Date/Time of Define-XML document generation: 2020-11-18T01:05:42Z
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 | |
| 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 |
Go to the top of the Define-XML document
Subject-Level Analysis Dataset (ADSL)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: DM.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: DM.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: DM.SUBJID | |
| SITEID | Study Site Identifier | text | 4 | Predecessor: DM.SITEID | |
| AGE | Age | integer | 8 | Predecessor: DM.AGE | |
| AGEU | Age Units | text | 5 | 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 DM.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" | |
| COMPLDT | Date of Completion | integer | DATE9 | Derived COMPLDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and DS.EPOCH="FOLLOW-UP" and DS.DSDECOD="COMPLETED" | |
| 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 | 36 | 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 | |
| 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 | 7 | 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(BE1DT, BE1DT2, VAX103DT+35, VAX102DT+35, VAX101DT+58);
Note: used for AE summary tables to cutoff AEs within 1 month after vax2 | |
| 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(BE2DT, BE2DT2, VAX103DT+168, VAX102DT+168, VAX101DT+191);
Note: used for AE summary tables to cutoff AEs within 6 month after vax2. | |
| DVSTDT | Start Date of Major PD | integer | DATE9 | Derived The earliest date of major 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
Note: For Phase 1 subjects only | |
| BLDV3ADT | Additional Bld Sample Date 3W after Vax1 | integer | DATE9 | Derived Blood draw date at 3 weeks after Vax 1 Visit
Note: For Phase 1 100 ug subjects only | |
| BLDV4ADT | Additional Bld Sample Date 4W after Vax1 | integer | DATE9 | Derived Blood draw date at 4 weeks after Vax 1 Visit
Note: For Phase 1 100 ug subjects only | |
| BLDV5ADT | Additional Bld Sample Date 5W after Vax1 | integer | DATE9 | Derived Blood draw date at 5 weeks after Vax 1 Visit
Note: For Phase 1 100 ug subjects only | |
| BLDV3DT | Blood Sample Date before Vax 2 | integer | DATE9 | Derived Blood draw date at Vax 2 Visit
Note: For Phase 1 subjects only | |
| BLDV4DT | Blood Sample Date 1 Week after Vax 2 | integer | DATE9 | Derived Blood draw date at 1 Week after Vax 2 Visit
Note: For Phase 1 subjects only | |
| BLDV5DT | Blood Sample Date 2 Weeks after Vax 2 | integer | DATE9 | Derived Blood draw date at 2 Weeks after Vax 2 Visit
Note: For Phase 1 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 | |
| BLDV8DT | Blood Sample Date 12 Months after Vax 2 | integer | DATE9 | Derived Blood draw date at 12 Months after Vax 2 Visit | |
| BLDV9DT | Blood Sample Date 24 Months after Vax 2 | integer | DATE9 | Derived Blood draw date at 24 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 major 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 that VAX102DT+7 |
| 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 |
| EVAL01FL | Dose 1 evaluable Immun Popu Flag | text | 1 | NY
| Derived If SAFFL="Y" and INCL1fl="Y" and INCL2fl="Y" and INCL4fl="Y" and INCL5fl="Y" and (index(SUPPDV.CAPE, "POP3")=0 for subjects's all DV records) then EVAL01FL="Y"; else EVI01FL="N"; |
| EVAL02FL | Dose 2 evaluable Immun Popu Flag | text | 1 | NY
| Derived If SAFFL="Y" and INCL1fl="Y" and INCL2fl="Y" and INCL7fl="Y" and INCL8fl="Y" and INCL9fl="Y" and (index(SUPPDV.CAPE, "POP3")=0 for subjects's all DV records) then EVI02FL="Y"; else EVI02FL="N"; |
| AAI01FL | Dose 1 all-available Immun Popu Flag | text | 1 | NY
| Derived If SAFFL="Y" and randfl="Y" and (vax101dt>. or vax102dt>.) and INCL3fl="Y" then AAI01FL="Y"; else AAI01FL="N"; |
| AAI02FL | Dose 2 all-available Immun Popu Flag | text | 1 | NY
| Derived If SAFFL="Y" and randfl="Y" and vax102dt>. and INCL8fl="Y" then AAI02FL="Y"; else AAI02FL="N"; |
| 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"; |
| 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 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 |
| BLDV3FL | Blood Sample Drawn before Vax 2 | text | 1 | NY
| Derived If non missing blood draw date at Vax 2 Visit then bldv3fl = 'Y''; else bldv3fl = 'N'.
