set to "Y" for a reaction or an event if a subject had a vaild record (where FACE.FASTRESC or VS.VSORRES ne missing) at any day from day 1 to day 7 after each dose for any local reacaction or systemic event, else set to 'N'. |
| Algorithm: ADCEVD.TRTA | Computation | if (VAX101='Placebo' and CETPTREF="VACCINATION 1") or (VAX102='Placebo' and CETPTREF="VACCINATION 2") then TRTA='Placebo';
else ADSL.TRT01A. |
| Algorithm: ADCEVD.TRTAN | Computation | if (VAX101='Placebo' and CETPTREF="VACCINATION 1") or (VAX102='Placebo' and CETPTREF="VACCINATION 2") then TRTAN=9';
else ADSL.TRT01AN. |
| Algorithm: ADCM.AENDT | Computation | DATEPART of (CM.CMENDTC) |
| Algorithm: ADCM.AENDTF | Computation | AENDTF = 'Y' if Year is imputed
AENDTF = 'M' if Year is present and Month is imputed
AENDTF = 'D' if only day is imputed |
| Algorithm: ADCM.AENDY | Computation | AENDT – ADSL.TRTSDT + 1 if AENDT >= TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT |
| Algorithm: ADCM.ASTDT | Computation | DATEPART of (CM.CMSTDTC) |
| Algorithm: ADCM.ASTDTF | Computation | ASTDTF = 'Y' if Year is imputed
ASTDTF = 'M' if Year is present and Month is imputed
ASTDTF = 'D' if only day is imputed |
| Algorithm: ADCM.ASTDY | Computation | ASTDT – ADSL.TRTSDT + 1 if ASTDT >= TRTSDT, else ASTDT – ADSL.TRTSDT if ASTDT< TRTSDT |
| Algorithm: ADCM.ATC1CD | Computation | Derived from WHODrug Dictionary |
| Algorithm: ADCM.ATC1T | Computation | Derived from WHODrug Dictionary |
| Algorithm: ADCM.ATC2CD | Computation | Derived from WHODrug Dictionary |
| Algorithm: ADCM.ATC2T | Computation | Derived from WHODrug Dictionary |
| Algorithm: ADCM.ATC3CD | Computation | Derived from WHODrug Dictionary |
| Algorithm: ADCM.ATC3T | Computation | Derived from WHODrug Dictionary |
| Algorithm: ADCM.ATC4CD | Computation | Derived from WHODrug Dictionary |
| Algorithm: ADCM.ATC4T | Computation | Derived from WHODrug Dictionary |
| Algorithm: ADCM.ATC5CD | Computation | Derived from WHODrug Dictionary |
| Algorithm: ADCM.ATC5T | Computation | Derived from WHODrug Dictionary |
| Algorithm: ADCM.DRGNAME1 | Computation | if length of DRUGNAME gt 200, then put letters gt 200 in DRGNAME1 |
| Algorithm: ADCM.DRUGNAME | Computation | Derived from WHODrug Dictionary |
| Algorithm: ADCM.ONPERFL | Computation | If ONTR01FL or ONTR02FL= ‘Y’ then ONPERFL=’Y’ |
| Algorithm: ADCM.ONTR01FL | Computation | If NOT LAST PERIOD then
if (ASTDT <= (TR[xx]EDT + G_PRT_PERIOD_LAG) > . and ((AENDT >=TRXXSDT) or (upcase(CMENRTPT)='ONGOING'))) or (ASTDT >= TR[xx]SDT and ASTDT <= (TR[xx]EDT + G_PRT_PERIOD_LAG)) then ONTRxxFL = 'Y' ;
If LAST PERIOD then
if (ASTDT <= (TR[xx]EDT + G_PRT_LASTPERIOD_LAG) > . and ((AENDT >=TRXXSDT) or (upcase(CMENRTPT)='ONGOING')) ) or (ASTDT >= TR[xx]SDT and ASTDT <= (TR[xx]EDT + G_PRT_LASTPERIOD_LAG)) then ONTRxxFL = 'Y' ;
[xx] will replaced by 01 and 02 in the code, G_PRT_PERIOD_LAG is set as 365
if cm happend after unblinding but before vax 3 and vax 3 is not missing, then set to missing |
| Algorithm: ADCM.ONTR02FL | Computation | If NOT LAST PERIOD then
if (ASTDT <= (TR[xx]EDT + G_PRT_PERIOD_LAG) > . and ((AENDT >=TRXXSDT) or (upcase(CMENRTPT)='ONGOING'))) or (ASTDT >= TR[xx]SDT and ASTDT <= (TR[xx]EDT + G_PRT_PERIOD_LAG)) then ONTRxxFL = 'Y' ;
If LAST PERIOD then
if (ASTDT <= (TR[xx]EDT + G_PRT_LASTPERIOD_LAG) > . and ((AENDT >=TRXXSDT) or (upcase(CMENRTPT)='ONGOING')) ) or (ASTDT >= TR[xx]SDT and ASTDT <= (TR[xx]EDT + G_PRT_LASTPERIOD_LAG)) then ONTRxxFL = 'Y' ;
[xx] will replaced by 01 and 02 in the code, G_PRT_PERIOD_LAG is set as 365
if cm happend after unblinding but before vax 3 and vax 3 is not missing, then set to missing |
| Algorithm: ADCM.PREFL | Computation | if ASTDT < TR01SDT then PREFL='Y' |
| Algorithm: ADCM.VAXNO | Computation | the number of last vaccine before CM occurred
if CM happened in VPHASE 'After unblinding and before Vaccination 3', then set VAXNO to most latest Dose before the CM. |
| Algorithm: ADCM.VPHASE | Computation | 1. if CM happend before adsl.UNBLNDDT and VAX3 or both adsl.UNBLNDDT and VAX3 are missing;
If CM happend before vax 1 then VPHASE='Pre-Vaccination'; (Note: CM start time is collected per CRF)
If CM happend on or after vax1 and (before vax2 or vax2 is missing) then VPHASE='Vaccination 1';
if CM happend on or after vax2 and before or on the same day of ADSL.V01DT then VPHASE='Vaccination 2';
if CM happend after ADSL.V01DT and before or on the same day of ADSL.V02DT then VPHASE='Follow Up 1';
if CM happend after ADSL.V02DT then VPHASE='Follow Up 2';
2. if CM happend after or on adsl.UNBLNDDT;
If CM happend after or on adsl.UNBLNDDT and (before vax3 or vax3 is missing) then VPHASE=''After unblinding and before Vaccination 3';
If CM happend after or on vax3 and (before vax4 or vax4 is missing) then VPHASE='Vaccination 3';
if CM happend after or on vax4 and before or on the same day of ADSL.V03DT then VPHASE='Vaccination 4';
if CM happend after ADSL.V03DT and before or on the same day of ADSL.V04DT then VPHASE='Follow Up 3';
if CM happend after ADSL.V04DT then VPHASE='Follow Up 4'; |
| Algorithm: ADDS.ADT | Computation | Datepart( numeric value of DS.DSDTC)
Imputation of Partial Dates:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year. |
| Algorithm: ADDS.ASTDT | Computation | Datepart(numeric value of DS.DSSTDTC) |
| Algorithm: ADDS.ASTDY | Computation | if ASTDT >= ADSL.TRTSDT then ASTDY = ASTDT - ADSL.TRTSDT + 1
otherwise ASTDY = ASTDT – ADSL.TRTSDT |
| Algorithm: ADDS.M1P2CUT | Computation | 1. find date for V3: non-missing value for ADSL.BLDV6DT, and ADDS.M1PD2DT, if both these 2 variables have values, then choose the bigger one.
2. if missing V3, and EOT=EOS and not missing, then EOT date;
3. if EOT not eq to EOS, then the later of Dose2 date or unplanned dose date +42 days
4. if only one dose, then Dose1+42+42 days.
5. cutoff to the day before not null Xover Dose1 date |
| Algorithm: ADDS.M1P2EXC | Computation | For DSPHASE not equal to 'SCREENING' or 'VACCINATION' or "REPEAT SCREENING 1"
if ASTDT>M1P2CUT, then 'Y'
if missing M1P2CUT, and subject have open label period activity, then 'Y'. |
| Algorithm: ADDS.M1PD2DT | Computation | Derived from SV.svstdtc where SV.visit contains 'MONTH1_POSTVAX2' or 'V7_MONTH1_S' or ('V7_MONTH1_S_R' for cohortn=1.16)；
if null SV.SVSTDTC then derived from ADSL.BLDV6DT |
| Algorithm: ADDS.M1PX2DT | Computation | Derived from SV.svstdtc where SV.visit contains 'V103_MONTH1' |
| Algorithm: ADDS.M6PD2DT | Computation | Derived from SV.svstdtc where SV.visit contains 'V4_MONTH6_L' or 'V8_MONTH6_S'；
if null SV.SVSTDTC then derived from ADSL.BLDV7DT； |
| Algorithm: ADDV.ASTDT | Computation | Convert DV.DVSTDTC to numeric format |
| Algorithm: ADDV.PREFL | Computation | If ASTDT < ADSL.TRTSDT then PREFL='Y' |
| Algorithm: ADDV.TRPFL | Computation | if (ASTDTM >= APHASDTM and substr(APHASE,1,9) = 'TREATMENT' then TRPFL='Y' else TRPFL = 'N' |
| Algorithm: ADFACEVD.ADT | Computation | date part of FACE.FADTC or date part of VS.VSDTC |
| Algorithm: ADFACEVD.ADTM | Computation | Datetime format of FACE.FADTC or VS.VSDTC |
| Algorithm: ADFACEVD.ATPT | Computation | 1) FACE.FATPT or VS.VSTPT; 2) For unplanned readings, ATPT is populated with DAY <#> for relative day: # = FADTC/VSDTC - date of last vaccination + 1; 3) Set to missing where FATEST in ('Maximum Severity', 'Maximum Temperature', 'Maximum Diameter'). |
| Algorithm: ADFACEVD.AVAL | Computation | For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. |
| Algorithm: ADFACEVD.AVALC | Computation | For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE').
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD.
Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". |
| Algorithm: ADFACEVD.AVALCAT1 | Computation | Create AVALCAT1 if FATESTCD in ("DIAMETER" "MAXDIAM") and aval > 0:
if 0 < AVAL <= 2.0 then AVALCAT1=">0-2.0"
if 2 < AVAL <= 5.0 then AVALCAT1=">2.0-5.0"
if 5 < AVAL <= 10.0 then AVALCAT1=">5.0-10.0"
if AVAL > 10.0 then AVALCAT1=">10.0" |
| Algorithm: ADFACEVD.AVISIT | Computation | 1) FACE.VISIT or VS.VISIT. 2) For unplanned readings, AVISIT=concatenate ('UNPLANNED VISIT', AVISITN) separated by a blank space. |
| Algorithm: ADFACEVD.CUTUNBFL | Computation | if FADTC/VSDTC>=UNBLNDDT. Then CUTUNBFL="Y" |
| Algorithm: ADFACEVD.DTYPE | Computation | Set to "MAXIMUM" if FATEST in ('Maximum Severity', 'Maximum Temperature', 'Maximum Diameter') |
| Algorithm: ADFACEVD.EVENTDFL | Computation | This flag is derived at SUBJECT/FATPTREF/FAOBJ/FATEST/FATPT level:
For FATEST in ('Occurrence Indicator') and FAOBJ in ('REDNESS' 'SWELLING'): Set to 'Y' if a subject had a event (avalc='Y' and diameter>=2.5 cm) on the day within FATPTREF/FAOBJ/FATEST level; else set to 'N'.
For (FATEST in ('Occurrence Indicator') and FAOBJ not in ('REDNESS' 'SWELLING')) or (FATESTCD='MEDTFVPN' and FAOBJ='MEDICATIONS'): Set to 'Y' if a subject had a event (avalc='Y') on the day within FATPTREF/FAOBJ/FATEST/FATPT level; else set to 'N'.
For FATEST in ('Severity/Intensity', 'Maximum Severity') : Set to 'Y' if a subject had a event (avalc in ('MILD', 'MODERATE', 'SEVERE', 'GRADE4')) on the day within FATPTREF/FAOBJ/FATEST/FATPT level; else set to 'N'.
For FATEST in ('Diameter', 'Maximum Diameter') : Set to 'Y' if a subject had a event (aval>=2.5 cm) on the day within FATPTREF/FAOBJ/FATPT level; else set to 'N'.
For FATEST in ('Maximum Temperature') : Set to 'Y' if a subject had a event (38.0 °C <=aval<=42.0 °C) on the day within FATPTREF/FAOBJ/FATPT level; else set to 'N'. |
| Algorithm: ADFACEVD.EVENTFL | Computation | This flag is derived at USUBJID/FATPTREF/FAOBJ level:
For FAOBJ in ('REDNESS' 'SWELLING'): Set to 'Y' if a subject had a record (diameter>=2.5 cm) at any day from day 1 to day 7; else set to 'N'.
For FAOBJ='MEDICATIONS': Set to 'Y' if a subject had a record (avalc='Y') at any day after each dose; else set to 'N'.
For FAOBJ='FEVER' : Set to 'Y' if a subject had a record (38.0 °C <=aval<=42.0 °C) at any day after each dose; else set to 'N'. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
For FAOBJ not in ('REDNESS' 'SWELLING' 'MEDICATIONS' 'FEVER'): Set to 'Y' for an reaction or an event if a subject had a record (avalc in ('MILD', 'MODERATE','SEVER','GRADE 4')) at any day after each dose; else set to 'N'. |
| Algorithm: ADFACEVD.EVENTOCC | Computation | This variable is derived at SUBJECT/FATPTREF/FAOBJ level.
EVENTOCC is the number of events. When a subject reported an event at least 1 day (with EVENTDF='Y'), then EVENTOCC=1; If the occurrence is consecutive >=2 days, it should be still counted once. But if the event recurred after one or more day’s disappearance, then EVENTOCC+1.
For example, subject A had redness (diameter>=2.5cm) on Day 1, 2, 4, 5, 6.
The symptom on Day 1-2 and Day 4-6 is counted once respectively , so EVENTOCC is 2 for subject A. |
| Algorithm: ADFACEVD.FAENINT | Computation | Set to "7D" if FATEST in ('Maximum Severity', 'Maximum Temperature', 'Maximum Diameter') |
| Algorithm: ADFACEVD.FAGRPID | Computation | FACE.FAGRPID or FAGRPID=concatenate (VS.VSTPTREF, VS.VSSCAT) separated by hyphen "-". |
| Algorithm: ADFACEVD.FALNKID | Computation | 1) FACE.FALNKID; 2) VS.VSLNKID;
3) Set to missing where FATEST in ('Maximum Severity', 'Maximum Diameter', 'Maximum Temperature'). |
| Algorithm: ADFACEVD.FAOBJ | Computation | FACE.FAOBJ or set to ‘FEVER’ for fever related parameters |
| Algorithm: ADFACEVD.FASTINT | Computation | Set to 'P0H' if FATEST in ('Maximum Severity', 'Maximum Temperature', 'Maximum Diameter') |
| Algorithm: ADFACEVD.FATEST | Computation | ADFACEVD includes:
1) the records from FACE domain: set to FACE.FATEST. For unplanned readings, only clinical assessments within 7 days after each vaccination are invovled.
2) the fever records from VS domain: FATEST="Occurrence Indicator";
3) the parameters derived in ADFACEVD, their values of FATEST have 'Severity/Intensity', 'Maximum Severity', 'Maximum Diameter' or 'Maximum Temperature'. See the algorithms of AVALC for detailed derivation. |
| Algorithm: ADFACEVD.FATESTCD | Computation | 1) FACE.FATESTCD. 2) Set to 'SEV', 'MAXSEV', 'MAXDIAM', 'MAXTEMP where FATEST in ('Severity/Intensity', 'Maximum Severity', 'Maximum Diameter', 'Maximum Temperature'). |
| Algorithm: ADFACEVD.FTEMCAT | Computation | Derived only for FAOBJ='FEVER'.
For VSORRESU='F':
if .<input(VS.VSORRES,best.)<100.4 then "<38.0 C";
else if 100.4<=input(VS.VSORRES,best.)<=101.1 then "38.0 C to 38.4 C" ;
else if 101.2<=input(VS.VSORRES,best.)<=102.0 then ">38.4 C to 38.9 C" ;
else if 102.1<=input(VS.VSORRES,best.)<=104.0 then ">38.9 C to 40.0 C";
else if input(VS.VSORRES,best.)>104.0 and VSSTRESN<=42.0 then ">40.0 C".
else if VSSTRESN>42 then 'Missing'.
For VSORRESU='C':
if .<input(VS.VSORRES,best.)<38.0 then "<38.0 C";
else if 38.0<=input(VS.VSORRES,best.)<=38.4 then "38.0 C to 38.4 C" ;
else if 38.5<=input(VS.VSORRES,best.)<=38.9 then ">38.4 C to 38.9 C" ;
else if 39.0<=input(VS.VSORRES,best.)<=40.0 then ">38.9 C to 40.0 C";
else if input(VS.VSORRES,best.)>40 and VSSTRESN<=42.0 then ">40.0 C".
else if VSSTRESN>42 then 'Missing'. |
| Algorithm: ADFACEVD.FTEMCATN | Computation | Numerive Code of FTEMCAT
.="Missing"
0="<38.0 C"
1="38.0 C to 38.4 C"
2= ">38.4 C to 38.9 C"
3=">38.9 C to 40.0 C"
4=">40.0 C" |
| Algorithm: ADFACEVD.KNOWVDFL | Computation | This flag is derived at SUBJECT/FATPTREF/FAOBJ/FATEST/FATPT level:
Set to "Y" if a subject had a valid record (where the event was reported regardless if it occurred or not) at that day from day 1 to day 7 within FATPTREF/FAOBJ/FATEST/FATPT level, else set to 'N'. |
| Algorithm: ADFACEVD.KNOWVFL | Computation | This flag is derived at USUBJID/FATPTREF/FAOBJ level:
Set to "Y" for a reaction or an event if a subject had a valid record where AVALC in ('Y' 'N') at any day from day 1 to day 7 after each dose.
else set to 'N'. |
| Algorithm: ADFACEVD.PARAM | Computation | If upcase(FATESTCD) = "DIAMETER" then PARAM = concatenate (FAOBJ, FATEST, "cm") separated by a blank space; else if upcase(FATESTCD) ^= "DIAMETER and FATEST ne missing then PARAM = concatenate (FAOBJ, FATEST) separated by a blank space; else if FAOBJ="MEDICATIONS" and FATEST eq missing then PARAM='Medications duration'. See the algorithms of AVALC for detailed derivation.
Note: Use sentence case for param values. |
| Algorithm: ADFACEVD.PARCAT1 | Computation | Set to 'REACTOGENICITY' if index(FACAT, 'REACTOGENICITY') or index(VSCAT, 'REACTOGENICITY'). |
| Algorithm: ADFACEVD.TRTA | Computation | if (VAX101='Placebo' and ATPTREF="VACCINATION 1") or (VAX102='Placebo' and ATPTREF="VACCINATION 2") then TRTA='Placebo';
else ADSL.TRT01A. |
| Algorithm: ADFACEVD.TRTAN | Computation | if (VAX101='Placebo' and ATPTREF="VACCINATION 1") or (VAX102='Placebo' and ATPTREF="VACCINATION 2") then TRTAN=9';
else ADSL.TRT01AN. |
| Algorithm: ADMH.ADT | Computation | ADT = date part of MH.MHDTC
Imputation of Partial Dates:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year. |
| Algorithm: ADMH.ADTF | Computation | = "D" if day is imputed.
= "M" if month and day are imputed.
= "Y" if month, day and year are imputed.ADMH |
| Algorithm: ADMH.ADURN | Computation | if MH.MHDUR exists then calculate ADURN in years and round it to 2 decimals. |
| Algorithm: ADMH.AENDT | Computation | AENDT = date part of MH.MHENDTC
Imputation of Partial Dates:
If Day is missing, last day of Month
If Month is missing, last month of Year. |
| Algorithm: ADMH.AENDTF | Computation | = "D" if day is imputed.
