Date/Time of Define-XML document generation: 2020-11-19T23:07:16Z
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 | |
| ADC19EF | Covid-19 Efficacy Analysis Dataset | BASIC DATA STRUCTURE | One record or multiple records per subject per analysis parameter per analysis timepoint | Analysis | STUDYID, USUBJID, PARAMCD, ADT | adc19ef.xpt | |
| ADFACEVD | Diary and Non-event Analysis Dataset | BASIC DATA STRUCTURE | One record or multiple records per subject per analysis parameter per analysis timepoint | Analysis | STUDYID, USUBJID, PARAMCD, ATPT | adfacevd.xpt | |
| ADSYMPT | Covid-19 Signs and Symptoms Analysis Dataset | BASIC DATA STRUCTURE | One record or multiple records per subject per analysis parameter per analysis timepoint | Analysis | STUDYID, USUBJID, PARAMCD, ADT | adsympt.xpt | |
| ADVA | Immunogenicity Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis parameter per analysis visit | Analysis | STUDYID, USUBJID, PARAMCD, AVISITN | adva.xpt | |
| ADAE | Adverse Events Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record or multiple records per subject per each adverse event per event start date | Analysis | STUDYID, USUBJID, AETERM, 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 | |
| ADDS | Disposition Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record or multiple records per subject per disposition status | Analysis | STUDYID, USUBJID, DSDECOD | adds.xpt | |
| ADMH | Medical History Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record or multiple records per subject per medical event | Analysis | STUDYID, USUBJID, MHTERM | admh.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 | AGEU
| Predecessor: DM.AGEU |
| SEX | Sex | text | 1 | SEX
| Predecessor: DM.SEX |
| SEXN | Sex (N) | integer | 8 | 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 | 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
| Predecessor: DM.ETHNIC |
| ETHNICN | Ethnicity (N) | integer | 8 | 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". | |
| COUNTRY | Country | text | 3 | Predecessor: DM.COUNTRY | |
| SAFFL | Safety Population Flag | text | 1 | NY
| Derived If RANDFL='Y' and (VAX101DT ne . or VAX102DT ne . ) and (index(SUPPDV.CAPE, "POP1")=0 for subjects's all DV records) then SAFFL='Y', else SAFFL='N' |
| RANDFL | Randomized Population Flag | text | 1 | NY
| 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 | 27 | Predecessor: DM.ARM | |
| ARMCD | Planned Arm Code | text | 9 | Predecessor: DM.ARMCD | |
| ACTARM | Description of Actual Arm | text | 27 | Derived Based on the actual vaccinations taken by subjects. Same as ARM if no medication error for the vaccinated subjects.
For subjects with medication error, if the subject takes one dose of study drug and the other of placebo, then ACTARM will be study drug; else if the subject takes only placebo, then ACTARM will be placebo.
ACTARM=' ' for screen failure and not assigned subjects;
ACTARM='Not Treated' for not treated subjets;
ACTARM='Unplanned Treatment' for subjects with ARM='NOT ASSIGNED' but treated | |
| ACTARMCD | Actual Arm Code | text | 9 | Derived Based on the actual vaccinations taken by subjects. Same as ARMCD if no medication error for the vaccinated subjects.
For subjects with medication error, if the subject takes one dose of study drug and the other of placebo, then ACTARM will be study drug; else if the subject takes only placebo, then ACTARM will be placebo.
ACTARMCD=' ' for screen failure and not assigned subjects;
ACTARMCD='NOTTRT' for not treated subjets;
ACTARM='UNPLAN' for subjects with ARM='NOT ASSIGNED' but treated | |
| TRT01P | Planned Treatment for Period 01 | text | 27 | Derived Derived from DM.ARM | |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Assigned BNT162b1 Phase 1 (10 mcg)=1 BNT162b1 Phase 1 (100 mcg)=4 BNT162b1 Phase 1 (20 mcg)=2 BNT162b1 Phase 1 (30 mcg)=3 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 | |
| TRT01A | Actual Treatment for Period 01 | text | 27 | Derived Derived from ADSL.ACTARM | |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Assigned BNT162b1 Phase 1 (10 mcg)=1 BNT162b1 Phase 1 (100 mcg)=4 BNT162b1 Phase 1 (20 mcg)=2 BNT162b1 Phase 1 (30 mcg)=3 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 'Unplanned Treatmen'=99 | |
| 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 | DATEFL
| 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 | 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 | DATEFL
| 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 Min (Datepart of EX.EXSTDTC) by subject level | |
| TRTSTM | Time of First Exposure to Treatment | integer | TIME8 | Derived Min (Timepart of EX.EXSTDTC) by subject level | |
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Derived Max (Datepart of EX.EXENDTC) by subject level | |
| TRTETM | Time of Last Exposure to Treatment | integer | TIME8 | Derived Max (Timepart of 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 the last EX.EXENDTC | |
| TR01ETM | Time of Last Exposure in Period 01 | integer | TIME8 | Derived Timepart of the last EX.EXENDTC | |
| 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 the last EX.EXENDTC | |
| 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) | |
| VAX103DT | Vaccination Date 03 | integer | DATE9 | Derived Date of the vaccination 3 (3rd vaccination date) | |
| 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 vaccinateion 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 | AGEU
| Derived AGETRU01='YEARS' for non-missing AGETR01. |
| AGEGR1 | Pooled Age Group 1 | text | 11 | 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 | 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 | ARACE [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 | Assigned Numeric Code of ARACE 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‘； | |
| RACEGR1 | Pooled Race Group 1 | text | 25 | 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 | Assigned Numeric Code of the DM.RACE. 1 if RACEGR1="WHITE"; 2 if RACEGR1="BLACK 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 EPOCH="FOLLOW-UP" and DS.DSDECOD^=“COMPLETED” | |
| EOSDCRS | End Of Study Discontinuation Reason | text | 49 | Derived EOSDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and DS.EPOCH="FOLLOW-UP" and DS.DSDECOD^=“COMPLETED” | |
| EOTDCDT | End Of Treatment Discontinuation Date | integer | DATE9 | Derived EOSDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and index(DS.EPOCH, "VACCINATION")>0 and DS.DSDECOD^=“COMPLETED” | |
| EOTDCRS | End Of Treatment Discontinuation Reason | text | 49 | Derived EOTDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and DS.EPOCH="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 | 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 | 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 | Assigned For Phase 1 only: Numeric Code of DOSPLVL 1=10 ug, 2=20 ug, 3=30 ug, 5=100 ug/10 ug, 6=Placebo | |
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Assigned For Phase 1 only: Numeric Code of DOSALVL 1=10 ug, 2=20 ug, 3=30 ug, 5=100 ug/10 ug, 6=Placebo | |
| CDECASE | Clinical disease endpoint case flag | text | 3 | Predecessor: SUPPDM.QVAL where SUPPDM.QNAM='CDECASE' | |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Assigned Numeric Code of AGEGR2. 1='<65 Years'; 2='>=65 Years'; | |
| AGEGR2 | Pooled Age Group 2 | text | 10 | Derived Derived using following derivations:
if 65<=agetr01 then AGEGR2='>=65 Years';
if agetr01<65 then AGEGR2='<65 Years'; | |
| AGEGR3N | Pooled Age Group 3 (N) | integer | 8 | Assigned Numeric Code of AGEGR3. 1='16-17 Years'; 2='18-55 Years'; 3='>55 Years'; | |
| AGEGR3 | Pooled Age Group 3 | text | 11 | 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'; | |
| 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) | |
| VAX103TM | Vaccination Time 03 | integer | TIME8 | Derived Time of the vaccination 3 (3rd vaccination date) | |
| VAX101 | Vaccination 01 | text | 37 | Derived Dose 1: combined form the vaccination at dose 1 and the corresponding dosage | |
| VAX102 | Vaccination 02 | text | 36 | Derived Dose 2: combined form the vaccination at dose 2 and the corresponding dosage | |
| VAX103 | Vaccination 03 | text | 36 | Derived Dose 3: combined form the vaccination at dose 3 and the corresponding dosage | |
| SCREEN | Screening | text | 1 | Derived If RFICDT ne . then SCREEN='Y'; | |
| COHORT | Cohort Group | text | 75 | Predecessor: SUPPDS.QVAL where SUPPDS.QNAM="DSRANGRP" | |
| COHORTN | Cohort Group (N) | float | 8 | Assigned For Phase 1 only: 1.14 if cohort="Stage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO)" 1.145 if cohort="Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)" 1.15 if cohort="Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO)" 1.16 if cohort="Stage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO)" 1.17 if cohort="Stage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO)" 1.175 if cohort="Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)" 1.18 if cohort="Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO)" 1.34 if cohort="Stage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO)" 1.345 if cohort="Stage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)" 1.35 if cohort="Stage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO)" 1.37 if cohort="Stage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO)" 1.375 if cohort="Stage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)" 1.38 if cohort="Stage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO)" | |
| PHASEN | Study Phase (N) | integer | 8 | Assigned 1 for subjects from Phase 1; 2 for subjects from Phase 2 (defined in phase2-360-participants.xlsx) ; 3 for subjects from Phase 2/3 and included in DS6000 (define in phase3-6k-participants.xlsx); 4 for all other subjects from Phase 3 | |
| PHASE | Study Phase | text | 20 | Derived "Phase 1" for subjects from Phase 1;
"Phase 2_ds360/ds6000" for subjects from Phase 2;
"Phase 3_ds6000" for subjects from Phase 3 and included in DS6000;
"Phase 3" for other subjects from Phase 3 | |
| JPNFL | Japenese Subject Flag | text | 1 | NY
| Derived "Y" for subjects in Japenese subject list; else "N". |
| V01DT | Date of Visit at 1M after Vax2 | 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(VAX103DT+35, BE1DT, BE1DT2, VAX102DT+35, VAX101DT+58);
Note: used for AE summary tables to cutoff AEs within 1 month after vax2. And for subjects took a unscheduled dose 3, the 1 month after vax2 windown was calculated by vax103dt+35. | |
| V02DT | Date of Visit at 6M after Vax2 | 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(VAX103DT+168, BE2DT, BE2DT2, VAX102DT+168, VAX101DT+191);
Note: used for AE summary tables to cutoff AEs within 6 month after vax2. And for subjects took a unscheduled dose 3, the 6 month after vax2 windown was calculated by vax103dt+168. | |
| DVSTDT | Start Date of Important PD | integer | DATE9 | Derived The earliest date of import PD | |
| 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 If non missing blood draw date at 1 Week after Vax 1 Visit then bldv2fl = 'Y''; else bldv2fl = 'N'.
Note: For Phase 1 subjects only | |
| BLDV4ADT | Additional Bld Sample Date 4W after Vax1 | integer | DATE9 | Derived If non missing blood draw date at Vax 2 Visit then bldv3fl = 'Y''; else bldv3fl = 'N'.
Note: For Phase 1 subjects only | |
| BLDV5ADT | Additional Bld Sample Date 5W after Vax1 | integer | DATE9 | Derived If non missing blood draw date at 1 Week after Vax 2 Visit then bldv4fl = 'Y''; else bldv4fl = 'N'.
Note: For Phase 1 subjects only | |
| BLDV6ADT | Additional Bld Sample Date 7W after Vax1 | integer | DATE9 | Derived If non missing blood draw date at 2 Weeks after Vax 2 Visit then bldv5fl = 'Y''; else bldv5fl = 'N'.
Note: For Phase 1 subjects only | |
| BLDV3DT | Blood Sample Date before Vax 2 | integer | DATE9 | Derived Blood draw date at 3 weeks after Vax 1 Visit
Note: For Phase 1 100 ug subjects only | |
| BLDV4DT | Blood Sample Date 1 Week after Vax 2 | integer | DATE9 | Derived Blood draw date at 4 weeks after Vax 1 Visit
Note: For Phase 1 100 ug subjects only | |
| BLDV5DT | Blood Sample Date 2 Weeks after Vax 2 | integer | DATE9 | Derived Blood draw date at 5 weeks after Vax 1 Visit
Note: For Phase 1 100 ug subjects only | |
| BLDV6DT | Blood Sample Date 1 Month after Vax 2 | integer | DATE9 | Derived Blood draw date at 1 Month after Vax 2 Visit. (Note for Phase 2 serology: For subjects without this visit, if there is a convalescent 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.) | |
| BLDV7DT | Blood Sample Date 6 Months after Vax 2 | integer | DATE9 | Derived Blood draw date at 6 Months after Vax 2 Visit | |
| INCL1FL | Are eligible for the study at rand | text | 1 | NY
| 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 INCLerea and meets no exclusion INCLerea; |
| INCL2FL | Have received Vax 1 as randomized | text | 1 | NY
| Derived Receive at least one vaccine to which they are randomly assigned |
| INCL3FL | Have valid and DTM immuno result 1 | text | 1 | NY
| Derived Will apply to Phase 1 only. Have at least 1 valid and determinate immunogenicity result after Dose 1 but before Dose 2 |
| INCL4FL | Have valid and DTM immuno result 2 | text | 1 | NY
| Derived Will apply to Phase 1 only. Have at least 1 valid and determinate immunogenicity result 21 days after Dose 1. |
| INCL5FL | Have BD within the timeframe 1 | text | 1 | NY
| 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 | NY
| Derived Derive from SUPPDV.CAPE. 'Y' if the subjects with all records of SUPPDV.CAPE is "NO" or missing or CAPE indicates "POP2" only and this date of PD is earlier than VAX102DT+14 |
| INCL7FL | Received 2 doses as rand within window | text | 1 | NY
| 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 | NY
| Derived Have at least 1 valid and determinate immunogenicity result after Dose 2 |
| INCL9FL | Have BD within the timeframe 2 | text | 1 | NY
| 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 |
| EVALEFFL | Evaluable Efficacy Popu Flag | text | 1 | NY
| Derived If SAFFL="Y" and RFICDT>. and RANDFL="Y" and ARM ne "SCREEN FAILURE" and INCL1fl="Y" and INCL2fl="Y" and INCL7fl="Y" and VAX102DT>. and (index(SUPPDV.CAPE, "POP2")=0 for subjects's all DV records or any records with DV date 7 days after Dose 2 and index(SUPPDV.CAPE, "POP2")>0 ) then EVALEFFL="Y"; else EVALEFFL="N"; |
| EV14EFFL | Evaluable Efficacy Popu Flag - 14 days | text | 1 | Derived If SAFFL="Y" and RFICDT>. and RANDFL="Y" and ARM ne "SCREEN FAILURE" and INCL1fl="Y" and INCL2fl="Y" and INCL7fl="Y" and VAX102DT>. and (index(SUPPDV.CAPE, "POP2")=0 for subjects's all DV records or any records with DV date 14 days after Dose 2 and index(SUPPDV.CAPE, "POP2")>0 ) then EVALEFFL="Y"; else EVALEFFL="N" | |
| AAI1EFFL | Dose 1 all-available Efficacy Popu Flag | text | 1 | NY
| Derived If SAFFL="Y" and randfl="Y" and (vax101dt>. or vax102dt>.) then AAI1EFFL="Y"; else AAI1EFFL="N"; |
| AAI2EFFL | Dose 2 all-available Efficacy Popu Flag | text | 1 | NY
| Derived If SAFFL="Y" and randfl="Y" and vax101dt>. and vax102dt>. then AAI2EFFL="Y"; else AAI2EFFL="N"; |
| BLDV1FL | Blood Sample Drawn before Vax 1 | text | 1 | NY
| 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 | NY
| Derived Blood draw date at 1 Week after Vax 1 Visit
Note: For Phase 1 subjects only |
| BLDV3FL | Blood Sample Drawn before Vax 2 | text | 1 | NY
| Derived Blood draw date at Vax 2 Visit
Note: For Phase 1 subjects only |
| BLDV4FL | Blood Sample Drawn 1 Week after Vax 2 | text | 1 | NY
| Derived Blood draw date at 1 Week after Vax 2 Visit
Note: For Phase 1 subjects only |
| BLDV5FL | Blood Sample Drawn 2 Weeks after Vax 2 | text | 1 | NY
| Derived Blood draw date at 2 Weeks after Vax 2 Visit
Note: For Phase 1 subjects only |
| BLDV6FL | Blood Sample Drawn 1 Month after Vax 2 | text | 1 | NY
| Derived If non missing blood draw date at 1 Month after Vax 2 Visit then bldv6fl = 'Y''; else bldv6fl = 'N'. (Note for Phase 2 serology: For subjects without this visit, if there is a convalescent visit that happened within 28-42 days post dose 2, the convalescent visit will be used to replace this one, and bldv3fl will be set to "Y".) |
| BLDV7FL | Blood Sample Drawn 6 Months after Vax 2 | text | 1 | NY
| Derived If non missing blood draw date at 6 Months after Vax 2 Visit then bldv7fl = 'Y''; else bldv7fl = 'N'. |
| MULENRFL | Multiply Enrolled Subjects | text | 1 | Y
| Derived "Y" for subjects that were multiply enrolled subjests. |
| STEXCFL | Site/Subject Exclusion Flag for SQE | text | 1 | Y
| Derived “Y” if subjets has SQE defined in DV |
| UNKRDFL | Unknown Randomization Group Flag | text | 1 | Y
| Derived “Y" if ADSL.ARM is 'NOT ASSIGNED' and raddtc is not missing (This is derived for subject with incorrect rand number) |
| EXCL3FL | Exclusion Flag 3 | text | 1 | NY
| Derived Will apply to Phase 1 only. if (VAX101DT>. or vax102dt>.) and INCL3FL="N" then EXCL3FL="Y" |
| EXCRIT3 | Exclusion Criterion 3 | text | 98 | Derived 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" | |
| EXCL8FL | Exclusion Flag 8 | text | 1 | NY
| Derived if VAX102DT ne . and INCL8FL="N" then EXCL8FL="Y" |
| EXCRIT8 | Exclusion Criterion 8 | text | 80 | Derived Assign to "did not have at least 1 valid and determinate immunogenicity result after Dose 2" when EXCL8FL="Y" | |
| EXCL1FL | Exclusion Flag 1 | text | 1 | NY
| Derived if INCL1FL="N" then EXCL1FL="Y" |
| EXCRIT1 | Exclusion Criterion 1 | text | 43 | Derived Assign to "not eligible for the study at randomization" when EXCL1FL="Y" | |
| EXCL2FL | Exclusion Flag 2 | text | 1 | NY
| Derived if EXCL1FL ne "Y" and INCL2FL="N" then EXCL2FL="Y" |
| EXCRIT2 | Exclusion Criterion 2 | text | 36 | Derived Assign to "did not receive Dose 1 as randomized" when EXCL2FL="Y" | |
| EXCL4FL | Exclusion Flag 4 | text | 1 | NY
| Derived Will apply to Phase 1 only. if EXCL2FL ne "Y" and INCL4FL="N" then EXCL4FL="Y" |
| EXCRIT4 | Exclusion Criterion 4 | text | 88 | Derived 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 | NY
| Derived Will apply to Phase 1 only. if EXCL2FL ne "Y" and INCL5FL="N" then EXCL5FL="Y" |
| EXCRIT5 | Exclusion Criterion 5 | text | 60 | Derived Will apply to Phase 1 only. Assign to "did not have blood collection within 19-23 days after Dose 1" when EXCL5FL="Y" | |
| EXCL7FL | Exclusion Flag 7 | text | 1 | NY
| Derived if EXCL2FL ne "Y" and INCL7FL="N" then EXCL7FL="Y" |
| EXCRIT7 | Exclusion Criterion 7 | text | 129 | Derived 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" | |
| EXCL9FL | Exclusion Flag 9 | text | 1 | NY
| Derived if VAX102DT ne . and EXCL2FL ne "Y" and INCL9FL="N" then EXCL9FL="Y" |
| EXCRIT9 | Exclusion Criterion 9 | text | 60 | Derived 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" | |
| EXCL6FL | Exclusion Flag 6 | text | 1 | NY
| Derived if INCL6FL="N" then EXCL6FL="Y" |
| EXCRIT6 | Exclusion Criterion 6 | text | 145 | Derived 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), POP3=Immunogenicity. | |
| DS30KFL | Phase 3 30k Subjects Flag | text | 1 | NY
| Derived "Y" for non-phase 1 subjects that are randomized on or before 09Oct2020 and obtained IC on or after 27Jul2020. |
| NIGV1FL | N-binding Antibody Neg at Visit 1 Flag | text | 1 | NY
| Derived if isorres="NEG" and index(visit,"V1_DAY1_") and isdy<=1 then NIGV1FL="Y";
else if isorres="POS" and index(visit,"V1_DAY1_") and isdy<=1 then NIGV1FL="N"; |
| NAATNFL | NAAT Negative at Visit 1 Flag | text | 1 | NY
| Derived if index(visit,"V1_DAY1_") and mbtestcd='RTCOV2NS' and mborres="NEG" and mbdy<=1 then NAATNFL="Y";
else if index(visit,"V1_DAY1_") and mbtestcd='RTCOV2NS' and mborres="POS" and mbdy<=1 then NAATNFL="N"; |
| COVBLST | Baseline SARS-CoV-2 Status | text | 3 | Derived Subjects are considered with COVID-19 history if 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"; | |
| BMICAT | Baseline BMI Category | text | 13 | 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<25 then BMICAT="Normal weight";
else if 25<=vsstresn<30 then BMICAT="Overweight";
else if 30<=vsstresn then BMICAT="Obese";
if vsstresn=. then BMICAT="Missing"; | |
| BMICATN | Baseline BMI Category (N) | integer | 8 | Derived 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; | |
| FU2MPD2 | 2M Post Dose 2 Follow-up Time in Days | integer | 8 | Derived if randfl="Y" then do;
if vax102dt=. then FU2MPD2=0;
else if not missing(eosdcdt) then FU2MPD2=eosdcdt=vax102dt+1;
else FU2MPD2="&cutoff2"d-vax102dt+1;
end;
Note: cutoff2 date is 14Nov2020 | |
| F2MP2CAT | 2M Post Dose 2 Follow-up Time Category | text | 11 | Derived "0-2 weeks" for 0<=FU2MPD2/7<2;
"2-4 weeks" for 2<=FU2MPD2/7<4;
"4-6 weeks" for 4<=FU2MPD2/7<6;
"6-8 weeks" for 6<=FU2MPD2/7<8;
etc. | |
| F2MP2CAN | 2M Post Dose 2 Follow-up Time Cat (N) | integer | 8 | Derived 1 for 0<=FU2MPD2/7<2;
2 for 2<=FU2MPD2/7<4;
3 for 4<=FU2MPD2/7<6;
4 for 6<=FU2MPD2/7<8;
etc. | |
| COMBODFL | Flag for Comorbodities | text | 1 | NY
| Derived "Y" if subject with Medical History With Comorbodities. |
| PC1MD2FL | Positive SARS-CoV-2 Prior to 1M PD2 | text | 1 | Derived "Y" if subject with any positive NAAT result before 1 month post dose 2. | |
| HIVFL | HIV Positive Subjects Flag | text | 1 | Derived "Y" if subject with HIV positive. |
Go to the top of the Define-XML document
Covid-19 Efficacy Analysis Dataset (ADC19EF)
| Variable | Where Condition | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: ADSL.STUDYID | ||
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: ADSL.USUBJID | ||
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | ||
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | ||
| BRTHDT | Date of Birth | integer | DATE9 | Predecessor: ADSL.BRTHDT | ||
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | ||
| AGEGR1 | Pooled Age Group 1 | text | 11 | Predecessor: ADSL.AGEGR1 | ||
| SEX | Sex | text | 1 | SEX
| Predecessor: ADSL.SEX | |
| RACE | Race | text | 41 | RACE [7 Terms] | Predecessor: ADSL.RACE | |
| ETHNIC | Ethnicity | text | 22 | ETHNIC
| Predecessor: ADSL.ETHNIC | |
| ARMCD | Planned Arm Code | text | 9 | Predecessor: ADSL.ARMCD | ||
| ARM | Description of Planned Arm | text | 27 | Predecessor: ADSL.ARM | ||
| ACTARMCD | Actual Arm Code | text | 9 | Predecessor: ADSL.ACTARMCD | ||
| ACTARM | Description of Actual Arm | text | 27 | Predecessor: ADSL.ACTARM | ||
| PARAMN | Parameter (N) | integer | 8 | ADC19EF.PARAMN [35 Terms] | Assigned Numeric code for PARAM Please refer to codelist ADC19EF.PARAMN. | |
| PARAMCD | Parameter Code | text | 8 | ADC19EF.PARAMCD [35 Terms] | Assigned Character code for PARAM Please refer to codelist ADC19EF.PARAMCD. | |
| PARAM | Parameter | text | 94 | ADC19EF.PARAM [35 Terms] | Assigned Please refer to codelist ADC19EF.PARAM. | |
| PARCAT1 | Parameter Category 1 | text | 31 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN") then Set to ADSYMPT.PARCAT1.
if paramcd in ("PRSVCSAD") then Set to "SURVEILLANCE TIME".
if paramcd in ("NAATRAD") then Set to "CENTRAL/LOCAL NAAT RESULTS".
if paramcd in ("C19ONST" "CDCONST" "SEVCONST") then Set to "ILLNESS ONSET".