Note: For Phase 1 subjects only |
| BLDV4FL | Blood Sample Drawn 1 Week after Vax 2 | text | 1 | NY
| 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 |
| BLDV5FL | Blood Sample Drawn 2 Weeks after Vax 2 | text | 1 | NY
| 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 |
| 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'. |
| BLDV8FL | Blood Sample Drawn 12 Months after Vax 2 | text | 1 | NY
| Derived If non missing blood draw date at 12 Months after Vax 2 Visit then bldv8fl = 'Y''; else bldv8fl = 'N'. |
| BLDV9FL | Blood Sample Drawn 24 Months after Vax 2 | text | 1 | NY
| Derived If non missing blood draw date at 24 Months after Vax 2 Visit then bldv9fl = 'Y''; else bldv9fl = '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 VAX102DT ne . and 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 | 133 | Derived Assign to "had major 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 16Sep2020 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 vax101dt>. and isdy<=1 then NIGV1FL="Y";
else if isorres="POS" and index(visit,"V1_DAY1_") and vax101dt>. 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 vax101dt>. and mbdy<=1 then NAATNFL="Y";
else if index(visit,"V1_DAY1_") and mbtestcd='RTCOV2NS' and mborres="POS" and vax101dt>. 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="Obesity";
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="Obesity" 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 for 04NOV2020 for interim analysis 1 | |
| 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. |
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 [22 Terms] | Assigned Numeric code for PARAM Please refer to codelist ADC19EF.PARAMN. | |
| PARAMCD | Parameter Code | text | 8 | ADC19EF.PARAMCD [22 Terms] | Assigned Character code for PARAM Please refer to codelist ADC19EF.PARAMCD. | |
| PARAM | Parameter | text | 94 | ADC19EF.PARAM [22 Terms] | Assigned Please refer to codelist ADC19EF.PARAM. | |
| PARCAT1 | Parameter Category 1 | text | 29 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "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" "SEVCONST") then Set to "ILLNESS ONSET".
if paramcd in ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) then Set to "SURVEILLANCE TIME". | ||
| AVALVLM | Analysis Value | integer | 8 | |||
| 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 | 2 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "SEVCONST") then set to null.
if paramcd in ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "SEVCONST") then set to null.
if paramcd in ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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 | 2 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "SEVCONST") then set to null.
if paramcd in ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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 | 2 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "SEVCONST") then set to null.
if paramcd in ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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 | 2 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "SEVCONST") then set to null.
if paramcd in ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "SEVCONST") then set to null.
if paramcd in ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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 | 2 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "SEVCONST") then set to null.
if paramcd in ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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 | 2 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "SEVCONST") then set to null.
if paramcd in ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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 | 2 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "SEVCONST") then set to null.
if paramcd in ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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 | 2 | Derived if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "HCUICU" "PRPDSAD" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "SEVCONST") then set to null.
if paramcd in ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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 = "C19NIG" (N-BINDING ANTIBODY) | N-BINDING ANTIBODY | 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 = "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 = "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 ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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 = "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 = "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 ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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 = "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 = "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 ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) then Set to null. | ||
| 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 = "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 = "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 ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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 = "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 = "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 ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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 = "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 = "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 ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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 = "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 = "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 ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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 | Predecessor: ADSYMPT.AVALC | ||
| 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 = "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 = "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 ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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 [8 Terms] | Predecessor: ADSYMPT.AVISITN | |
| AVISIT | Analysis Visit | text | 14 | ADC19EF.AVISIT [8 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 = "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 = "SEVCONST" then Set to ASTDT where PARAMCD = "PRSVCSAD"
if paramcd = "ST27PD" 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 = "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 = "ST27PDA" 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 = "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 = "SEVCONST" then Set to null.
if paramcd = "ST27PD" then Set as Dose 2 + 7 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 = "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 = "ST27PDA" then Set as Dose 2 + 7 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 = "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 = "SEVCONST" then Set to null.
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 = "ST1CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date.
if paramcd = "ST17CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date.
if paramcd = "ST2CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date.
if paramcd = "ST27CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date.
