Date/Time of Define-XML document generation: 2021-06-02T07:25:48Z
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 | |
| ADXB | Sequencing Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis parameter per analysis timepoint | Analysis | STUDYID, USUBJID, PARAMCD, ADT | adxb.xpt |
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Subject-Level Analysis Dataset (ADSL)
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | 8 | Predecessor: DM.STUDYID | |
| USUBJID | Unique Subject Identifier | text | 22 | Predecessor: DM.USUBJID | |
| SUBJID | Subject Identifier for the Study | text | 8 | Predecessor: DM.SUBJID | |
| SITEID | Study Site Identifier | text | 4 | Predecessor: DM.SITEID | |
| AGE | Age | integer | 8 | Predecessor: DM.AGE | |
| AGEU | Age Units | text | 5 | Age Unit
| Predecessor: DM.AGEU |
| SEX | Sex | text | 1 | Sex
| Predecessor: DM.SEX |
| SEXN | Sex (N) | integer | 8 | Numeric Code of Sex
| Assigned Numeric Code of the DM.SEX. Equals 1 if SEX="M", Equals 2 if SEX="F". |
| RACE | Race | text | 41 | Race [7 Terms] | Predecessor: DM.RACE |
| RACEN | Race (N) | integer | 8 | Numeric Code of Race [7 Terms] | Assigned Numeric Code of the DM.RACE. 1 if RACE="WHITE"; 2 if RACE="BLACK OR AFRICAN AMERICAN"; 3 if RACE="AMERICAN INDIAN OR ALASKA NATIVE"; 4 if RACE="ASIAN"; 5 if RACE="NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER"; 6 if RACE="MULTIPLE"; 7 if RACE="NOT REPORTED"; |
| ETHNIC | Ethnicity | text | 22 | Ethnic Group
| Predecessor: DM.ETHNIC |
| ETHNICN | Ethnicity (N) | integer | 8 | Numeric Code of Ethnic Group
| Assigned Numeric Code of the DM.ETHNIC. 1 if ETHNIC="HISPANIC OR LATINO"; 2 if ETHNIC="NOT HISPANIC OR LATINO"; 3 if ETHNIC="NOT REPORTED". |
| RACIALD | Racial Designation | text | 8 | RACIALD
| Predecessor: SUPPDM.QVAL where SUPPDM.QNAM="RACIALD" |
| RACIALDN | Racial Designation (N) | integer | 8 | Numeric Code of RACIALD
| Assigned Numeric Code of RACIALD 5 if RACIALD="JAPANESE" 999 if RACIALDN="OTHER" |
| COUNTRY | Country | text | 3 | Predecessor: DM.COUNTRY | |
| SAFFL | Safety Population Flag | text | 1 | No Yes Response
| Derived If RANDFL='Y' and (VAX101DT ne . or VAX102DT ne . ) and (index(SUPPDV.QNAM.CAPE, "POP1")=0 for subjects's all DV records) then SAFFL='Y', else SAFFL='N' |
| RANDFL | Randomized Population Flag | text | 1 | No Yes Response
| Derived Assign 'Y' for participants who are assigned a randomization number and with non-missing randomization date. |
| ENRLFL | Enrolled Population Flag | text | 1 | Y
| Derived Assign 'Y' for participants who have a signed ICD. |
| DTHFL | Subject Death Flag | text | 1 | Y
| Predecessor: DM.DTHFL |
| ARM | Description of Planned Arm | text | 29 | Description of Planned Arm [11 Terms] | Derived if armcd="B1_10" then arm="BNT162b1 Phase 1 (10 mcg)"
if armcd="B1_100" then arm="BNT162b1 Phase 1 (100/10 mcg)"
if armcd="B1_20" then arm="BNT162b1 Phase 1 (20 mcg)"
if armcd="B1_30" then arm="BNT162b1 Phase 1 (30 mcg)"
if armcd="B2_10" then arm="BNT162b2 Phase 1 (10 mcg)"
if armcd="B2_20" then arm="BNT162b2 Phase 1 (20 mcg)"
if armcd="B2_30" then arm="BNT162b2 Phase 1 (30 mcg)"
if armcd="B2_P23_30" then arm="BNT162b2 Phase 2/3 (30 mcg)"
if armcd="NOTASSGN" then arm="NOT ASSIGNED"
if armcd="NOTTRT" then arm="Not Treated"
if armcd="PLACEBO" then arm="Placebo"