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Set to "SURVEILLANCE TIME". | ||
| AVALVLM | Analysis Value | integer | 8 | |||
| PARAMCD = "ST1PD" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST17PD" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST1CD" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SYMPTOMS | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST17CD" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SYMPTOMS | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST1SE" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR SEVERE COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR SEVERE COVID19 SYMPTOMS | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST17SE" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR SEVERE COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR SEVERE COVID19 SYMPTOMS | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST1PDA" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST17PDA" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST2PD" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST27PD" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST214PD" (SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST2CD" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SYMPTOMS | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST27CD" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SYMPTOMS | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST214CD" (SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SYMPTOMS | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST2SE" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR SEVERE COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR SEVERE COVID19 SYMPTOMS | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST27SE" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR SEVERE COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR SEVERE COVID19 SYMPTOMS | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST214SE" (SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR SEVERE COVID19 SYMPTOMS) | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR SEVERE COVID19 SYMPTOMS | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST2PDA" (SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST27PDA" (SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| PARAMCD = "ST214PDA" (SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE) | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE | integer | 3 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. | ||
| AVALCVLM | Analysis Value (C) | text | 3 | |||
| PARAMCD = "RTCOV2NS" (CEPHEID RT-PCR ASSAY FOR SARS-COV-2) | CEPHEID RT-PCR ASSAY FOR SARS-COV-2 | text | 3 | Predecessor: ADSYMPT.AVALC | ||
| PARAMCD = "SARSCOV2" (SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2) | SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 | text | 3 | Predecessor: ADSYMPT.AVALC | ||
| PARAMCD = "PRPDSAD" (PRESENCE OF PROTOCOL DEFINED SYMPTOMS AFTER DOSE) | PRESENCE OF PROTOCOL DEFINED SYMPTOMS AFTER DOSE | text | 1 | Derived if paramcd = "SARSCOV2" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG".
if paramcd = "HCUICU" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "PRPDSAD" then Create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within a ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e. ADSYMPT.AVALC = "Y") , set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null. if paramcd = "SEVCVS" then Set to null.
if paramcd = "SEVCVS" then Create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following: 1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then Create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then Create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSVCSAD" then Create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCRHN", "HCUICU" or Death set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "NAATRAD" then Create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid, when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then Create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then Create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then Create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Set to null. | ||
| PARAMCD = "PRCDCSAD" (PRESENCE OF CDC DEFINED SYMPTOMS AFTER DOSE) | PRESENCE OF CDC DEFINED SYMPTOMS AFTER DOSE | text | 1 | Derived if paramcd = "SARSCOV2" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG".
if paramcd = "HCUICU" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "PRPDSAD" then Create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within a ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e. ADSYMPT.AVALC = "Y") , set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null. if paramcd = "SEVCVS" then Set to null.
if paramcd = "SEVCVS" then Create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following: 1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then Create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then Create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSVCSAD" then Create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCRHN", "HCUICU" or Death set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "NAATRAD" then Create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid, when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then Create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then Create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then Create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Set to null. | ||
| PARAMCD = "NAATRAD" (COVID-19 NAAT RESULT AFTER DOSE) | COVID-19 NAAT RESULT AFTER DOSE | text | 3 | Derived if paramcd = "SARSCOV2" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG".
if paramcd = "HCUICU" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "PRPDSAD" then Create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within a ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e. ADSYMPT.AVALC = "Y") , set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null. if paramcd = "SEVCVS" then Set to null.
if paramcd = "SEVCVS" then Create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following: 1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then Create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then Create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSVCSAD" then Create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCRHN", "HCUICU" or Death set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "NAATRAD" then Create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid, when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then Create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then Create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then Create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Set to null. | ||
| PARAMCD = "C19ONST" (PROTOCOL DEFINED COVID-19 ILLNESS ONSET) | PROTOCOL DEFINED COVID-19 ILLNESS ONSET | text | 3 | Derived if paramcd = "SARSCOV2" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG".
if paramcd = "HCUICU" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "PRPDSAD" then Create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within a ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e. ADSYMPT.AVALC = "Y") , set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null. if paramcd = "SEVCVS" then Set to null.
if paramcd = "SEVCVS" then Create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following: 1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then Create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then Create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSVCSAD" then Create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCRHN", "HCUICU" or Death set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "NAATRAD" then Create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid, when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then Create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then Create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then Create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Set to null. | ||
| PARAMCD = "CDCONST" (CDC DEFINED COVID-19 ILLNESS ONSET) | CDC DEFINED COVID-19 ILLNESS ONSET | text | 3 | Derived if paramcd = "SARSCOV2" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG".
if paramcd = "HCUICU" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "PRPDSAD" then Create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within a ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e. ADSYMPT.AVALC = "Y") , set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null. if paramcd = "SEVCVS" then Set to null.
if paramcd = "SEVCVS" then Create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following: 1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then Create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then Create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSVCSAD" then Create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCRHN", "HCUICU" or Death set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "NAATRAD" then Create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid, when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then Create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then Create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then Create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Set to null. | ||
| PARAMCD = "C19NIG" (N-BINDING ANTIBODY) | N-BINDING ANTIBODY | text | 3 | Predecessor: ADSYMPT.AVALC | ||
| PARAMCD = "SEVCVS" (SEVERE COVID-19 SYMPTOMS - VITAL SIGNS) | SEVERE COVID-19 SYMPTOMS - VITAL SIGNS | text | 1 | Derived if paramcd = "SARSCOV2" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG".
if paramcd = "HCUICU" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "PRPDSAD" then Create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within a ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e. ADSYMPT.AVALC = "Y") , set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null. if paramcd = "SEVCVS" then Set to null.
if paramcd = "SEVCVS" then Create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following: 1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then Create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then Create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSVCSAD" then Create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCRHN", "HCUICU" or Death set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "NAATRAD" then Create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid, when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then Create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then Create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then Create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Set to null. | ||
| PARAMCD = "PRSVCSAD" (PRESENCE OF PROTOCOL DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE) | PRESENCE OF PROTOCOL DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE | text | 1 | Derived if paramcd = "SARSCOV2" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG".
if paramcd = "HCUICU" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "PRPDSAD" then Create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within a ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e. ADSYMPT.AVALC = "Y") , set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null. if paramcd = "SEVCVS" then Set to null.
if paramcd = "SEVCVS" then Create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following: 1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then Create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then Create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSVCSAD" then Create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCRHN", "HCUICU" or Death set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "NAATRAD" then Create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid, when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then Create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then Create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then Create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Set to null. | ||
| PARAMCD = "SEVCONST" (SEVERE COVID-19 ILLNESS ONSET) | SEVERE COVID-19 ILLNESS ONSET | text | 3 | Derived if paramcd = "SARSCOV2" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG".
if paramcd = "HCUICU" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "PRPDSAD" then Create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within a ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e. ADSYMPT.AVALC = "Y") , set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null. if paramcd = "SEVCVS" then Set to null.
if paramcd = "SEVCVS" then Create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following: 1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then Create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then Create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSVCSAD" then Create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCRHN", "HCUICU" or Death set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "NAATRAD" then Create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid, when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then Create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then Create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then Create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Set to null. | ||
| PARAMCD = "SEVCRF" (SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE) | SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE | text | 1 | Derived if paramcd = "SARSCOV2" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG".
if paramcd = "HCUICU" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "PRPDSAD" then Create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within a ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e. ADSYMPT.AVALC = "Y") , set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null. if paramcd = "SEVCVS" then Set to null.
if paramcd = "SEVCVS" then Create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following: 1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then Create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then Create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSVCSAD" then Create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCRHN", "HCUICU" or Death set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "NAATRAD" then Create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid, when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then Create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then Create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then Create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Set to null. | ||
| PARAMCD = "SEVCRHN" (SEVERE COVID-19 SYMPTOMS - SIGNIFICANT ACUTE RENAL, HEPATIC, OR NEUROLOGIC DYSFUNCTION) | SEVERE COVID-19 SYMPTOMS - SIGNIFICANT ACUTE RENAL, HEPATIC, OR NEUROLOGIC DYSFUNCTION | text | 1 | Derived if paramcd = "SARSCOV2" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG".
if paramcd = "HCUICU" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "PRPDSAD" then Create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within a ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e. ADSYMPT.AVALC = "Y") , set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null. if paramcd = "SEVCVS" then Set to null.
if paramcd = "SEVCVS" then Create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following: 1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then Create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then Create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSVCSAD" then Create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCRHN", "HCUICU" or Death set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "NAATRAD" then Create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid, when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then Create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then Create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then Create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Set to null. | ||
| PARAMCD = "HCUICU" (SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS) | SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS | text | 1 | Predecessor: ADSYMPT.AVALC | ||
| PARAMCD = "SEVCVSPR" (SEVERE COVID-19 SYMPTOMS - USE OF VASOPRESSORS) | SEVERE COVID-19 SYMPTOMS - USE OF VASOPRESSORS | text | 1 | Derived if paramcd = "SARSCOV2" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG".
if paramcd = "HCUICU" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "PRPDSAD" then Create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within a ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e. ADSYMPT.AVALC = "Y") , set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null. if paramcd = "SEVCVS" then Set to null.
if paramcd = "SEVCVS" then Create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following: 1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then Create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then Create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSVCSAD" then Create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCRHN", "HCUICU" or Death set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "NAATRAD" then Create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid, when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then Create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then Create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then Create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Set to null. | ||
| VISITNUM | Visit Number | integer | 8 | ADC19EF.VISITNUM [8 Terms] | Predecessor: ADSYMPT.VISITNUM | |
| VISIT | Visit Name | text | 14 | ADC19EF.VISIT [8 Terms] | Predecessor: ADSYMPT.VISIT | |
| AVISITN | Analysis Visit (N) | integer | 8 | ADC19EF.AVISITN [6 Terms] | Predecessor: ADSYMPT.AVISITN | |
| AVISIT | Analysis Visit | text | 14 | ADC19EF.AVISIT [6 Terms] | Predecessor: ADSYMPT.AVISIT | |
| ADT | Analysis Date | integer | DATE9 | Derived if paramcd = "SARSCOV2" then Set to ADSYMPT.ADT.
if paramcd = "RTCOV2NS" then Set to ADSYMPT.ADT.
if paramcd = "C19NIG" then Set to ADSYMPT.ADT.
if paramcd = "HCUICU" then Set to null.
if paramcd = "PRPDSAD" then Set to null.
if paramcd = "PRCDCSAD" then Set to null.
if paramcd = "SEVCVS" then Set to the earliest date from ADSYMPT.ADT when condition/s are present.
if paramcd = "SEVCRF" then Set to null.
if paramcd = "SEVCRHN" then Set to null.
if paramcd = "PRSVCSAD" then Set to null.
if paramcd = "NAATRAD" then "Set from ADSYMPT.ADT of concluded NAAT result based on specifications in AVAC of this record.
If both local and central results are missing/invalid, set this to null."
if paramcd = "C19ONST" then Set to ASTDT where PARAMCD = "PRPDSAD"
if paramcd = "CDCONST" then Set to ASTDT where PARAMCD = "PRCDCSAD"
if paramcd = "SEVCONST" then Set to ASTDT where PARAMCD = "PRSVCSAD"
if paramcd = "ST1PD" then Set to null.
if paramcd = "ST17PD" then Set to null.
if paramcd = "ST2PD" then Set to null.
if paramcd = "ST27PD" then Set to null.
if paramcd = "ST214PD" then Set to null.
if paramcd = "ST1CD" then Set to null.
if paramcd = "ST17CD" then Set to null.
if paramcd = "ST2CD" then Set to null.
if paramcd = "ST27CD" then Set to null.
if paramcd = "ST214CD" then Set to null.
if paramcd = "ST1SE" then Set to null.
if paramcd = "ST17SE" then Set to null.
if paramcd = "ST2SE" then Set to null.
if paramcd = "ST27SE" then Set to null.
if paramcd = "ST214SE" then Set to null.
if paramcd = "ST1PDA" then Set to null.
if paramcd = "ST17PDA" then Set to null.
if paramcd = "ST2PDA" then Set to null.
if paramcd = "ST27PDA" then Set to null.
if paramcd = "ST214PDA" then Set to null. | ||
| ADY | Analysis Relative Day | integer | 8 | Derived Set as following:
ADY = ADT - TRTSDT.
If ADT >= TRTSDT, ADY = ADT - TRTSDT + 1. | ||
| ASTDT | Analysis Start Date | integer | DATE9 | Derived if paramcd = "SARSCOV2" then Set to null.
if paramcd = "RTCOV2NS" then Set to null.
if paramcd = "C19NIG" then Set to null.
if paramcd = "HCUICU" then Set to ADSYMPT.ASTDT.
if paramcd = "PRPDSAD" then Set to the earliest date from ADSYMPT.ASTDT when condition/s are present.
if paramcd = "PRCDCSAD" then Set to the earliest date from ADSYMPT.ASTDT when condition/s are present.
if paramcd = "SEVCVS" then Set to null.
if paramcd = "SEVCRF" then Set to the earliest date from ADSYMPT.ASTDT when condition/s are present.
if paramcd = "SEVCRHN" then Set to the earliest date from ADSYMPT.ASTDT when condition/s are present.
if paramcd = "PRSVCSAD" then Set to the earliest date from ADT/ASTDT when condition/s are present.
if paramcd = "NAATRAD" then Set to null.
if paramcd = "C19ONST" then Set to null.
if paramcd = "CDCONST" then Set to null.
if paramcd = "SEVCONST" then Set to null.
if paramcd = "ST1PD" then Set to Dose 1 date.
if paramcd = "ST17PD" then Set as Dose 1 + 7 when Dose 1 date is not missing.
if paramcd = "ST2PD" then Set to Dose 2 date.
if paramcd = "ST27PD" then Set as Dose 2 + 7 when Dose 2 date is not missing.
if paramcd = "ST214PD" then Set as Dose 2 + 14 when Dose 2 date is not missing.
if paramcd = "ST1CD" then Set to Dose 1 date.
if paramcd = "ST17CD" then Set as Dose 1 + 7 when Dose 1 date is not missing.
if paramcd = "ST2CD" then Set to Dose 2 date.
if paramcd = "ST27CD" then Set as Dose 2 + 7 when Dose 2 date is not missing.
if paramcd = "ST214CD" then Set as Dose 2 + 14 when Dose 2 date is not missing.
if paramcd = "ST1SE" then Set to Dose 1 date.
if paramcd = "ST17SE" then Set as Dose 1 + 7 when Dose 1 date is not missing.
if paramcd = "ST2SE" then Set to Dose 2 date.
if paramcd = "ST27SE" then Set as Dose 2 + 7 when Dose 2 date is not missing.
if paramcd = "ST214SE" then Set as Dose 2 + 14 when Dose 2 date is not missing.
if paramcd = "ST1PDA" then Set to Dose 1 date.
if paramcd = "ST17PDA" then Set as Dose 1 + 7 when Dose 1 date is not missing.
if paramcd = "ST2PDA" then Set to Dose 2 date.
if paramcd = "ST27PDA" then Set as Dose 2 + 7 when Dose 2 date is not missing.
if paramcd = "ST214PDA" then Set as Dose 2 + 14 when Dose 2 date is not missing. | ||
| ASTDY | Analysis Start Relative Day | integer | 8 | Derived Set as following:
ASTDY = ASTDT - TRTSDT.
If ASTDT >= TRTSDT, ASTDY = ASTDT - TRTSDT + 1. | ||
| AENDT | Analysis End Date | integer | DATE9 | Derived if paramcd = "SARSCOV2" then Set to null.
if paramcd = "RTCOV2NS" then Set to null.
if paramcd = "C19NIG" then Set to null.
if paramcd = "HCUICU" then Set to ADSYMPT.AENDT.
if paramcd = "PRPDSAD" then Set to the latest date from ADSYMPT.AENDT when condition/s are present.
if paramcd = "PRCDCSAD" then Set to the latest date from ADSYMPT.AENDT when condition/s are present.
if paramcd = "SEVCVS" then Set to null.
if paramcd = "SEVCRF" then Set to the latest date from ADSYMPT.AENDT when condition/s are present and end dates of all contributing records are reported.
if paramcd = "SEVCRHN" then Set to the latest date from ADSYMPT.AENDT when condition/s are present and end dates of all contributing records are reported.
if paramcd = "PRSVCSAD" then Set to the latest date from AENDT when condition/s are present and contributing end dates except from vital signs are present/populated.
if paramcd = "NAATRAD" then Set to null.
if paramcd = "C19ONST" then Set to null.
if paramcd = "CDCONST" then Set to null.
if paramcd = "SEVCONST" then Set to null.
if paramcd = "ST1PD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST17PD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST2PD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST27PD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST214PD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST1CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "CDCONST".
if paramcd = "ST17CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "CDCONST".
if paramcd = "ST2CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "CDCONST".
if paramcd = "ST27CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "CDCONST".
if paramcd = "ST214CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "CDCONST".
if paramcd = "ST1SE" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "SEVCONST".
if paramcd = "ST17SE" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "SEVCONST".
if paramcd = "ST2SE" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "SEVCONST".
if paramcd = "ST27SE" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "SEVCONST".
if paramcd = "ST214SE" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "SEVCONST".
if paramcd = "ST1PDA" then Set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST17PDA" then Set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST2PDA" then Set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST27PDA" then Set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST214PDA" then Set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST". | ||
| AENDY | Analysis End Relative Day | integer | 8 | Derived Set as following:
AENDY = AENDT - TRTSDT.
If AENDT >= TRTSDT, AENDY = AENDT - TRTSDT + 1. | ||
| DCODT | Data Cutoff Date | integer | DATE9 | Assigned Set to data snapshot date (04Nov2020) | ||
| RANDDT | Date of Randomization | integer | DATE9 | Predecessor: ADSL.RANDDT | ||
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | ||
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | ||
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Predecessor: ADSL.VAX101DT | ||
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Predecessor: ADSL.VAX102DT | ||
| DVSTDT | Start Date of Important PD | integer | DATE9 | Predecessor: ADSL.DVSTDT | ||
| DTHDT | Date of Death | integer | DATE9 | Predecessor: ADSL.DTHDT | ||
| EOTDCDT | End Of Treatment Discontinuation Date | integer | DATE9 | Predecessor: ADSL.EOTDCDT | ||
| EOSDCDT | End Of Study Discontinuation Date | integer | DATE9 | Predecessor: ADSL.EOSDCDT | ||
| RANDFL | Randomized Population Flag | text | 1 | NY
| Predecessor: ADSL.RANDFL | |
| EVALEFFL | Evaluable Efficacy Popu Flag | text | 1 | NY
| Predecessor: ADSL.EVALEFFL | |
| EV14EFFL | Evaluable Efficacy Popu Flag - 14 days | text | 1 | Predecessor: ADSL.EV14EFFL | ||
| AAI1EFFL | Dose 1 all-available Efficacy Popu Flag | text | 1 | NY
| Predecessor: ADSL.AAI1EFFL | |
| AAI2EFFL | Dose 2 all-available Efficacy Popu Flag | text | 1 | NY
| Predecessor: ADSL.AAI2EFFL | |
| DTHFL | Subject Death Flag | text | 1 | Y
| Predecessor: ADSL.DTHFL | |
| C19ILHFL | Prior Covid-19 Illness History Flag | text | 1 | Y
| Predecessor: ADSYMPT.C19ILHFL | |
| CNCRSLFL | Consider Result for Analysis Flag | text | 1 | Y
| Derived Set for records where PARAMCD is "SARSCOV2" or "RTCOV2NS" or "C19NIG" as following:
If only one result is present per PARAMCD within a given visit set to "Y'.
For unplanned results, set "Y" if result date is up to 4 days before, on/after the symptom start date and symptom end date is missing. If the symptom end date is present, the result date must be within 4 days after the end date.
If multiple unplanned results qualify above condition, set to "Y" based on the result as POS > IND > NEG > UNK/missing. | |
| VRBLNGFL | NVA Baseline Result Negative Flag | text | 1 | NY
| Derived Set for all records of a subject based on following:
If NVA result date is on or before Dose 1 date and AVAC = "NEG" when PARAMCD = "C19NIG", set to "Y".
If NVA result date is on or before Dose 1 date and AVAC = "POS" when PARAMCD = "C19NIG", set to "N".
Otherwise, set to null. | |
| CRD1NGFL | NAAT Result At Dose 1 Negative Flag | text | 1 | NY
| Derived Set for all records of a subject based on following:
If NAAT result date is on or before Dose 1 date and AVAC = "NEG" when PARAMCD = "RTCOV2NS", set to "Y".
If NAAT result date is on or before Dose 1 date and AVAC = "POS" when PARAMCD = "RTCOV2NS", set to "N".
Otherwise, set to null. | |
| CRD2NGFL | NAAT Result At Dose 2 Negative Flag | text | 1 | NY
| Derived Set for all records of a subject based on following:
If NAAT result date is on or before Dose 2 date and AVAC = "NEG" when PARAMCD = "RTCOV2NS", set to "Y".
If NAAT result date is on or before Dose 2 date and AVAC = "POS" when PARAMCD = "RTCOV2NS", set to "N".
Otherwise, set to null. | |
| PDSYMFL | Protocol Defined SYMP Present Flag | text | 1 | NY
| Derived Set for all records of a subject as following:
If a subject has any record with AVALC = "Y" when PARAMCD = "PRPDSAD", set to "Y".
Otherwise set to "N". | |
| PDSDMFL | Protocol Defined SYMP Date Missing Flag | text | 1 | NY
| Derived Set for all records of a subject as following:
If PDSYMFL = "Y" and symptom start date is missing, set to "Y".
Otherwise set to "N". | |
| CDCSYMFL | CDC Defined SYMP Present Flag | text | 1 | NY
| Derived Set for all records of a subject as following:
If a subject has any record with AVALC = "Y" when PARAMCD = "PRCDCSAD", set to "Y".
Otherwise set to "N". | |
| SEVSYMFL | Severe Covid SYMP Present Flag | text | 1 | NY
| Derived Set for all records of a subject as following:
If a subject has any record with AVALC = "Y" when PARAMCD = "SEVCVS", set to "Y".
Otherwise set to "N". | |
| ILD1FL | Illness Occur After Dose 1 Flag | text | 1 | NY
| Derived Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" and AVALC is "POS" as following:
If illness onset date is greater then Dose 1 date, set to "Y". Otherwise set to "N". | |
| ILD17FL | Illness Occur 7 Days After Dose 1 Flag | text | 1 | NY
| Derived Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" and AVALC is "POS" as following:
If illness onset date is greater then 7 days post Dose 1 date, set to "Y". Otherwise set to "N". | |
| ILD2FL | Illness Occur After Dose 2 Flag | text | 1 | NY
| Derived Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" and AVALC is "POS" as following:
If illness onset date is greater then Dose 2 date, set to "Y". Otherwise set to "N". | |
| ILD27FL | Illness Occur 7 Days After Dose 2 Flag | text | 1 | NY
| Derived Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" and AVALC is "POS" as following:
If illness onset date is greater then 7 days post Dose 2 date, set to "Y". Otherwise set to "N". | |
| ILD214FL | Illness Occur 14 Days After Dose 2 Flag | text | 1 | NY
| Derived Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" and AVALC is "POS" as following:
If illness onset date is greater then 14 days post Dose 2 date, set to "Y". Otherwise set to "N". | |
| FILOCRFL | First Illness Occurrence Flag | text | 1 | Y
| Derived Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" as following:
if AVALC = "POS" and is the first onset of illness after dose, set to "Y". | |
| PDRMUFL | PD SYMP Result Missing or Unknown Flag | text | 1 | NY
| Derived Set to "Y" for all records of a subject, if protocol defined symptom/s are present and test result from local and/or central lab concluded as indeterminate, missing or unknown and symptom/s start date is before a first positive(PARAMCD is "C19ONST") case.
Otherwise set to "N" for all records of a subject. Also set as "N" for subjects who did not report any protocol defined symptoms.
Note: If a subject has reported these symptom/s more than once at different visits, set to "Y" if all of the test results are concluded as indeterminate, missing or unknown. | |
| CDCRMUFL | CDC SYMP Result Missing or Unknown Flag | text | 1 | NY
| Derived Set to "Y" for all records of a subject, if CDC defined symptom/s are present and test result from local and/or central lab concluded as indeterminate, missing or unknown and symptom/s start date is before a first positive(PARAMCD is "CDCONST") case.
Otherwise set to "N" for all records of a subject. Also set to "N" for subjects who did not report any CDC defined symptoms.
Note: If a subject has reported these symptom/s more than once at different visits, set to "Y" if all of the test results are concluded as indeterminate, missing or unknown. | |
| PDP1FL | VE Prot Def Pop Incl Post D1 Flag | text | 1 | NY
| Derived Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date.
2. Otherwise set to "N".
If subject reports protocol define symptoms and/or has , the following condition/s may overwrite the previous value.
3. If there is an unscheduled NAAT test on or before Dose 1 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptoms and start date of symptom is missing, on or after Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. | |
| PDP17FL | VE Prot Def Pop Incl 7D Post D1 Flag | text | 1 | NY
| Derived Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date.
2. Otherwise set to "N".
If subject reports protocol define symptoms, the following condition/s may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 1 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptom and start date of symptom is missing, on or after Dose 1 and within 7 days post Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. | |
| PDP27FL | VE Prot Def Pop Incl 7D Post D2 Flag | text | 1 | NY
| Derived Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates.
2. Otherwise set to "N".
If subject reports protocol define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 2 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptom and start date of symptom is missing, on or after Dose 1 and within 7 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. | |
| PDP214FL | VE Prot Def Pop Incl 14D Post D2 Flag | text | 1 | NY
| Derived Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates.
2. Otherwise set to "N".
If subject reports protocol define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 14 days after Dose 2 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptom and start date of symptom is missing, on or after Dose 1 and within 14 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. | |
| CDP1FL | VE CDC Def Pop Incl Post Dose 1 Flag | text | 1 | NY
| Derived Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date.
2. Otherwise set to "N".
If subject reports CDC define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. | |
| CDP17FL | VE CDC Def Pop Incl 7D Post Dose 1 Flag | text | 1 | NY
| Derived Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date.
2. Otherwise set to "N".
If subject reports CDC define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 1 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and within 7 days post Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. | |
| CDP27FL | VE CDC Def Pop Incl 7D Post Dose 2 Flag | text | 1 | NY
| Derived Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates.
2. Otherwise set to "N".
If subject reports CDC define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 2 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and within 7 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. | |
| CDP214FL | VE CDC Def Pop Incl 14D Post Dose 2 Flag | text | 1 | NY
| Derived Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates.
2. Otherwise set to "N".
If subject reports CDC define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 14 days after Dose 2 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and within 14 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. | |
| NMPDOCFL | No Major Protocol Deviation Occur Flag | text | 1 | Y
| Derived Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" as following:
if DVSTDT is null, set to "Y".