= "M" if month and day are imputed.
= "Y" if month, day and year are imputed. |
| Algorithm: ADMH.AENDY | Computation | AENDT – ADSL.TRTSDT + 1 if AENDT >= TRTSDT,
else AENDT – ADSL.TRTSDT if AENDT < TRTSDT |
| Algorithm: ADMH.ASTDT | Computation | ASTDT = date part of MH.MHSTDTC
Imputation of Partial Dates:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year. |
| Algorithm: ADMH.ASTDTF | Computation | = "D" if day is imputed.
= "M" if month and day are imputed.
= "Y" if month, day and year are imputed.ADMH |
| Algorithm: ADMH.ASTDY | Computation | if ASTDT >= TRTSDT then ASTDT – ADSL.TRTSDT + 1;
else if ASTDT< TRTSDT then ASTDT – ADSL.TRTSDT; |
| Algorithm: ADMH.COMORBFL | Computation | "Y" if mhterm with Comorbidities. |
| Algorithm: ADSL.AAI01FL | Computation | Will apply to Phase 1 only. If SAFFL="Y" and randfl="Y" and (vax101dt>. or vax102dt>.) and INCL3fl="Y" and not (index(SUPPDV.QNAM.CAPE, "POP3") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI01FL="Y"; else AAI01FL="N"; |
| Algorithm: ADSL.AAI02FL | Computation | If SAFFL="Y" and randfl="Y" and vax102dt>. and INCL8fl="Y" and not ((index(SUPPDV.QNAM.CAPE, "POP3") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI02FL="Y"; else AAI02FL="N"; |
| Algorithm: ADSL.AAI1EFFL | Computation | If SAFFL="Y" and randfl="Y" and (vax101dt>. or vax102dt>.) and not((index(SUPPDV.QNAM.CAPE, "POP2") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI1EFFL="Y"; else AAI1EFFL="N"; |
| Algorithm: ADSL.AAI2EFFL | Computation | If SAFFL="Y" and randfl="Y" and vax101dt>. and vax102dt>. and (UNBLNDDT=. or (UNBLNDDT>=vax102dt+7>.)) and not((index(SUPPDV.QNAM.CAPE, "POP2") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI2EFFL="Y"; else AAI2EFFL="N"; |
| Algorithm: ADSL.ACTARM | Computation | Based on the actual vaccinations taken by subjects. Same as ARM if no medication error for the vaccinated subjects
ACTARM=' NOT ASSIGNED ' for not assigned subjects;
ACTARM=' SCREEN FAILURE ' for screen failure subjects;
ACTARM='Not Treated' for not treated subjets or subjects without determined treatment; |
| Algorithm: ADSL.ACTARMCD | Computation | Based on the actual vaccinations taken by subjects. Same as ARMCD if no medication error for the vaccinated subjects.
ACTARM=' NOTASSGN ' for not assigned subjects;
ACTARM=' SCRNFAIL ' for screen failure subjects;
ACTARMCD='NOTTRT' for not treated subjets or subjects without determined treatment; |
| Algorithm: ADSL.AGEGR1 | Computation | Derived using following derivations:
if 12<=agetr01<=15 then AGEGR1='12-15 Years';(Phase 2/3 cohort)
if 18<=agetr01<=55 then AGEGR1='18-55 Years';(Phase 1 cohort)
if 16<=agetr01<=55 then AGEGR1='16-55 Years';(Phase 2/3 cohort)
if 65<=agetr01 then AGEGR1='65-85 Years'; (Phase 1 cohort)
if 56<=agetr01 then AGEGR1='>55 Years'; (Phase 2/3 cohort) |
| Algorithm: ADSL.AGEGR2 | Computation | Derived using following derivations:
if 65<=agetr01 then AGEGR2='>=65 Years';
if agetr01<65 then AGEGR2='<65 Years'; |
| Algorithm: ADSL.AGEGR3 | Computation | Derived using following derivations:
if 16<=agetr01<=17 then AGEGR3='16-17 Years';
if 18<=agetr01<=55 then AGEGR3='18-55 Years';
if 55<agetr01 then AGEGR3='>55 Years'; |
| Algorithm: ADSL.AGEGR4 | Computation | Derived using following derivations for Phase 3 subjects only:
if 12<=agetr01<=15 then AGEGR4='12-15 Years';
if 16<=agetr01<=25 then AGEGR4='16-25 Years'; |
| Algorithm: ADSL.AGETGR3 | Computation | Derived using following derivations:
if 16<=agetr03<=55 then AGETGR3='16-55 Years';
if 56<=agetr03 then AGETGR3='>55 Years'; |
| Algorithm: ADSL.AGETR01 | Computation | Derive AGETR01 from BIRTHDT (after applying imputation for partial date) and date of vaccination1. For participants who were randomized but not vaccinated, the randomization date will be used in place of the date of vaccination at Dose 1 for the age calculation. If the randomization date is also missing, then the informed consent date will be used for the age calculation.
Note: For example: If the vaccination 1 date is one day before the subject's 19th birthday, the subject is 18 years old. |
| Algorithm: ADSL.AGETR03 | Computation | Derive AGETR03 from BIRTHDT (after applying imputation for partial date) and date of first dose of crossover period.
Note: For example: If dose 3 date is one day before the subject's 19th birthday, the subject is 18 years old. |
| Algorithm: ADSL.ARACE | Computation | if RACEN=1 then ARACE='WHITE';
if RACEN=2 then ARACE='BLACK OR AFRICAN AMERICAN';
if RACEN=3 then ARACE='AMERICAN INDIAN OR ALASKA NATIVE';
if RACEN=4 then ARACE='ASIAN';
if RACEN=5 then ARACE='NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER';
if RACEN=6 then ARACE='MULTIRACIAL';
if RACEN=7 then ARACE='NOT REPORTED'; |
| Algorithm: ADSL.ARM | Computation | if armcd="B1_10" then arm="BNT162b1 Phase 1 (10 mcg)"
if armcd="B1_100" then arm="BNT162b1 Phase 1 (100/10 mcg)"
if armcd="B1_20" then arm="BNT162b1 Phase 1 (20 mcg)"
if armcd="B1_30" then arm="BNT162b1 Phase 1 (30 mcg)"
if armcd="B2_10" then arm="BNT162b2 Phase 1 (10 mcg)"
if armcd="B2_20" then arm="BNT162b2 Phase 1 (20 mcg)"
if armcd="B2_30" then arm="BNT162b2 Phase 1 (30 mcg)"
if armcd="B2_P23_30" then arm="BNT162b2 Phase 2/3 (30 mcg)"
if armcd="NOTASSGN" then arm="NOT ASSIGNED"
if armcd="NOTTRT" then arm="Not Treated"
if armcd="PLACEBO" then arm="Placebo"
if armcd="SCRNFAIL" then arm="SCREEN FAILURE" |
| Algorithm: ADSL.BDCSRDT | Computation | if randfl="Y" then do;
if (tr02sdt>. or UNBLNDDT>. ) and boostfl ne "Y" then do;
if .<tr02sdt-1<"&cutoff2"d then BDCSRDT=tr02sdt-1;
else BDCSRDT="&cutoff2"d;
if .<UNBLNDDT-1<=BDCSRDT then BDCSRDT=UNBLNDDT-1;
end;
else do;
if .<UNBLNDDT-1<="&cutoff2"d then BDCSRDT=UNBLNDDT-1;
else BDCSRDT="&cutoff2"d;
if .<eosdcdt<=BDCSRDT then BDCSRDT=eosdcdt;
end;
end;
Note: &cutoff2 will be the data cutoff date which specified in the table footnote. |
| Algorithm: ADSL.BLDV1DT | Computation | Blood draw date at Vax 1 Visit |
| Algorithm: ADSL.BLDV1FL | Computation | If non missing blood draw date at Vax 1 Visit then bldv1fl = 'Y''; else bldv1fl = 'N'. |
| Algorithm: ADSL.BLDV2DT | Computation | Blood draw date at 1 Week after Vax 1 Visit |
| Algorithm: ADSL.BLDV2FL | Computation | If non missing blood draw date at 1 Week after Vax 1 Visit then bldv2fl = 'Y''; else bldv2fl = 'N'. |
| Algorithm: ADSL.BLDV3ADT | Computation | For 100 ug only, blood draw date at 3 weeks after Vax 1 Visit |
| Algorithm: ADSL.BLDV3DT | Computation | Blood draw date at Vax 2 Visit |
| Algorithm: ADSL.BLDV3FL | Computation | If non missing blood draw date at Vax 2 Visit then bldv3fl = 'Y''; else bldv3fl = 'N'. |
| Algorithm: ADSL.BLDV4ADT | Computation | For 100 ug only, blood draw date at 4 weeks after Vax 1 Visit |
| Algorithm: ADSL.BLDV4DT | Computation | Blood draw date at 1 Week after Vax 2 Visit |
| Algorithm: ADSL.BLDV4FL | Computation | If non missing blood draw date at 1 Week after Vax 2 Visit then bldv4fl = 'Y''; else bldv4fl = 'N'. |
| Algorithm: ADSL.BLDV5ADT | Computation | For 100 ug only, blood draw date at 5 weeks after Vax 1 Visit |
| Algorithm: ADSL.BLDV5DT | Computation | Blood draw date at 2 Weeks after Vax 2 Visit |
| Algorithm: ADSL.BLDV5FL | Computation | If non missing blood draw date at 2 Weeks after Vax 2 Visit then bldv5fl = 'Y''; else bldv5fl = 'N'. |
| Algorithm: ADSL.BLDV6ADT | Computation | For 100 ug only, blood draw date at 3 weeks + 1 month after Vax 1 Visit |
