Date/Time of Define-XML document generation: 2021-04-30T16:03:16Z
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 | |
| 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 | |
| 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 |
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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 | 3 | 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-v1-13aug2020-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
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 | |
| 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 | |
| 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 | |
| PHASE | Study Phase | text | 20 | Study Phase
| Predecessor: ADSL.PHASE | |
| PHASEN | Study Phase (N) | integer | 8 | Numeric Code of Study Phase
| Predecessor: ADSL.PHASEN | |
| 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 | ||
| PARCAT | Parameter Category | text | 38 | Predecessor: FACE.FACAT or VS.VSCAT | ||
| 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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 = "MAXTEMP" (Fever maximum temperature) | Fever maximum temperature | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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 | No Yes Response
| Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. | ||
| 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 | Predecessor: EX.EXSTDTC | ||
| EXENDTC | End Date/Time of Treatment | datetime | 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') | ||
| VSSTRESC | Character Result/Finding in Std Format | text | 5 | Predecessor: VS.VSSTRESC 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 [7 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'.
For index(VSSTRESC, 'FEVER') then 'Unknown'. | |
| FTEMCATN | Fever Temperature Category (N) | integer | 8 | FTEMCATN [6 Terms] | 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"
99=“Unknown" | |
| 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 or avalc in ('MILD', 'MODERATE',''SEVER','GRADE 4')) 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) or avalc in (’Y', 'MILD', 'MODERATE',''SEVER', 'GRADE 4')) 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) or AVALC in ('MILD', ‘MODERATE', 'SEVERE", 'GRADE4')) 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 or avalc in ('Y', 'MILD', 'MODERATE', 'SEVERE', 'GRADE4')) 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 |
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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 |
| 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 | Predecessor: ADSL.RACEGR1N | |
| 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. | |
| AEMOD | Updated with unsolicited AE data | text | 1 | Predecessor: SUPPAE.QVAL where SUPPAE.QNAM='AEMOD' | |
| REACCRIT | Meets Reactogenicity Criteria | text | 1 | Y
| Predecessor: SUPPAE.QVAL where SUPPAE.QNAM='REACCRIT' |
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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 |
| 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 |
| PHASE | Study Phase | text | 20 | Study Phase
| Predecessor: ADSL.PHASE |
| PHASEN | Study Phase (N) | integer | 8 | Numeric Code of Study Phase
| Predecessor: ADSL.PHASEN |
| 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) or (FACE.FATESTCD='SEV' and FACE.FASTRESC in ('SEVERE','GRADE 4')) 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 | Predecessor: CE.CESTDTC | |
| CEENDTC | End Date/Time of Clinical Event | datetime | 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 | Predecessor: EX.EXSTDTC | |
| EXENDTC | End Date/Time of Treatment | datetime | 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 in ('Y' 'MILD' 'MODERATE' 'SEVERE', 'GRADE 4') 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) or (FACE,FAOBJ in ('REDNESS' 'SWELLING' and FACE.FASTRESC in ('MILD' 'MODERATE' 'SEVERE','GRADE 4')).
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) or (VS.VACAT='REACTOGENICITY - ADVERSE EVENT' and index(VS.VSSTRESC,'FEVER')) 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) or (FATESTCD='SEV' and FASTRESC in ('MILD' 'MODERATE' 'SEVERE' 'GRADE 4'))).
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) or (VS.VSCAT='REACTOGENICITY - ADVERSE EVENT' and index(VS.VSSTRESC,'FEVER'))) 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 and SUPPCE.AEMOD ne 'Y') or (CE.CEENRTPT='ONGOING' and CE.CEENDTC is missing and SUPPCE.AEMOD='Y').