Also set to "Y" if DVSTDT occurs after the ADT of PARAMCDs specified above. |
Go to the top of the Define-XML document
Diary and Non-event Analysis Dataset (ADFACEVD)
| Variable | Where Condition | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: FACE.STUDYID or VS.STUDYID | ||
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: FACE.USUBJID or VS.USUBJID | ||
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | ||
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | ||
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | ||
| AGEU | Age Units | text | 5 | AGEU
| Predecessor: ADSL.AGEU | |
| SEX | Sex | text | 1 | SEX
| Predecessor: ADSL.SEX | |
| SEXN | Sex (N) | integer | 8 | Predecessor: ADSL.SEXN | ||
| RACE | Race | text | 41 | RACE [7 Terms] | Predecessor: ADSL.RACE | |
| RACEN | Race (N) | integer | 8 | Predecessor: ADSL.RACEN | ||
| ARACE | Analysis Race | text | 41 | ARACE [7 Terms] | Predecessor: ADSL.ARACE | |
| ARACEN | Analysis Race (N) | integer | 8 | Predecessor: ADSL.ARACEN | ||
| ETHNIC | Ethnicity | text | 22 | ETHNIC
| Predecessor: ADSL.ETHNIC | |
| ETHNICN | Ethnicity (N) | integer | 8 | Predecessor: ADSL.ETHNICN | ||
| COUNTRY | Country | text | 3 | Predecessor: ADSL.COUNTRY | ||
| SAFFL | Safety Population Flag | text | 1 | NY
| Predecessor: ADSL.SAFFL | |
| ARM | Description of Planned Arm | text | 27 | Predecessor: ADSL.ARM | ||
| ARMCD | Planned Arm Code | text | 9 | Predecessor: ADSL.ARMCD | ||
| ACTARM | Description of Actual Arm | text | 27 | Predecessor: ADSL.ACTARM | ||
| ACTARMCD | Actual Arm Code | text | 9 | 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 | 27 | Predecessor: ADSL.TRT01A | ||
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | ||
| TRT01P | Planned Treatment for Period 01 | text | 27 | Predecessor: ADSL.TRT01P | ||
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | ||
| 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 | ||
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Predecessor: ADSL.VAX101DT | ||
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Predecessor: ADSL.VAX102DT | ||
| VAX103DT | Vaccination Date 03 | integer | DATE9 | Predecessor: ADSL.VAX103DT | ||
| COHORT | Cohort Group | text | 75 | Predecessor: ADSL.COHORT | ||
| COHORTN | Cohort Group (N) | float | 8 | Predecessor: ADSL.COHORTN | ||
| DOSPLVL | Planned Dosing Level | text | 52 | Predecessor: ADSL.DOSPLVL | ||
| DOSPLVLN | Planned Dosing Level (N) | integer | 8 | Predecessor: ADSL.DOSPLVLN | ||
| DOSALVL | Actual Dosing Level | text | 52 | Predecessor: ADSL.DOSALVL | ||
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Predecessor: ADSL.DOSALVLN | ||
| PHASE | Study Phase | text | 20 | Predecessor: ADSL.PHASE | ||
| PHASEN | Study Phase (N) | integer | 8 | Predecessor: ADSL.PHASEN | ||
| AGEGR1 | Pooled Age Group 1 | text | 11 | Predecessor: ADSL.AGEGR1 | ||
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | ||
| AGEGR2 | Pooled Age Group 2 | text | 10 | Predecessor: ADSL.AGEGR2 | ||
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | ||
| RACEGR1 | Pooled Race Group 1 | text | 25 | Predecessor: ADSL.RACEGR1 | ||
| RACEGR1N | Pooled Race Group 1 (N) | integer | 8 | Predecessor: ADSL.RACEGR1N | ||
| VAX101 | Vaccination 01 | text | 37 | Predecessor: ADSL.VAX101 | ||
| VAX102 | Vaccination 02 | text | 36 | Predecessor: ADSL.VAX102 | ||
| VAX103 | Vaccination 03 | text | 36 | Predecessor: ADSL.VAX103 | ||
| DS30KFL | Phase 3 30k Subjects Flag | text | 1 | NY
| Predecessor: ADSL.DS30KFL | |
| COVBLST | Baseline SARS-CoV-2 Status | text | 3 | Predecessor: ADSL.COVBLST | ||
| MULENRFL | Multiply Enrolled Subjects | text | 1 | Predecessor: ADSL.MULENRFL | ||
| STEXCFL | Site/Subject Exclusion Flag for SQE | text | 1 | Predecessor: ADSL.STEXCFL | ||
| HIVFL | HIV Positive Subjects Flag | text | 1 | Predecessor: ADSL.HIVFL | ||
| SRCDOM | Source Data | text | 2 | Predecessor: FACE.DOMAIN or VS.DOMAIN | ||
| SRCSEQ | Source Sequence Number | integer | 8 | Derived 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. Use sentence case for param values. | |
| PARAMCD | Parameter Code | text | 8 | ADFACEVD.PARAMCD [53 Terms] | Assigned Character code for PARAM Please refer to codelist ADFACEVD.PARAMCD. | |
| PARAMN | Parameter (N) | integer | 8 | ADFACEVD.PARAMN [53 Terms] | Assigned Numeric code for PARAM Please refer to codelist ADFACEVD.PARAMN. | |
| FAOBJ | Object of the Observation | text | 36 | Derived FACE.FAOBJ or set to ‘FEVER’ for fever related parameters | ||
| PARCAT1 | Parameter Category 1 | text | 14 | Derived Set to 'REACTOGENICITY' if index(FACAT, 'REACTOGENICITY') or index(VSCAT, 'REACTOGENICITY'). | ||
| PARCAT2 | Parameter Category 2 | text | 19 | Predecessor: FACE.FASCAT or VS.VSSCAT | ||
| AVALCVLM | Analysis Value (C) | text | 10 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "MSPIS" (Pain at injection site maximum severity) | Pain at injection site maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCPIS" (Pain at injection site occurrence indicator) | Pain at injection site occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "SEVPIS" (Pain at injection site severity/intensity) | Pain at injection site severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCISR" (Redness occurrence indicator) | Redness occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCINS" (Swelling occurrence indicator) | Swelling occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "MEDTFVPN" (Medications medication to treat fever or pain) | Medications medication to treat fever or pain | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCCHILLS" (Chills occurrence indicator) | Chills occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCDIAR" (Diarrhea occurrence indicator) | Diarrhea occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "MAXSFAT" (Fatigue maximum severity) | Fatigue maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCFATIG" (Fatigue occurrence indicator) | Fatigue occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "SEVFATI" (Fatigue severity/intensity) | Fatigue severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCFEVER" (Fever occurrence indicator) | Fever occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "MAXSHEA" (Headache maximum severity) | Headache maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCHEAD" (Headache occurrence indicator) | Headache occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "SEVHEAD" (Headache severity/intensity) | Headache severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "MAXSJP" (Joint pain maximum severity) | Joint pain maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCJOPAIN" (Joint pain occurrence indicator) | Joint pain occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "SEVJOIN" (Joint pain severity/intensity) | Joint pain severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCMPNIS" (Muscle pain occurrence indicator) | Muscle pain occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCVOMI" (Vomiting occurrence indicator) | Vomiting occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "DIARE" (Redness diameter cm) | Redness diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "MSERE" (Redness maximum severity) | Redness maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "SEVREDN" (Redness severity/intensity) | Redness severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "MAXDIAR" (Diarrhea maximum severity) | Diarrhea maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "SEVDIAR" (Diarrhea severity/intensity) | Diarrhea severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "MAXCHIL" (Chills maximum severity) | Chills maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "SEVCHIL" (Chills severity/intensity) | Chills severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCHOFA" (Hospitalized for tiredness (fatigue) occurrence indicator) | Hospitalized for tiredness (fatigue) occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "MAXSMP" (Muscle pain maximum severity) | Muscle pain maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "SEVMUSP" (Muscle pain severity/intensity) | Muscle pain severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "DIASW" (Swelling diameter cm) | Swelling diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "MSESW" (Swelling maximum severity) | Swelling maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "SEVSWEL" (Swelling severity/intensity) | Swelling severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCHIS" (Hospitalized for injection site pain occurrence indicator) | Hospitalized for injection site pain occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCHOHE" (Hospitalized for headache occurrence indicator) | Hospitalized for headache occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCHOMP" (Hospitalized for muscle pain occurrence indicator) | Hospitalized for muscle pain occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "STPDMEDP" (Medications stop date meds given to trt/pnt symptoms) | Medications stop date meds given to trt/pnt symptoms | date | ISO 8601 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCHOJP" (Hospitalized for joint pain occurrence indicator) | Hospitalized for joint pain occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCHODI" (Hospitalized for diarrhea occurrence indicator) | Hospitalized for diarrhea occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "MAXSVOM" (Vomiting maximum severity) | Vomiting maximum severity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "SEVVOMI" (Vomiting severity/intensity) | Vomiting severity/intensity | text | 8 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCHOCHIL" (Hospitalized for chills occurrence indicator) | Hospitalized for chills occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "MEDDUR" (Medications duration) | Medications duration | text | 7 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "G4CRR" (Redness grade 4 criteria met) | Redness grade 4 criteria met | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "MADRE" (Redness maximum diameter cm) | Redness maximum diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "MIDRE" (Redness minimum diameter cm) | Redness minimum diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "G4CRS" (Swelling grade 4 criteria met) | Swelling grade 4 criteria met | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "MADSW" (Swelling maximum diameter cm) | Swelling maximum diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "MIDSW" (Swelling minimum diameter cm) | Swelling minimum diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| PARAMCD = "OCHOVO" (Hospitalized for vomiting occurrence indicator) | Hospitalized for vomiting occurrence indicator | text | 1 | Derived For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. | ||
| 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).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MSPIS" (Pain at injection site maximum severity) | Pain at injection site maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVPIS" (Pain at injection site severity/intensity) | Pain at injection site severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MEDDUR" (Medications duration) | Medications duration | integer | 2 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MAXSFAT" (Fatigue maximum severity) | Fatigue maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVFATI" (Fatigue severity/intensity) | Fatigue severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MAXTEMP" (Fever maximum temperature) | Fever maximum temperature | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MAXSHEA" (Headache maximum severity) | Headache maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVHEAD" (Headache severity/intensity) | Headache severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MAXSJP" (Joint pain maximum severity) | Joint pain maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVJOIN" (Joint pain severity/intensity) | Joint pain severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "DIARE" (Redness diameter cm) | Redness diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MDIRE" (Redness maximum diameter) | Redness maximum diameter | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MSERE" (Redness maximum severity) | Redness maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVREDN" (Redness severity/intensity) | Redness severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MAXDIAR" (Diarrhea maximum severity) | Diarrhea maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVDIAR" (Diarrhea severity/intensity) | Diarrhea severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MAXCHIL" (Chills maximum severity) | Chills maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVCHIL" (Chills severity/intensity) | Chills severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MAXSMP" (Muscle pain maximum severity) | Muscle pain maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVMUSP" (Muscle pain severity/intensity) | Muscle pain severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "DIASW" (Swelling diameter cm) | Swelling diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MDISW" (Swelling maximum diameter) | Swelling maximum diameter | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MSESW" (Swelling maximum severity) | Swelling maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVSWEL" (Swelling severity/intensity) | Swelling severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MAXSVOM" (Vomiting maximum severity) | Vomiting maximum severity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "SEVVOMI" (Vomiting severity/intensity) | Vomiting severity/intensity | integer | 1 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MADRE" (Redness maximum diameter cm) | Redness maximum diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MIDRE" (Redness minimum diameter cm) | Redness minimum diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MADSW" (Swelling maximum diameter cm) | Swelling maximum diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| PARAMCD = "MIDSW" (Swelling minimum diameter cm) | Swelling minimum diameter cm | float | 4 | Derived For the parameters from FACE,
1) AVAL=FACE.FASTRESN.
2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. | ||
| AVALCAT1 | Analysis Value Category 1 | text | 9 | 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 | 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 | Predecessor: FACE.FASTAT or VS.VSSTAT | ||
| FAREASND | Reason Not Performed | text | 41 | Predecessor: FACE.FAREASND or VS.VSREASND | ||
| FAEVAL | Evaluator | text | 13 | 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 | 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 | Derived 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 | Derived Carried over from EX.EXDOSE.
Detailed algorithm as below:
For local reaction merge FACE with EX by USUBJID 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 | Derived VS.VSORRES where index(VS.VSTESTCD,”TEMP”) and CLTYP in ('DIARY CARD' 'CRF') | ||
| VSORRESU | Original Units | text | 1 | Derived VS.VSORRESU where index(VS.VSTESTCD,”TEMP”) and CLTYP in ('DIARY CARD' 'CRF') | ||
| VSSTRESN | Numeric Result/Finding in Standard Units | float | 8 | Derived VS.VSSTRESN where index(VS.VSTESTCD,”TEMP”) and CLTYP in ('DIARY CARD' 'CRF') | ||
| VSSTRESU | Standard Units | text | 1 | Derived VS.VSSTRESU where index(VS.VSTESTCD,”TEMP”) and CLTYP in ('DIARY CARD' 'CRF') | ||
| FTEMCAT | Fever Temperature Category | text | 17 | Derived Derived only for FAOBJ='FEVER'.
For VSORRESU='F':
if .<input(VS.VSORRES,best.)<100.4 then "<38.0 C";
else if 100.4<=input(VS.VSORRES,best.)<=101.1 then "38.0 C to 38.4 C" ;
else if 101.2<=input(VS.VSORRES,best.)<=102.0 then ">38.4 C to 38.9 C" ;
else if 102.1<=input(VS.VSORRES,best.)<=104.0 then ">38.9 C to 40.0 C";
else if input(VS.VSORRES,best.)>104.0 and VSSTRESN<=42.0 then ">40.0 C".
else if VSSTRESN>42 then 'Missing'.
For VSORRESU='C':
if .<input(VS.VSORRES,best.)<38.0 then "<38.0 C";
else if 38.0<=input(VS.VSORRES,best.)<=38.4 then "38.0 C to 38.4 C" ;
else if 38.5<=input(VS.VSORRES,best.)<=38.9 then ">38.4 C to 38.9 C" ;
else if 39.0<=input(VS.VSORRES,best.)<=40.0 then ">38.9 C to 40.0 C";
else if input(VS.VSORRES,best.)>40 and VSSTRESN<=42.0 then ">40.0 C".
else if VSSTRESN>42 then 'Missing'. | ||
| FTEMCATN | Fever Temperature Category (N) | integer | 8 | Assigned Numerive Code of FTEMCAT .="Missing" 0="<38.0 C" 1="38.0 C to 38.4 C" 2= ">38.4 C to 38.9 C" 3=">38.9 C to 40.0 C" 4=">40.0 C" | ||
| KNOWVFL | Known Value Flag | text | 1 | NY
| 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 | NY
| Derived This flag is derived at USUBJID/FATPTREF/FAOBJ level:
For FAOBJ in ('REDNESS' 'SWELLING'): Set to 'Y' if a subject had a record (diameter>=2.5 cm) at any day from day 1 to day 7; else set to 'N'.
For FAOBJ='MEDICATIONS': Set to 'Y' if a subject had a record (avalc='Y') at any day after each dose; else set to 'N'.
For FAOBJ='FEVER' : Set to 'Y' if a subject had a record (38.0 °C <=aval<=42.0 °C) at any day after each dose; else set to 'N'. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
For FAOBJ not in ('REDNESS' 'SWELLING' 'MEDICATIONS' 'FEVER'): Set to 'Y' for an reaction or an event if a subject had a record (avalc in ('MILD', 'MODERATE',''SEVER') at any day after each dose; else set to 'N'. | |
| KNOWVDFL | Day Known Value Flag | text | 1 | NY
| 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 | NY
| Derived This flag is derived at SUBJECT/FATPTREF/FAOBJ/FATEST/FATPT level:
For FATEST in ('Occurrence Indicator') and FAOBJ in ('REDNESS' 'SWELLING'): Set to 'Y' if a subject had a event (avalc='Y' and diameter>=2.5 cm) on the day within FATPTREF/FAOBJ/FATEST level; else set to 'N'.
For FATEST in ('Occurrence Indicator') or 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') on the day within FATPTREF/FAOBJ/FATEST/FATPT level; else set to 'N'.
For FATEST in ('Diameter', 'Maximum Diameter') : Set to 'Y' if a subject had a event (aval>=2.5 cm) on the day within FATPTREF/FAOBJ/FATPT level; else set to 'N'.
For FATEST in ('Maximum Temperature') : Set to 'Y' if a subject had a event (38.0 °C <=aval<=42.0 °C) on the day within FATPTREF/FAOBJ/FATPT level; else set to 'N'. | |
| 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 | 27 | 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 | 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 | 27 | Predecessor: ADSL.TRT01P | ||
| TRTPN | Planned Treatment (N) | integer | 8 | Predecessor: ADSL.TRT01PN |
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Covid-19 Signs and Symptoms Analysis Dataset (ADSYMPT)
| Variable | Where Condition | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: ADSL.STUDYID | ||
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: ADSL.USUBJID | ||
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | ||
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | ||
| BRTHDT | Date of Birth | integer | DATE9 | Predecessor: ADSL.BRTHDT | ||
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | ||
| AGEGR1 | Pooled Age Group 1 | text | 11 | Predecessor: ADSL.AGEGR1 | ||
| SEX | Sex | text | 1 | SEX
| Predecessor: ADSL.SEX | |
| RACE | Race | text | 41 | RACE [7 Terms] | Predecessor: ADSL.RACE | |
| ETHNIC | Ethnicity | text | 22 | ETHNIC
| Predecessor: ADSL.ETHNIC | |
| ARMCD | Planned Arm Code | text | 9 | Predecessor: ADSL.ARMCD | ||
| ARM | Description of Planned Arm | text | 27 | Predecessor: ADSL.ARM | ||
| ACTARMCD | Actual Arm Code | text | 9 | Predecessor: ADSL.ACTARMCD | ||
| ACTARM | Description of Actual Arm | text | 27 | Predecessor: ADSL.ACTARM | ||
| PARAMN | Parameter (N) | integer | 8 | ADSYMPT.PARAMN [32 Terms] | Assigned Numeric code for PARAM Please refer to codelist ADSYMPT.PARAMN. | |
| PARAMCD | Parameter Code | text | 8 | ADSYMPT.PARAMCD [32 Terms] | Assigned Character code for PARAM Please refer to codelist ADSYMPT.PARAMCD. | |
| PARAM | Parameter | text | 48 | ADSYMPT.PARAM [32 Terms] | Derived Set to FA.FAOBJ when upcase(FA.FAOBJ) = "CHILLS" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "DIARRHEA" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "FEVER" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW LOSS OF TASTE OR SMELL" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED COUGH" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED MUSCLE PAIN" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED SHORTNESS OF BREATH" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED SORE THROAT" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "VOMITING" and FA.FACAT = "EFFICACY" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to "NEW OR INCREASED NASAL CONGESTION" when upcase(FA.FAOBJ) = "NEW OR INCREASED NASAL CONGESTION" or "NASAL CONGESTION" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to "NEW OR INCREASED WHEEZING" when upcase(FA.FAOBJ) = "NEW OR INCREASED WHEEZING" or upcase(FA.FAOBJ) = "WHEEZING" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "FATIGUE" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "HEADACHE" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to "RHINORRHOEA" when upcase(FA.FAOBJ) contains "RUNNY NOSE" or upcase(FA.FAOBJ) = "RHINORRHOEA" and FA.FAOBJ ^= "NEW OR INCREASED NASAL DISCHARGE" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NAUSEA" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to CE.CESCAT when CE.CESCAT = "SIGNIFICANT ACUTE RENAL DYSFUNCTION".
Set to CE.CESCAT when CE.CESCAT = "SIGNIFICANT ACUTE HEPATIC DYSFUNCTION".
Set to MB.MBTEST when upcase(MB.MBTESTCD) = "SARSCOV2" and MB.MBMETHOD = "IMMUNOCHROMATOGRAPHY".
Set to MB.MBTEST when upcase(MB.MBTESTCD) = "RTCOV2NS" and MB.MBMETHOD = "REVERSE TRANSCRIPTASE PCR".
Set to VS.VSTEST when VS.VSTESTCD = "RESP".
Set to VS.VSTEST when VS.VSTESTCD = "HR".
Set to VS.VSTEST when VS.VSTESTCD = "OXYSAT"
Set to VS.VSTEST when VS.VSTESTCD = "DIABP".
Set to VS.VSTEST when VS.VSTESTCD = "SYSBP".
Set to PR.PRTRT when upcase(PR.PRTRT) = "NON-INVASIVE POSITIVE PRESSURE VENTILATION".
Set to PR.PRTRT when upcase(PR.PRTRT) = "HIGH FLOW OXYGEN THERAPY".
Set to IS.ISTEST when IS.ISTESTCD = "C19NIG"
Set to "SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS" when HOTERM = "ICU'.
Set to DS.DSDECOD when DS.DSDECOD = "DEATH". | |
| PARCAT1 | Parameter Category 1 | text | 31 | Derived if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to "GENERAL VITAL SIGNS".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to "SIGNS AND SYMPTOMS OF DISEASE".
if paramcd in ("SARDFN" "SAHDFN") then Set to CE.CECAT.
if paramcd in ("DEATH") then Set to DS.DSCAT.
if paramcd in ("HCUICU") then Set to HO.HOCAT.
if paramcd in ("C19NIG") then Set to IS.ISCAT.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBCAT.
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PRCAT. | ||
| PARCAT2 | Parameter Category 2 | text | 19 | Derived if paramcd in ("NIPPV" "HFOXTHRP") then Set to "RESPIRATORY FAILURE".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASCAT.
if paramcd in ("HCUICU" "C19NIG" "SARSCOV2" "RTCOV2NS" "RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "SARDFN" "SAHDFN" "DEATH") then Set to null. | ||
| AVALVLM | Analysis Value | integer | 8 | Derived if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN.
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA" "HCUICU" "C19NIG" "SARSCOV2" "RTCOV2NS" "NIPPV" "HFOXTHRP" "SARDFN" "SAHDFN" "DEATH") then Set to null. | ||
| PARAMCD = "RESP" (RESPIRATORY RATE) | RESPIRATORY RATE | integer | 3 | Derived if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN.
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA" "HCUICU" "C19NIG" "SARSCOV2" "RTCOV2NS" "NIPPV" "HFOXTHRP" "SARDFN" "SAHDFN" "DEATH") then Set to null. | ||
| PARAMCD = "HR" (HEART RATE) | HEART RATE | integer | 3 | Derived if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN.
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA" "HCUICU" "C19NIG" "SARSCOV2" "RTCOV2NS" "NIPPV" "HFOXTHRP" "SARDFN" "SAHDFN" "DEATH") then Set to null. | ||
| PARAMCD = "OXYSAT" (OXYGEN SATURATION) | OXYGEN SATURATION | integer | 3 | Derived if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN.
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA" "HCUICU" "C19NIG" "SARSCOV2" "RTCOV2NS" "NIPPV" "HFOXTHRP" "SARDFN" "SAHDFN" "DEATH") then Set to null. | ||
| PARAMCD = "DIABP" (DIARRHEA) | DIASTOLIC BLOOD PRESSURE | integer | 3 | Derived if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN.
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA" "HCUICU" "C19NIG" "SARSCOV2" "RTCOV2NS" "NIPPV" "HFOXTHRP" "SARDFN" "SAHDFN" "DEATH") then Set to null. | ||
| PARAMCD = "SYSBP" (SYSTOLIC BLOOD PRESSURE) | SYSTOLIC BLOOD PRESSURE | integer | 3 | Derived if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN.
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA" "HCUICU" "C19NIG" "SARSCOV2" "RTCOV2NS" "NIPPV" "HFOXTHRP" "SARDFN" "SAHDFN" "DEATH") then Set to null. | ||
| PARAMCD = "PO2FIO2" (PP ARTERIAL O2/FRACTION INSPIRED O2) | PP ARTERIAL O2/FRACTION INSPIRED O2 | integer | 3 | Derived if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN.
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA" "HCUICU" "C19NIG" "SARSCOV2" "RTCOV2NS" "NIPPV" "HFOXTHRP" "SARDFN" "SAHDFN" "DEATH") then Set to null. | ||
| AVALCVLM | Analysis Value (C) | text | 50 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "RTCOV2NS" (SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2) | CEPHEID RT-PCR ASSAY FOR SARS-COV-2 | text | 3 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "C19NIG" (N-BINDING ANTIBODY) | N-BINDING ANTIBODY | text | 3 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "CHILLS" (CHILLS) | CHILLS | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "DIARRHEA" (DIASTOLIC BLOOD PRESSURE) | DIARRHEA | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "FEVER" (FEVER) | FEVER | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "NLTSTSML" (NEW LOSS OF TASTE OR SMELL) | NEW LOSS OF TASTE OR SMELL | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "NCOUG" (NEW OR INCREASED COUGH) | NEW OR INCREASED COUGH | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "NMUSPN" (NEW OR INCRESED MUSCLE PAIN) | NEW OR INCREASED MUSCLE PAIN | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "NSTBRTH" (NEW OR INCREASED SHORTNESS OF BREATH) | NEW OR INCREASED SHORTNESS OF BREATH | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "NSRTHROT" (NEW OR INCRESED SORE THROAT) | NEW OR INCREASED SORE THROAT | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "VOMIT" (VOMITING) | VOMITING | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "FATIGUE" (FATIGUE) | FATIGUE | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "SARSCOV2" (CEPHEID RT-PCR ASSAY FOR SARS-COV-2) | SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 | text | 3 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "NNSLCONG" (NEW OR INCREASED NASAL CONGESTION) | NEW OR INCREASED NASAL CONGESTION | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "RIHNRA" (RHINORRHOEA) | RHINORRHOEA | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "HEADACHE" (HEADACHE) | HEADACHE | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "NAUSEA" (NAUSEA) | NAUSEA | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "DEATH" (DEATH) | DEATH | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "WHEEZ" (NEW OR INCREASED WHEEZING) | NEW OR INCREASED WHEEZING | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "HFOXTHRP" (HIGH FLOW OXYGEN THERAPY) | HIGH FLOW OXYGEN THERAPY | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "SARDFN" (SIGNIFICANT ACUTE RENAL DYSFUNCTION) | SIGNIFICANT ACUTE RENAL DYSFUNCTION | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "HCUICU" (SUJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS) | SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "SAHDFN" (SIGNIFICANT ACUTE HEPATIC DYSFUNCTION) | SIGNIFICANT ACUTE HEPATIC DYSFUNCTION | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "NIPPV" (NON-INVASIVE POSITIVE PRESSURE VENTILATION) | NON-INVASIVE POSITIVE PRESSURE VENTILATION | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "MCHVENT" (MECHANICAL VENTILATION) | MECHANICAL VENTILATION | text | 1 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| PARAMCD = "VSOPRES" (VASOPRESSORS AGENTS) | VASOPRESSORS AGENTS | text | 50 | Derived if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. | ||
| VISITNUM | Visit Number | integer | 8 | Predecessor: CE.VISITNUM or FA.VISITNUM or HO.VISITNUM or IS.VISITNUM or MB.VISITNUM or PR.VISITNUM or VS.VISITNUM | ||
| VISIT | Visit Name | text | 14 | Predecessor: CE.VISIT or FA.VISIT or HO.VISIT or IS.VISIT or MB.VISIT or PR.VISIT or VS.VISIT | ||
| AVISITN | Analysis Visit (N) | integer | 8 | ADSYMPT.AVISITN [6 Terms] | Derived Set to VISITNUM of source dataset. | |
| AVISIT | Analysis Visit | text | 14 | ADSYMPT.AVISIT [6 Terms] | Derived Set to VISIT of source dataset. | |
| ADT | Analysis Date | integer | DATE9 | Derived if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FADTC.
if paramcd in ("HCUICU") then Set to HO.HODTC.
if paramcd in ("C19NIG") then Set to IS.ISDTC.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBDTC.