if armcd="SCRNFAIL" then arm="SCREEN FAILURE" |
| ARMCD | Planned Arm Code | text | 9 | Planned Arm Code [11 Terms] | Predecessor: DM.ARMCD |
| ACTARM | Description of Actual Arm | text | 29 | Description of Actual Arm [12 Terms] | Derived Based on the actual vaccinations taken by subjects. Same as ARM if no medication error for the vaccinated subjects
ACTARM=' NOT ASSIGNED ' for not assigned subjects;
ACTARM=' SCREEN FAILURE ' for screen failure subjects;
ACTARM='Not Treated' for not treated subjets or subjects without determined treatment; |
| ACTARMCD | Actual Arm Code | text | 9 | Actual Arm Code [12 Terms] | Derived Based on the actual vaccinations taken by subjects. Same as ARMCD if no medication error for the vaccinated subjects.
ACTARM=' NOTASSGN ' for not assigned subjects;
ACTARM=' SCRNFAIL ' for screen failure subjects;
ACTARMCD='NOTTRT' for not treated subjets or subjects without determined treatment; |
| TRT01P | Planned Treatment for Period 01 | text | 29 | TRT01P [9 Terms] | Derived Obtained from DM.ARM directly. |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | TRT01PN [9 Terms] | Assigned BNT162b1 Phase 1 (10 mcg)=1; BNT162b1 Phase 1 (20 mcg)=2; BNT162b1 Phase 1 (30 mcg)=3; BNT162b1 Phase 1 (100/10 mcg)=4; BNT162b2 Phase 1 (10 mcg)=5; BNT162b2 Phase 1 (20 mcg)=6; BNT162b2 Phase 1 (30 mcg)=7; BNT162b2 Phase 2/3 (30 mcg)=8; Placebo=9 |
| TRT02P | Planned Treatment for Period 02 | text | 27 | TRT02P
| Derived assign as "BNT162b2 Phase 1 (30 mcg)" for Phase 1 subjects and "BNT162b2 Phase 2/3 (30 mcg)" for Phase 2/3 subjects if EX.EXDOSE and EX.EXSTDTC are not missing when EX.EXTPTREF='VACCINATION 3' or 'VACCINATION 4' |
| TRT02PN | Planned Treatment for Period 02 (N) | integer | 8 | TRT02PN
| Assigned BNT162b2 Phase 1 (30 mcg)=7; BNT162b2 Phase 2/3 (30 mcg)=8 |
| TRT01A | Actual Treatment for Period 01 | text | 29 | TRT01A [9 Terms] | Derived Derived from DM.ACTARM. If subject received any of doses as BNT162b2, then the subject will be assigned as 'BNT162b2 Phase 1 (30 mcg)' for phase 1 subject and 'BNT162b2 Phase 2/3 (30 mcg)' for phase 2/3 subject. If the subject received 1 or 2 doses of placebo and no BNT, the subject will be assigned as "Placebo". If subject with all indeterminate vaccinations, set TRT01A to missing. |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | TRT01AN [9 Terms] | Assigned BNT162b1 Phase 1 (10 mcg)=1; BNT162b1 Phase 1 (20 mcg)=2; BNT162b1 Phase 1 (30 mcg)=3; BNT162b1 Phase 1 (100/10 mcg)=4; BNT162b2 Phase 1 (10 mcg)=5; BNT162b2 Phase 1 (20 mcg)=6; BNT162b2 Phase 1 (30 mcg)=7; BNT162b2 Phase 2/3 (30 mcg)=8; Placebo=9 |
| TRT02A | Actual Treatment for Period 02 | text | 27 | TRT02A
| Derived Derived from EX.EXTRT where EXTPTREF in ("Vaccination 3" "Vaccination 4"). If subject received any of these 2 doses as BNT162b2, then the subject will be assigned as 'BNT162b2 Phase 1 (30 mcg)' for phase 1 subject and 'BNT162b2 Phase 2/3 (30 mcg)' for phase 2/3 subject. If subject with all indeterminate vaccinations, set TRT02A to missing. |
| TRT02AN | Actual Treatment for Period 02 (N) | integer | 8 | TRT02AN
| Assigned BNT162b2 Phase 1 (30 mcg)=7; BNT162b2 Phase 2/3 (30 mcg)=8; |
| TRTSEQP | Planned Sequence of Treatments | text | 38 | Derived combination of TRT01P and TRT02P for randomized subject | |