| Algorithm: ADSL.BLDV6DT | Computation | Blood draw date at 1 Month after Vax 2 Visit. (Only apply to Phase 2/3 to serology: For subjects had Visit 3 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened within 28-42 days post dose 2, the convalescent visit will be used to replace this one, and bldv6dt will be set to the date of the convalescent visit. If multiple records fall into such window, the one closed to 30 days post dose 2 will be chosen. If multiple records at the same day, the one with available immunogenicity results will be chosen.) |
| Algorithm: ADSL.BLDV6FL | Computation | If non missing blood draw date at 1 Month after Vax 2 Visit then bldv6fl = 'Y''; else bldv6fl = 'N'. (Only apply to Phase 2/3 to serology: For subjects had Visit 3 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened within 28-42 days post dose 2, the convalescent visit will be used to replace this one, and bldv6fl will be set to "Y".) |
| Algorithm: ADSL.BLDV7DT | Computation | Blood draw date at 6 Months after Vax 2 Visit. (Only apply to Phase 2/3 to serology: For subjects had Visit 4 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened after 42 days post dose 2, the convalescent visit will be used to replace this one, and bldv7dt will be set to the date of the convalescent visit. If multiple records fall into such window, the one closed to 190 days post dose 2 will be chosen. If multiple records at the same day, the one with available immunogenicity results will be chosen.) |
| Algorithm: ADSL.BLDV7FL | Computation | If non missing blood draw date at 6 Months after Vax 2 Visit then bldv7fl = 'Y''; else bldv7fl = 'N'. (Only apply to Phase 2/3 to serology: For subjects had Visit 4 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened after 42 days post dose 2, the convalescent visit will be used to replace this one, and bldv7fl will be set to "Y".) |
| Algorithm: ADSL.BMICAT | Computation | Carry BMI from SDTM.VS where index(visit, "V1_DAY1") and vstestcd="BMI" and vsdy<=1
if .<vsstresn<18.5 then BMICAT="Underweight";
else if 18.5<=vsstresn<=24.9 then BMICAT="Normal weight";
else if 25<=vsstresn<=29.9 then BMICAT="Overweight";
else if 30<=vsstresn then BMICAT="Obese";
if vsstresn=. then BMICAT="Missing"; |
| Algorithm: ADSL.BRTHDT | Computation | Datepart of DM.BRTHDTC
Imputation of Partial Dates:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year. |
| Algorithm: ADSL.BRTHDTF | Computation | BRTHDTF = 'M' if Month and Day are imputed in BRTHDT
BRTHDTF = 'D' if only Day is imputed in BRTHDT |
| Algorithm: ADSL.CD4CAT | Computation | if .<LB.LBSTRESN*1000<200 then assigned as "<200"; else if 200<=LB.LBSTRESN*1000<=500 then assigned as "200-500"; else if LB.LBSTRESN*1000>500 then assigned as ">500"; where LB.LBTESTCD="CD4" and LBSTRESU="10^9/L" and LB.LBSTAT ne "NOT DONE" and index(visit, "V1_DAY1_VAX1") and LBDY<=1 |
| Algorithm: ADSL.CD4CATN | Computation | 1="<200"
2="200-500"
3=">500" |
| Algorithm: ADSL.COHORT | Computation | For Phase 1 only: SUPPDS.QVAL where SUPPDS.QNAM=’ DSRANGRP’ |
| Algorithm: ADSL.COMBODFL | Computation | "Y" if subject with Medical History With Comorbodities. Terms were defined in 19 external excel files whose filename contains 'report-cci'. |
| Algorithm: ADSL.COVBLST | Computation | Subjects are considered with COVID-19 history if MH.MHDECOD in ("Asymptomatic COVID-19" "COVID-19" "COVID-19 pneumonia" "COVID-19 treatment" "Suspected COVID-19" "SARS-CoV-2 antibody test positive" "SARS-CoV-2 carrier" "SARS-CoV-2 sepsis" "SARS-CoV-2 test positive" "SARS-CoV-2 viraemia" "Multisystem inflammatory syndrome in children").
if subjects with COVID-19 history or NIGV1FL="N" or NAATNFL="N" then COVBLST="POS";
if subjects without COVID-19 history and NIGV1FL="Y" and NAATNFL="Y" then COVBLST="NEG"; |
| Algorithm: ADSL.DOSALVL | Computation | For Phase 1 only:
Assign actual dose level. eg: 10 ug, 20 ug, 30 ug, 100 ug/10 ug
For Placebo: Assign 'Placebo' |
| Algorithm: ADSL.DOSPLVL | Computation | For Phase 1 only:
Assign planned dose level. eg: 10 ug, 20 ug, 30 ug,100 ug/10 ug
For Placebo: Assign 'Placebo' |
| Algorithm: ADSL.DS30KFL | Computation | "Y" for non-phase 1 subjects that are randomized on or before 9Oct2020 and obtained IC on or after 27Jul2020. |
| Algorithm: ADSL.DS3KFL | Computation | "Y" for phase 2/3 subjects had follow up 168 days after Dose 2 at the point of EOS or data cutoff and reiceved 2 planned doses of BNT162b2; else "N". |
| Algorithm: ADSL.DTHDT | Computation | If DM.DTHDTC is not missing and not partial then DTHDT=Datepart of DM.DTHDTC;
Else if DM.DTHDTC is partial then impute DTHDT using imputation START rules.
Partial Death Dates Imputation Rules:
If day (DD) and month (MMM) are missing in DM.DTHDTC, then use first day (01) and first month (JAN) for DD and MMM respectively.
If day (DD) missing then use first day (01) of the month for DD.
It is recommended that the database be designed to mandate a complete death date. If there is a record for death, but the date is missing or is partial, it will be imputed based on the last contact date.
If the entire death date DM.DTHDTC is missing OR If imputed Death Date (DTHDT) is ON or PRIOR to Last Know Alive Date then reset DTHDT=(Last Known Alive Date) +1 |
| Algorithm: ADSL.DTHDTF | Computation | If DTHDT was imputed, DTHDTF must be populated and is required.
DTHDTF = 'Y' if Year is imputed
DTHDTF = 'M' if Year is present and Month is imputed
DTHDTF = 'D' if only day is imputed |
| Algorithm: ADSL.DVSTDT | Computation | The earliest date of important PD |
| Algorithm: ADSL.ENRLFL | Computation | Assign 'Y' for participants who have a signed ICD. |
| Algorithm: ADSL.EOSDCDT | Computation | EOSDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and DSPHASE="FOLLOW-UP" and DS.DSDECOD^=“COMPLETED” |
| Algorithm: ADSL.EOSDCRS | Computation | EOSDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and DSPHASE="FOLLOW-UP" and DS.DSDECOD^=“COMPLETED” |
| Algorithm: ADSL.EOTDCDT | Computation | EOTDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and index(SUPPDS.QNAM.DSPHASE, "VACCINATION")>0 and DS.DSDECOD^=“COMPLETED” |
| Algorithm: ADSL.EOTDCRS | Computation | EOTDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and SUPPDS.QNAM.DSPHASE="VACCINATION" and DS.DSDECOD^=“COMPLETED” |
| Algorithm: ADSL.EOTXDCDT | Computation | EOTXDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and SUPPDS.QNAM='DSPHASE' and SUPPDS.QVAL="OPEN LABEL TREATMENT" and DS.DSDECOD^=“COMPLETED” |
| Algorithm: ADSL.EOTXDCRS | Computation | EOTXDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and SUPPDS.QNAM='DSPHASE' and SUPPDS.QVAL="OPEN LABEL TREATMENT" and DS.DSDECOD^=“COMPLETED” |
| Algorithm: ADSL.EV1MD2FL | Computation | Subjects will be set to “N” if any of the following conditions are met:
•N-Binding is POS at visit 3.
•Convalescent visit with POS result in the absence of visit 3 and is within 28-42 days PD2.
•Convalescent N-Binding result is POS and is before Visit 3 date or up to 7 days after Visit 3 date.
•Subjects without symptoms and have unscheduled POS swab results within 1MPD2 .
•Subjects with POS swab results at Dose 1/Dose 2 or POS for N-Binding at Dose 1.
•Subjects with presence of symptoms on or after Dose 1 and within 1MPD2 that are without valid NEG swab results.