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PRDTC.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSDTC.
if paramcd in ("SARDFN" "SAHDFN" "DEATH") then Set to null. | ||
| ADY | Analysis Relative Day | integer | 8 | Derived Set as following:
ADY = ADT - TRTSDT.
If ADT >= TRTSDT, ADY = ADT - TRTSDT + 1. | ||
| ASTDT | Analysis Start Date | integer | DATE9 | Derived if paramcd in ("SARDFN" "SAHDFN") then Set to CE.CESTDTC.
if paramcd in ("DEATH") then Set to DS.DSSTDTC.
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FASTRESC where FA.FATESTCD = "FSYMDATE" and FA.FACAT = "EFFICACY" and FASCAT = "RESPIRATORY ILLNESS" within a matching FA.VISIT of a subject.
if paramcd in ("HCUICU") then Set to HO.HOSTDTC.
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PRSTDTC.
if paramcd in ("SARSCOV2" "RTCOV2NS" "RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "C19NIG") then Set to null. | ||
| ASTDY | Analysis Start Relative Day | integer | 8 | Derived Set as following:
ASTDY = ASTDT - TRTSDT.
If ASTDT >= TRTSDT, ASTDY = ASTDT - TRTSDT + 1. | ||
| AENDT | Analysis End Date | integer | DATE9 | Derived if paramcd in ("SARDFN" "SAHDFN") then Set to CE.CEENDTC.
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FASTRESC where FA.FATESTCD = "LSYMDATE" and FA.FACAT = "EFFICACY" and FASCAT = "RESPIRATORY ILLNESS" within a matching FA.VISIT of a subject..
if paramcd in ("HCUICU") then Set to HO.HOENDTC.
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PRENDTC.
if paramcd in ("SARSCOV2" "RTCOV2NS" "RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "C19NIG" "DEATH") then Set to null. | ||
| AENDY | Analysis End Relative Day | integer | 8 | Derived Set as following:
AENDY = AENDT - TRTSDT.
If AENDT >= TRTSDT, AENDY = AENDT - TRTSDT + 1. | ||
| ISSPEC | IS Specimen Type | text | 5 | Predecessor: IS.ISSPEC | ||
| ISMETHOD | IS Method of Test or Examination | text | 24 | Predecessor: IS.ISMETHOD | ||
| MBLOC | Specimen Collection Location | text | 24 | Predecessor: MB.MBLOC | ||
| MBSPEC | MB Specimen Type | text | 22 | Predecessor: MB.MBSPEC | ||
| MBMETHOD | MB Method of Test or Examination | text | 25 | Predecessor: MB.MBMETHOD | ||
| PRPRESP | Pre-specified | text | 1 | Predecessor: PR.PRPRESP | ||
| VSSTRESU | Standard Units | text | 11 | Predecessor: VS.VSSTRESU | ||
| RANDDT | Date of Randomization | integer | DATE9 | Predecessor: ADSL.RANDDT | ||
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | ||
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | ||
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Predecessor: ADSL.VAX101DT | ||
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Predecessor: ADSL.VAX102DT | ||
| ENRLFL | Enrolled Population Flag | text | 1 | Y
| Predecessor: ADSL.ENRLFL | |
| RANDFL | Randomized Population Flag | text | 1 | NY
| Predecessor: ADSL.RANDFL | |
| SAFFL | Safety Population Flag | text | 1 | NY
| Predecessor: ADSL.SAFFL | |
| EVALEFFL | Evaluable Efficacy Popu Flag | text | 1 | NY
| Predecessor: ADSL.EVALEFFL | |
| EV14EFFL | Evaluable Efficacy Popu Flag - 14 days | text | 1 | Predecessor: ADSL.EV14EFFL | ||
| AAI1EFFL | Dose 1 all-available Efficacy Popu Flag | text | 1 | NY
| Predecessor: ADSL.AAI1EFFL | |
| AAI2EFFL | Dose 2 all-available Efficacy Popu Flag | text | 1 | NY
| Predecessor: ADSL.AAI2EFFL | |
| C19ILHFL | Prior Covid-19 Illness History Flag | text | 1 | Y
| Derived Set this to "Y", if subject reported any of the following terms in MH.MHDECOD .
"Asymptomatic COVID-19"
"COVID-19"
"COVID-19 pneumonia"
"COVID-19 treatment"
"Suspected COVID-19"
"SARS-CoV-2 antibody test positive"
"SARS-CoV-2 carrier"
"SARS-CoV-2 sepsis"
"SARS-CoV-2 test positive"
"SARS-CoV-2 viraemia"
"Multisystem inflammatory syndrome in children" | |
| HIVFL | HIV Positive Subjects Flag | text | 1 | Predecessor: ADSL.HIVFL |
Go to the top of the Define-XML document
Immunogenicity Analysis Dataset (ADVA)
| Variable | Where Condition | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: IS.STUDYID | ||
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: IS.USUBJID | ||
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | ||
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | ||
| TRTP | Planned Treatment | text | 27 | Predecessor: ADSL.TRT01P | ||
| TRTPN | Planned Treatment (N) | integer | 8 | Predecessor: ADSL.TRT01PN | ||
| TRTA | Actual Treatment | text | 27 | Predecessor: ADSL.TRT01A | ||
| TRTAN | Actual Treatment (N) | integer | 8 | Predecessor: ADSL.TRT01AN | ||
| ISDTC | Date/Time of Collection | date | ISO 8601 | Predecessor: IS.ISDTC | ||
| ADT | Analysis Date | integer | DATE9 | Derived ADT = date part of IS.ISDTC | ||
| ADY | Analysis Relative Day | integer | 8 | Predecessor: IS.ISDY | ||
| AVISIT | Analysis Visit | text | 39 | ADVA.AVISIT [9 Terms] | Derived Derive AVISIT based on IS.Visit/Visitnum for records with non-missing value (AVAL ne .); | |
| AVISITN | Analysis Visit (N) | float | 8 | ADVA.AVISITN [9 Terms] | Assigned Numeric Code of the AVISIT. 1 if AVISIT= "Before Vaccination 1"; 2 if AVISIT= "1 Week after Vaccination 1"; 3 if AVISIT= "3 Weeks after Vaccination 1"; (Note: This is the visit before vaccination 2); 3.1 if AVISIT= "4 Weeks after Vaccination 1"; (Note: For 100ug only); 3.2 if AVISIT= "5 Weeks after Vaccination 1"; (Note: For 100ug only); 3.3 if AVISIT= "1 Month and 3 weeks after Vaccination 1"; (Note: For 100ug only); 4 if AVISIT= "1 Week after Vaccination 2"; 5 if AVISIT= "2 Weeks after Vaccination 2"; 6 if AVISIT= "1 Month after Vaccination 2"; 7 if AVISIT= "6 Months after Vaccination 2"; 8 if AVISIT= "12 Months after Vaccination 2"; 9 if AVISIT= "24 Months after Vaccination 2"; | |
| VISIT | Visit Name | text | 20 | Predecessor: IS.VISIT | ||
| VISITNUM | Visit Number | integer | 8 | Predecessor: IS.VISITNUM | ||
| PARCAT1 | Parameter Category 1 | text | 8 | Predecessor: IS.ISCAT | ||
| PARCAT1N | Parameter Category 1 (N) | integer | 8 | Assigned Numeric Code from PARCAT1. 1 if PARCAT1="SEROLOGY". | ||
| PARAM | Parameter | text | 75 | ADVA.PARAM [9 Terms] | Derived param=trim(left(istest))||' ('||trim(left("titer"))||') - '||trim(left(ismethod)) for C2NGNT50 and C2NGNT90;
trim(left(IS.ISTEST)) || '(' || trim(left(IS.ISSTRESU)) || ')' || ' - ' || trim(left(IS.ISMETHOD)) for C19S1IGG and C19RBDIG;
trim(left(istest))||' - '||trim(left(ismethod)) for C19NIG;
istest of numerator “to” istest of denominator for ratios. | |
| PARAMN | Parameter (N) | integer | 8 | ADVA.PARAMN [9 Terms] | Derived See ADVA_Parameters table in complexalgorithms.pdf and derive PARAMN based on PARAM. | |
| PARAMCD | Parameter Code | text | 8 | ADVA.PARAMCD [9 Terms] | Predecessor: IS.ISTESTCD | |
| AVALVLM | Analysis Value | float | 8 | Derived If ISSTRESC in (' ', 'IND', 'QNS', 'INDETERMINATE') then set to missing; if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ; else set to IS.ISSTRESN. *LLoQ equals the value of ISLLOQ. For N-binding antibody test, 0 for negative and 1 for positive. For parameter with paramn from 11 to 14: AVAL is the ratio of the corresponding parameters specified in PARAM; eg: For PARAMN=11 (PARAM='SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG'), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| PARAMCD = "C19RBDIG" (COVID-19 RBD IgG (U/mL) - Luminex Immunoassay) | COVID-19 RBD IgG (U/mL) - Luminex Immunoassay | float | 10 | Derived If ISSTRESC in (' ', 'IND', 'QNS', 'INDETERMINATE') then set to missing; if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ; else set to IS.ISSTRESN. *LLoQ equals the value of ISLLOQ. For N-binding antibody test, 0 for negative and 1 for positive. For parameter with paramn from 11 to 14: AVAL is the ratio of the corresponding parameters specified in PARAM; eg: For PARAMN=11 (PARAM='SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG'), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| PARAMCD = "C19S1IGG" (COVID-19 S1 IgG (U/mL) - Luminex Immunoassay) | COVID-19 S1 IgG (U/mL) - Luminex Immunoassay | float | 10 | Derived If ISSTRESC in (' ', 'IND', 'QNS', 'INDETERMINATE') then set to missing; if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ; else set to IS.ISSTRESN. *LLoQ equals the value of ISLLOQ. For N-binding antibody test, 0 for negative and 1 for positive. For parameter with paramn from 11 to 14: AVAL is the ratio of the corresponding parameters specified in PARAM; eg: For PARAMN=11 (PARAM='SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG'), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| PARAMCD = "C2NGNT50" (SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay) | SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay | float | 12 | Derived If ISSTRESC in (' ', 'IND', 'QNS', 'INDETERMINATE') then set to missing; if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ; else set to IS.ISSTRESN. *LLoQ equals the value of ISLLOQ. For N-binding antibody test, 0 for negative and 1 for positive. For parameter with paramn from 11 to 14: AVAL is the ratio of the corresponding parameters specified in PARAM; eg: For PARAMN=11 (PARAM='SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG'), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| PARAMCD = "C2NGNT90" (SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay) | SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay | float | 12 | Derived If ISSTRESC in (' ', 'IND', 'QNS', 'INDETERMINATE') then set to missing; if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ; else set to IS.ISSTRESN. *LLoQ equals the value of ISLLOQ. For N-binding antibody test, 0 for negative and 1 for positive. For parameter with paramn from 11 to 14: AVAL is the ratio of the corresponding parameters specified in PARAM; eg: For PARAMN=11 (PARAM='SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG'), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| PARAMCD = "NT50_RB" (SARS-CoV-2 serum neutralizing titer 50 to COVID-19 RBD Ig) | SARS-CoV-2 serum neutralizing titer 50 to COVID-19 RBD Ig | float | 7 | Derived If ISSTRESC in (' ', 'IND', 'QNS', 'INDETERMINATE') then set to missing; if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ; else set to IS.ISSTRESN. *LLoQ equals the value of ISLLOQ. For N-binding antibody test, 0 for negative and 1 for positive. For parameter with paramn from 11 to 14: AVAL is the ratio of the corresponding parameters specified in PARAM; eg: For PARAMN=11 (PARAM='SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG'), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| PARAMCD = "NT50_S1" (SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG) | SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG | float | 7 | Derived If ISSTRESC in (' ', 'IND', 'QNS', 'INDETERMINATE') then set to missing; if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ; else set to IS.ISSTRESN. *LLoQ equals the value of ISLLOQ. For N-binding antibody test, 0 for negative and 1 for positive. For parameter with paramn from 11 to 14: AVAL is the ratio of the corresponding parameters specified in PARAM; eg: For PARAMN=11 (PARAM='SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG'), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| PARAMCD = "NT90_RB" (SARS-CoV-2 serum neutralizing titer 90 to COVID-19 RBD Ig) | SARS-CoV-2 serum neutralizing titer 90 to COVID-19 RBD Ig | float | 7 | Derived If ISSTRESC in (' ', 'IND', 'QNS', 'INDETERMINATE') then set to missing; if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ; else set to IS.ISSTRESN. *LLoQ equals the value of ISLLOQ. For N-binding antibody test, 0 for negative and 1 for positive. For parameter with paramn from 11 to 14: AVAL is the ratio of the corresponding parameters specified in PARAM; eg: For PARAMN=11 (PARAM='SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG'), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| PARAMCD = "NT90_S1" (SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG) | SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG | float | 7 | Derived If ISSTRESC in (' ', 'IND', 'QNS', 'INDETERMINATE') then set to missing; if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ; else set to IS.ISSTRESN. *LLoQ equals the value of ISLLOQ. For N-binding antibody test, 0 for negative and 1 for positive. For parameter with paramn from 11 to 14: AVAL is the ratio of the corresponding parameters specified in PARAM; eg: For PARAMN=11 (PARAM='SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG'), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| PARAMCD = "C19NIG" (N-binding antibody - N-binding Antibody Assay) | N-binding antibody - N-binding Antibody Assay | integer | 1 | Derived If ISSTRESC in (' ', 'IND', 'QNS', 'INDETERMINATE') then set to missing; if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ; else set to IS.ISSTRESN. *LLoQ equals the value of ISLLOQ. For N-binding antibody test, 0 for negative and 1 for positive. For parameter with paramn from 11 to 14: AVAL is the ratio of the corresponding parameters specified in PARAM; eg: For PARAMN=11 (PARAM='SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG'), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point | ||
| AVALCVLM | Analysis Value (C) | text | 12 | Derived Character value for AVAL | ||
| PARAMCD = "C19RBDIG" (COVID-19 RBD IgG (U/mL) - Luminex Immunoassay) | COVID-19 RBD IgG (U/mL) - Luminex Immunoassay | float | 10 | Derived Character value for AVAL | ||
| PARAMCD = "C19S1IGG" (COVID-19 S1 IgG (U/mL) - Luminex Immunoassay) | COVID-19 S1 IgG (U/mL) - Luminex Immunoassay | float | 10 | Derived Character value for AVAL | ||
| PARAMCD = "C2NGNT50" (SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay) | SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay | float | 13 | Derived Character value for AVAL | ||
| PARAMCD = "C2NGNT90" (SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay) | SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay | float | 13 | Derived Character value for AVAL | ||
| PARAMCD = "NT50_RB" (SARS-CoV-2 serum neutralizing titer 50 to COVID-19 RBD Ig) | SARS-CoV-2 serum neutralizing titer 50 to COVID-19 RBD Ig | float | 7 | Derived Character value for AVAL | ||
| PARAMCD = "NT50_S1" (SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG) | SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG | float | 7 | Derived Character value for AVAL | ||
| PARAMCD = "NT90_RB" (SARS-CoV-2 serum neutralizing titer 90 to COVID-19 RBD Ig) | SARS-CoV-2 serum neutralizing titer 90 to COVID-19 RBD Ig | float | 7 | Derived Character value for AVAL | ||
| PARAMCD = "NT90_S1" (SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG) | SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG | float | 7 | Derived Character value for AVAL | ||
| PARAMCD = "C19NIG" (N-binding antibody - N-binding Antibody Assay) | N-binding antibody - N-binding Antibody Assay | text | 3 | Derived Character value for AVAL | ||
| BASE | Baseline Value | float | 8 | Derived AVAL from the record with ABLFL="Y" at USUBJID/PARAM level | ||
| BASEC | Baseline Value (C) | text | 8 | Derived AVALC from the record with ABLFL="Y" at USUBJID/PARAM level | ||
| BASETYPE | Baseline Type | text | 15 | Derived trim(left("Study"))||' ('||trim(left(dtype))||')'; | ||
| ABLFL | Baseline Record Flag | text | 1 | Y
| Derived Set to 'Y' for a valid result (AVAL ne .) where collected before vax1. | |
| APSBLFL | Post Baseline Record Flag | text | 1 | NY
| Derived Set to 'Y' for a post-baseline result where collected after vax1 | |
| ABLPBLFL | Baseline and post-baseline flag | text | 1 | NY
| Derived Set to 'Y' if a subject has results both at baseline and post-baseline. Set to 'N' if a subject only has post-baseline results. | |
| DTYPE | Derivation Type | text | 7 | ADVA.DTYPE
| Derived Set to 'LLOQIMP' for parameters that imputed for LLOQ. Set to 'Derived' for parameters for ratios. | |
| R2BASE | Ratio to Baseline | integer | 8 | Derived R2BASE = AVAL/BASE for post baseline readings | ||
| SRCDOM | Source Data | text | 2 | Derived Set to "IS" if DTYPE ne 'Derived'. | ||
| SRCVAR | Source Variable | text | 8 | Derived Set to "ISSTRESN" if DTYPE ne 'Derived'. | ||
| SRCSEQ | Source Sequence Number | integer | 8 | Derived IS.ISSEQ if DTYPE ne 'Derived'. | ||
| ANL01FL | Analysis Record Flag 01:Window Record | text | 1 | NY
| Derived Flag the record that is selected based on Windowing (AVISIT ne missing) | |
| ANL03FL | Analysis Flag 03:valid value | text | 1 | NY
| Derived Flag the record with non-missing result (AVAL ne . ) and ISSTRESC not in ('','IND', 'QNS','INDETERMINATE') | |
| ANL04FL | Analysis Flag 04:ge LLoQ | text | 1 | NY
| Derived Flag the record with non-missing AVAL and AVAL ge LLoQ*. | |
| EPOCH | Epoch | text | 11 | Predecessor: IS.EPOCH | ||
| ISLLOQ | Lower Limit of Quantitation | float | 8 | Predecessor: IS.ISLLOQ | ||
| ISSTRESC | Result or Finding in Standard Format | text | 12 | Predecessor: IS.ISSTRESC | ||
| EVIMMFL | Evaluable immunogenicity population | text | 1 | NY
| Derived if avisitn<4 then do; if eval01fl="Y" then EVIMMFL="Y"; else EVIMMFL="N"; end; else if avisitn>=4 then do; if eval02fl="Y" then EVIMMFL="Y"; else EVIMMFL="N"; end; | |
| AAIMMFL | All-available immunogenicity population | text | 1 | NY
| Derived if avisitn<4 then do; if aai01fl="Y" then AAIMMFL="Y"; else AAIMMFL="N"; end; else if avisitn>=4 then do; if aai02fl="Y" then AAIMMFL="Y"; else AAIMMFL="N"; end; | |
| BSSEROC | Baseline serostatus | text | 7 | Derived if base<islloq then BSSEROC="< LLOQ"; if base>=islloq then BSSEROC=">= LLOQ"; if missing baseline then BSSEROC="Missing" | ||
| BSSERON | Baseline serostatus (N) | integer | 8 | Derived if BSSEROC="Missing" then BSSERON=0; if BSSEROC="< LLOQ" then BSSERON=1; if BSSEROC=">= LLOQ" then BSSERON=2; | ||
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | ||
| AGEU | Age Units | text | 5 | AGEU
| Predecessor: ADSL.AGEU | |
| SEX | Sex | text | 1 | SEX
| Predecessor: ADSL.SEX | |
| SEXN | Sex (N) | integer | 8 | Predecessor: ADSL.SEXN | ||
| RACE | Race | text | 32 | RACE [7 Terms] | Predecessor: ADSL.RACE | |
| RACEN | Race (N) | integer | 8 | Predecessor: ADSL.RACEN | ||
| SAFFL | Safety Population Flag | text | 1 | NY
| Predecessor: ADSL.SAFFL | |
| ARM | Description of Planned Arm | text | 27 | Predecessor: ADSL.ARM | ||
| ARMCD | Planned Arm Code | text | 9 | Predecessor: ADSL.ARMCD | ||
| ACTARM | Description of Actual Arm | text | 27 | Predecessor: ADSL.ACTARM | ||
| ACTARMCD | Actual Arm Code | text | 9 | Predecessor: ADSL.ACTARMCD | ||
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTSDT | ||
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Predecessor: ADSL.TRTEDT | ||
| TRTSTM | Time of First Exposure to Treatment | integer | TIME8 | Predecessor: ADSL.TRTSTM | ||
| TRTETM | Time of Last Exposure to Treatment | integer | TIME8 | Predecessor: ADSL.TRTETM | ||
| TRT01A | Actual Treatment for Period 01 | text | 27 | Predecessor: ADSL.TRT01A | ||
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | ||
| TRT01P | Planned Treatment for Period 01 | text | 27 | Predecessor: ADSL.TRT01P | ||
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | ||
| 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 | ||
| COHORTN | Cohort Group (N) | float | 8 | Predecessor: ADSL.COHORT | ||
| COHORT | Cohort Group | text | 75 | Predecessor: ADSL.COHORT | ||
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Predecessor: ADSL.VAX101DT | ||
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Predecessor: ADSL.VAX102DT | ||
| AAI01FL | Dose 1 all-available Immun Popu Flag | text | 1 | NY
| Predecessor: ADSL.AAI01FL | |
| EVAL02FL | Dose 2 evaluable Immun Popu Flag | text | 1 | NY
| Predecessor: ADSL.EVAL02FL | |
| AAI02FL | Dose 2 all-available Immun Popu Flag | text | 1 | NY
| Predecessor: ADSL.AAI02FL | |
| EVAL01FL | Dose 1 evaluable Immun Popu Flag | text | 1 | NY
| Predecessor: ADSL.EVAL01FL | |
| DOSALVL | Actual Dosing Level | text | 52 | Predecessor: ADSL.DOSALVL | ||
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Predecessor: ADSL.DOSALVLN | ||
| DOSPLVL | Planned Dosing Level | text | 52 | Predecessor: ADSL.DOSPLVL | ||
| DOSPLVLN | Planned Dosing Level (N) | integer | 8 | Predecessor: ADSL.DOSPLVLN | ||
| AGEGR1 | Pooled Age Group 1 | text | 11 | Predecessor: ADSL.AGEGR1 | ||
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | ||
| AGEGR2 | Pooled Age Group 2 | text | 11 | Predecessor: ADSL.AGEGR2 | ||
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | ||
| PHASE | Study Phase | text | 20 | Predecessor: ADSL.PHASE | ||
| PHASEN | Study Phase (N) | integer | 8 | Predecessor: ADSL.PHASEN | ||
| TRTAR | Actual Treatment for Reporting | text | 55 | Predecessor: ADSL.TRTAR | ||
| TRTARN | Actual Treatment (N) for Reporting | integer | 8 | Predecessor: ADSL.TRTARN | ||
| TRTPR | Planned Treatment for Reporting | text | 55 | Predecessor: ADSL.TRTPR | ||
| TRTPRN | Planned Treatment (N) for Reporting | integer | 8 | Predecessor: ADSL.TRTPRN | ||
| COVBLST | Baseline SARS-CoV-2 Status | text | 3 | Predecessor: ADSL.COVBLST | ||
| PD1POSDT | Post-dose Positive Swab Result Date | integer | DATE9 | Predecessor: ADSL.PD1POSDT |
Go to the top of the Define-XML document
Adverse Events Analysis Dataset (ADAE)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | |
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | |
| ARM | Description of Planned Arm | text | 27 | Predecessor: ADSL.ARM | |
| ARMCD | Planned Arm Code | text | 9 | Predecessor: ADSL.ARMCD | |
| ACTARM | Description of Actual Arm | text | 27 | Predecessor: ADSL.ACTARM | |
| ACTARMCD | Actual Arm Code | text | 9 | Predecessor: ADSL.ACTARMCD | |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | AGEU
| Predecessor: ADSL.AGEU |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Predecessor: ADSL.AGEGR1 | |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | |
| AGEGR2 | Pooled Age Group 2 | text | 10 | Predecessor: ADSL.AGEGR2 | |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | |
| AGEGR3 | Pooled Age Group 3 | text | 11 | Predecessor: ADSL.AGEGR3 | |
| AGEGR3N | Pooled Age Group 3 (N) | integer | 8 | Predecessor: ADSL.AGEGR3N | |
| RACE | Race | text | 41 | RACE [7 Terms] | Predecessor: ADSL.RACE |
| RACEN | Race (N) | integer | 8 | Predecessor: ADSL.RACEN | |
| SEX | Sex | text | 1 | SEX
| Predecessor: ADSL.SEX |
| SEXN | Sex (N) | integer | 8 | Predecessor: ADSL.SEXN | |
| ETHNIC | Ethnicity | text | 22 | ETHNIC
| Predecessor: ADSL.ETHNIC |
| ETHNICN | Ethnicity (N) | integer | 8 | Predecessor: ADSL.ETHNICN | |
| COUNTRY | Country | text | 3 | Predecessor: ADSL.COUNTRY | |
| ARACE | Analysis Race | text | 41 | ARACE [7 Terms] | Predecessor: ADSL.ARACE |
| ARACEN | Analysis Race (N) | integer | 8 | 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 | 27 | Predecessor: ADSL.TRT01A | |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | |
| TRT01P | Planned Treatment for Period 01 | text | 27 | Predecessor: ADSL.TRT01P | |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | 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 | |
| VAX103DT | Vaccination Date 03 | integer | DATE9 | Predecessor: ADSL.VAX103DT | |
| VAX103TM | Vaccination Time 03 | integer | TIME8 | Predecessor: ADSL.VAX103TM | |
| SAFFL | Safety Population Flag | text | 1 | NY
| Predecessor: ADSL.SAFFL |
| COHORT | Cohort Group | text | 75 | Predecessor: ADSL.COHORT | |
| COHORTN | Cohort Group (N) | float | 8 | Predecessor: ADSL.COHORTN | |
| DOSALVL | Actual Dosing Level | text | 52 | Predecessor: ADSL.DOSALVL | |
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Predecessor: ADSL.DOSALVLN | |
| DOSPLVL | Planned Dosing Level | text | 52 | Predecessor: ADSL.DOSPLVL | |
| DOSPLVLN | Planned Dosing Level (N) | integer | 8 | Predecessor: ADSL.DOSPLVLN | |
| VAX101 | Vaccination 01 | text | 37 | Predecessor: ADSL.VAX101 | |
| VAX102 | Vaccination 02 | text | 36 | Predecessor: ADSL.VAX102 | |
| VAX103 | Vaccination 03 | text | 36 | Predecessor: ADSL.VAX103 | |
| V01DT | Date of Visit at 1M after Vax2 | integer | DATE9 | Predecessor: ADSL.V01DT | |
| V02DT | Date of Visit at 6M after Vax2 | integer | DATE9 | Predecessor: ADSL.V02DT | |
| RANDFL | Randomized Population Flag | text | 1 | Y
| Predecessor: ADSL.RANDFL |
| PHASE | Study Phase | text | 20 | Predecessor: ADSL.PHASE | |
| PHASEN | Study Phase (N) | integer | 8 | Predecessor: ADSL.PHASEN | |
| DS30KFL | Phase 3 30k Subjects Flag | text | 1 | Predecessor: ADSL.DS30KFL | |
| COVBLST | Baseline SARS-CoV-2 Status | text | 3 | Predecessor: ADSL.COVBLST | |
| MULENRFL | Multiply Enrolled Subjects | text | 1 | Predecessor: ADSL.MULENRFL | |
| 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 | 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 | 79 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: AE.AEDECOD |
| 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 | 57 | 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 | 74 | 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 | 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 | 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 | STENRF
| Predecessor: AE.AEENRTPT |
| AEENTPT | End Reference Time Point | text | 22 | Predecessor: AE.AEENTPT | |
| AETOXGR | Standard Toxicity Grade | text | 1 | Predecessor: AE.AETOXGR | |
| DICTVER | Dictionary Name and Version | text | 12 | Predecessor: SUPPAE.QVAL where SUPPAE.QNAM='DICTVER' | |
| ADESFL | Discontinued due to AE | text | 1 | 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 description in ADRG.