| TRTSEQA | Actual Sequence of Treatments | text | 38 | Derived combination of TRT01A and TRT02A for treated subject | |
| BRTHDT | Date of Birth | integer | DATE9 | Derived Datepart of DM.BRTHDTC
Imputation of Partial Dates:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year. | |
| BRTHDTF | Date of Birth Imput. Flag | text | 1 | Date Imputation Flag
| Derived BRTHDTF = 'M' if Month and Day are imputed in BRTHDT
BRTHDTF = 'D' if only Day is imputed in BRTHDT |
| DTHDTC | Date/Time of Death | date | ISO 8601 | Predecessor: DM.DTHDTC | |
| DTHDT | Date of Death | integer | DATE9 | Derived If DM.DTHDTC is not missing and not partial then DTHDT=Datepart of DM.DTHDTC;
Else if DM.DTHDTC is partial then impute DTHDT using imputation START rules.
Partial Death Dates Imputation Rules:
If day (DD) and month (MMM) are missing in DM.DTHDTC, then use first day (01) and first month (JAN) for DD and MMM respectively.
If day (DD) missing then use first day (01) of the month for DD.
It is recommended that the database be designed to mandate a complete death date. If there is a record for death, but the date is missing or is partial, it will be imputed based on the last contact date.
If the entire death date DM.DTHDTC is missing OR If imputed Death Date (DTHDT) is ON or PRIOR to Last Know Alive Date then reset DTHDT=(Last Known Alive Date) +1 | |
| DTHDTF | Date of Death Imputation Flag | text | 1 | Date Imputation Flag
| Derived If DTHDT was imputed, DTHDTF must be populated and is required.
DTHDTF = 'Y' if Year is imputed
DTHDTF = 'M' if Year is present and Month is imputed
DTHDTF = 'D' if only day is imputed |
| RANDDT | Date of Randomization | integer | DATE9 | Derived [Protocol]
Randomization Date is defined usually those who have been randomized the study. (For study design where subject gets randomized multiple time then RANDDT will be derive based on 1st Randomization Date)
RANDDT = MIN of DS.DSSTDTC where DS.DSDECOD = "RANDOMIZED" | |
| RANDNO | Randomization Number | text | 6 | Predecessor: DS.DSREFID where DS.DSDECOD = "RANDOMIZED" | |
| RFSTDT | Subject Reference Start Date | integer | DATE9 | Derived Datepart of DM.RFSTDTC | |
| RFSTTM | Subject Reference Start Time | integer | TIME8 | Derived Timepart of DM.RFSTDTC | |
| RFENDT | Subject Reference End Date | integer | DATE9 | Derived Datepart of DM.RFENDTC | |
| RFENTM | Subject Reference End Time | float | TIME8 | Derived Timepart of DM.RFENDTC | |
| RFPENDT | Date of End of Participation | integer | DATE9 | Predecessor: DM.RFPENDTC | |
| RFICDT | Date of Informed Consent | integer | DATE9 | Predecessor: DM.RFICDTC | |
| TRTSDT | Date of First Exposure to Treatment | integer | DATE9 | Derived Datepart of min(EX.EXSTDTC) by subject level | |
| TRTSTM | Time of First Exposure to Treatment | integer | TIME8 | Derived Timepart of min(EX.EXSTDTC) by subject level | |
| TRTEDT | Date of Last Exposure to Treatment | integer | DATE9 | Derived Datepart of max(EX.EXENDTC) by subject level | |
| TRTETM | Time of Last Exposure to Treatment | integer | TIME8 | Derived Timepart of max(EX.EXENDTC) by subject level | |
| TR01SDT | Date of First Exposure in Period 01 | integer | DATE9 | Derived Datepart of EX.EXSTDTC for Vaccination 1 | |
| TR01STM | Time of First Exposure in Period 01 | integer | TIME8 | Derived Timepart of EX.EXSTDTC for Vaccination 1 | |