Else "Y". |
| Algorithm: ADSL.EVAL01FL | Computation | Will apply to Phase 1 only. If INCL1fl="Y" and INCL2fl="Y" and INCL4fl="Y" and INCL5fl="Y" and (index(SUPPDV.QNAM.CAPE, "POP3")=0 for subjects's all DV records) then EVAL01FL="Y"; else EVAL01FL="N"; |
| Algorithm: ADSL.EVAL02FL | Computation | If INCL1fl="Y" and INCL2fl="Y" and (INCL7fl="Y" and vax10udt=.) and INCL8fl="Y" and INCL9fl="Y" and (index(SUPPDV.QNAM.CAPE, "POP3")=0 for subjects's all DV records) then EVAL02FL="Y"; else EVAL02FL="N"; |
| Algorithm: ADSL.EVALEFFL | Computation | If SAFFL="Y" and RFICDT>. and RANDFL="Y" and ARM ne "SCREEN FAILURE" and INCL1FL="Y" and INCL2fl="Y" and (INCL7fl="Y" and (vax10udt=. or (vax10udt>vax102dt>. and vax10udt>=vax102dt+7))) and VAX102DT>. and (UNBLNDDT=. or (UNBLNDDT>=vax102dt+7>.)) and (index(SUPPDV.QNAM.CAPE, "POP2")=0 for subjects's all DV records or any records with DV date 7 days after Dose 2 and index(SUPPDV.QNAM.CAPE, "POP2")>0 ) and (index(SUPPDV.QNAM.CAPE, "POP3")=0 and index(SUPPDV.QNAM.CAPE, "POP5")=0 for subjects's all DV records)then EVALEFFL="Y"; else EVALEFFL="N"; |
| Algorithm: ADSL.EXCL10FL | Computation | "Y" if INCL10FL="N" |
| Algorithm: ADSL.EXCL1FL | Computation | if INCL1FL="N" then EXCL1FL="Y" |
| Algorithm: ADSL.EXCL2FL | Computation | if EXCL1FL ne "Y" and INCL2FL="N" then EXCL2FL="Y" |
| Algorithm: ADSL.EXCL3FL | Computation | Will apply to Phase 1 only. if (VAX101DT>. or vax102dt>.) and INCL3FL="N" then EXCL3FL="Y" |
| Algorithm: ADSL.EXCL4FL | Computation | Will apply to Phase 1 only. if EXCL2FL ne "Y" and INCL4FL="N" then EXCL4FL="Y" |
| Algorithm: ADSL.EXCL5FL | Computation | Will apply to Phase 1 only. if EXCL2FL ne "Y" and INCL5FL="N" then EXCL5FL="Y" |
| Algorithm: ADSL.EXCL6FL | Computation | if INCL6FL="N" then EXCL6FL="Y" |
| Algorithm: ADSL.EXCL7FL | Computation | if EXCL2FL ne "Y" and INCL7FL="N" then EXCL7FL="Y" |
| Algorithm: ADSL.EXCL8FL | Computation | if VAX102DT ne . and INCL8FL="N" then EXCL8FL="Y" |
| Algorithm: ADSL.EXCL9FL | Computation | if VAX102DT ne . and EXCL2FL ne "Y" and INCL9FL="N" then EXCL9FL="Y" |
| Algorithm: ADSL.EXCRIT10 | Computation | for INCL10FL="N" and vax102dt not missing:
assign to "unblinded prior to 7 days post Dose 2" for UNBLNDDT<VAX102DT+7;
assign to "unblinded on or after 7 days but prior to 14 days post Dose 2" for VAX102DT+7<=UNBLNDDT<VAX102DT+14;
assign to "unblinded on or after 14 days but no later than 1 month post Dose 2 visit" for VAX102DT+14<=UNBLNDDT<=V3 date; |
| Algorithm: ADSL.FPX1CA1N | Computation | 1 for 0<=FPX1CUT/28<1;
2 for 1<=FPX1CUT/28<2;
3 for 2<=FPX1CUT/28<3;
4 for 3<=FPX1CUT/28<4;
etc. |
| Algorithm: ADSL.FPX1CAT1 | Computation | "0-1 Month" for FPX1CA1N=1;
"1-2 Months" for FPX1CA1N=2;
"2-3 Months" for FPX1CA1N=3;
"3-4 Months" for FPX1CA1N=4;
etc. |
| Algorithm: ADSL.FPX1CUT | Computation | if (UNBLNDDT>. or tr02sdt>. ) and boostfl ne "Y" then do;
if tr02sdt=. then FPX1CUT=0;
else if not missing(eosdcdt) and eosdcdt>=tr02sdt then FPX1CUT=eosdcdt-tr02sdt+1;
else FPX1CUT="&cutoff2"d-tr02sdt+1;
end;
Note: only populate for subjects unblinded or received cross over doses |
| Algorithm: ADSL.FUNBCUT | Computation | if (UNBLNDDT>. or tr02sdt>. ) and boostfl ne "Y" then do;
if UNBLNDDT=. then FUNBCUT=0;
else if not missing(eosdcdt) then FUNBCUT=eosdcdt-UNBLNDDT+1;
else FUNBCUT="&cutoff2"d-UNBLNDDT+1;
end; |
| Algorithm: ADSL.FUP1CA1N | Computation | 1 for 0<=FUP1CUT/28<1;
2 for 1<=FUP1CUT/28<2;
3 for 2<=FUP1CUT/28<3;
4 for 3<=FUP1CUT/28<4;
etc. |
| Algorithm: ADSL.FUP1CAT1 | Computation | "0-1 Month" for FUP1CA1N=1;
"1-2 Months" for FUP1CA1N=2;
"2-3 Months" for FUP1CA1N=3;
"3-4 Months" for FUP1CA1N=4;
etc. |
| Algorithm: ADSL.FUP1CUT | Computation | if randfl="Y" then do;
if vax101dt=. then FUP1CUT=0;
else if not missing(eosdcdt) then FUP1CUT=eosdcdt-vax101dt+1;
else FUP1CUT="&cutoff2"d-vax101dt+1;
end; |
| Algorithm: ADSL.FUP1UNB | Computation | if randfl="Y" then do;
if vax101dt=. then FUP1UNB=0;
else if not missing(BDCSRDT) then FUP1UNB=BDCSRDT-vax101dt+1;
end; |
| Algorithm: ADSL.FUP2CA1N | Computation | 1 for 0<=FUP2CUT/28<1;
2 for 1<=FUP2CUT/28<2;
3 for 2<=FUP2CUT/28<3;
4 for 3<=FUP2CUT/28<4;
etc. |
| Algorithm: ADSL.FUP2CA2N | Computation | 1 for 0<=FUP2UNB/28<1;
2 for 1<=FUP2UNB/28<2;
3 for 2<=FUP2UNB/28<3;
4 for 3<=FUP2UNB/28<4;
etc." |
| Algorithm: ADSL.FUP2CAT1 | Computation | "0-1 Month" for FUP2CA1N=1;
"1-2 Months" for FUP2CA1N=2;
"2-3 Months" for FUP2CA1N=3;
"3-4 Months" for FUP2CA1N=4;
etc. |
| Algorithm: ADSL.FUP2CAT2 | Computation | "0-1 Month" for FUP2CA2N=1;
"1-2 Months" for FUP2CA2N=2;
"2-3 Months" for FUP2CA2N=3;
"3-4 Months" for FUP2CA2N=4;
etc. |
| Algorithm: ADSL.FUP2CUT | Computation | if randfl="Y" then do;
if vax102dt=. then FUP2CUT=0;
else if not missing(eosdcdt) then do;
FUP2CUT=eosdcdt-vax102dt+1;
if vax10udt>. then FUP2CUT=eosdcdt-vax10udt+1;
end;
else do;
FUP2CUT="&cutoff2"d-vax102dt+1;
if vax10udt>. then FUP2CUT="&cutoff2"d-vax10udt+1;
end;
end; |
| Algorithm: ADSL.FUP2UNB | Computation | if randfl="Y" then do;
if vax102dt=. then FUP2UNB=0;
else if not missing(BDCSRDT) then do;
FUP2UNB=BDCSRDT-vax102dt+1;
if vax10udt>. then FUP2UNB=BDCSRDT-vax10udt+1;
end;
end; |
| Algorithm: ADSL.HIVFL | Computation | "Y" if subject with HIV positive, subjects with HIV were determined by their medical history, HIV related term were defined in an external file: 201114-hiv-preferred-terms.xlsx |
| Algorithm: ADSL.INCL10FL | Computation | "Y" If unblinding date after the visit date of 1 month post dose 2. else "N" for non-missing unblinding date.
Note: not populated for subjects unblnding beyond 14 days after dose 2 but missing both BLDV6DT and SV.V3. ; not populated for missing dose 2. |
| Algorithm: ADSL.INCL1FL | Computation | Assign value 'Y' if meet following criteria; Else Assign value 'N';
1. Signed IC;
2. Randomized;
3. Not screen failure;
4. Meets all inclusion criteria and meets no exclusion criteria; |
| Algorithm: ADSL.INCL2FL | Computation | Receive the first dose of vaccine to which they are randomly assigned |
| Algorithm: ADSL.INCL3FL | Computation | Will apply to Phase 1 only. Have at least 1 valid and determinate immunogenicity result after Dose 1 but before Dose 2
Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. N-binding is diagnostic assay and not considered as valid and determinate immunogenicity result. |
| Algorithm: ADSL.INCL4FL | Computation | Will apply to Phase 1 only. Have at least 1 valid and determinate immunogenicity result 21 days after Dose 1.
Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. |
| Algorithm: ADSL.INCL5FL | Computation | Will apply to Phase 1 only. Have blood collection within an appropriate window after Dose 1, with visit window 19-23 days after dose 1. |
| Algorithm: ADSL.INCL6FL | Computation | Derive from SUPPDV.QNAM.CAPE. 'Y' if the subjects with all records of SUPPDV.QNAM.CAPE is "NO" or missing or CAPE indicates "POP2" only and this date of PD is earlier that VAX102DT+14 |
| Algorithm: ADSL.INCL7FL | Computation | Receive 2 randomized vaccinations within the pre-defined window
Vaccination window – can be 19-42 days after dose 1:
if 19<=VAX102DT-VAX101DT<=42 and ARM ne "" and
((index(upcase(vax102),"BNT162B2") and index(upcase(arm),"BNT162B2")) or (index(upcase(vax102),"PLACEBO") and index(upcase(arm),"PLACEBO")))
and vax101=vax102 then INCL7FL="Y"; else INCL7FL="N"; |
| Algorithm: ADSL.INCL8FL | Computation | Have at least 1 valid and determinate immunogenicity result after Dose 2
Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. N-binding is diagnostic assay and not considered as valid and determinate immunogenicity result. |
| Algorithm: ADSL.INCL9FL | Computation | Have blood collection within an appropriate window after Dose 2.