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 | DATEFL
| Derived "D" if day is imputed.
= "M" if month and day are imputed.
= "Y" if month, day and year are imputed.ADMH |
| ASTDY | Analysis Start Relative Day | integer | 8 | Derived if (ASTDT<ADSL.VAX101DT) then ASTDY= ASTDT – ADSL.VAX101DT;
if (ASTDT≥ ADSL.VAX101DT) and (ASTDT<ADSL.VAX102DT) then ASTDY= ASTDT – ADSL.VAX101DT + 1
if (ASTDT≥ ADSL.VAX102DT) ASTDY= ASTDT – ADSL.VAX102DT + 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 (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, refer to ADRG for details. | |
| AENDY | Analysis End Relative Day | integer | 8 | Derived if (ASTDT<ADSL.VAX101DT) then AENDY= AENDT – ADSL.VAX101DT;
if (ASTDT≥ ADSL.VAX101DT) and (ASTDT<ADSL.VAX102DT) then AENDY= AENDT – ADSL.VAX101DT + 1
if (ASTDT≥ ADSL.VAX102DT) 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 | |
| ADURU | Analysis Duration Units | text | 4 | UNIT
| Derived assign value 'DAYS' if ADURN is not missing |
| AESER | Serious Event | text | 1 | Predecessor: AE.AESER | |
| AESCONG | Congenital Anomaly or Birth Defect | text | 1 | Predecessor: AE.AESCONG | |
| AESDISAB | Persist or Signif Disability/Incapacity | text | 1 | Predecessor: AE.AESDISAB | |
| AESDTH | Results in Death | text | 1 | Predecessor: AE.AESDTH | |
| AESHOSP | Requires or Prolongs Hospitalization | text | 1 | Predecessor: AE.AESHOSP | |
| AESLIFE | Is Life Threatening | text | 1 | Predecessor: AE.AESLIFE | |
| AESMIE | Other Medically Important Serious Event | text | 1 | Predecessor: AE.AESMIE | |
| AEMERES | Is AE a Result of a Medication Error | text | 1 | Predecessor: SUPPAE.QVAL where SUPPAE.QNAM='AEMERES' | |
| AEREL | Causality | text | 11 | 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 | Predecessor: SUPPAE.QVAL where SUPPAE.QNAM='AECMGIV' | |
| AENDGIV | Was a Non-Drug Treatment given | text | 1 | Predecessor: SUPPAE.QVAL where SUPPAE.QNAM='AENDGIV' | |
| AEOUT | Outcome of Adverse Event | text | 32 | Predecessor: AE.AEOUT | |
| AESUBJDC | Discontinued because of this AE | text | 1 | Predecessor: SUPPAE.QVAL where SUPPAE.QNAM='AESUBJDC' | |
| AEREFID | Reference ID | text | 10 | Predecessor: AE.AEREFID | |
| AERELN | Causality (N) | integer | 8 | Assigned Numeric Code of AEREL AERELN=1 for RELATED; ARRELN=3 for NOT RELATED | |
| AREL | Analysis Causality | text | 11 | Predecessor: AE.AEREL | |
| ARELN | Analysis Causality (N) | integer | 8 | 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 | Assigned Numeric Code of AE.AETOXGR 1=Grade 1; 2=Grade 2; 3=Grade 3; 4=Grade 4 | |
| ATOXGR | Analysis Toxicity Grade | text | 7 | Derived Derived from AE.AETOXGR | |
| ATOXGRN | Analysis Toxicity Grade (N) | integer | 8 | 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 | 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.EXSTDTM 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 | 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 vaccination 1/2 | |
| APERIOD | Period | integer | 8 | Derived Numeric Code of aperiodc
1 for all subjects take vaccination | |
| APERIODC | Period (C) | text | 9 | Derived aperiodc='Period 01' for all subjects vacinated | |
| 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 APERSDTM = datetime of (ADSL.TRTSDTM) for all subjects vaccinated | |
| 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 APERSDTM =datetime of (Datepart(ADSL.TREDTM) +365 and timepart(ADSL.TREDTM))
Note: 365 is the flag set by study level. | |
| VPHASE | Vaccine Phase | text | 15 | Derived If AE happend before vax 1 then VPHASE='Pre-Vaccination'; (Note: AE start time is collected per CRF)
If AE happend on or after vax1 and before vax2 then VPHASE='Vaccination 1';
if AE happend on or after vax2 and before or on the same day of ADSL.V01DT then VPHASE='Vaccination 2';
if AE happend after ADSL.V01DT and before or on the same day of ADSL.V02DT then VPHASE='Follow Up 1';
if AE happend after ADSL.V02DT then VPHASE='Follow Up 2'; | |
| VPHASEN | Vaccine Phase(N) | integer | 8 | Derived 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'; | |
| INWDFL | Within Reporting Window Flag | text | 1 | Y
| Derived if VPHASEN not in (0, 99) 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 taken before AE occurred |
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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 | AGEU
| Predecessor: ADSL.AGEU |
| SEX | Sex | text | 1 | SEX
| Predecessor: ADSL.SEX |
| SEXN | Sex (N) | integer | 8 | Predecessor: ADSL.SEXN | |
| RACE | Race | text | 41 | RACE [7 Terms] | Predecessor: ADSL.RACE |
| RACEN | Race (N) | integer | 8 | Predecessor: ADSL.RACEN | |
| ARACE | Analysis Race | text | 41 | ARACE [7 Terms] | Predecessor: ADSL.ARACE |
| ARACEN | Analysis Race (N) | integer | 8 | Predecessor: ADSL.ARACEN | |
| SAFFL | Safety Population Flag | text | 1 | NY
| Predecessor: ADSL.SAFFL |
| ARM | Description of Planned Arm | text | 27 | Predecessor: ADSL.ARM | |
| ARMCD | Planned Arm Code | text | 9 | Predecessor: ADSL.ARMCD | |
| ACTARM | Description of Actual Arm | text | 27 | Predecessor: ADSL.ACTARM | |
| ACTARMCD | Actual Arm Code | text | 9 | 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 | 27 | Predecessor: ADSL.TRT01A | |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | |
| TRT01P | Planned Treatment for Period 01 | text | 27 | Predecessor: ADSL.TRT01P | |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | |
| 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 | |
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Predecessor: ADSL.VAX101DT | |
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Predecessor: ADSL.VAX102DT | |
| VAX103DT | Vaccination Date 03 | integer | DATE9 | Predecessor: ADSL.VAX103DT | |
| COHORT | Cohort Group | text | 75 | Predecessor: ADSL.COHORT | |
| COHORTN | Cohort Group (N) | float | 8 | Predecessor: ADSL.COHORTN | |
| DOSPLVL | Planned Dosing Level | text | 52 | Predecessor: ADSL.DOSPLVL | |
| DOSPLVLN | Planned Dosing Level (N) | integer | 8 | Predecessor: ADSL.DOSPLVLN | |
| DOSALVL | Actual Dosing Level | text | 52 | Predecessor: ADSL.DOSALVL | |
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Predecessor: ADSL.DOSALVLN | |
| PHASE | Study Phase | text | 20 | Predecessor: ADSL.PHASE | |
| PHASEN | Study Phase (N) | integer | 8 | Predecessor: ADSL.PHASEN | |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Predecessor: ADSL.AGEGR1 | |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | |
| AGEGR2 | Pooled Age Group 2 | text | 10 | Predecessor: ADSL.AGEGR2 | |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Predecessor: ADSL.AGEGR2N | |
| VAX101 | Vaccination 01 | text | 37 | Predecessor: ADSL.VAX101 | |
| VAX102 | Vaccination 02 | text | 36 | Predecessor: ADSL.VAX102 | |
| VAX103 | Vaccination 03 | text | 36 | Predecessor: ADSL.VAX103 | |
| DS30KFL | Phase 3 30k Subjects Flag | text | 1 | NY
| Predecessor: ADSL.DS30KFL |
| COVBLST | Baseline SARS-CoV-2 Status | text | 3 | Predecessor: ADSL.COVBLST | |
| MULENRFL | Multiply Enrolled Subjects | text | 1 | Predecessor: ADSL.MULENRFL | |
| STEXCFL | Site/Subject Exclusion Flag for SQE | text | 1 | Predecessor: ADSL.STEXCFL | |
| HIVFL | HIV Positive Subjects Flag | text | 1 | Predecessor: ADSL.HIVFL | |
| TRTA | Actual Treatment | text | 27 | 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 | 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 | 27 | Predecessor: ADSL.TRT01P | |
| TRTPN | Planned Treatment (N) | integer | 8 | 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 | Predecessor: CE.CELLT | |
| CEDECOD | Dictionary-Derived Term | text | 19 | Predecessor: CE.CEDECOD | |
| CEPTCD | Preferred Term Code | integer | 8 | Predecessor: CE.CEPTCD | |
| CEBODSYS | Body System or Organ Class | text | 52 | Predecessor: CE.CEBODSYS | |
| CEBDSYCD | Body System or Organ Class Code | integer | 8 | Predecessor: CE.CEBDSYCD | |
| CECAT | Category for Clinical Event | text | 14 | Predecessor: CE.CECAT | |
| CESCAT | Subcategory for Clinical Event | text | 19 | Predecessor: CE.CESCAT | |
| CEPRESP | Clinical Event Pre-Specified | text | 1 | Predecessor: CE.CEPRESP | |
| CEOCCUR | Clinical Event Occurrence | text | 1 | Predecessor: CE.CEOCCUR | |
| CESTAT | Completion Status | text | 1 | Predecessor: CE.CESTAT | |
| CEREASND | Reason Clinical Event Not Collected | text | 1 | Predecessor: CE.CEREASND | |
| ASEV | Analysis Severity/Intensity | text | 6 | Derived Set to 'Severe' for cases in FACE: 1) where FACE.FADTC is within 7 days after each vaccination and FACE.FATESTCD in ("DIAMETER" ‘MINDIAM' 'MAXDIAM') and FACE.FASTRESN>=10.5 and FACE.FAOBJ in ('REDNESS' 'SWELLING'); | |
| CESEV | Severity/Intensity | text | 28 | Predecessor: CE.CESEV | |
| CELOC | Location of Event | text | 14 | LOC
| Predecessor: CE.CELOC |
| CELAT | Laterality | text | 5 | LAT
| Predecessor: CE.CELAT |
| CESTDTC | Start Date/Time of Clinical Event | date | ISO 8601 | Predecessor: CE.CESTDTC | |
| CEENDTC | End Date/Time of Clinical Event | date | 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 | STENRF
| 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 | Derived Carried over from EX.EXDOSE.
Detailed algorithm as below:
Merge local reaction records (CE.CESCAT =”ADMINISTRATION SITE” ) with EX by USUBJID and (CE.CELNKID equals EX.EXLNKID)
Merge Systemic events (CE.CESCAT =”SYSTEMIC” ) with EX by USUBJID and (CE.CELNKID = EX.EXLNKGRP)
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 | Derived Carried over from EX.EXTRT. Same algorithm to merge EX as mentioned for EXDOSE | |
| EXDOSU | Dose Units | text | 3 | Derived Carried over from EX.EXDOSU. Same algorithm to merge EX as mentioned for EXDOSE | |
| EXSTDTC | Start Date/Time of Treatment | datetime | ISO 8601 | Derived Carried over from EX.EXSTDTC. Same algorithm to merge EX as mentioned for EXDOSE | |
| EXENDTC | End Date/Time of Treatment | datetime | ISO 8601 | Derived Carried over from EX.EXENDTC. Same algorithm to merge EX as mentioned for EXDOSE | |
| ASTDT | Analysis Start Date | integer | DATE9 | Derived ASTDT is the first day of the reactions/events within USUBJID/FATPTREF/FAOBJ level.
If first.FACE.FAOBJ then set ASTDT to datepart of FACE.FADTC when FACE.FAOBJ not in ('REDNESS' 'SWELLING' 'MEDICATIONS') and FACE.FASTRESC=”Y” and FACE.FATESTCD=”OCCUR”.
If first.FACE.FAOBJ then set ASTDT to datepart of FACE.FADTC when FACE.FAOBJ in ('REDNESS' 'SWELLING') and (FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FACE.FASTRESN>=2.5).
For CETERM='FEVER', if first.VSTESTCD then set ASTDT to datepart of VS.VSDTC where VS.VSCAT='REACTOGENICITY' and index(VS.VSTESTCD,'TEMP') and 38.0<=VS.VSSTRESN<=42.0 within USUBJID/VSTPTREF/VSTESTCD level.
Similar algorithm for readings with ASEV='Severe' (To derive start date for subjects with severe redness or swelling)
where FACE.FADTC is not missing and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FACE.FASTRESN>10 and FACE.FAOBJ in ('REDNESS' 'SWELLING'); | |
| AENDT | Analysis End Date | integer | DATE9 | Derived AENDT is the resolution date of the reactions/events within USUBJID/FATPTREF/FAOBJ level.
1) if a reaction/event resolved on the last diary day:
If last.FACE.FAOBJ then set AENDT to datepart of FACE.FADTC where FACE.FAOBJ not in ('REDNESS' 'SWELLING' 'MEDICATIONS') and FACE.FASTRESC=”Y” and FACE.FATESTCD=”OCCUR”.
If last.FACE.FAOBJ then set AENDT to datepart of FACE.FADTC where FACE.FAOBJ in ('REDNESS' 'SWELLING') and (FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FASTRESN>=2.5).
For CETERM='FEVER', if last.VSTESTCD then set AENDT to datepart of VS.VSDTC where VS.VSCAT='REACTOGENICITY' and index(VS.VSTESTCD,'TEMP') and 38.0<=VS.VSSTRESN<=42.0 within USUBJID/VSTPTREF/VSTESTCD level.
2) if a reaction/event still happend on the last diary day
AENDT was derived as numeric value of SUPPCE.RCENDTC if SUPPCE.RCENDTC is collected and not partial.
AENDT was derived as missing if (SUPPCE.RCENDTC is partial or SUPPCE.ONGNXVIS='Y') or (SUPPCE.RCENDTC and SUPPCE.ONGNXVIS are both missing).
If CETPTREF="VACCINATION 1" and VAX102DT ne. and (numeric value of SUPPCE.RCENDTC>VAX102DT or SUPPCE.ONGNXVIS='Y'), set AENDT to VAX102DT.
Note: For partial date or missing, need to check with stats for algorithmn (Do we need imputation for partial date).
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
| Derived 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 | NY
| Derived 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 | NY
| Derived This flag is derived at SUBJECT/FATPTREF/FAOBJ level:
For CE.CETERM in ('REDNESS' 'SWELLING'): Set to 'Y' if a subject had a reaction (FACE.FASTRESN >=2.5 and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') ) at any day from day 1 to day 7 after each dose; else set to 'N'.
For CE.CETERM not in ('REDNESS' 'SWELLING' 'FEVER'): Set to 'Y' if a subject had a reaction or an event (FACE.FATESTCD='SEV' and FACE.FASTRESC in ('MILD', 'MODERATE',''SEVER'')) at any day from day 1 to day 7 after each dose; else set to 'N'.
For CE.CETERM="FEVER", set to 'Y' if a subject had a record (38.0<=VS.VSSTRESN<=42.0) at any day from day 1 to day 7 after each dose within USUBJID/VSTPTREF/VSTESTCD level; else set to 'N'. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
Note: The unplanned assessments beyond 7 days after each vaccination are excluded when deriving ADCEVD. |
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Disposition Analysis Dataset (ADDS)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: DS.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: DS.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | |
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | |
| ADT | Analysis Date | integer | DATE9 | Derived Datepart( numeric value of DS.DSDTC)
Imputation of Partial Dates:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year. | |
| ASTDT | Analysis Start Date | integer | DATE9 | Derived Datepart(numeric value of DS.DSSTDTC) | |
| ASTDY | Analysis Start Relative Day | integer | 8 | Derived if ASTDT >= ADSL.TRTSDT then ASTDY = ASTDT - ADSL.TRTSDT + 1
otherwise ASTDY = ASTDT – ADSL.TRTSDT | |
| DSPHASE | Disposition Phase | text | 11 | Predecessor: SUPPDS.QVAL where SUPPDS.QNAM="DSPHASE" | |
| DSPHASEN | Disposition Phase Code (N) | integer | 8 | Assigned Numeric code for DSPHASE 1="SCREENING" 26="VACCINATION" 31="FOLLOW-UP" | |
| DSCAT | Category for Disposition Event | text | 17 | Predecessor: DS.DSCAT | |
| DSDECOD | Standardized Disposition Term | text | 49 | Predecessor: DS.DSDECOD | |
| DSDECODN | Standardized Disposition Term (N) | integer | 8 | Assigned Numeric code for DS.DSDECOD .Numeric code populated for only discontinued reasons 2=COMPLETED 13=SCREEN FAILURE 1=ADVERSE EVENT 3=DEATH 5=LOST TO FOLLOW-UP 7=OTHER 8=PHYSICIAN DECISION 9=PREGNANCY 11=PROTOCOL DEVIATION 14=STUDY TERMINATED BY SPONSOR 16=WITHDRAWAL BY SUBJECT 17=MEDICATION ERROR WITHOUT ASSOCIATED ADVERSE EVENT 18=NO LONGER MEETS ELIGIBILITY CRITERIA 25=REFUSED FURTHER STUDY PROCEDURES | |
| DSTERM | Reported Term for the Disposition Event | text | 100 | Predecessor: DS.DSTERM | |
| DSRANGRP | Randomization Group | text | 1 | Predecessor: SUPPDS.QVAL where SUPPDS.QNAM="DSRANGRP" | |
| M1PD2DT | 1 Month Post Dose 2 Visit Date | integer | DATE9 | Derived Derived from SV.svstdtc where SV.visit contains 'MONTH1_POSTVAX2'. | |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | AGEU
| Predecessor: ADSL.AGEU |
| SEX | Sex | text | 1 | SEX
| Predecessor: ADSL.SEX |
| SEXN | Sex (N) | integer | 8 | Predecessor: ADSL.SEXN | |
| RACE | Race | text | 41 | RACE [7 Terms] | Predecessor: ADSL.RACE |
| RACEN | Race (N) | integer | 8 | Predecessor: ADSL.RACEN | |
| ARACE | Analysis Race | text | 41 | ARACE [7 Terms] | Predecessor: ADSL.ARACE |
| ARACEN | Analysis Race (N) | integer | 8 | Predecessor: ADSL.ARACEN | |
| RANDFL | Randomized Population Flag | text | 1 | NY
| Predecessor: ADSL.RANDFL |
| SAFFL | Safety Population Flag | text | 1 | NY
| Predecessor: ADSL.SAFFL |
| ARM | Description of Planned Arm | text | 27 | Predecessor: ADSL.ARM | |
| ARMCD | Planned Arm Code | text | 9 | Predecessor: ADSL.ARMCD | |
| ACTARM | Description of Actual Arm | text | 27 | Predecessor: ADSL.ACTARM | |
| ACTARMCD | Actual Arm Code | text | 9 | 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 | |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Predecessor: ADSL.AGEGR1 | |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | |
| COHORT | Cohort Group | text | 75 | Predecessor: ADSL.COHORT | |
| COHORTN | Cohort Group (N) | float | 8 | Predecessor: ADSL.COHORTN | |
| DOSALVL | Actual Dosing Level | text | 52 | Predecessor: ADSL.DOSALVL | |
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Predecessor: ADSL.DOSALVLN | |
| DOSPLVL | Planned Dosing Level | text | 52 | Predecessor: ADSL.DOSPLVL | |
| DOSPLVLN | Planned Dosing Level (N) | integer | 8 | Predecessor: ADSL.DOSPLVLN | |
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Predecessor: ADSL.VAX101DT | |
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Predecessor: ADSL.VAX102DT | |
| VAX103DT | Vaccination Date 03 | integer | DATE9 | Predecessor: ADSL.VAX103DT | |
| VAX101 | Vaccination 01 | text | 37 | Predecessor: ADSL.VAX101 | |
| VAX102 | Vaccination 02 | text | 36 | Predecessor: ADSL.VAX102 | |
| VAX103 | Vaccination 03 | text | 36 | Predecessor: ADSL.VAX103 | |
| TRT01A | Actual Treatment for Period 01 | text | 27 | Predecessor: ADSL.TRT01A | |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | |
| TRT01P | Planned Treatment for Period 01 | text | 27 | Predecessor: ADSL.TRT01P | |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | |
| 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 | |
| PHASE | Study Phase | text | 20 | Predecessor: ADSL.PHASE | |
| PHASEN | Study Phase (N) | integer | 8 | Predecessor: ADSL.PHASEN | |
| EOSDCDT | End Of Study Discontinuation Date | integer | DATE9 | Predecessor: ADSL.EOSDCDT | |
| EOTDCDT | End Of Treatment Discontinuation Date | integer | DATE9 | Predecessor: ADSL.EOTDCDT | |
| BLDV6DT | Blood Sample Date 1 Month after Vax 2 | integer | DATE9 | Predecessor: ADSL.BLDV6DT | |
| DOMAIN | Domain Abbreviation | text | 2 | Assigned DS.DOMAIN | |
| DSSEQ | Sequence Number | integer | 8 | Predecessor: DS.DSSEQ |
Go to the top of the Define-XML document
Medical History Analysis Dataset (ADMH)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: MH.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: MH.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: ADSL.SUBJID | |
| SITEID | Study Site Identifier | text | 4 | Predecessor: ADSL.SITEID | |
| MHSEQ | Sequence Number | integer | 8 | Predecessor: MH.MHSEQ | |
| MHTERM | Reported Term for the Medical History | text | 100 | Predecessor: MH.MHTERM | |
| MHDECOD | Dictionary-Derived Term | text | 62 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHDECOD |
| MHPTCD | Preferred Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHPTCD |
| MHBODSYS | Body System or Organ Class | text | 67 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHBODSYS |
| MHBDSYCD | Body System or Organ Class Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHBDSYCD |
| MHLLT | Lowest Level Term | text | 69 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHLLT |
| MHLLTCD | Lowest Level Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHLLTCD |
| MHHLT | High Level Term | text | 82 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHHLT |
| MHHLTCD | High Level Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHHLTCD |
| MHHLGT | High Level Group Term | text | 86 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHHLGT |
| MHHLGTCD | High Level Group Term Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHHLGTCD |
| MHSOC | Primary System Organ Class | text | 67 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHSOC |
| MHSOCCD | Primary System Organ Class Code | integer | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.1 | Predecessor: MH.MHSOCCD |
| MHCAT | Category for Medical History | text | 23 | Predecessor: MH.MHCAT | |
| MHSTDTC | Start Date/Time of Medical History Event | datetime | ISO 8601 | Predecessor: MH.MHSTDTC | |
| MHENDTC | End Date/Time of Medical History Event | datetime | ISO 8601 | Predecessor: MH.MHENDTC | |
| MHENRTPT | End Relative to Reference Time Point | text | 7 | Predecessor: MH.MHENRTPT | |
| MHENTPT | End Reference Time Point | text | 22 | Predecessor: MH.MHENTPT | |
| DICTVER | Dictionary Name and Version | text | 12 | Predecessor: SUPPMH.DICTVER | |
| MHSPID | Sponsor-Defined Identifier | text | 2 | Predecessor: MH.MHSPID | |
| ASTDT | Analysis Start Date | integer | DATE9 | Derived ASTDT = date part of MH.MHSTDTC
Imputation of Partial Dates:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year. | |
| ASTDTF | Analysis Start Date Imputation Flag | text | 1 | DATEFL
| Derived "D" if day is imputed.
= "M" if month and day are imputed.
= "Y" if month, day and year are imputed.ADMH |
| ASTDY | Analysis Start Relative Day | integer | 8 | Derived if ASTDT >= TRTSDT then ASTDT – ADSL.TRTSDT + 1;
else if ASTDT< TRTSDT then ASTDT – ADSL.TRTSDT; | |
| AENDT | Analysis End Date | integer | DATE9 | Derived AENDT = date part of MH.MHENDTC
Imputation of Partial Dates:
If Day is missing, last day of Month
If Month is missing, last month of Year. | |
| AENDTF | Analysis End Date Imputation Flag | text | 1 | DATEFL
| Derived "D" if day is imputed.
= "M" if month and day are imputed.
= "Y" if month, day and year are imputed. |
| AENDY | Analysis End Relative Day | integer | 8 | Derived AENDT – ADSL.TRTSDT + 1 if AENDT >= TRTSDT,
else AENDT – ADSL.TRTSDT if AENDT < TRTSDT | |
| COMORBFL | Comorbidity Flag | text | 1 | Derived "Y" for mhterm with comorbidity defined in external source files (file name report-cci-xxxxxxx.csv) | |
| CAT1 | Charlson Comorbidity Index Category 1 | text | 37 | Derived Derived from Category column based on external source file report-comorbidity-categories.xlsx
Note: One MH term can be classified to multiple categories. | |
| CAT2 | Charlson Comorbidity Index Category 2 | text | 27 | Derived Derived from Category column based on external source file report-comorbidity-categories.xlsx
Note: One MH term can be classified to multiple categories. | |
| ADT | Analysis Date | integer | DATE9 | Derived ADT = date part of MH.MHDTC
Imputation of Partial Dates:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year. | |
| ADTF | Analysis Date Imputation Flag | text | 1 | DATEFL
| Derived "D" if day is imputed.