| TR01EDT | Date of Last Exposure in Period 01 | integer | DATE9 | Derived Datepart of EX.EXENDTC for last vaccination of double blinded period. The last vaccination is defined as latest vaccination for subjects without Vaccination 3 or as last vaccination before Vaccination 3. | |
| TR01ETM | Time of Last Exposure in Period 01 | integer | TIME8 | Derived Timepart of EX.EXENDTC for last vaccination of double blinded period. The last vaccination is defined as latest vaccination for subjects without Vaccination 3 or as last vaccination before Vaccination 3. | |
| TR02SDT | Date of First Exposure in Period 02 | integer | DATE9 | Derived Datepart of EX.EXSTDTC for the first Vaccination for subjects with Vaccination 3/4. | |
| TR02STM | Time of First Exposure in Period 02 | integer | TIME8 | Derived Timepart of EX.EXSTDTC for the first Vaccination for subjects with Vaccination 3/4. | |
| TR02EDT | Date of Last Exposure in Period 02 | integer | DATE9 | Derived Datepart of EX.EXENDTC for last vaccination for subjects with Vaccination 3/4. | |
| TR02ETM | Time of Last Exposure in Period 02 | integer | TIME8 | Derived Timepart of EX.EXENDTC for last vaccination for subjects with Vaccination 3/4. | |
| TRTSDTM | Datetime of First Exposure to Treatment | integer | DATETIME20 | Derived Min (EX.EXSTDTC) by subject level | |
| TRTEDTM | Datetime of Last Exposure to Treatment | integer | DATETIME20 | Derived Max (EX.EXSTDTC) by subject level | |
| TR01SDTM | Datetime of First Exposure in Period 01 | integer | DATETIME20 | Derived Datetime of EX.EXSTDTC for Vaccination 1 | |
| TR01EDTM | Datetime of Last Exposure in Period 01 | integer | DATETIME20 | Derived Datetime of EX.EXENDTC for last vaccination of double blinded period. The last vaccination is defined as latest vaccination for subjects without Vaccination 3 or as last vaccination before Vaccination 3. | |
| TR02SDTM | Datetime of First Exposure in Period 02 | integer | DATETIME20 | Derived Datetime of EX.EXSTDTC for the first Vaccination for subjects with Vaccination 3/4. | |
| TR02EDTM | Datetime of Last Exposure in Period 02 | integer | DATETIME20 | Derived Datetime of EX.EXENDTC for last vaccination for subjects with Vaccination 3/4. | |
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Derived Date of the vaccination 1 (first vaccination date) | |
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Derived Date of the vaccination 2 (2nd vaccination date) | |
| VAX201DT | Vaccination Date 03 | integer | DATE9 | Derived Date of the vaccination at Visit 101 (3rd vaccination date), Datepart of EX.EXSTDTC where EX.VISIT in ('V101_VAX3' 'V8A_VAX3'). | |
| VAX202DT | Vaccination Date 04 | integer | DATE9 | Derived Date of the vaccination at Visit 102 (4th vaccination date), Datepart of EX.EXSTDTC where EX.VISIT='V102_VAX4'. | |
| AGETR01 | Age at Vaccination 01 | integer | 8 | Derived Derive AGETR01 from BIRTHDT (after applying imputation for partial date) and date of vaccination1. For participants who were randomized but not vaccinated, the randomization date will be used in place of the date of vaccination at Dose 1 for the age calculation. If the randomization date is also missing, then the informed consent date will be used for the age calculation.