Phase 1 – with visit window 6-8 days after dose 2
Phase 2/3 – 28-42 days after dose 2 |
| Algorithm: ADSL.JPNFL | Computation | "Y" if SUPPDM.QNAM = 'RACIALD' and SUPPDM.QVAL = 'JAPANESE' |
| Algorithm: ADSL.MULENRFL | Computation | "Y" for subjects that were multiply enrolled subjests. |
| Algorithm: ADSL.NAATNFL | Computation | if index(mb.visit,"V1_DAY1_") and mb.mbtestcd='RTCOV2NS' and mb.mborres="NEG" and mb.mbdy<=1 then NAATNFL="Y";
else if index(mb.visit,"V1_DAY1_") and mb.mbtestcd='RTCOV2NS' and mb.mborres="POS" and mb.mbdy<=1 then NAATNFL="N"; |
| Algorithm: ADSL.NIGV1FL | Computation | Derived from is.istest='N-binding antibody'
if is.isorres="NEG" and index(visit,"V1_DAY1_") and is.isdy<=1 then NIGV1FL="Y";
else if is.isorres="POS" and index(visit,"V1_DAY1_") and is.isdy<=1 then NIGV1FL="N";
Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. |
| Algorithm: ADSL.OBESEFL | Computation | "Y" if adolescent with enrolled age 12-15 meets the BMI cut off for obesity with age/sex groups. The standard for obesity is provided in an external file bmi-12-15-scale.xlsx. |
| Algorithm: ADSL.OPBOUFL | Computation | “Y” if (tr02sdt>. or UNBLNDDT>.) and actarm in ("Placebo"); else "N" |
| Algorithm: ADSL.PEDIMMFL | Computation | PEDIMMFL was derived from an external excel file: c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsx (there are 660 subjects in total who are based on an random selection of 280 active+50 placebo from each of the age groups). |
| Algorithm: ADSL.PEDREAFL | Computation | if reactofl="Y" and phasen ne 1 and agegr4n in (1 2) then PEDREAFL="Y"; |
| Algorithm: ADSL.PHASE | Computation | "Phase 1" for subjects from Phase 1, who were picked from an external excel file: c4591001-phase-1-subjects-from-dmw.xlsx;
"Phase 2_ds360/ds6000" for subjects from Phase 2, who were picked from an external excel file: first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsx;
"Phase 3_ds6000" for subjects from Phase 3 and included in DS6000, who were picked from an external excel file: newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsx;
"Phase 3" for other subjects from Phase 3 |
| Algorithm: ADSL.RACEGR1 | Computation | if RACE='WHITE' then RACEGR1="WHITE";
else if RACE='BLACK OR AFRICAN AMERICAN' then RACEGR1="BLACK OR AFRICAN AMERICAN";
else RACEGR1="ALL OTHERS" |
| Algorithm: ADSL.RAND1FL | Computation | if RANDFL="Y" and MULENRFL^="Y" and then RAND1FL="Y"; else RAND1FL="N"; |
| Algorithm: ADSL.RANDDT | Computation | [Protocol]
Randomization Date is defined usually those who have been randomized the study. (For study design where subject gets randomized multiple time then RANDDT will be derive based on 1st Randomization Date)
RANDDT = MIN of DS.DSSTDTC where DS.DSDECOD = "RANDOMIZED" |
| Algorithm: ADSL.RANDFL | Computation | Assign 'Y' for participants who are assigned a randomization number and with non-missing randomization date. |
| Algorithm: ADSL.REVXICDT | Computation | DS.DSSTDTC for Re-vax Informed Consent. |
| Algorithm: ADSL.RFENDT | Computation | Datepart of DM.RFENDTC |
| Algorithm: ADSL.RFENTM | Computation | Timepart of DM.RFENDTC |
| Algorithm: ADSL.RFSTDT | Computation | Datepart of DM.RFSTDTC |
| Algorithm: ADSL.RFSTTM | Computation | Timepart of DM.RFSTDTC |
| Algorithm: ADSL.RNACAT | Computation | Derived numeric value from LB.LBORRES where LB.LBTESTCD="HIVR_US". Assigned as "<50" if subject's LBORRES does not contain any numeric value and not equal to positive. If derived numeric value is less than 50 then assigned as "<50"; if derived numeric value is equal to or greater than 50 then assigned as ">=50". |
| Algorithm: ADSL.RNACATN | Computation | 1="<50"
2=">=50" |
| Algorithm: ADSL.RSEXSAF | Computation | DV.DVTERM where SUPPDV.QNAM.CAPE contain 'POP5' then RSEXSAF="Unreliable data due to lack of PI oversight"; else if only 'POP1' then RSEXSAF="Did not provide informed consent"; |
| Algorithm: ADSL.SAF1FL | Computation | if SAFFL="Y" and MULENRFL^="Y" and HIVFL^="Y" and trt01a ne "" then SAF1FL="Y"; else SAF1FL="N"; |
| Algorithm: ADSL.SAF2FL | Computation | if SAFFL="Y" and MULENRFL^="Y" and trt01a ne "" then SAF2FL="Y"; else SAF2FL="N"; |
| Algorithm: ADSL.SAFFL | Computation | If RANDFL='Y' and (VAX101DT ne . or VAX102DT ne . ) and (index(SUPPDV.QNAM.CAPE, "POP1")=0 for subjects's all DV records) then SAFFL='Y', else SAFFL='N' |
| Algorithm: ADSL.SCREEN | Computation | If RFICDT ne . then SCREEN='Y'; |
| Algorithm: ADSL.STCSRDT | Computation | STCSRDT=min(eosdcdt, "&cutoff2"d) for subjects with ranfl="Y" |
| Algorithm: ADSL.TR01EDT | Computation | Datepart of EX.EXENDTC for last vaccination of double blinded period. The last vaccination is defined as latest vaccination for subjects without Vaccination 3 or as last vaccination before Vaccination 3. |
| Algorithm: ADSL.TR01EDTM | Computation | Datetime of EX.EXENDTC for last vaccination of double blinded period. The last vaccination is defined as latest vaccination for subjects without Vaccination 3 or as last vaccination before Vaccination 3. |
| Algorithm: ADSL.TR01ETM | Computation | Timepart of EX.EXENDTC for last vaccination of double blinded period. The last vaccination is defined as latest vaccination for subjects without Vaccination 3 or as last vaccination before Vaccination 3. |
| Algorithm: ADSL.TR01SDT | Computation | Datepart of EX.EXSTDTC for Vaccination 1 |
| Algorithm: ADSL.TR01SDTM | Computation | Datetime of EX.EXSTDTC for Vaccination 1 |
| Algorithm: ADSL.TR01STM | Computation | Timepart of EX.EXSTDTC for Vaccination 1 |
| Algorithm: ADSL.TR02EDT | Computation | Datepart of EX.EXENDTC for last vaccination for subjects with Vaccination 3/4. |
| Algorithm: ADSL.TR02EDTM | Computation | Datetime of EX.EXENDTC for last vaccination for subjects with Vaccination 3/4. |
| Algorithm: ADSL.TR02ETM | Computation | Timepart of EX.EXENDTC for last vaccination for subjects with Vaccination 3/4. |
| Algorithm: ADSL.TR02SDT | Computation | Datepart of EX.EXSTDTC for the first Vaccination for subjects with Vaccination 3/4. |
| Algorithm: ADSL.TR02SDTM | Computation | Datetime of EX.EXSTDTC for the first Vaccination for subjects with Vaccination 3/4. |
| Algorithm: ADSL.TR02STM | Computation | Timepart of EX.EXSTDTC for the first Vaccination for subjects with Vaccination 3/4. |
| Algorithm: ADSL.TRT01A | Computation | Derived from DM.ACTARM. If subject received any of doses as BNT162b2, then the subject will be assigned as 'BNT162b2 Phase 1 (30 mcg)' for phase 1 subject and 'BNT162b2 Phase 2/3 (30 mcg)' for phase 2/3 subject. If the subject received 1 or 2 doses of placebo and no BNT, the subject will be assigned as "Placebo". If subject with all indeterminate vaccinations, set TRT01A to missing. |
| Algorithm: ADSL.TRT01P | Computation | Obtained from DM.ARM directly. |
| Algorithm: ADSL.TRT02A | Computation | Derived from EX.EXTRT where EXTPTREF in ("Vaccination 3" "Vaccination 4"). If subject received any of these 2 doses as BNT162b2, then the subject will be assigned as 'BNT162b2 Phase 1 (30 mcg)' for phase 1 subject and 'BNT162b2 Phase 2/3 (30 mcg)' for phase 2/3 subject. If subject with all indeterminate vaccinations, set TRT02A to missing. |
| Algorithm: ADSL.TRT02P | Computation | assign as "BNT162b2 Phase 1 (30 mcg)" for Phase 1 subjects and "BNT162b2 Phase 2/3 (30 mcg)" for Phase 2/3 subjects if EX.EXDOSE and EX.EXSTDTC are not missing when EX.EXTPTREF='VACCINATION 3' or 'VACCINATION 4' |
| Algorithm: ADSL.TRTEDT | Computation | Datepart of max(EX.EXENDTC) by subject level |
| Algorithm: ADSL.TRTEDTM | Computation | Max (EX.EXSTDTC) by subject level |
| Algorithm: ADSL.TRTETM | Computation | Timepart of max(EX.EXENDTC) by subject level |
| Algorithm: ADSL.TRTSDT | Computation | Datepart of min(EX.EXSTDTC) by subject level |
| Algorithm: ADSL.TRTSDTM | Computation | Min (EX.EXSTDTC) by subject level |
| Algorithm: ADSL.TRTSEQA | Computation | combination of TRT01A and TRT02A for treated subject |
| Algorithm: ADSL.TRTSEQP | Computation | combination of TRT01P and TRT02P for randomized subject |
| Algorithm: ADSL.TRTSTM | Computation | Timepart of min(EX.EXSTDTC) by subject level |
| Algorithm: ADSL.UNBLNDDT | Computation | DS.DSSTDTC when DSDECOD="TREATMENT UNBLINDED" |
| Algorithm: ADSL.V01DT | Computation | Derived BE1DT from CO.CODTC from Visit 7 after second dose for phase 1 and from visit 3 for phase 2/3
Derived BE1DT2 from SV.SVSTDTC from visit 7 after second dose for phase 1 and from visit 3 for phase 2/3
V01DT=COALESCE(VAX10UDT+35, BE1DT, BE1DT2, VAX102DT+35, VAX101DT+58);
Then, for unblinded subjects, compare V01DT with the day before treatment unblinding, set V01DT=min(V01DT,UNBLNDDT-1)
Note: used for AE summary tables to cutoff AEs within 1 month after vax2 |
| Algorithm: ADSL.V02DT | Computation | Derived BE2DT from CO.CODTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
Derived BE2DT2 from SV.SVSTDTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
V02DT=COALESCE(VAX10UDT+189, BE2DT, BE2DT2, VAX102DT+189, VAX101DT+189+23);
Then, for unblinded subjects, compare V02DT with the day before treatment unblinding, set V02DT=min(V02DT,UNBLNDDT-1)
Note: used for AE summary tables to cutoff AEs within 6 month after vax2. |
| Algorithm: ADSL.V02OBDT | Computation | Derived BE2DT from CO.CODTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
Derived BE2DT2 from SV.SVSTDTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
V02DT=COALESCE(VAX10UDT+189, BE2DT, BE2DT2, VAX102DT+189, VAX101DT+189+23);