= "M" if month and day are imputed.
= "Y" if month, day and year are imputed.ADMH |
| ADURN | Analysis Duration (N) | float | 8 | Derived if MH.MHDUR exists then calculate ADURN in years and round it to 2 decimals. | |
| ADURU | Analysis Duration Units | text | 5 | UNIT
| Derived if adurn ne . then ADURU= 'YEARS' |
| AGE | Age | integer | 8 | Predecessor: ADSL.AGE | |
| AGEU | Age Units | text | 5 | AGEU
| Predecessor: ADSL.AGEU |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Predecessor: ADSL.AGEGR1 | |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Predecessor: ADSL.AGEGR1N | |
| SEX | Sex | text | 1 | SEX
| Predecessor: ADSL.SEX |
| SEXN | Sex (N) | integer | 8 | Predecessor: ADSL.SEXN | |
| RACE | Race | text | 41 | RACE [7 Terms] | Predecessor: ADSL.RACE |
| RACEN | Race (N) | integer | 8 | Predecessor: ADSL.RACEN | |
| ARACE | Analysis Race | text | 41 | ARACE [7 Terms] | Predecessor: ADSL.ARACE |
| ARACEN | Analysis Race (N) | integer | 8 | Predecessor: ADSL.ARACEN | |
| SAFFL | Safety Population Flag | text | 1 | NY
| Predecessor: ADSL.SAFFL |
| ARM | Description of Planned Arm | text | 27 | Predecessor: ADSL.ARM | |
| ARMCD | Planned Arm Code | text | 9 | Predecessor: ADSL.ARMCD | |
| ACTARM | Description of Actual Arm | text | 27 | Predecessor: ADSL.ACTARM | |
| ACTARMCD | Actual Arm Code | text | 9 | Predecessor: ADSL.ACTARMCD | |
| RANDDT | Date of Randomization | integer | DATE9 | Predecessor: ADSL.RANDDT | |
| 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 | 27 | Predecessor: ADSL.TRT01A | |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01AN | |
| TRT01P | Planned Treatment for Period 01 | text | 27 | Predecessor: ADSL.TRT01P | |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | Predecessor: ADSL.TRT01PN | |
| 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 | |
| COHORT | Cohort Group | text | 75 | Predecessor: ADSL.COHORT | |
| COHORTN | Cohort Group (N) | float | 8 | Predecessor: ADSL.COHORTN | |
| DOSALVL | Actual Dosing Level | text | 52 | Predecessor: ADSL.DOSALVL | |
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Predecessor: ADSL.DOSALVLN | |
| DOSPLVL | Planned Dosing Level | text | 52 | Predecessor: ADSL.DOSPLVL | |
| DOSPLVLN | Planned Dosing Level (N) | integer | 8 | Predecessor: ADSL.DOSPLVLN | |
| PHASE | Study Phase | text | 20 | Predecessor: ADSL.PHASE | |
| PHASEN | Study Phase (N) | integer | 8 | Predecessor: ADSL.PHASEN | |
| DS30KFL | Phase 3 30k Subjects Flag | text | 1 | Predecessor: ADSL.DS30KFL |
Go to the top of the Define-XML document
CodeLists
ADC19EF.AVISIT
| Permitted Value (Code) |
|---|
| COVID_A |
| COVID_B |
| COVID_C |
| COVID_D |
| V1_DAY1_VAX1_L |
| V2_VAX2_L |
ADC19EF.AVISITN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | COVID_A |
| 2 | COVID_B |
| 3 | COVID_C |
| 4 | COVID_D |
| 60765 | V1_DAY1_VAX1_L |
| 60766 | V2_VAX2_L |
ADC19EF.PARAM
| Permitted Value (Code) |
|---|
| CDC DEFINED COVID-19 ILLNESS ONSET |
| CEPHEID RT-PCR ASSAY FOR SARS-COV-2 |
| COVID-19 NAAT RESULT AFTER DOSE |
| N-BINDING ANTIBODY |
| PRESENCE OF CDC DEFINED SYMPTOMS AFTER DOSE |
| PRESENCE OF PROTOCOL DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE |
| PRESENCE OF PROTOCOL DEFINED SYMPTOMS AFTER DOSE |
| PROTOCOL DEFINED COVID-19 ILLNESS ONSET |
| SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 |
| SEVERE COVID-19 ILLNESS ONSET |
| SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE |
| SEVERE COVID-19 SYMPTOMS - SIGNIFICANT ACUTE RENAL, HEPATIC, OR NEUROLOGIC DYSFUNCTION |
| SEVERE COVID-19 SYMPTOMS - USE OF VASOPRESSORS |
| SEVERE COVID-19 SYMPTOMS - VITAL SIGNS |
| SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR SEVERE COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR SEVERE COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR SEVERE COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR SEVERE COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR SEVERE COVID19 SYMPTOMS |
| SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS |
ADC19EF.PARAMCD
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| C19NIG | N-BINDING ANTIBODY |
| C19ONST | PROTOCOL DEFINED COVID-19 ILLNESS ONSET |
| CDCONST | CDC DEFINED COVID-19 ILLNESS ONSET |
| HCUICU | SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS |
| NAATRAD | COVID-19 NAAT RESULT AFTER DOSE |
| PRCDCSAD | PRESENCE OF CDC DEFINED SYMPTOMS AFTER DOSE |
| PRPDSAD | PRESENCE OF PROTOCOL DEFINED SYMPTOMS AFTER DOSE |
| PRSVCSAD | PRESENCE OF PROTOCOL DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE |
| RTCOV2NS | CEPHEID RT-PCR ASSAY FOR SARS-COV-2 |
| SARSCOV2 | SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 |
| SEVCONST | SEVERE COVID-19 ILLNESS ONSET |
| SEVCRF | SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE |
| SEVCRHN | SEVERE COVID-19 SYMPTOMS - SIGNIFICANT ACUTE RENAL, HEPATIC, OR NEUROLOGIC DYSFUNCTION |
| SEVCVS | SEVERE COVID-19 SYMPTOMS - VITAL SIGNS |
| SEVCVSPR | SEVERE COVID-19 SYMPTOMS - USE OF VASOPRESSORS |
| ST17CD | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SYMPTOMS |
| ST17PD | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS |
| ST17PDA | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE |
| ST17SE | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR SEVERE COVID19 SYMPTOMS |
| ST1CD | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SYMPTOMS |
| ST1PD | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS |
| ST1PDA | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE |
| ST1SE | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR SEVERE COVID19 SYMPTOMS |
| ST214CD | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SYMPTOMS |
| ST214PD | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS |
| ST214PDA | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE |
| ST214SE | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR SEVERE COVID19 SYMPTOMS |
| ST27CD | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SYMPTOMS |
| ST27PD | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS |
| ST27PDA | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE |
| ST27SE | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR SEVERE COVID19 SYMPTOMS |
| ST2CD | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SYMPTOMS |
| ST2PD | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS |
| ST2PDA | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE |
| ST2SE | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR SEVERE COVID19 SYMPTOMS |
ADC19EF.PARAMN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 40 | SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 |
| 41 | CEPHEID RT-PCR ASSAY FOR SARS-COV-2 |
| 90 | N-BINDING ANTIBODY |
| 91 | SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS |
| 101 | PRESENCE OF PROTOCOL DEFINED SYMPTOMS AFTER DOSE |
| 102 | PRESENCE OF CDC DEFINED SYMPTOMS AFTER DOSE |
| 103 | SEVERE COVID-19 SYMPTOMS - VITAL SIGNS |
| 104 | SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE |
| 105 | SEVERE COVID-19 SYMPTOMS - USE OF VASOPRESSORS |
| 106 | SEVERE COVID-19 SYMPTOMS - SIGNIFICANT ACUTE RENAL, HEPATIC, OR NEUROLOGIC DYSFUNCTION |
| 107 | PRESENCE OF PROTOCOL DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE |
| 110 | COVID-19 NAAT RESULT AFTER DOSE |
| 120 | PROTOCOL DEFINED COVID-19 ILLNESS ONSET |
| 125 | CDC DEFINED COVID-19 ILLNESS ONSET |
| 130 | SEVERE COVID-19 ILLNESS ONSET |
| 141 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS |
| 142 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS |
| 143 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS |
| 144 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS |
| 145 | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS |
| 151 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SYMPTOMS |
| 152 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SYMPTOMS |
| 153 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SYMPTOMS |
| 154 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SYMPTOMS |
| 155 | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SYMPTOMS |
| 161 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR SEVERE COVID19 SYMPTOMS |
| 162 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR SEVERE COVID19 SYMPTOMS |
| 163 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR SEVERE COVID19 SYMPTOMS |
| 164 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR SEVERE COVID19 SYMPTOMS |
| 165 | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR SEVERE COVID19 SYMPTOMS |
| 171 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE |
| 172 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE |
| 173 | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE |
| 174 | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE |
| 175 | SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SYMPTOMS - ALL AVAILABLE |
ADC19EF.VISIT
| Permitted Value (Code) |
|---|
| COVID_A |
| COVID_AR1 |
| COVID_B |
| COVID_BR1 |
| COVID_C |
| COVID_D |
| V1_DAY1_VAX1_L |
| V2_VAX2_L |
ADC19EF.VISITNUM
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | COVID_A |
| 2 | COVID_B |
| 3 | COVID_C |
| 4 | COVID_D |
| 1001 | COVID_AR1 |
| 2001 | COVID_BR1 |
| 60765 | V1_DAY1_VAX1_L |
| 60766 | V2_VAX2_L |
ADFACEVD.AVISIT
| Permitted Value (Code) |
|---|
| UNPLANNED VISIT 0.001 |
| UNPLANNED VISIT 1.001 |
| UNPLANNED VISIT 60748.001 |
| UNPLANNED VISIT 60749.001 |
| UNPLANNED VISIT 60750.001 |
| UNPLANNED VISIT 60765.001 |
| UNPLANNED VISIT 60765.002 |
| UNPLANNED VISIT 60765.003 |
| UNPLANNED VISIT 60766.001 |
| UNPLANNED VISIT 60766.002 |
| V1_DAY1_VAX1_L |
| V1_DAY1_VAX1_S |
| V2_VAX2_L |
| V3_MONTH1_POSTVAX2_L |
| V4_WEEK3_VAX2_S |
| V4_WEEK3_VAX2_S_R |
| V6_WEEK2_POSTVAX2_S |
| 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 | V4_WEEK3_VAX2_S_R |
| 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 |
| 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 |
ADSYMPT.AVISIT
| Permitted Value (Code) |
|---|
| COVID_A |
| COVID_B |
| COVID_C |
| COVID_D |
| V1_DAY1_VAX1_L |
| V2_VAX2_L |
ADSYMPT.AVISITN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | COVID_A |
| 2 | COVID_B |
| 3 | COVID_C |
| 4 | COVID_D |
| 60765 | V1_DAY1_VAX1_L |
| 60766 | V2_VAX2_L |
ADSYMPT.PARAM
| Permitted Value (Code) |
|---|
| CEPHEID RT-PCR ASSAY FOR SARS-COV-2 |
| CHILLS |
| DEATH |
| DIARRHEA |
| DIASTOLIC BLOOD PRESSURE |
| FATIGUE |
| FEVER |
| HEADACHE |
| HEART RATE |
| HIGH FLOW OXYGEN THERAPY |
| MECHANICAL VENTILATION |
| N-BINDING ANTIBODY |
| NAUSEA |
| NEW LOSS OF TASTE OR SMELL |
| NEW OR INCREASED COUGH |
| NEW OR INCREASED MUSCLE PAIN |
| NEW OR INCREASED NASAL CONGESTION |
| NEW OR INCREASED SHORTNESS OF BREATH |
| NEW OR INCREASED SORE THROAT |
| NEW OR INCREASED WHEEZING |
| NON-INVASIVE POSITIVE PRESSURE VENTILATION |
| OXYGEN SATURATION |
| PP ARTERIAL O2/FRACTION INSPIRED O2 |
| RHINORRHOEA |
| RESPIRATORY RATE |
| SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 |
| SIGNIFICANT ACUTE HEPATIC DYSFUNCTION |
| SIGNIFICANT ACUTE RENAL DYSFUNCTION |
| SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS |
| SYSTOLIC BLOOD PRESSURE |
| VASOPRESSORS AGENTS |
| VOMITING |
ADSYMPT.PARAMCD
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| C19NIG | N-BINDING ANTIBODY |
| CHILLS | CHILLS |
| DEATH | DEATH |
| DIABP | DIARRHEA |
| DIARRHEA | DIASTOLIC BLOOD PRESSURE |
| FATIGUE | FATIGUE |
| FEVER | FEVER |
| HCUICU | SUJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS |
| HEADACHE | HEADACHE |
| HFOXTHRP | HIGH FLOW OXYGEN THERAPY |
| HR | HEART RATE |
| MCHVENT | MECHANICAL VENTILATION |
| NAUSEA | NAUSEA |
| NCOUG | NEW OR INCREASED COUGH |
| NIPPV | NON-INVASIVE POSITIVE PRESSURE VENTILATION |
| NLTSTSML | NEW LOSS OF TASTE OR SMELL |
| NMUSPN | NEW OR INCRESED MUSCLE PAIN |
| NNSLCONG | NEW OR INCREASED NASAL CONGESTION |
| NSRTHROT | NEW OR INCRESED SORE THROAT |
| NSTBRTH | NEW OR INCREASED SHORTNESS OF BREATH |
| OXYSAT | OXYGEN SATURATION |
| PO2FIO2 | PP ARTERIAL O2/FRACTION INSPIRED O2 |
| RESP | RESPIRATORY RATE |
| RIHNRA | RHINORRHOEA |
| RTCOV2NS | SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 |
| SAHDFN | SIGNIFICANT ACUTE HEPATIC DYSFUNCTION |
| SARDFN | SIGNIFICANT ACUTE RENAL DYSFUNCTION |
| SARSCOV2 | CEPHEID RT-PCR ASSAY FOR SARS-COV-2 |
| SYSBP | SYSTOLIC BLOOD PRESSURE |
| VOMIT | VOMITING |
| VSOPRES | VASOPRESSORS AGENTS |
| WHEEZ | NEW OR INCREASED WHEEZING |
ADSYMPT.PARAMN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | CHILLS |
| 2 | DIARRHEA |
| 3 | FEVER |
| 4 | NEW LOSS OF TASTE OR SMELL |
| 5 | NEW OR INCREASED COUGH |
| 6 | NEW OR INCREASED MUSCLE PAIN |
| 7 | NEW OR INCREASED SHORTNESS OF BREATH |
| 8 | NEW OR INCREASED SORE THROAT |
| 9 | VOMITING |
| 11 | NEW OR INCREASED NASAL CONGESTION |
| 14 | NEW OR INCREASED WHEEZING |
| 15 | FATIGUE |
| 16 | HEADACHE |
| 17 | RHINORRHOEA |
| 18 | NAUSEA |
| 25 | SIGNIFICANT ACUTE RENAL DYSFUNCTION |
| 30 | SIGNIFICANT ACUTE HEPATIC DYSFUNCTION |
| 40 | SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 |
| 41 | CEPHEID RT-PCR ASSAY FOR SARS-COV-2 |
| 50 | RESPIRATORY RATE |
| 51 | HEART RATE |
| 52 | OXYGEN SATURATION |
| 53 | DIASTOLIC BLOOD PRESSURE |
| 54 | SYSTOLIC BLOOD PRESSURE |
| 60 | PP ARTERIAL O2/FRACTION INSPIRED O2 |
| 71 | NON-INVASIVE POSITIVE PRESSURE VENTILATION |
| 74 | MECHANICAL VENTILATION |
| 76 | HIGH FLOW OXYGEN THERAPY |
| 80 | VASOPRESSORS AGENTS |
| 90 | N-BINDING ANTIBODY |
| 91 | SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS |
| 99 | DEATH |
ADVA.AVISIT
| Permitted Value (Code) |
|---|
| Before Vaccination 1 |
| 1 Week after Vaccination 1 |
| 3 Weeks after Vaccination 1 |
| 4 Weeks after Vaccination 1 |
| 1 Week after Vaccination 2 |
| 2 Weeks after Vaccination 2 |
| 1 Month after Vaccination 2 |
| 5 Weeks after Vaccination 1 |
| 1 Month and 3 weeks after Vaccination 1 |
ADVA.AVISITN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | Before Vaccination 1 |
| 2 | 1 Week after Vaccination 1 |
| 3 | 3 Weeks after Vaccination 1 |
| 4 | 1 Week after Vaccination 2 |
| 5 | 2 Weeks after Vaccination 2 |
| 6 | 1 Month after Vaccination 2 |
| 3.1 | 4 Weeks after Vaccination 1 |
| 3.2 | 5 Weeks after Vaccination 1 |
| 3.3 | 1 Month and 3 weeks after Vaccination 1 |
ADVA.DTYPE [C81224]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| Derived [*] | Derived |
| LLOQIMP [*] | LLOQIMP |
* Extended Value
ADVA.PARAM
| Permitted Value (Code) |
|---|
| COVID-19 RBD IgG (U/mL) - Luminex Immunoassay |
| COVID-19 S1 IgG (U/mL) - Luminex Immunoassay |
| N-binding antibody - N-binding Antibody Assay |
| SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay |
| SARS-CoV-2 serum neutralizing titer 50 to COVID-19 RBD Ig |
| SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG |
| SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay |
| SARS-CoV-2 serum neutralizing titer 90 to COVID-19 RBD Ig |
| SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG |
ADVA.PARAMCD
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| C19NIG | N-binding antibody - N-binding Antibody Assay |
| C19RBDIG | COVID-19 RBD IgG (U/mL) - Luminex Immunoassay |
| C19S1IGG | COVID-19 S1 IgG (U/mL) - Luminex Immunoassay |
| C2NGNT50 | SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay |
| C2NGNT90 | SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay |
| NT50_RB | SARS-CoV-2 serum neutralizing titer 50 to COVID-19 RBD Ig |
| NT90_RB | SARS-CoV-2 serum neutralizing titer 90 to COVID-19 RBD Ig |
| NT50_S1 | SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG |
| NT90_S1 | SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG |
ADVA.PARAMN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay |
| 2 | SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay |
| 3 | COVID-19 S1 IgG (U/mL) - Luminex Immunoassay |
| 4 | COVID-19 RBD IgG (U/mL) - Luminex Immunoassay |
| 5 | N-binding antibody - N-binding Antibody Assay |
| 11 | SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG |
| 12 | SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG |
| 13 | SARS-CoV-2 serum neutralizing titer 50 to COVID-19 RBD Ig |
| 14 | SARS-CoV-2 serum neutralizing titer 90 to COVID-19 RBD Ig |
AGEU [C66781]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| YEARS [C29848] | Year |
ARACE
| Permitted Value (Code) |
|---|
| ASIAN |
| AMERICAN INDIAN OR ALASKA NATIVE |
| BLACK OR AFRICAN AMERICAN |
| MULTIRACIAL |
| NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER |
| NOT REPORTED |
| WHITE |
DATEFL [C81223]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| D [C81212] | Day Imputed |
| M [C81211] | Month Day Imputed |
ETHNIC [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 |
LAT [C99073]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| LEFT [C25229] | Left |
| RIGHT [C25228] | Right |
LOC [C74456]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| DELTOID MUSCLE [C32446] | Deltoid |
NY [C66742]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| N [C49487] | No |
| Y [C49488] | Yes |
RACE [C74457]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ASIAN [C41260] | Asian |
| AMERICAN INDIAN OR ALASKA NATIVE [C41259] | American indian or alaska native |
| BLACK OR AFRICAN AMERICAN [C16352] | Black or african american |
| MULTIPLE [*] | Multiple |
| NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER [C41219] | Native hawaiian or other pacific islander |
| NOT REPORTED [C43234] | Not reported |
| WHITE [C41261] | White |
* Extended Value
SEX [C66731]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| F [C16576] | Female |
| M [C20197] | Male |
STENRF [C66728]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ONGOING [C53279] | Continue |
UNIT [C71620]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| DAYS [C25301] | Day |
| YEARS [C29848] | Year |
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 |
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 |
| Algorithm: ADAE.ADURU | Computation | assign value 'DAYS' if ADURN is not missing |
| 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 vaccination 1/2 |
| Algorithm: ADAE.AENDT | Computation | Convert AEENDTC to DATE9 format
Note: No imputation for AENDT, refer to ADRG for details. |
| Algorithm: ADAE.AENDTM | Computation | Convert AEENDTC to IS8601 format. |
| Algorithm: ADAE.AENDY | Computation | if (ASTDT<ADSL.VAX101DT) then AENDY= AENDT – ADSL.VAX101DT;
if (ASTDT≥ ADSL.VAX101DT) and (ASTDT<ADSL.VAX102DT) then AENDY= AENDT – ADSL.VAX101DT + 1
if (ASTDT≥ ADSL.VAX102DT) 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.EXSTDTM 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 | APERSDTM =datetime of (Datepart(ADSL.TREDTM) +365 and timepart(ADSL.TREDTM))
Note: 365 is the flag set by study level. |
| Algorithm: ADAE.APERETM | Computation | Timepart(APEREDTM) |
| Algorithm: ADAE.APERIOD | Computation | Numeric Code of aperiodc
1 for all subjects take vaccination |
| Algorithm: ADAE.APERIODC | Computation | aperiodc='Period 01' for all subjects vacinated |
| Algorithm: ADAE.APERSDT | Computation | Datepart(APERSDTM) |
| Algorithm: ADAE.APERSDTM | Computation | APERSDTM = datetime of (ADSL.TRTSDTM) for all subjects vaccinated |
| Algorithm: ADAE.APERSTM | Computation | Timepart(APERSDTM) |
| Algorithm: ADAE.ASTDT | Computation | Convert imputed AESTDTC to DATE9 format.
Imputate partial start date per description in ADRG.
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.ADMH |
| Algorithm: ADAE.ASTDTM | Computation | Convert AESTDTC to IS8601 format. |
| Algorithm: ADAE.ASTDY | Computation | if (ASTDT<ADSL.VAX101DT) then ASTDY= ASTDT – ADSL.VAX101DT;
if (ASTDT≥ ADSL.VAX101DT) and (ASTDT<ADSL.VAX102DT) then ASTDY= ASTDT – ADSL.VAX101DT + 1
if (ASTDT≥ ADSL.VAX102DT) ASTDY= ASTDT – ADSL.VAX102DT + 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 (AESTDTC) |
| Algorithm: ADAE.ATOXGR | Computation | Derived from AE.AETOXGR |
| Algorithm: ADAE.INWDFL | Computation | if VPHASEN not in (0, 99) then INWDFL = "Y" |
| Algorithm: ADAE.PREFL | Computation | ASTDTM<TRTSDTM then PREFL="Y" |
| Algorithm: ADAE.VAXNO | Computation | The number of last vaccine taken before AE occurred |
| Algorithm: ADAE.VPHASE | Computation | If AE happend before vax 1 then VPHASE='Pre-Vaccination'; (Note: AE start time is collected per CRF)
If AE happend on or after vax1 and before vax2 then VPHASE='Vaccination 1';
if AE happend on or after vax2 and before or on the same day of ADSL.V01DT then VPHASE='Vaccination 2';
if AE happend after ADSL.V01DT and before or on the same day of ADSL.V02DT then VPHASE='Follow Up 1';
if AE happend after ADSL.V02DT then VPHASE='Follow Up 2'; |
| Algorithm: ADAE.VPHASEN | Computation | 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'; |
| Algorithm: ADC19EF.ADT | Computation | if paramcd = "SARSCOV2" then Set to ADSYMPT.ADT.
if paramcd = "RTCOV2NS" then Set to ADSYMPT.ADT.
if paramcd = "C19NIG" then Set to ADSYMPT.ADT.
if paramcd = "HCUICU" then Set to null.
if paramcd = "PRPDSAD" then Set to null.
if paramcd = "PRCDCSAD" then Set to null.
if paramcd = "SEVCVS" then Set to the earliest date from ADSYMPT.ADT when condition/s are present.
if paramcd = "SEVCRF" then Set to null.
if paramcd = "SEVCRHN" then Set to null.
if paramcd = "PRSVCSAD" then Set to null.
if paramcd = "NAATRAD" then "Set from ADSYMPT.ADT of concluded NAAT result based on specifications in AVAC of this record.
If both local and central results are missing/invalid, set this to null."
if paramcd = "C19ONST" then Set to ASTDT where PARAMCD = "PRPDSAD"
if paramcd = "CDCONST" then Set to ASTDT where PARAMCD = "PRCDCSAD"
if paramcd = "SEVCONST" then Set to ASTDT where PARAMCD = "PRSVCSAD"
if paramcd = "ST1PD" then Set to null.
if paramcd = "ST17PD" then Set to null.
if paramcd = "ST2PD" then Set to null.
if paramcd = "ST27PD" then Set to null.
if paramcd = "ST214PD" then Set to null.
if paramcd = "ST1CD" then Set to null.
if paramcd = "ST17CD" then Set to null.
if paramcd = "ST2CD" then Set to null.
if paramcd = "ST27CD" then Set to null.
if paramcd = "ST214CD" then Set to null.
if paramcd = "ST1SE" then Set to null.
if paramcd = "ST17SE" then Set to null.
if paramcd = "ST2SE" then Set to null.
if paramcd = "ST27SE" then Set to null.
if paramcd = "ST214SE" then Set to null.
if paramcd = "ST1PDA" then Set to null.
if paramcd = "ST17PDA" then Set to null.
if paramcd = "ST2PDA" then Set to null.
if paramcd = "ST27PDA" then Set to null.
if paramcd = "ST214PDA" then Set to null. |
| Algorithm: ADC19EF.ADY | Computation | Set as following:
ADY = ADT - TRTSDT.