Note: For example: If the vaccination 1 date is one day before the subject's 19th birthday, the subject is 18 years old. | |
| AGETRU01 | Age Units at Vaccination 01 | text | 5 | Age Unit
| Assigned AGETRU01='YEARS' for non-missing AGETR01. |
| AGETR03 | Age at Vaccination 03 | integer | 8 | Derived Derive AGETR03 from BIRTHDT (after applying imputation for partial date) and date of first dose of crossover period.
Note: For example: If dose 3 date is one day before the subject's 19th birthday, the subject is 18 years old. | |
| AGETRU03 | Age Units at Vaccination 03 | text | 5 | Age Unit
| Assigned AGETRU01='YEARS' for non-missing AGETR03. |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Derived Derived using following derivations:
if 12<=agetr01<=15 then AGEGR1='12-15 Years';(Phase 2/3 cohort)
if 18<=agetr01<=55 then AGEGR1='18-55 Years';(Phase 1 cohort)
if 16<=agetr01<=55 then AGEGR1='16-55 Years';(Phase 2/3 cohort)
if 65<=agetr01 then AGEGR1='65-85 Years'; (Phase 1 cohort)
if 56<=agetr01 then AGEGR1='>55 Years'; (Phase 2/3 cohort) |
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Numeric Code of Pooled Age Group 1
| Assigned Numeric Code of AGEGR1. 1='12-15 Years'; (Phase 2/3 cohort) 2='16-55 Years'; (Phase 2/3 cohort) 3='18-55 Years'; (Phase 1 cohort) 4='65-85 Years'; (Phase 1 cohort) 5='>55 Years'; (Phase 2/3 cohort) |
| ARACE | Analysis Race | text | 41 | Analysis Race [7 Terms] | Derived if RACEN=1 then ARACE='WHITE';
if RACEN=2 then ARACE='BLACK OR AFRICAN AMERICAN';
if RACEN=3 then ARACE='AMERICAN INDIAN OR ALASKA NATIVE';
if RACEN=4 then ARACE='ASIAN';
if RACEN=5 then ARACE='NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER';
if RACEN=6 then ARACE='MULTIRACIAL';
if RACEN=7 then ARACE='NOT REPORTED'; |
| ARACEN | Analysis Race (N) | integer | 8 | Numeric Code of Analysis Race [7 Terms] | Assigned Numeric Code of ARACE Same as RACEN |
| RACEGR1 | Pooled Race Group 1 | text | 25 | Pooled Race Group 1
| Derived if RACE='WHITE' then RACEGR1="WHITE";
else if RACE='BLACK OR AFRICAN AMERICAN' then RACEGR1="BLACK OR AFRICAN AMERICAN";
else RACEGR1="ALL OTHERS" |
| RACEGR1N | Pooled Race Group 1 (N) | integer | 8 | Numeric Code of Pooled Race Group 1
| Assigned Numeric Code of the DM.RACEGR1. 1 if RACEGR1="WHITE"; 2 if RACEGR1="BLACK OR AFRICAN AMERICAN"; 3 if RACEGR1="ALL OTHERS" |
| EOSDCDT | End Of Study Discontinuation Date | integer | DATE9 | Derived EOSDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and DSPHASE="FOLLOW-UP" and DS.DSDECOD^=“COMPLETED” | |
| EOSDCRS | End Of Study Discontinuation Reason | text | 49 | Derived EOSDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and DSPHASE="FOLLOW-UP" and DS.DSDECOD^=“COMPLETED” | |
| EOTDCDT | End Of Treatment Discontinuation Date | integer | DATE9 | Derived EOTDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and index(SUPPDS.QNAM.DSPHASE, "VACCINATION")>0 and DS.DSDECOD^=“COMPLETED” | |
| EOTDCRS | End Of Treatment Discontinuation Reason | text | 49 | Derived EOTDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and SUPPDS.QNAM.DSPHASE="VACCINATION" and DS.DSDECOD^=“COMPLETED” | |
| INVID | Investigator Identifier | text | 7 | Predecessor: DM.INVID | |