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 = "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". | ||
| 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 Major 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 | ||
| COMPLDT | Date of Completion | integer | DATE9 | Predecessor: ADSL.COMPLDT | ||
| RANDFL | Randomized Population Flag | text | 1 | NY
| Predecessor: ADSL.RANDFL | |
| EVALEFFL | Evaluable Efficacy Popu Flag | text | 1 | NY
| Predecessor: ADSL.EVALEFFL | |
| 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". | |
| 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 "SEVCONST" and AVALC is "POS" as following:
If illness onset date is greater then Dose 1 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 "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". | |
| FILOCRFL | First Illness Occurrence Flag | text | 1 | Y
| Derived Set for records where PARAMCD is "C19ONST" 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. | |
| 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. | |
| 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. | |
| NMPDOCFL | No Major Protocol Deviation Occur Flag | text | 1 | Y
| Derived Set for records where PARAMCD is "C19ONST" 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
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 [29 Terms] | Assigned Numeric code for PARAM Please refer to codelist ADSYMPT.PARAMN. | |
| PARAMCD | Parameter Code | text | 8 | ADSYMPT.PARAMCD [29 Terms] | Assigned Character code for PARAM Please refer to codelist ADSYMPT.PARAMCD. | |
| PARAM | Parameter | text | 48 | ADSYMPT.PARAM [29 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 | 29 | 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 | float | 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 | 2 | 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 | float | 4 | 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. | ||
| AVALCVLM | Analysis Value (C) | 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 = "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 = "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 = "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 = "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 = "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 = "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. | ||
| 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 [8 Terms] | Derived Set to VISITNUM of source dataset. | |
| AVISIT | Analysis Visit | text | 14 | ADSYMPT.AVISIT [8 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 | |
| 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" |
Go to the top of the Define-XML document
CodeLists
ADC19EF.AVISIT
| Permitted Value (Code) |
|---|
| COVID_A |
| COVID_AR1 |
| COVID_B |
| COVID_BR1 |
| 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 |
| 1001 | COVID_AR1 |
| 2001 | COVID_BR1 |
| 60765 | V1_DAY1_VAX1_L |
| 60766 | V2_VAX2_L |
ADC19EF.PARAM
| Permitted Value (Code) |
|---|
| CEPHEID RT-PCR ASSAY FOR SARS-COV-2 |
| COVID-19 NAAT RESULT AFTER DOSE |
| N-BINDING ANTIBODY |
| 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 - VITAL SIGNS |
| SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SYMPTOMS |
| 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 SEVERE COVID19 SYMPTOMS |
| SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SYMPTOMS |
| 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 |
| HCUICU | SUJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS |
| NAATRAD | COVID-19 NAAT RESULT 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 |
| ST17CD | SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SYMPTOMS |
| 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 |
| ST1SE | SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 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 |
| 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 |
| 103 | SEVERE COVID-19 SYMPTOMS - VITAL SIGNS |
| 104 | SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE |
| 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 |
| 130 | SEVERE COVID-19 ILLNESS ONSET |
| 144 | SUBJECT'S SURVEILLANCE TIME 7 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 |
| 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 |
| 174 | SUBJECT'S SURVEILLANCE TIME 7 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 |
ADSYMPT.AVISIT
| Permitted Value (Code) |
|---|
| COVID_A |
| COVID_AR1 |
| COVID_B |
| COVID_BR1 |
| 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 |
| 1001 | COVID_AR1 |
| 2001 | COVID_BR1 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 71 | NON-INVASIVE POSITIVE PRESSURE VENTILATION |
| 76 | HIGH FLOW OXYGEN THERAPY |
| 90 | N-BINDING ANTIBODY |
| 91 | SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS |
| 99 | DEATH |
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 |
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 |
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: 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 = "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 = "SEVCONST" then Set to ASTDT where PARAMCD = "PRSVCSAD"
if paramcd = "ST27PD" 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 = "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 = "ST27PDA" 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 = "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 = "SEVCONST" then Set to null.
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 = "ST1CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date.
if paramcd = "ST17CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date.
if paramcd = "ST2CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date.
if paramcd = "ST27CD" then Set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, today's date.
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 = "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". |
| 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 = "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 = "SEVCONST" then Set to null.
if paramcd = "ST27PD" then Set as Dose 2 + 7 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 = "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 = "ST27PDA" then Set as Dose 2 + 7 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" "SEVCVS" "SEVCRF" "SEVCRHN" "PRSVCSAD" "NAATRAD" "C19ONST" "SEVCONST") then set to null.
if paramcd in ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) 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 = "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 = "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 ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) then Set to null. |
| 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 "SEVCONST" as following:
if AVALC = "POS" and is the first onset of illness after dose, set to "Y". |
| Algorithm: ADC19EF.ILD1FL | Computation | Set for records where PARAMCD is "C19ONST" 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.ILD27FL | Computation | Set for records where PARAMCD is "C19ONST" 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.NMPDOCFL | Computation | Set for records where PARAMCD is "C19ONST" 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" "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" "SEVCONST") then Set to "ILLNESS ONSET".