Then, for subjects took dose 3, compare V02DT with the day before dose 3, set V02DT=min(V02DT, TR02SDT-1)
Note: used for AE summary tables to cutoff AEs within 6 month after vax2 regardless unblinding. |
| Algorithm: ADSL.V03DT | Computation | Derived BE3DT2 from SV.SVSTDTC from 1 month after second dose in open label period visit
V03DT=COALESCE(BE3DT2, VAX202DT+35, VAX201DT+58)
Note: used for AE summary tables to cutoff AEs within 1 month after vax 4 in open label period |
| Algorithm: ADSL.V04DT | Computation | Derived BE4DT2 from SV.SVSTDTC from 6 months after second dose in open label period visit
V04DT=COALESCE(BE4DT2, VAX202DT+189, VAX201DT+189+23)
Note: used for AE summary tables to cutoff AEs within 6 month after vax 4 in open label period |
| Algorithm: ADSL.V3C19NIG | Computation | The value of N-binding test at 1 Month after Vax 2 Visit. For subjects had Visit 3 recorded as not done, and if there is a convalescent visit or vax3 visit that happened within 28-42 days post dose 2, the convalescent visit/vax3 visit will be used to replace this one. If there are two records fall in the window, the record closed to 30 days after dose 2 will be chosen. |
| Algorithm: ADSL.VAX101 | Computation | Dose 1: combined form the vaccination at dose 1 and the corresponding dosage; set to missing if the dose is INDETERMINATE. |
| Algorithm: ADSL.VAX101DT | Computation | Date of the vaccination 1 (first vaccination date) |
| Algorithm: ADSL.VAX101TM | Computation | Time of the vaccination 1 (first vaccination date) |
| Algorithm: ADSL.VAX102 | Computation | Dose 2: combined form the vaccination at dose 2 and the corresponding dosage; set to missing if the dose is INDETERMINATE. |
| Algorithm: ADSL.VAX102DT | Computation | Date of the vaccination 2 (2nd vaccination date) |
| Algorithm: ADSL.VAX102TM | Computation | Time of the vaccination 2 (2nd vaccination date) |
| Algorithm: ADSL.VAX10U | Computation | Unplanned Dose 2: combined form the vaccination at unplanned dose 2 and the corresponding dosage; set to missing if the dose is INDETERMINATE. |
| Algorithm: ADSL.VAX10UDT | Computation | Date of the unplanned vaccination 2 (3rd vaccination date in the first period) |
| Algorithm: ADSL.VAX10UTM | Computation | Time of the unplanned vaccination 2 (3rd vaccination date in the first period) |
| Algorithm: ADSL.VAX201 | Computation | If EX.EXTRT='BNT162b2' when EX.VISIT in ('V101_VAX3' 'V8A_VAX3'), then VAX201='BNT162b2 (30 (*ESC*){unicode 03BC}g)'; set to missing if the dose is INDETERMINATE. |
| Algorithm: ADSL.VAX201DT | Computation | Date of the vaccination at Visit 101 (3rd vaccination date), Datepart of EX.EXSTDTC where EX.VISIT in ('V101_VAX3' 'V8A_VAX3'). |
| Algorithm: ADSL.VAX201TM | Computation | Time of the vaccination at Visit 101 (3rd vaccination date), timepart of EX.EXSTDTC where EX.VISIT in ('V101_VAX3' 'V8A_VAX3'). |
| Algorithm: ADSL.VAX202 | Computation | If EX.EXTRT='BNT162b2' when EX.VISIT='V102_VAX4', then VAX202='BNT162b2 (30 (*ESC*){unicode 03BC}g)'; set to missing if the dose is INDETERMINATE. |
| Algorithm: ADSL.VAX202DT | Computation | Date of the vaccination at Visit 102 (4th vaccination date), Datepart of EX.EXSTDTC where EX.VISIT='V102_VAX4'. |
| Algorithm: ADSL.VAX202TM | Computation | Time of the vaccination at Visit 102 (4th vaccination date), timepart of EX.EXSTDTC where EX.VISIT='V102_VAX4'. |
| Algorithm: ADSL.VAX20U | Computation | Unplanned Dose in open label period: combined form the vaccination at unplanned dose after the first dose after crossover period and the corresponding dosage; set to missing if the dose is INDETERMINATE. |
| Algorithm: ADSL.VAX20UDT | Computation | Date of the unplanned vaccination 1 in open label period. |
| Algorithm: ADSL.VAX20UTM | Computation | Time of the unplanned vaccination 1 in open label period. |
| Algorithm: ADSL.X1CSRDT | Computation | X1CSRDT=min(eosdcdt, "&cutoff2"d) for subjects with ranfl="Y" and non-missing tr02sdt or non-missing UNBLNDDT and boostfl ne "Y" |
| Algorithm: ADSYMPT.ADT | Computation | if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FADTC.
if paramcd in ("HCUICU" "HCUHSP") then Set to HO.HODTC.
if paramcd in ("C19NIG") then Set to IS.ISDTC.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBDTC.
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PRDTC.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSDTC.
if paramcd in ("PRCDTH" "SECDTH") then ADSL.DTHDT
if paramcd in ("PO2FIO2") then LB.LBDTC
if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "VSOPRES") then Set to null. |
| Algorithm: ADSYMPT.ADY | Computation | Set as following:
ADY = ADT - TRTSDT.
If ADT >= TRTSDT, ADY = ADT - TRTSDT + 1. |
| Algorithm: ADSYMPT.AENDT | Computation | if paramcd in ("SARDFN" "SAHDFN") then Set to CE.CEENDTC.
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FASTRESC where FA.FATESTCD = "LSYMDATE" and FA.FACAT = "EFFICACY" and FASCAT = "RESPIRATORY ILLNESS" within a matching FA.VISIT of a subject..
if paramcd in ("HCUICU" "HCUHSP") then Set to HO.HOENDTC.
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PRENDTC.
if paramcd in ("VSOPRES") then set to CM.CMENDTC
if paramcd in ("SARSCOV2" "RTCOV2NS" "RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "C19NIG" "DEATH" "PRCDTH" "SECDTH" "PO2FIO2") then Set to null. |
| Algorithm: ADSYMPT.AENDY | Computation | Set as following:
AENDY = AENDT - TRTSDT.
If AENDT >= TRTSDT, AENDY = AENDT - TRTSDT + 1. |
| Algorithm: ADSYMPT.ASTDT | Computation | if paramcd in ("SARDFN" "SAHDFN") then Set to CE.CESTDTC.
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FASTRESC where FA.FATESTCD = "FSYMDATE" and FA.FACAT = "EFFICACY" and FASCAT = "RESPIRATORY ILLNESS" within a matching FA.VISIT of a subject.
if paramcd in ("HCUICU" "HCUHSP") then Set to HO.HOSTDTC.
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PRSTDTC.
if paramcd in ("VSOPRES") then set to CM.CMSTDTC
if paramcd in ("SARSCOV2" "RTCOV2NS" "RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "C19NIG" "DEATH" "PRCDTH" "SECDTH" "PO2FIO2") then Set to null. |
| Algorithm: ADSYMPT.ASTDY | Computation | Set as following:
ASTDY = ASTDT - TRTSDT.
If ASTDT >= TRTSDT, ASTDY = ASTDT - TRTSDT + 1. |
| Algorithm: ADSYMPT.AVAL | Computation | if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN.
if paramcd in ("PO2FIO2") then set to LB.LBORRES
else Set to null. |
| Algorithm: ADSYMPT.AVALC | Computation | if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES.
if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC
if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y".
if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. |
| Algorithm: ADSYMPT.AVISIT | Computation | Follow AVISITN specification from below, but assign VISIT from source data instead. |
| Algorithm: ADSYMPT.AVISITN | Computation | Set to VISITNUM of source dataset and for any existing multiple unplanned visits that are at least 4 days apart from the end of previous unplanned visit.
When multiple unplanned visits are present and start of next unplanned visit is within 3 days of end of current unplanned visit, collapse the next unplanned visit into current unplanned visit and assign current VISITNUM to the next unplanned visit. Also set any repeat visits such as "..ARx" back to its main/parent visit. |
| Algorithm: ADSYMPT.C19ILHL | Computation | Set this to "Y", if subject reported any of the following terms in MH.MHDECOD .
"Asymptomatic COVID-19"
"COVID-19"
"COVID-19 pneumonia"
"COVID-19 treatment"
"Suspected COVID-19"
"SARS-CoV-2 antibody test positive"
"SARS-CoV-2 carrier"
"SARS-CoV-2 sepsis"
"SARS-CoV-2 test positive"
"SARS-CoV-2 viraemia"
"Multisystem inflammatory syndrome in children" |
| Algorithm: ADSYMPT.PARAM | Computation | Set to FA.FAOBJ when upcase(FA.FAOBJ) = "CHILLS" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "DIARRHEA" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "FEVER" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW LOSS OF TASTE OR SMELL" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED COUGH" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED MUSCLE PAIN" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED SHORTNESS OF BREATH" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED SORE THROAT" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "VOMITING" and FA.FACAT = "EFFICACY" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to "NEW OR INCREASED NASAL CONGESTION" when upcase(FA.FAOBJ) = "NEW OR INCREASED NASAL CONGESTION" or "NASAL CONGESTION" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to "NEW OR INCREASED WHEEZING" when upcase(FA.FAOBJ) = "NEW OR INCREASED WHEEZING" or upcase(FA.FAOBJ) = "WHEEZING" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "FATIGUE" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "HEADACHE" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to "RHINORRHOEA" when upcase(FA.FAOBJ) contains "RUNNY NOSE" or upcase(FA.FAOBJ) = "RHINORRHOEA" and FA.FAOBJ ^= "NEW OR INCREASED NASAL DISCHARGE" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NAUSEA" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to CE.CESCAT when CE.CESCAT = "SIGNIFICANT ACUTE RENAL DYSFUNCTION".
Set to CE.CESCAT when CE.CESCAT = "SIGNIFICANT ACUTE HEPATIC DYSFUNCTION".
Set to CE.CESCAT when CE.CESCAT = "SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION".
Set to MB.MBTEST when upcase(MB.MBTESTCD) = "SARSCOV2" and MB.MBMETHOD = "IMMUNOCHROMATOGRAPHY".