If ADT >= TRTSDT, ADY = ADT - TRTSDT + 1. |
| Algorithm: ADC19EF.AENDT | Computation | if paramcd = "SARSCOV2" then Set to null.
if paramcd = "RTCOV2NS" then Set to null.
if paramcd = "C19NIG" then Set to null.
if paramcd = "HCUICU" then Set to ADSYMPT.AENDT.
if paramcd = "PRPDSAD" then Set to the latest date from ADSYMPT.AENDT when condition/s are present.
if paramcd = "PRCDCSAD" then Set to the latest date from ADSYMPT.AENDT when condition/s are present.
if paramcd = "SEVCVS" then Set to null.
if paramcd = "SEVCRF" then Set to the latest date from ADSYMPT.AENDT when condition/s are present and end dates of all contributing records are reported.
if paramcd = "SEVCRHN" then Set to the latest date from ADSYMPT.AENDT when condition/s are present and end dates of all contributing records are reported.
if paramcd = "PRSVCSAD" then Set to the latest date from AENDT when condition/s are present and contributing end dates except from vital signs are present/populated.
if paramcd = "NAATRAD" then Set to null.
if paramcd = "C19ONST" then Set to null.
if paramcd = "CDCONST" then Set to null.
if paramcd = "SEVCONST" then Set to null.
if paramcd = "ST1PD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST17PD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST2PD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST27PD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST214PD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST1CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "CDCONST".
if paramcd = "ST17CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "CDCONST".
if paramcd = "ST2CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "CDCONST".
if paramcd = "ST27CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "CDCONST".
if paramcd = "ST214CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "CDCONST".
if paramcd = "ST1SE" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "SEVCONST".
if paramcd = "ST17SE" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "SEVCONST".
if paramcd = "ST2SE" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "SEVCONST".
if paramcd = "ST27SE" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "SEVCONST".
if paramcd = "ST214SE" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "SEVCONST".
if paramcd = "ST1PDA" then Set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST17PDA" then Set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST2PDA" then Set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST27PDA" then Set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST".
if paramcd = "ST214PDA" then Set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST". |
| Algorithm: ADC19EF.AENDY | Computation | Set as following:
AENDY = AENDT - TRTSDT.
If AENDT >= TRTSDT, AENDY = AENDT - TRTSDT + 1. |
| Algorithm: ADC19EF.ASTDT | Computation | if paramcd = "SARSCOV2" then Set to null.
if paramcd = "RTCOV2NS" then Set to null.
if paramcd = "C19NIG" then Set to null.
if paramcd = "HCUICU" then Set to ADSYMPT.ASTDT.
if paramcd = "PRPDSAD" then Set to the earliest date from ADSYMPT.ASTDT when condition/s are present.
if paramcd = "PRCDCSAD" then Set to the earliest date from ADSYMPT.ASTDT when condition/s are present.
if paramcd = "SEVCVS" then Set to null.
if paramcd = "SEVCRF" then Set to the earliest date from ADSYMPT.ASTDT when condition/s are present.
if paramcd = "SEVCRHN" then Set to the earliest date from ADSYMPT.ASTDT when condition/s are present.
if paramcd = "PRSVCSAD" then Set to the earliest date from ADT/ASTDT when condition/s are present.
if paramcd = "NAATRAD" then Set to null.
if paramcd = "C19ONST" then Set to null.
if paramcd = "CDCONST" then Set to null.
if paramcd = "SEVCONST" then Set to null.
if paramcd = "ST1PD" then Set to Dose 1 date.
if paramcd = "ST17PD" then Set as Dose 1 + 7 when Dose 1 date is not missing.
if paramcd = "ST2PD" then Set to Dose 2 date.
if paramcd = "ST27PD" then Set as Dose 2 + 7 when Dose 2 date is not missing.
if paramcd = "ST214PD" then Set as Dose 2 + 14 when Dose 2 date is not missing.
if paramcd = "ST1CD" then Set to Dose 1 date.
if paramcd = "ST17CD" then Set as Dose 1 + 7 when Dose 1 date is not missing.
if paramcd = "ST2CD" then Set to Dose 2 date.
if paramcd = "ST27CD" then Set as Dose 2 + 7 when Dose 2 date is not missing.
if paramcd = "ST214CD" then Set as Dose 2 + 14 when Dose 2 date is not missing.
if paramcd = "ST1SE" then Set to Dose 1 date.
if paramcd = "ST17SE" then Set as Dose 1 + 7 when Dose 1 date is not missing.
if paramcd = "ST2SE" then Set to Dose 2 date.
if paramcd = "ST27SE" then Set as Dose 2 + 7 when Dose 2 date is not missing.
if paramcd = "ST214SE" then Set as Dose 2 + 14 when Dose 2 date is not missing.
if paramcd = "ST1PDA" then Set to Dose 1 date.
if paramcd = "ST17PDA" then Set as Dose 1 + 7 when Dose 1 date is not missing.
if paramcd = "ST2PDA" then Set to Dose 2 date.
if paramcd = "ST27PDA" then Set as Dose 2 + 7 when Dose 2 date is not missing.
if paramcd = "ST214PDA" then Set as Dose 2 + 14 when Dose 2 date is not missing. |
| Algorithm: ADC19EF.ASTDY | Computation | Set as following:
ASTDY = ASTDT - TRTSDT.
If ASTDT >= TRTSDT, ASTDY = ASTDT - TRTSDT + 1. |
| Algorithm: ADC19EF.AVAL | Computation | if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "CDCONST" "SEVCONST") then set to null.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing ore derived result is below 0, set to 0. |
| Algorithm: ADC19EF.AVALC | Computation | if paramcd = "SARSCOV2" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2".
if paramcd = "RTCOV2NS" then Set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS".
if paramcd = "C19NIG" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG".
if paramcd = "HCUICU" then Set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU".
if paramcd = "PRPDSAD" then Create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within a ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e. ADSYMPT.AVALC = "Y") , set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null.
if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null. if paramcd = "SEVCVS" then Set to null.
if paramcd = "SEVCVS" then Create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following: 1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = 'SEVCRF" then Create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "SEVCRHN" then Create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "PRSVCSAD" then Create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCRHN", "HCUICU" or Death set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null.
if paramcd = "NAATRAD" then Create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid, when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing.
if paramcd = "C19ONST" then Create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "CDCONST" then Create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is with in the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK".
if paramcd = "SEVCONST" then Create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported.
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Set to null. |
| Algorithm: ADC19EF.CDCRMUFL | Computation | Set to "Y" for all records of a subject, if CDC defined symptom/s are present and test result from local and/or central lab concluded as indeterminate, missing or unknown and symptom/s start date is before a first positive(PARAMCD is "CDCONST") case.
Otherwise set to "N" for all records of a subject. Also set to "N" for subjects who did not report any CDC defined symptoms.
Note: If a subject has reported these symptom/s more than once at different visits, set to "Y" if all of the test results are concluded as indeterminate, missing or unknown. |
| Algorithm: ADC19EF.CDCSYMFL | Computation | Set for all records of a subject as following:
If a subject has any record with AVALC = "Y" when PARAMCD = "PRCDCSAD", set to "Y".
Otherwise set to "N". |
| Algorithm: ADC19EF.CDP17FL | Computation | Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date.
2. Otherwise set to "N".
If subject reports CDC define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 1 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and within 7 days post Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. |
| Algorithm: ADC19EF.CDP1FL | Computation | Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date.
2. Otherwise set to "N".
If subject reports CDC define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. |
| Algorithm: ADC19EF.CDP214FL | Computation | Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates.
2. Otherwise set to "N".
If subject reports CDC define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 14 days after Dose 2 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and within 14 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. |
| Algorithm: ADC19EF.CDP27FL | Computation | Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates.
2. Otherwise set to "N".
If subject reports CDC define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 2 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and within 7 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. |
| Algorithm: ADC19EF.CNCRSLFL | Computation | Set for records where PARAMCD is "SARSCOV2" or "RTCOV2NS" or "C19NIG" as following:
If only one result is present per PARAMCD within a given visit set to "Y'.
For unplanned results, set "Y" if result date is up to 4 days before, on/after the symptom start date and symptom end date is missing. If the symptom end date is present, the result date must be within 4 days after the end date.
If multiple unplanned results qualify above condition, set to "Y" based on the result as POS > IND > NEG > UNK/missing. |
| Algorithm: ADC19EF.CRD1NGFL | Computation | Set for all records of a subject based on following:
If NAAT result date is on or before Dose 1 date and AVAC = "NEG" when PARAMCD = "RTCOV2NS", set to "Y".
If NAAT result date is on or before Dose 1 date and AVAC = "POS" when PARAMCD = "RTCOV2NS", set to "N".
Otherwise, set to null. |
| Algorithm: ADC19EF.CRD2NGFL | Computation | Set for all records of a subject based on following:
If NAAT result date is on or before Dose 2 date and AVAC = "NEG" when PARAMCD = "RTCOV2NS", set to "Y".
If NAAT result date is on or before Dose 2 date and AVAC = "POS" when PARAMCD = "RTCOV2NS", set to "N".
Otherwise, set to null. |
| Algorithm: ADC19EF.FILOCRFL | Computation | Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" as following:
if AVALC = "POS" and is the first onset of illness after dose, set to "Y". |
| Algorithm: ADC19EF.ILD17FL | Computation | Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" and AVALC is "POS" as following:
If illness onset date is greater then 7 days post Dose 1 date, set to "Y". Otherwise set to "N". |
| Algorithm: ADC19EF.ILD1FL | Computation | Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" and AVALC is "POS" as following:
If illness onset date is greater then Dose 1 date, set to "Y". Otherwise set to "N". |
| Algorithm: ADC19EF.ILD214FL | Computation | Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" and AVALC is "POS" as following:
If illness onset date is greater then 14 days post Dose 2 date, set to "Y". Otherwise set to "N". |
| Algorithm: ADC19EF.ILD27FL | Computation | Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" and AVALC is "POS" as following:
If illness onset date is greater then 7 days post Dose 2 date, set to "Y". Otherwise set to "N". |
| Algorithm: ADC19EF.ILD2FL | Computation | Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" and AVALC is "POS" as following:
If illness onset date is greater then Dose 2 date, set to "Y". Otherwise set to "N". |
| Algorithm: ADC19EF.NMPDOCFL | Computation | Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" as following:
if DVSTDT is null, set to "Y".
Also set to "Y" if DVSTDT occurs after the ADT of PARAMCDs specified above. |
| Algorithm: ADC19EF.PARCAT1 | Computation | if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "PRCDCSAD" "SEVCVS" "SEVCRF" "SEVCRHN") then Set to ADSYMPT.PARCAT1.
if paramcd in ("PRSVCSAD") then Set to "SURVEILLANCE TIME".
if paramcd in ("NAATRAD") then Set to "CENTRAL/LOCAL NAAT RESULTS".
if paramcd in ("C19ONST" "CDCONST" "SEVCONST") then Set to "ILLNESS ONSET".
if paramcd in ("ST1PD", "ST17PD" "ST2PD" "ST27PD" "ST214PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST214CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE" "ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA") then Set to "SURVEILLANCE TIME". |
| Algorithm: ADC19EF.PDP17FL | Computation | Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date.
2. Otherwise set to "N".
If subject reports protocol define symptoms, the following condition/s may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 1 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptom and start date of symptom is missing, on or after Dose 1 and within 7 days post Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. |
| Algorithm: ADC19EF.PDP1FL | Computation | Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date.
2. Otherwise set to "N".
If subject reports protocol define symptoms and/or has , the following condition/s may overwrite the previous value.
3. If there is an unscheduled NAAT test on or before Dose 1 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptoms and start date of symptom is missing, on or after Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. |
| Algorithm: ADC19EF.PDP214FL | Computation | Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates.
2. Otherwise set to "N".
If subject reports protocol define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 14 days after Dose 2 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptom and start date of symptom is missing, on or after Dose 1 and within 14 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. |
| Algorithm: ADC19EF.PDP27FL | Computation | Set this to all records with in a subject as following:
1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates.
2. Otherwise set to "N".
If subject reports protocol define symptoms, the following condition may overwrite the previous value.
3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 2 and the result is not negative set to "N".
4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptom and start date of symptom is missing, on or after Dose 1 and within 7 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. |
| Algorithm: ADC19EF.PDRMUFL | Computation | Set to "Y" for all records of a subject, if protocol defined symptom/s are present and test result from local and/or central lab concluded as indeterminate, missing or unknown and symptom/s start date is before a first positive(PARAMCD is "C19ONST") case.
Otherwise set to "N" for all records of a subject. Also set as "N" for subjects who did not report any protocol defined symptoms.
Note: If a subject has reported these symptom/s more than once at different visits, set to "Y" if all of the test results are concluded as indeterminate, missing or unknown. |
| Algorithm: ADC19EF.PDSDMFL | Computation | Set for all records of a subject as following:
If PDSYMFL = "Y" and symptom start date is missing, set to "Y".
Otherwise set to "N". |
| Algorithm: ADC19EF.PDSYMFL | Computation | Set for all records of a subject as following:
If a subject has any record with AVALC = "Y" when PARAMCD = "PRPDSAD", set to "Y".
Otherwise set to "N". |
| Algorithm: ADC19EF.SEVSYMFL | Computation | Set for all records of a subject as following:
If a subject has any record with AVALC = "Y" when PARAMCD = "SEVCVS", set to "Y".
Otherwise set to "N". |
| Algorithm: ADC19EF.VRBLNGFL | Computation | Set for all records of a subject based on following:
If NVA result date is on or before Dose 1 date and AVAC = "NEG" when PARAMCD = "C19NIG", set to "Y".
If NVA result date is on or before Dose 1 date and AVAC = "POS" when PARAMCD = "C19NIG", set to "N".
Otherwise, set to null. |
| Algorithm: ADCEVD.ADURN | Computation | ADURN=AENDT - ASTDT+1. |
| Algorithm: ADCEVD.ADURU | Computation | Set to ”Days” if ADURN is not missing. |
| Algorithm: ADCEVD.AENDT | Computation | AENDT is the resolution date of the reactions/events within USUBJID/FATPTREF/FAOBJ level.
1) if a reaction/event resolved on the last diary day:
If last.FACE.FAOBJ then set AENDT to datepart of FACE.FADTC where FACE.FAOBJ not in ('REDNESS' 'SWELLING' 'MEDICATIONS') and FACE.FASTRESC=”Y” and FACE.FATESTCD=”OCCUR”.
If last.FACE.FAOBJ then set AENDT to datepart of FACE.FADTC where FACE.FAOBJ in ('REDNESS' 'SWELLING') and (FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FASTRESN>=2.5).
For CETERM='FEVER', if last.VSTESTCD then set AENDT to datepart of VS.VSDTC where VS.VSCAT='REACTOGENICITY' and index(VS.VSTESTCD,'TEMP') and 38.0<=VS.VSSTRESN<=42.0 within USUBJID/VSTPTREF/VSTESTCD level.
2) if a reaction/event still happend on the last diary day
AENDT was derived as numeric value of SUPPCE.RCENDTC if SUPPCE.RCENDTC is collected and not partial.
AENDT was derived as missing if (SUPPCE.RCENDTC is partial or SUPPCE.ONGNXVIS='Y') or (SUPPCE.RCENDTC and SUPPCE.ONGNXVIS are both missing).
If CETPTREF="VACCINATION 1" and VAX102DT ne. and (numeric value of SUPPCE.RCENDTC>VAX102DT or SUPPCE.ONGNXVIS='Y'), set AENDT to VAX102DT.
Note: For partial date or missing, need to check with stats for algorithmn (Do we need imputation for partial date).
Similar algorithm for readings with ASEV='Severe' (To derive start date for subjects with severe redness or swelling):
where FACE.FADTC is not missing and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FACE.FASTRESN>10 and FACE.FAOBJ in ('REDNESS' 'SWELLING'); |
| Algorithm: ADCEVD.ASEV | Computation | Set to 'Severe' for cases in FACE: 1) where FACE.FADTC is within 7 days after each vaccination and FACE.FATESTCD in ("DIAMETER" ‘MINDIAM' 'MAXDIAM') and FACE.FASTRESN>=10.5 and FACE.FAOBJ in ('REDNESS' 'SWELLING'); |
| Algorithm: ADCEVD.ASTDT | Computation | ASTDT is the first day of the reactions/events within USUBJID/FATPTREF/FAOBJ level.
If first.FACE.FAOBJ then set ASTDT to datepart of FACE.FADTC when FACE.FAOBJ not in ('REDNESS' 'SWELLING' 'MEDICATIONS') and FACE.FASTRESC=”Y” and FACE.FATESTCD=”OCCUR”.
If first.FACE.FAOBJ then set ASTDT to datepart of FACE.FADTC when FACE.FAOBJ in ('REDNESS' 'SWELLING') and (FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FACE.FASTRESN>=2.5).
For CETERM='FEVER', if first.VSTESTCD then set ASTDT to datepart of VS.VSDTC where VS.VSCAT='REACTOGENICITY' and index(VS.VSTESTCD,'TEMP') and 38.0<=VS.VSSTRESN<=42.0 within USUBJID/VSTPTREF/VSTESTCD level.
Similar algorithm for readings with ASEV='Severe' (To derive start date for subjects with severe redness or swelling)
where FACE.FADTC is not missing and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FACE.FASTRESN>10 and FACE.FAOBJ in ('REDNESS' 'SWELLING'); |
| Algorithm: ADCEVD.EVENTFL | Computation | This flag is derived at SUBJECT/FATPTREF/FAOBJ level:
For CE.CETERM in ('REDNESS' 'SWELLING'): Set to 'Y' if a subject had a reaction (FACE.FASTRESN >=2.5 and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') ) at any day from day 1 to day 7 after each dose; else set to 'N'.
For CE.CETERM not in ('REDNESS' 'SWELLING' 'FEVER'): Set to 'Y' if a subject had a reaction or an event (FACE.FATESTCD='SEV' and FACE.FASTRESC in ('MILD', 'MODERATE',''SEVER'')) at any day from day 1 to day 7 after each dose; else set to 'N'.
For CE.CETERM="FEVER", set to 'Y' if a subject had a record (38.0<=VS.VSSTRESN<=42.0) at any day from day 1 to day 7 after each dose within USUBJID/VSTPTREF/VSTESTCD level; else set to 'N'. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
Note: The unplanned assessments beyond 7 days after each vaccination are excluded when deriving ADCEVD. |
| Algorithm: ADCEVD.EXDOSE | Computation | Carried over from EX.EXDOSE.
Detailed algorithm as below:
Merge local reaction records (CE.CESCAT =”ADMINISTRATION SITE” ) with EX by USUBJID and (CE.CELNKID equals EX.EXLNKID)
Merge Systemic events (CE.CESCAT =”SYSTEMIC” ) with EX by USUBJID and (CE.CELNKID = EX.EXLNKGRP)
Create ADCEVD by setting local reactions and systemic events from above step Keeping from EX EXDOSE , EXTRT, EXDOSU, EXSTDTC, EXENDTC |
| Algorithm: ADCEVD.EXDOSU | Computation | Carried over from EX.EXDOSU. Same algorithm to merge EX as mentioned for EXDOSE |
| Algorithm: ADCEVD.EXENDTC | Computation | Carried over from EX.EXENDTC. Same algorithm to merge EX as mentioned for EXDOSE |
| Algorithm: ADCEVD.EXSTDTC | Computation | Carried over from EX.EXSTDTC. Same algorithm to merge EX as mentioned for EXDOSE |
| Algorithm: ADCEVD.EXTRT | Computation | Carried over from EX.EXTRT. Same algorithm to merge EX as mentioned for EXDOSE |
| Algorithm: ADCEVD.KNOWVFL | Computation | 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: ADDS.ADT | Computation | Datepart( numeric value of DS.DSDTC)
Imputation of Partial Dates:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year. |
| Algorithm: ADDS.ASTDT | Computation | Datepart(numeric value of DS.DSSTDTC) |
| Algorithm: ADDS.ASTDY | Computation | if ASTDT >= ADSL.TRTSDT then ASTDY = ASTDT - ADSL.TRTSDT + 1
otherwise ASTDY = ASTDT – ADSL.TRTSDT |
| Algorithm: ADDS.M1PD2DT | Computation | Derived from SV.svstdtc where SV.visit contains 'MONTH1_POSTVAX2'. |
| 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.ATPTN | Computation | Numeric Part of ATPT |
| 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).
3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1.
*The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'.
*The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR').
*If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT.
For the fever related parameters from VS (FAOBJ='FEVER'),
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. |
| Algorithm: ADFACEVD.AVALC | Computation | For the parameters from FACE,
1) AVALC=FACE.FASTRESC;
2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE).
3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ.
3) If FATEST in ('Maximum Diameter') then set AVALC to missing.
4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing.
For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and (VS.VSCAT='REACTOGENICITY' or VS.VISIT eq missing).
1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator';
if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ;
else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'.
else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing.
Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were invovled in ADFACEVD. |
| 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.DTYPE | Computation | Set to "MAXIMUM" if FATEST in ('Maximum Severity', 'Maximum Temperature', 'Maximum Diameter') |
| Algorithm: ADFACEVD.EVENTDFL | Computation | This flag is derived at SUBJECT/FATPTREF/FAOBJ/FATEST/FATPT level:
For FATEST in ('Occurrence Indicator') and FAOBJ in ('REDNESS' 'SWELLING'): Set to 'Y' if a subject had a event (avalc='Y' and diameter>=2.5 cm) on the day within FATPTREF/FAOBJ/FATEST level; else set to 'N'.
For FATEST in ('Occurrence Indicator') or 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') on the day within FATPTREF/FAOBJ/FATEST/FATPT level; else set to 'N'.
For FATEST in ('Diameter', 'Maximum Diameter') : Set to 'Y' if a subject had a event (aval>=2.5 cm) on the day within FATPTREF/FAOBJ/FATPT level; else set to 'N'.
For FATEST in ('Maximum Temperature') : Set to 'Y' if a subject had a event (38.0 °C <=aval<=42.0 °C) on the day within FATPTREF/FAOBJ/FATPT level; else set to 'N'. |
| Algorithm: ADFACEVD.EVENTFL | Computation | This flag is derived at USUBJID/FATPTREF/FAOBJ level:
For FAOBJ in ('REDNESS' 'SWELLING'): Set to 'Y' if a subject had a record (diameter>=2.5 cm) at any day from day 1 to day 7; else set to 'N'.
For FAOBJ='MEDICATIONS': Set to 'Y' if a subject had a record (avalc='Y') at any day after each dose; else set to 'N'.
For FAOBJ='FEVER' : Set to 'Y' if a subject had a record (38.0 °C <=aval<=42.0 °C) at any day after each dose; else set to 'N'. Temperatures >42.0°C (>107.6°F) are omitted from the analysis.
For FAOBJ not in ('REDNESS' 'SWELLING' 'MEDICATIONS' 'FEVER'): Set to 'Y' for an reaction or an event if a subject had a record (avalc in ('MILD', 'MODERATE',''SEVER') 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.EXDOSE | Computation | Carried over from EX.EXDOSE.
Detailed algorithm as below:
For local reaction merge FACE with EX by USUBJID 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. |
| Algorithm: ADFACEVD.FAENINT | Computation | Set to "7D" if FATEST in ('Maximum Severity', 'Maximum Temperature', 'Maximum Diameter') |
| Algorithm: ADFACEVD.FAGRPID | Computation | FACE.FAGRPID or FAGRPID=concatenate (VS.VSTPTREF, VS.VSSCAT) separated by hyphen "-". |
| Algorithm: ADFACEVD.FALNKID | Computation | 1) FACE.FALNKID; 2) VS.VSLNKID;
3) Set to missing where FATEST in ('Maximum Severity', 'Maximum Diameter', 'Maximum Temperature'). |
| Algorithm: ADFACEVD.FAOBJ | Computation | FACE.FAOBJ or set to ‘FEVER’ for fever related parameters |
| Algorithm: ADFACEVD.FASTINT | Computation | Set to 'P0H' if FATEST in ('Maximum Severity', 'Maximum Temperature', 'Maximum Diameter') |
| Algorithm: ADFACEVD.FATEST | Computation | ADFACEVD includes:
1) the records from FACE domain: set to FACE.FATEST. For unplanned readings, only clinical assessments within 7 days after each vaccination are invovled.
2) the fever records from VS domain: FATEST="Occurrence Indicator";
3) the parameters derived in ADFACEVD, their values of FATEST have 'Severity/Intensity', 'Maximum Severity', 'Maximum Diameter' or 'Maximum Temperature'. See the algorithms of AVALC for detailed derivation. |
| Algorithm: ADFACEVD.FATESTCD | Computation | 1) FACE.FATESTCD. 2) Set to 'SEV', 'MAXSEV', 'MAXDIAM', 'MAXTEMP where FATEST in ('Severity/Intensity', 'Maximum Severity', 'Maximum Diameter', 'Maximum Temperature'). |
| Algorithm: ADFACEVD.FTEMCAT | Computation | Derived only for FAOBJ='FEVER'.
For VSORRESU='F':
if .<input(VS.VSORRES,best.)<100.4 then "<38.0 C";
else if 100.4<=input(VS.VSORRES,best.)<=101.1 then "38.0 C to 38.4 C" ;
else if 101.2<=input(VS.VSORRES,best.)<=102.0 then ">38.4 C to 38.9 C" ;
else if 102.1<=input(VS.VSORRES,best.)<=104.0 then ">38.9 C to 40.0 C";
else if input(VS.VSORRES,best.)>104.0 and VSSTRESN<=42.0 then ">40.0 C".
else if VSSTRESN>42 then 'Missing'.
For VSORRESU='C':
if .<input(VS.VSORRES,best.)<38.0 then "<38.0 C";
else if 38.0<=input(VS.VSORRES,best.)<=38.4 then "38.0 C to 38.4 C" ;
else if 38.5<=input(VS.VSORRES,best.)<=38.9 then ">38.4 C to 38.9 C" ;
else if 39.0<=input(VS.VSORRES,best.)<=40.0 then ">38.9 C to 40.0 C";
else if input(VS.VSORRES,best.)>40 and VSSTRESN<=42.0 then ">40.0 C".
else if VSSTRESN>42 then 'Missing'. |
| Algorithm: ADFACEVD.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. Use sentence case for param values. |
| Algorithm: ADFACEVD.PARCAT1 | Computation | Set to 'REACTOGENICITY' if index(FACAT, 'REACTOGENICITY') or index(VSCAT, 'REACTOGENICITY'). |
| Algorithm: ADFACEVD.SRCSEQ | Computation | 1) FACE.FASEQ or VS.VSSEQ.