if paramcd in ("ST27PD" "ST1CD", "ST17CD" "ST2CD" "ST27CD" "ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST27PDA" ) then Set to "SURVEILLANCE TIME". |
| 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.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: ADSL.AAI01FL | Computation | If SAFFL="Y" and randfl="Y" and (vax101dt>. or vax102dt>.) and INCL3fl="Y" then AAI01FL="Y"; else AAI01FL="N"; |
| Algorithm: ADSL.AAI02FL | Computation | If SAFFL="Y" and randfl="Y" and vax102dt>. and INCL8fl="Y" then AAI02FL="Y"; else AAI02FL="N"; |
| 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.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
Note: For Phase 1 subjects only |
| Algorithm: ADSL.BLDV2FL | 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.BLDV3ADT | Computation | Blood draw date at 3 weeks after Vax 1 Visit
Note: For Phase 1 100 ug subjects only |
| Algorithm: ADSL.BLDV3DT | Computation | Blood draw date at Vax 2 Visit
Note: For Phase 1 subjects only |
| Algorithm: ADSL.BLDV3FL | 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.BLDV4ADT | Computation | Blood draw date at 4 weeks after Vax 1 Visit
Note: For Phase 1 100 ug subjects only |
| Algorithm: ADSL.BLDV4DT | Computation | Blood draw date at 1 Week after Vax 2 Visit
Note: For Phase 1 subjects only |
| Algorithm: ADSL.BLDV4FL | 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.BLDV5ADT | Computation | Blood draw date at 5 weeks after Vax 1 Visit
Note: For Phase 1 100 ug subjects only |
| Algorithm: ADSL.BLDV5DT | Computation | Blood draw date at 2 Weeks after Vax 2 Visit
Note: For Phase 1 subjects only |
| Algorithm: ADSL.BLDV5FL | 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.BLDV8DT | Computation | Blood draw date at 12 Months after Vax 2 Visit |
| Algorithm: ADSL.BLDV8FL | Computation | If non missing blood draw date at 12 Months after Vax 2 Visit then bldv8fl = 'Y''; else bldv8fl = 'N'. |
| Algorithm: ADSL.BLDV9DT | Computation | Blood draw date at 24 Months after Vax 2 Visit |
| Algorithm: ADSL.BLDV9FL | Computation | If non missing blood draw date at 24 Months after Vax 2 Visit then bldv9fl = 'Y''; else bldv9fl = '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="Obesity";
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="Obesity" 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.COMPLDT | Computation | COMPLDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and DS.EPOCH="FOLLOW-UP" and DS.DSDECOD="COMPLETED" |
| 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 16Sep2020 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 major 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.EVAL01FL | Computation | If SAFFL="Y" and INCL1fl="Y" and INCL2fl="Y" and INCL4fl="Y" and INCL5fl="Y" and (index(SUPPDV.CAPE, "POP3")=0 for subjects's all DV records) then EVAL01FL="Y"; else EVI01FL="N"; |
| Algorithm: ADSL.EVAL02FL | Computation | If SAFFL="Y" and INCL1fl="Y" and INCL2fl="Y" and INCL7fl="Y" and INCL8fl="Y" and INCL9fl="Y" and (index(SUPPDV.CAPE, "POP3")=0 for subjects's all DV records) then EVI02FL="Y"; else EVI02FL="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 VAX102DT ne . and 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 major 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 for 04NOV2020 for interim analysis 1 |
| 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 that VAX102DT+7 |
| 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 vax101dt>. and mbdy<=1 then NAATNFL="Y";
else if index(visit,"V1_DAY1_") and mbtestcd='RTCOV2NS' and mborres="POS" and vax101dt>. and mbdy<=1 then NAATNFL="N"; |
| Algorithm: ADSL.NIGV1FL | Computation | if isorres="NEG" and index(visit,"V1_DAY1_") and vax101dt>. and isdy<=1 then NIGV1FL="Y";
else if isorres="POS" and index(visit,"V1_DAY1_") and vax101dt>. and isdy<=1 then NIGV1FL="N"; |
| 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 DM.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(BE1DT, BE1DT2, VAX103DT+35, VAX102DT+35, VAX101DT+58);
Note: used for AE summary tables to cutoff AEs within 1 month after vax2 |
| Algorithm: ADSL.V02DT | Computation | Derived BE2DT from CO.CODTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
Derived BE2DT2 from SV.SVSTDTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
V02DT=COALESCE(BE2DT, BE2DT2, VAX103DT+168, VAX102DT+168, VAX101DT+191);
Note: used for AE summary tables to cutoff AEs within 6 month after vax2. |
| 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.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.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: 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. |
Go to the top of the Define-XML document