Set to MB.MBTEST when upcase(MB.MBTESTCD) = "RTCOV2NS" and MB.MBMETHOD = "REVERSE TRANSCRIPTASE PCR".
Set to VS.VSTEST when VS.VSTESTCD = "RESP".
Set to VS.VSTEST when VS.VSTESTCD = "HR".
Set to VS.VSTEST when VS.VSTESTCD = "OXYSAT"
Set to VS.VSTEST when VS.VSTESTCD = "DIABP".
Set to VS.VSTEST when VS.VSTESTCD = "SYSBP".
Set to LB.LBTEST when LB.LBTEST = "PP Arterial O2/Fraction Inspired O2".
Set to PR.PRTRT when upcase(PR.PRTRT) = "INTUBATION".
Set to PR.PRTRT when upcase(PR.PRTRT) = "NON-INVASIVE POSITIVE PRESSURE VENTILATION".
Set to "CONTINUOUS POSITIVE AIRWAY PRESSURE" when upcase(PR.PRTRT) = "CONTINUOUS POSITIVE AIRWAY PRESSURE" or upcase(PR.PRTRT) = "CPAP".
Set to PR.PRTRT when upcase(PR.PRTRT) = "OXYGEN THERAPY"
Set to PR.PRTRT when upcase(PR.PRTRT) = "MECHANICAL VENTILATION".
Set to PR.PRTRT when upcase(PR.PRTRT) = "EXTRACORPOREAL MEMBRANE OXYGENATION".
Set to PR.PRTRT when upcase(PR.PRTRT) = "HIGH FLOW OXYGEN THERAPY".
Set to CM.CMSCAT when CM.CMCAT = "GENERAL CONCOMITANT MEDICATIONS" and CM.CMSCAT = "VASOPRESSORS AGENTS". Keep only one record per subject per CM.CMSTDTC where CM.CMTRT is not missing.
Set to IS.ISTEST when IS.ISTESTCD = "C19NIG"
Set to "SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS" when (HOTERM = "ICU') or (SUPPHO.QNAM = "HCUICU" and QVAL="Y").
Set to "HOSPITALIZED DUE TO COVID-19 ILLNESS?" when SUPPHO.QNAM = "HCUHSP" and QVAL="Y"
Set to DD.DDTEST when DD.DDTESTCD = "PRCDTH". Note: Only bring records when ADSL.DTHDT not null or DD.DDSTRESC is not null.
Set to DD.DDTEST when DD.DDTESTCD = "SECDTH". Note: Only bring records when DD.DDSTRESC is populated.
Set to DS.DSDECOD when DS.DSDECOD = "DEATH". |
| Algorithm: ADSYMPT.PARCAT1 | Computation | if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to "GENERAL VITAL SIGNS".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to "SIGNS AND SYMPTOMS OF DISEASE".
if paramcd in ("SARDFN" "SAHDFN" "SANDFN") then Set to CE.CECAT.
if paramcd in ("DEATH") then Set to DS.DSCAT.
if paramcd in ("HCUICU" "HCUHSP") then Set to HO.HOCAT.
if paramcd in ("C19NIG") then Set to IS.ISCAT.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBCAT.
if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PRCAT.
if paramcd in ("VSOPRES") then Set to CM.CMCAT
if paramcd in ("PO2FIO2") then set to LB.LBCAT
if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDCAT |
| Algorithm: ADSYMPT.PARCAT2 | Computation | if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to "RESPIRATORY FAILURE".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASCAT.
if paramcd in ("HCUICU" "HCUHSP" "C19NIG" "SARSCOV2" "RTCOV2NS" "RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "SARDFN" "SAHDFN" "SANDFN" "PRCDTH" "SECDTH" "DEATH") then Set to null.
if paramcd in ("VSOPRES") then Set to CM.CMSCAT
if paramcd in ("PO2FIO2") then set to LB.LBSCAT |
| Algorithm: ADVA.AAIMMFL | Computation | For Phase 1:
if avisitn<4 then do; /*related to dose 1 all-available immunogenicity population*/
if aai01fl="Y" then AAIMMFL="Y";
else AAIMMFL="N";
end;
else if avisitn>=4 then do;/*related to dose 2 all-available immunogenicity population*/
if aai02fl="Y" then AAIMMFL="Y";
else AAIMMFL="N";
end;
For Phase 2/3:
if aai02fl="Y" then AAIMMFL="Y";
else AAIMMFL="N"; |
| Algorithm: ADVA.ABLFL | Computation | Set to 'Y' for a valid result (AVAL ne .) where collected before vax1.
Note: For phase 1 BNTb2 30 ug subjects, repeat test results are used in Vist 1/4/7/8, so only repeated V1 results are used to derive ABLFL |
| Algorithm: ADVA.ABLPBLFL | Computation | Set to 'Y' if a subject has results both at baseline and post-baseline.
Set to 'N' if a subject only has baseline or post-baseline results. |
| Algorithm: ADVA.ADT | Computation | date part of IS.ISDTC |
| Algorithm: ADVA.ANL01FL | Computation | Flag the record that is selected based on Windowing
1. AVISIT ne missing;
2. Vax 1 date ne missing;
3. For Visit 1, visit date should no later than Vax 1 date;
4. For Visit 3, visit date should no later than Vax 3 (re-vax) date;
Note: For phase 1 BNTb2 30 ug subjects, repeat test results are used in Vist 1/4/7/8, so ANL01FL is set to missing for original results. |
| Algorithm: ADVA.ANL03FL | Computation | Flag the record with non-missing result (AVAL ne . ) and ISSTRESC not in ('IND', 'QNS') |
| Algorithm: ADVA.ANL04FL | Computation | Flag the record with non-missing AVAL and AVAL ge LLoQ. |
| Algorithm: ADVA.APEREDT | Computation | For Period 1, min(TR01EDTM + 365days ,TR02SDTM) for subjects with TR02SDTM, TR01EDTM + 365 days for subjects without TR02SDTM; TR02EDTM + 365 days for Period 2 |
| Algorithm: ADVA.APERIOD | Computation | if adt<TR02SDT or without TR02SDT or (adt=TR02SDT and index(visit, "V3_MONTH1_POSTVAX2")) then APERIOD=1;
if adt>TR02SDT or (adt=TR02SDT and index(visit, "V101_VAX3")) then APERIOD=2;
null if not dosed. |
| Algorithm: ADVA.APERSDTM | Computation | TR01SDTM for Period 1; TR02SDTM for Period 2, |
| Algorithm: ADVA.APSBLFL | Computation | Set to 'Y' for a post-baseline result where collected after vax1 |
| Algorithm: ADVA.AVAL | Computation | If ISSTRESC in (' ', 'IND', 'QNS') then set to missing;
if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ;
else set to IS.ISSTRESN.
*LLoQ equals the value of ISLLOQ.
For N-binding antibody test, 0 for negative and 1 for positive.
For parameter with paramn equal 11 and 12:
AVAL is the ratio of the corresponding parameters specified in PARAM
eg: For PARAMN=11 (PARAM='COV2_MNG_SERUM_NT50 to Covid 19 S1 IGG), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point |
| Algorithm: ADVA.AVALC | Computation | Character value for AVAL |
| Algorithm: ADVA.AVISIT | Computation | Derive AVISIT based on IS.Visit/Visitnum for records with non-missing value (AVAL ne .)
Note: For phase 1 BNTb2 30 ug subjects, repeat test results are used in Vist 1/4/7/8, so AVISITN is set to missing for original results.
Note: set AVISIT='' for ISTESTCD='C19NIG' as no need to report this test. |
| Algorithm: ADVA.BASE | Computation | AVAL from the record with ABLFL="Y" at USUBJID/PARAM level |
| Algorithm: ADVA.BASE4F | Computation | AVAL from the record with ABLFL="Y" at USUBJID/PARAM level; if BASE<islloq or BASEC="BLQ" then BASE4F=islloq |
| Algorithm: ADVA.BASEC | Computation | AVALC from the record with ABLFL="Y" at USUBJID/PARAM level |
| Algorithm: ADVA.BASETYPE | Computation | trim(left("Study"))||' ('||trim(left(dtype))||')'; |
| Algorithm: ADVA.BSSEROC | Computation | if base<islloq then BSSEROC="< LLOQ";
if base>=islloq then BSSEROC=">= LLOQ";
if missing baseline then BSSEROC="Missing" |
| Algorithm: ADVA.EVIMMFL | Computation | For Phase 1:
if avisitn<4 then do; /*related to dose 1 evaluable immunogenicity population*/
if eval01fl="Y" then EVIMMFL="Y";
else EVIMMFL="N";
end;
else if avisitn>=4 then do; /*related to dose 2 evaluable immunogenicity population*/
if eval02fl="Y" then EVIMMFL="Y";
else EVIMMFL="N";
end;
For Phase 2/3:
if eval02fl="Y" then EVIMMFL="Y";
else EVIMMFL="N"; |
| Algorithm: ADVA.FOLD4FL | Computation | if r2base4f ge 4 then fold4fl="Y" |
| Algorithm: ADVA.PARAM | Computation | trim(left(IS.ISTEST)) || '(' || trim(left(IS.ISSTRESU)) || ')' || ' - ' || trim(left(IS.ISMETHOD)) |
| Algorithm: ADVA.R2BASE | Computation | R2BASE = AVAL/BASE for post baseline readings |
| Algorithm: ADVA.R2BASE4F | Computation | R2BASE4F = AVAL/BASE4F for post baseline readings |
| Algorithm: ADVA.SRCSEQ | Computation | IS.ISSEQ when DTYPE ne 'Derived'. |
| Algorithm: ADVA.TRTA | Computation | TRT01A for Period 1; TRT02A for Period 2 |
| Algorithm: ADVA.TRTAN | Computation | TRT01AN for Period 1; TRT02AN for Period 2 |
| Algorithm: ADVA.TRTP | Computation | TRT01P for Period 1; TRT02P for Period 2 |
| Algorithm: ADVA.TRTPN | Computation | TRT01PN for Period 1; TRT02PN for Period 2 |
Go to the top of the Define-XML document