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 [(AEMOD ne 'Y' and (numeric value of SUPPCE.RCENDTC>VAX102DT or SUPPCE.ONGNXVIS='Y')) OR (SUPPCE.AEMOD='Y' and (numeric value of CE.CEENDTC>VAX102DT or CE.CEENRTPT='ONGOING'))], 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') or (FACE.FASTRESC in ('MILD' 'MODERATE' 'SEVER' 'GRADE 4') and FACE.FATESTCD='SEV')) 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 or index(VS.VSSTRESC,'FEVER')) 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. |
| AEMOD | Updated with unsolicited AE data | text | 1 | Y
| Predecessor: SUPPCE.QVAL where SUPPCE.QNAM='AEMOD' |
| CEDIFFRS | Reason Investigator Changed Assessment | text | 80 | Predecessor: SUPPCE.QVAL where SUPPCE.QNAM='CEDIFFRS' | |
| CESTDTC1 | Start Date/Time of Clinical Event 1 | date | ISO 8601 | Predecessor: SUPPCE.QVAL where SUPPCE.QNAM='CESTDTC1' | |
| CEENDTC1 | End Date/Time of Clinical Event 1 | date | ISO 8601 | Predecessor: SUPPCE.QVAL where SUPPCE.QNAM='CEENDTC1' | |
| CESEV1 | Severity/Intensity 1 | text | 8 | Predecessor: SUPPCE.QVAL where SUPPCE.QNAM='CESEV1' | |
| CEEVAL | Evaluator | text | 13 | Predecessor: SUPPCE.QVAL where SUPPCE.QNAM='CEEVAL' |
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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 |
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 |
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 |
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 |
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 |
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 |
| Unknown |
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 |
| 99 | Unknown |
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 |
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 |
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 |
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: 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) or (FATESTCD='SEV' and FASTRESC in ('MILD' 'MODERATE' 'SEVERE' 'GRADE 4'))).
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) or (VS.VSCAT='REACTOGENICITY - ADVERSE EVENT' and index(VS.VSSTRESC,'FEVER'))) 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 and SUPPCE.AEMOD ne 'Y') or (CE.CEENRTPT='ONGOING' and CE.CEENDTC is missing and SUPPCE.AEMOD='Y').
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 [(AEMOD ne 'Y' and (numeric value of SUPPCE.RCENDTC>VAX102DT or SUPPCE.ONGNXVIS='Y')) OR (SUPPCE.AEMOD='Y' and (numeric value of CE.CEENDTC>VAX102DT or CE.CEENRTPT='ONGOING'))], 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) or (FACE.FATESTCD='SEV' and FACE.FASTRESC in ('SEVERE','GRADE 4')) 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 in ('Y' 'MILD' 'MODERATE' 'SEVERE', 'GRADE 4') 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) or (FACE,FAOBJ in ('REDNESS' 'SWELLING' and FACE.FASTRESC in ('MILD' 'MODERATE' 'SEVERE','GRADE 4')).
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) or (VS.VACAT='REACTOGENICITY - ADVERSE EVENT' and index(VS.VSSTRESC,'FEVER')) 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') or (FACE.FASTRESC in ('MILD' 'MODERATE' 'SEVER' 'GRADE 4') and FACE.FATESTCD='SEV')) 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 or index(VS.VSSTRESC,'FEVER')) 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: 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. Set AVAL to missing where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'. |
| Algorithm: ADFACEVD.AVALC | Computation | For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' and FACAT ne 'REACTOGENICITY - ADVERSE EVENT' 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'))
or (VS.VSSTRESC where index(VS.VSTESTCD,'TEMP') and VS.VSCAT='REACTOGENICITY - ADVERSE EVENT')
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if (input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0) or index(VS.VSSTRESC, 'FEVER') 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 where PARCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE') or set AVALC to 'UNKNOWN' where PARCAT eq 'REACTOGENICITY - ADVERSE EVENT'.
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) or AVALC in ('MILD', ‘MODERATE', 'SEVERE", 'GRADE4')) 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 or avalc in ('Y', 'MILD', 'MODERATE', 'SEVERE', 'GRADE4')) 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 or avalc in ('MILD', 'MODERATE',''SEVER','GRADE 4')) 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) or avalc in (’Y', 'MILD', 'MODERATE',''SEVER', 'GRADE 4')) 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'.
For index(VSSTRESC, 'FEVER') then 'Unknown'. |
| 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"
99=“Unknown" |
| 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: 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-v1-13aug2020-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" |
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