2) Set to missing for those derived parameters: where FATEST in ('Maximum Severity', 'Maximum Diameter', 'Maximum Temperature'). |
| 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: ADFACEVD.VSORRES | Computation | VS.VSORRES where index(VS.VSTESTCD,”TEMP”) and CLTYP in ('DIARY CARD' 'CRF') |
| Algorithm: ADFACEVD.VSORRESU | Computation | VS.VSORRESU where index(VS.VSTESTCD,”TEMP”) and CLTYP in ('DIARY CARD' 'CRF') |
| Algorithm: ADFACEVD.VSSTRESN | Computation | VS.VSSTRESN where index(VS.VSTESTCD,”TEMP”) and CLTYP in ('DIARY CARD' 'CRF') |
| Algorithm: ADFACEVD.VSSTRESU | Computation | VS.VSSTRESU where index(VS.VSTESTCD,”TEMP”) and CLTYP in ('DIARY CARD' 'CRF') |
| Algorithm: ADMH.ADT | Computation | ADT = date part of MH.MHDTC
Imputation of Partial Dates:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year. |
| Algorithm: ADMH.ADTF | Computation | "D" if day is imputed.
= "M" if month and day are imputed.
= "Y" if month, day and year are imputed.ADMH |
| Algorithm: ADMH.ADURN | Computation | if MH.MHDUR exists then calculate ADURN in years and round it to 2 decimals. |
| Algorithm: ADMH.ADURU | Computation | if adurn ne . then ADURU= 'YEARS' |
| Algorithm: ADMH.AENDT | Computation | AENDT = date part of MH.MHENDTC
Imputation of Partial Dates:
If Day is missing, last day of Month
If Month is missing, last month of Year. |
| Algorithm: ADMH.AENDTF | Computation | "D" if day is imputed.
= "M" if month and day are imputed.
= "Y" if month, day and year are imputed. |
| Algorithm: ADMH.AENDY | Computation | AENDT – ADSL.TRTSDT + 1 if AENDT >= TRTSDT,
else AENDT – ADSL.TRTSDT if AENDT < TRTSDT |
| Algorithm: ADMH.ASTDT | Computation | ASTDT = date part of MH.MHSTDTC
Imputation of Partial Dates:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year. |
| Algorithm: ADMH.ASTDTF | Computation | "D" if day is imputed.
= "M" if month and day are imputed.
= "Y" if month, day and year are imputed.ADMH |
| Algorithm: ADMH.ASTDY | Computation | if ASTDT >= TRTSDT then ASTDT – ADSL.TRTSDT + 1;
else if ASTDT< TRTSDT then ASTDT – ADSL.TRTSDT; |
| Algorithm: ADMH.CAT1 | Computation | Derived from Category column based on external source file report-comorbidity-categories.xlsx
Note: One MH term can be classified to multiple categories. |
| Algorithm: ADMH.CAT2 | Computation | Derived from Category column based on external source file report-comorbidity-categories.xlsx
Note: One MH term can be classified to multiple categories. |
| Algorithm: COMORBFL | Computation | "Y" for mhterm with comorbidity defined in external source files (file name report-cci-xxxxxxx.csv) |
| Algorithm: ADSL.AAI1EFFL | Computation | If SAFFL="Y" and randfl="Y" and (vax101dt>. or vax102dt>.) then AAI1EFFL="Y"; else AAI1EFFL="N"; |
| Algorithm: ADSL.AAI2EFFL | Computation | If SAFFL="Y" and randfl="Y" and vax101dt>. and vax102dt>. 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.
For subjects with medication error, if the subject takes one dose of study drug and the other of placebo, then ACTARM will be study drug; else if the subject takes only placebo, then ACTARM will be placebo.
ACTARM=' ' for screen failure and not assigned subjects;
ACTARM='Not Treated' for not treated subjets;
ACTARM='Unplanned Treatment' for subjects with ARM='NOT ASSIGNED' but treated |
| Algorithm: ADSL.ACTARMCD | Computation | Based on the actual vaccinations taken by subjects. Same as ARMCD if no medication error for the vaccinated subjects.
For subjects with medication error, if the subject takes one dose of study drug and the other of placebo, then ACTARM will be study drug; else if the subject takes only placebo, then ACTARM will be placebo.
ACTARMCD=' ' for screen failure and not assigned subjects;
ACTARMCD='NOTTRT' for not treated subjets;
ACTARM='UNPLAN' for subjects with ARM='NOT ASSIGNED' but treated |
| 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.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 vaccinateion 1 date is one day before the subject's 19th birthday, the subject is 18 years old. |
| Algorithm: ADSL.AGETRU01 | Computation | AGETRU01='YEARS' for non-missing AGETR01. |
| 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.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 | Blood draw date at 1 Week after Vax 1 Visit
Note: For Phase 1 subjects only |
| Algorithm: ADSL.BLDV3ADT | Computation | If non missing blood draw date at 1 Week after Vax 1 Visit then bldv2fl = 'Y''; else bldv2fl = 'N'.
Note: For Phase 1 subjects only |
| Algorithm: ADSL.BLDV3DT | Computation | Blood draw date at 3 weeks after Vax 1 Visit
Note: For Phase 1 100 ug subjects only |
| Algorithm: ADSL.BLDV3FL | Computation | Blood draw date at Vax 2 Visit
Note: For Phase 1 subjects only |
| Algorithm: ADSL.BLDV4ADT | Computation | If non missing blood draw date at Vax 2 Visit then bldv3fl = 'Y''; else bldv3fl = 'N'.
Note: For Phase 1 subjects only |
| Algorithm: ADSL.BLDV4DT | Computation | Blood draw date at 4 weeks after Vax 1 Visit
Note: For Phase 1 100 ug subjects only |
| Algorithm: ADSL.BLDV4FL | Computation | Blood draw date at 1 Week after Vax 2 Visit
Note: For Phase 1 subjects only |
| Algorithm: ADSL.BLDV5ADT | Computation | If non missing blood draw date at 1 Week after Vax 2 Visit then bldv4fl = 'Y''; else bldv4fl = 'N'.
Note: For Phase 1 subjects only |
| Algorithm: ADSL.BLDV5DT | Computation | Blood draw date at 5 weeks after Vax 1 Visit
Note: For Phase 1 100 ug subjects only |
| Algorithm: ADSL.BLDV5FL | Computation | Blood draw date at 2 Weeks after Vax 2 Visit
Note: For Phase 1 subjects only |
| Algorithm: ADSL.BLDV6ADT | Computation | If non missing blood draw date at 2 Weeks after Vax 2 Visit then bldv5fl = 'Y''; else bldv5fl = 'N'.
Note: For Phase 1 subjects only |
| Algorithm: ADSL.BLDV6DT | Computation | Blood draw date at 1 Month after Vax 2 Visit. (Note for Phase 2 serology: For subjects without this visit, if there is a convalescent 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.) |
| Algorithm: ADSL.BLDV6FL | Computation | If non missing blood draw date at 1 Month after Vax 2 Visit then bldv6fl = 'Y''; else bldv6fl = 'N'. (Note for Phase 2 serology: For subjects without this visit, if there is a convalescent visit that happened within 28-42 days post dose 2, the convalescent visit will be used to replace this one, and bldv3fl will be set to "Y".) |
| Algorithm: ADSL.BLDV7DT | Computation | Blood draw date at 6 Months after Vax 2 Visit |
| Algorithm: ADSL.BLDV7FL | Computation | If non missing blood draw date at 6 Months after Vax 2 Visit then bldv7fl = 'Y''; else bldv7fl = 'N'. |
| 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<25 then BMICAT="Normal weight";
else if 25<=vsstresn<30 then BMICAT="Overweight";
else if 30<=vsstresn then BMICAT="Obese";
if vsstresn=. then BMICAT="Missing"; |
| Algorithm: ADSL.BMICATN | Computation | 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; |
| 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.COMBODFL | Computation | "Y" if subject with Medical History With Comorbodities. |
| Algorithm: ADSL.COVBLST | Computation | Subjects are considered with COVID-19 history if 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 09Oct2020 and obtained IC on or after 27Jul2020. |
| 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 import 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 EPOCH="FOLLOW-UP" and DS.DSDECOD^=“COMPLETED” |
| Algorithm: ADSL.EOSDCRS | Computation | EOSDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and DS.EPOCH="FOLLOW-UP" and DS.DSDECOD^=“COMPLETED” |
| Algorithm: ADSL.EOTDCDT | Computation | EOSDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and index(DS.EPOCH, "VACCINATION")>0 and DS.DSDECOD^=“COMPLETED” |
| Algorithm: ADSL.EOTDCRS | Computation | EOTDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and DS.EPOCH="VACCINATION" and DS.DSDECOD^=“COMPLETED” |
| Algorithm: ADSL.EV14EFFL | Computation | If SAFFL="Y" and RFICDT>. and RANDFL="Y" and ARM ne "SCREEN FAILURE" and INCL1fl="Y" and INCL2fl="Y" and INCL7fl="Y" and VAX102DT>. and (index(SUPPDV.CAPE, "POP2")=0 for subjects's all DV records or any records with DV date 14 days after Dose 2 and index(SUPPDV.CAPE, "POP2")>0 ) then EVALEFFL="Y"; else EVALEFFL="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 VAX102DT>. and (index(SUPPDV.CAPE, "POP2")=0 for subjects's all DV records or any records with DV date 7 days after Dose 2 and index(SUPPDV.CAPE, "POP2")>0 ) then EVALEFFL="Y"; else EVALEFFL="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.EXCRIT1 | Computation | Assign to "not eligible for the study at randomization" when EXCL1FL="Y" |
| Algorithm: ADSL.EXCRIT2 | Computation | Assign to "did not receive Dose 1 as randomized" when EXCL2FL="Y" |
| Algorithm: ADSL.EXCRIT3 | Computation | 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" |
| Algorithm: ADSL.EXCRIT4 | Computation | 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" |
| Algorithm: ADSL.EXCRIT5 | Computation | Will apply to Phase 1 only. Assign to "did not have blood collection within 19-23 days after Dose 1" when EXCL5FL="Y" |
| Algorithm: ADSL.EXCRIT6 | Computation | 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), POP3=Immunogenicity. |
| Algorithm: ADSL.EXCRIT7 | Computation | 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" |
| Algorithm: ADSL.EXCRIT8 | Computation | Assign to "did not have at least 1 valid and determinate immunogenicity result after Dose 2" when EXCL8FL="Y" |
| Algorithm: ADSL.EXCRIT9 | Computation | 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" |
| Algorithm: ADSL.F2MP2CAN | Computation | 1 for 0<=FU2MPD2/7<2;
2 for 2<=FU2MPD2/7<4;
3 for 4<=FU2MPD2/7<6;
4 for 6<=FU2MPD2/7<8;
etc. |
| Algorithm: ADSL.F2MP2CAT | Computation | "0-2 weeks" for 0<=FU2MPD2/7<2;
"2-4 weeks" for 2<=FU2MPD2/7<4;
"4-6 weeks" for 4<=FU2MPD2/7<6;
"6-8 weeks" for 6<=FU2MPD2/7<8;
etc. |
| Algorithm: ADSL.FU2MPD2 | Computation | if randfl="Y" then do;
if vax102dt=. then FU2MPD2=0;
else if not missing(eosdcdt) then FU2MPD2=eosdcdt=vax102dt+1;
else FU2MPD2="&cutoff2"d-vax102dt+1;
end;
Note: cutoff2 date is 14Nov2020 |
| Algorithm: ADSL.HIVFL | Computation | "Y" if subject with HIV positive. |
| 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 INCLerea and meets no exclusion INCLerea; |
| Algorithm: ADSL.INCL2FL | Computation | Receive at least one 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 |
| Algorithm: ADSL.INCL4FL | Computation | Will apply to Phase 1 only. Have at least 1 valid and determinate immunogenicity result 21 days after Dose 1. |
| 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.CAPE. 'Y' if the subjects with all records of SUPPDV.CAPE is "NO" or missing or CAPE indicates "POP2" only and this date of PD is earlier than 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 |
| 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" for subjects in Japenese subject list; else "N". |
| Algorithm: ADSL.MULENRFL | Computation | "Y" for subjects that were multiply enrolled subjests. |
| Algorithm: ADSL.NAATNFL | Computation | if index(visit,"V1_DAY1_") and mbtestcd='RTCOV2NS' and mborres="NEG" and mbdy<=1 then NAATNFL="Y";
else if index(visit,"V1_DAY1_") and mbtestcd='RTCOV2NS' and mborres="POS" and mbdy<=1 then NAATNFL="N"; |
| Algorithm: ADSL.NIGV1FL | Computation | if isorres="NEG" and index(visit,"V1_DAY1_") and isdy<=1 then NIGV1FL="Y";
else if isorres="POS" and index(visit,"V1_DAY1_") and isdy<=1 then NIGV1FL="N"; |
| Algorithm: ADSL.PC1MD2FL | Computation | "Y" if subject with any positive NAAT result before 1 month post dose 2. |
| Algorithm: ADSL.PHASE | Computation | "Phase 1" for subjects from Phase 1;
"Phase 2_ds360/ds6000" for subjects from Phase 2;
"Phase 3_ds6000" for subjects from Phase 3 and included in DS6000;
"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.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.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.SAFFL | Computation | If RANDFL='Y' and (VAX101DT ne . or VAX102DT ne . ) and (index(SUPPDV.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.STEXCFL | Computation | “Y” if subjets has SQE defined in DV |
| Algorithm: ADSL.TR01EDT | Computation | Datepart of the last EX.EXENDTC |
| Algorithm: ADSL.TR01EDTM | Computation | Datetime of the last EX.EXENDTC |
| Algorithm: ADSL.TR01ETM | Computation | Timepart of the last EX.EXENDTC |
| 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.TRT01A | Computation | Derived from ADSL.ACTARM |
| Algorithm: ADSL.TRT01P | Computation | Derived from DM.ARM |
| Algorithm: ADSL.TRTEDT | Computation | Max (Datepart of EX.EXENDTC) by subject level |
| Algorithm: ADSL.TRTEDTM | Computation | Max (EX.EXSTDTC) by subject level |
| Algorithm: ADSL.TRTETM | Computation | Max (Timepart of EX.EXENDTC) by subject level |
| Algorithm: ADSL.TRTSDT | Computation | Min (Datepart of EX.EXSTDTC) by subject level |
| Algorithm: ADSL.TRTSDTM | Computation | Min (EX.EXSTDTC) by subject level |
| Algorithm: ADSL.TRTSTM | Computation | Min (Timepart of EX.EXSTDTC) by subject level |
| Algorithm: ADSL.UNKRDFL | Computation | “Y" if ADSL.ARM is 'NOT ASSIGNED' and raddtc is not missing (This is derived for subject with incorrect rand number) |
| 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(VAX103DT+35, BE1DT, BE1DT2, VAX102DT+35, VAX101DT+58);
Note: used for AE summary tables to cutoff AEs within 1 month after vax2. And for subjects took a unscheduled dose 3, the 1 month after vax2 windown was calculated by vax103dt+35. |
| 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(VAX103DT+168, BE2DT, BE2DT2, VAX102DT+168, VAX101DT+191);
Note: used for AE summary tables to cutoff AEs within 6 month after vax2. And for subjects took a unscheduled dose 3, the 6 month after vax2 windown was calculated by vax103dt+168. |
| Algorithm: ADSL.VAX101 | Computation | Dose 1: combined form the vaccination at dose 1 and the corresponding dosage |
| 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 |
| 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.VAX103 | Computation | Dose 3: combined form the vaccination at dose 3 and the corresponding dosage |
| Algorithm: ADSL.VAX103DT | Computation | Date of the vaccination 3 (3rd vaccination date) |
| Algorithm: ADSL.VAX103TM | Computation | Time of the vaccination 3 (3rd vaccination date) |
| Algorithm: ADSYMPT.ADT | Computation | if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FADTC.
if paramcd in ("HCUICU") then Set to HO.HODTC.
if paramcd in ("C19NIG") then Set to IS.ISDTC.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBDTC.
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PRDTC.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSDTC.
if paramcd in ("SARDFN" "SAHDFN" "DEATH") then Set to null. |
| Algorithm: ADSYMPT.ADY | Computation | Set as following:
ADY = ADT - TRTSDT.
If ADT >= TRTSDT, ADY = ADT - TRTSDT + 1. |
| Algorithm: ADSYMPT.AENDT | Computation | if paramcd in ("SARDFN" "SAHDFN") then Set to CE.CEENDTC.
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FASTRESC where FA.FATESTCD = "LSYMDATE" and FA.FACAT = "EFFICACY" and FASCAT = "RESPIRATORY ILLNESS" within a matching FA.VISIT of a subject..
if paramcd in ("HCUICU") then Set to HO.HOENDTC.
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PRENDTC.
if paramcd in ("SARSCOV2" "RTCOV2NS" "RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "C19NIG" "DEATH") then Set to null. |
| Algorithm: ADSYMPT.AENDY | Computation | Set as following:
AENDY = AENDT - TRTSDT.
If AENDT >= TRTSDT, AENDY = AENDT - TRTSDT + 1. |
| Algorithm: ADSYMPT.ASTDT | Computation | if paramcd in ("SARDFN" "SAHDFN") then Set to CE.CESTDTC.
if paramcd in ("DEATH") then Set to DS.DSSTDTC.
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FASTRESC where FA.FATESTCD = "FSYMDATE" and FA.FACAT = "EFFICACY" and FASCAT = "RESPIRATORY ILLNESS" within a matching FA.VISIT of a subject.
if paramcd in ("HCUICU") then Set to HO.HOSTDTC.
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PRSTDTC.
if paramcd in ("SARSCOV2" "RTCOV2NS" "RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "C19NIG") then Set to null. |
| Algorithm: ADSYMPT.ASTDY | Computation | Set as following:
ASTDY = ASTDT - TRTSDT.
If ASTDT >= TRTSDT, ASTDY = ASTDT - TRTSDT + 1. |
| Algorithm: ADSYMPT.AVAL | Computation | if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN.
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA" "HCUICU" "C19NIG" "SARSCOV2" "RTCOV2NS" "NIPPV" "HFOXTHRP" "SARDFN" "SAHDFN" "DEATH") then Set to null. |
| Algorithm: ADSYMPT.AVALC | Computation | if paramcd in ("SARDFN" "SAHDFN" "DEATH" "HCUICU") then Set to "Y".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC.
if paramcd in ("C19NIG") then Set to IS.ISORRES.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. If upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK".
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PROCCUR.
if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to null. |
| Algorithm: ADSYMPT.AVISIT | Computation | Set to VISIT of source dataset. |
| Algorithm: ADSYMPT.AVISITN | Computation | Set to VISITNUM of source dataset. |
| Algorithm: ADSYMPT.C19ILHFL | Computation | Set this to "Y", if subject reported any of the following terms in MH.MHDECOD .
"Asymptomatic COVID-19"
"COVID-19"
"COVID-19 pneumonia"
"COVID-19 treatment"
"Suspected COVID-19"
"SARS-CoV-2 antibody test positive"
"SARS-CoV-2 carrier"
"SARS-CoV-2 sepsis"
"SARS-CoV-2 test positive"
"SARS-CoV-2 viraemia"
"Multisystem inflammatory syndrome in children" |
| Algorithm: ADSYMPT.PARAM | Computation | Set to FA.FAOBJ when upcase(FA.FAOBJ) = "CHILLS" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "DIARRHEA" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "FEVER" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW LOSS OF TASTE OR SMELL" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED COUGH" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED MUSCLE PAIN" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED SHORTNESS OF BREATH" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED SORE THROAT" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "VOMITING" and FA.FACAT = "EFFICACY" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to "NEW OR INCREASED NASAL CONGESTION" when upcase(FA.FAOBJ) = "NEW OR INCREASED NASAL CONGESTION" or "NASAL CONGESTION" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to "NEW OR INCREASED WHEEZING" when upcase(FA.FAOBJ) = "NEW OR INCREASED WHEEZING" or upcase(FA.FAOBJ) = "WHEEZING" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "FATIGUE" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "HEADACHE" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to "RHINORRHOEA" when upcase(FA.FAOBJ) contains "RUNNY NOSE" or upcase(FA.FAOBJ) = "RHINORRHOEA" and FA.FAOBJ ^= "NEW OR INCREASED NASAL DISCHARGE" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NAUSEA" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS".
Set to CE.CESCAT when CE.CESCAT = "SIGNIFICANT ACUTE RENAL DYSFUNCTION".
Set to CE.CESCAT when CE.CESCAT = "SIGNIFICANT ACUTE HEPATIC DYSFUNCTION".
Set to MB.MBTEST when upcase(MB.MBTESTCD) = "SARSCOV2" and MB.MBMETHOD = "IMMUNOCHROMATOGRAPHY".
Set to MB.MBTEST when upcase(MB.MBTESTCD) = "RTCOV2NS" and MB.MBMETHOD = "REVERSE TRANSCRIPTASE PCR".
Set to VS.VSTEST when VS.VSTESTCD = "RESP".
Set to VS.VSTEST when VS.VSTESTCD = "HR".
Set to VS.VSTEST when VS.VSTESTCD = "OXYSAT"
Set to VS.VSTEST when VS.VSTESTCD = "DIABP".
Set to VS.VSTEST when VS.VSTESTCD = "SYSBP".
Set to PR.PRTRT when upcase(PR.PRTRT) = "NON-INVASIVE POSITIVE PRESSURE VENTILATION".
Set to PR.PRTRT when upcase(PR.PRTRT) = "HIGH FLOW OXYGEN THERAPY".
Set to IS.ISTEST when IS.ISTESTCD = "C19NIG"
Set to "SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS" when HOTERM = "ICU'.
Set to DS.DSDECOD when DS.DSDECOD = "DEATH". |
| Algorithm: ADSYMPT.PARCAT1 | Computation | if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to "GENERAL VITAL SIGNS".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to "SIGNS AND SYMPTOMS OF DISEASE".
if paramcd in ("SARDFN" "SAHDFN") then Set to CE.CECAT.
if paramcd in ("DEATH") then Set to DS.DSCAT.
if paramcd in ("HCUICU") then Set to HO.HOCAT.
if paramcd in ("C19NIG") then Set to IS.ISCAT.
if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBCAT.
if paramcd in ("NIPPV" "HFOXTHRP") then Set to PR.PRCAT. |
| Algorithm: ADSYMPT.PARCAT2 | Computation | if paramcd in ("NIPPV" "HFOXTHRP") then Set to "RESPIRATORY FAILURE".
if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASCAT.
if paramcd in ("HCUICU" "C19NIG" "SARSCOV2" "RTCOV2NS" "RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "SARDFN" "SAHDFN" "DEATH") then Set to null. |
| Algorithm: ADVA.AAIMMFL | Computation | if avisitn<4 then do; if aai01fl="Y" then AAIMMFL="Y"; else AAIMMFL="N"; end; else if avisitn>=4 then do; if aai02fl="Y" then AAIMMFL="Y"; else AAIMMFL="N"; end; |
| Algorithm: ADVA.ABLFL | Computation | Set to 'Y' for a valid result (AVAL ne .) where collected before vax1. |
| Algorithm: ADVA.ABLPBLFL | Computation | Set to 'Y' if a subject has results both at baseline and post-baseline. Set to 'N' if a subject only has post-baseline results. |
| Algorithm: ADVA.ADT | Computation | ADT = date part of IS.ISDTC |
| Algorithm: ADVA.ANL01FL | Computation | Flag the record that is selected based on Windowing (AVISIT ne missing) |
| Algorithm: ADVA.ANL03FL | Computation | Flag the record with non-missing result (AVAL ne . ) and ISSTRESC not in ('','IND', 'QNS','INDETERMINATE') |
| Algorithm: ADVA.ANL04FL | Computation | Flag the record with non-missing AVAL and AVAL ge LLoQ*. |
| Algorithm: ADVA.APSBLFL | Computation | Set to 'Y' for a post-baseline result where collected after vax1 |
| Algorithm: ADVA.AVAL | Computation | If ISSTRESC in (' ', 'IND', 'QNS', 'INDETERMINATE') then set to missing; if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ; else set to IS.ISSTRESN. *LLoQ equals the value of ISLLOQ. For N-binding antibody test, 0 for negative and 1 for positive. For parameter with paramn from 11 to 14: AVAL is the ratio of the corresponding parameters specified in PARAM; eg: For PARAMN=11 (PARAM='SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG'), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point |
| Algorithm: ADVA.AVALC | Computation | Character value for AVAL |
| Algorithm: ADVA.AVISIT | Computation | Derive AVISIT based on IS.Visit/Visitnum for records with non-missing value (AVAL ne .); |
| Algorithm: ADVA.BASE | Computation | AVAL from the record with ABLFL="Y" at USUBJID/PARAM level |
| Algorithm: ADVA.BASEC | Computation | AVALC from the record with ABLFL="Y" at USUBJID/PARAM level |
| Algorithm: ADVA.BASETYPE | Computation | trim(left("Study"))||' ('||trim(left(dtype))||')'; |
| Algorithm: ADVA.BSSEROC | Computation | if base<islloq then BSSEROC="< LLOQ"; if base>=islloq then BSSEROC=">= LLOQ"; if missing baseline then BSSEROC="Missing" |
| Algorithm: ADVA.BSSERON | Computation | if BSSEROC="Missing" then BSSERON=0; if BSSEROC="< LLOQ" then BSSERON=1; if BSSEROC=">= LLOQ" then BSSERON=2; |
| Algorithm: ADVA.DTYPE | Computation | Set to 'LLOQIMP' for parameters that imputed for LLOQ. Set to 'Derived' for parameters for ratios. |
| Algorithm: ADVA.EVIMMFL | Computation | if avisitn<4 then do; if eval01fl="Y" then EVIMMFL="Y"; else EVIMMFL="N"; end; else if avisitn>=4 then do; if eval02fl="Y" then EVIMMFL="Y"; else EVIMMFL="N"; end; |
| Algorithm: ADVA.PARAM | Computation | param=trim(left(istest))||' ('||trim(left("titer"))||') - '||trim(left(ismethod)) for C2NGNT50 and C2NGNT90;
trim(left(IS.ISTEST)) || '(' || trim(left(IS.ISSTRESU)) || ')' || ' - ' || trim(left(IS.ISMETHOD)) for C19S1IGG and C19RBDIG;
trim(left(istest))||' - '||trim(left(ismethod)) for C19NIG;
istest of numerator “to” istest of denominator for ratios. |
| Algorithm: ADVA.PARAMN | Computation | See ADVA_Parameters table in complexalgorithms.pdf and derive PARAMN based on PARAM. |
| Algorithm: ADVA.R2BASE | Computation | R2BASE = AVAL/BASE for post baseline readings |
| Algorithm: ADVA.SRCDOM | Computation | Set to "IS" if DTYPE ne 'Derived'. |
| Algorithm: ADVA.SRCSEQ | Computation | IS.ISSEQ if DTYPE ne 'Derived'. |
| Algorithm: ADVA.SRCVAR | Computation | Set to "ISSTRESN" if DTYPE ne 'Derived'. |
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