| INVNAM | Investigator Name | text | 37 | Predecessor: DM.INVNAM | |
| DOSALVL | Actual Dosing Level | text | 52 | Actual Dosing Level
| Derived For Phase 1 only:
Assign actual dose level. eg: 10 ug, 20 ug, 30 ug, 100 ug/10 ug
For Placebo: Assign 'Placebo' |
| DOSPLVL | Planned Dosing Level | text | 52 | Planned Dosing Level
| Derived For Phase 1 only:
Assign planned dose level. eg: 10 ug, 20 ug, 30 ug,100 ug/10 ug
For Placebo: Assign 'Placebo' |
| DOSPLVLN | Planned Dosing Level (N) | integer | 8 | Numeric Code of Planned Dosing Level
| Assigned For Phase 1 only: Numeric Code of DOSPLVL 1=10 ug, 2=20 ug, 3=30 ug, 5=100/10 ug, 6=Placebo |
| DOSALVLN | Actual Dosing Level (N) | integer | 8 | Numeric Code of Actual Dosing Level
| Assigned For Phase 1 only: Numeric Code of DOSALVL 1=10 ug, 2=20 ug, 3=30 ug, 5=100/10 ug, 6=Placebo |
| CDECASE | Clinical disease endpoint case flag | text | 1 | Predecessor: SUPPDM.QVAL where SUPPDM.QNAM="CDECASE" | |
| REACTOFL | Reactogenicity Population Flag | text | 1 | No Yes Response
| Predecessor: SUPPDM.QVAL where SUPPDM.QNAM="REACTOFL" |
| VAX10UDT | Vaccination Date Unplanned | integer | DATE9 | Derived Date of the unplanned vaccination 2 (3rd vaccination date in the first period) | |
| VAX20UDT | Vaccination Date Unplanned in Period 02 | integer | DATE9 | Derived Date of the unplanned vaccination 1 in open label period. | |
| COHORT | Cohort Group | text | 75 | Cohort [13 Terms] | Derived For Phase 1 only: SUPPDS.QVAL where SUPPDS.QNAM=’ DSRANGRP’ |
| COHORTN | Cohort Group (N) | float | 8 | Numeric Code of Cohort [13 Terms] | Assigned For Phase 1 only: Numeric Code of COHORT, See details in Cohort List. |
| PHASEN | Study Phase (N) | integer | 8 | Numeric Code of Study Phase
| Assigned 1 for subjects from Phase 1; 2 for subjects from Phase 2; 3 for subjects from Phase 3 and included in DS6000; 4 for other subjects from Phase 3 |
| PHASE | Study Phase | text | 20 | Study Phase
| Derived "Phase 1" for subjects from Phase 1, who were picked from an external excel file: c4591001-phase-1-subjects-from-dmw.xlsx;
"Phase 2_ds360/ds6000" for subjects from Phase 2, who were picked from an external excel file: first-c4591001-360-participants-enrolled-v1-13aug2020-update.xlsx;
"Phase 3_ds6000" for subjects from Phase 3 and included in DS6000, who were picked from an external excel file: newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsx;
"Phase 3" for other subjects from Phase 3 |
| AGEGR2 | Pooled Age Group 2 | text | 10 | Pooled Age Group 2
| Derived Derived using following derivations:
if 65<=agetr01 then AGEGR2='>=65 Years';
if agetr01<65 then AGEGR2='<65 Years'; |
| AGEGR3 | Pooled Age Group 3 | text | 11 | Pooled Age Group 3
| Derived Derived using following derivations:
if 16<=agetr01<=17 then AGEGR3='16-17 Years';
if 18<=agetr01<=55 then AGEGR3='18-55 Years';
if 55<agetr01 then AGEGR3='>55 Years'; |
| AGEGR4 | Pooled Age Group 4 | text | 11 | Pooled Age Group 4
| Derived Derived using following derivations for Phase 3 subjects only:
if 12<=agetr01<=15 then AGEGR4='12-15 Years';
if 16<=agetr01<=25 then AGEGR4='16-25 Years'; |
| AGEGR4N | Pooled Age Group 4 (N) | integer | 8 | Numeric Code of Pooled Age Group 4
| Assigned Numeric Code of AGEGR4. 1='12-15 Years'; 2='16-25 Years'; |
| AGEGR2N | Pooled Age Group 2 (N) | integer | 8 | Numeric Code of Pooled Age Group 2
| Assigned Numeric Code of AGEGR2. 1='<65 Years'; 2='>=65 Years'; |
| AGEGR3N | Pooled Age Group 3 (N) | integer | 8 | Numeric Code of Pooled Age Group 3
| Assigned Numeric Code of AGEGR3. 1='16-17 Years'; 2='18-55 Years'; 3='>55 Years'; |
| AGETGR3 | Age Group at Vaccination 03 | text | 11 | Age Group at Vaccination 03
| Derived Derived using following derivations:
if 16<=agetr03<=55 then AGETGR3='16-55 Years';
if 56<=agetr03 then AGETGR3='>55 Years'; |
| AGETGR3N | Age Group at Vaccination 03 (N) | integer | 8 | Numeric Code of Age Group at Vaccination 03
| Assigned Numeric Code of AGETGR3. 1='16-55 Years'; 2='>55 Years'; |
| VAX101 | Vaccination 01 | text | 37 | Derived Dose 1: combined form the vaccination at dose 1 and the corresponding dosage; set to missing if the dose is INDETERMINATE. | |
| VAX102 | Vaccination 02 | text | 36 | Derived Dose 2: combined form the vaccination at dose 2 and the corresponding dosage; set to missing if the dose is INDETERMINATE. | |
| VAX201 | Vaccination 03 | text | 36 | Derived If EX.EXTRT='BNT162b2' when EX.VISIT in ('V101_VAX3' 'V8A_VAX3'), then VAX201='BNT162b2 (30 (*ESC*){unicode 03BC}g)'; set to missing if the dose is INDETERMINATE. | |
| VAX202 | Vaccination 04 | text | 36 | Derived If EX.EXTRT='BNT162b2' when EX.VISIT='V102_VAX4', then VAX202='BNT162b2 (30 (*ESC*){unicode 03BC}g)'; set to missing if the dose is INDETERMINATE. | |
| VAX10U | Vaccination Unplanned | text | 36 | Derived Unplanned Dose 2: combined form the vaccination at unplanned dose 2 and the corresponding dosage; set to missing if the dose is INDETERMINATE. | |
| VAX20U | Vaccination Unplanned in Period 02 | text | 1 | Derived Unplanned Dose in open label period: combined form the vaccination at unplanned dose after the first dose after crossover period and the corresponding dosage; set to missing if the dose is INDETERMINATE. | |
| VAX101TM | Vaccination Time 01 | integer | TIME8 | Derived Time of the vaccination 1 (first vaccination date) | |
| VAX102TM | Vaccination Time 02 | integer | TIME8 | Derived Time of the vaccination 2 (2nd vaccination date) | |
| VAX201TM | Vaccination Time 03 | integer | TIME8 | Derived Time of the vaccination at Visit 101 (3rd vaccination date), timepart of EX.EXSTDTC where EX.VISIT in ('V101_VAX3' 'V8A_VAX3'). | |
| VAX202TM | Vaccination Time 04 | integer | TIME8 | Derived Time of the vaccination at Visit 102 (4th vaccination date), timepart of EX.EXSTDTC where EX.VISIT='V102_VAX4'. | |
| VAX10UTM | Vaccination Time Unplanned | integer | TIME8 | Derived Time of the unplanned vaccination 2 (3rd vaccination date in the first period) | |
| VAX20UTM | Vaccination Time Unplanned in Period 02 | integer | TIME8 | Derived Time of the unplanned vaccination 1 in open label period. | |
| UNBLNDDT | Treatment Unblinded Date | integer | DATE9 | Derived DS.DSSTDTC when DSDECOD="TREATMENT UNBLINDED" | |
| REVXICDT | Re-vax Informed Consent Date | integer | DATE9 | Derived DS.DSSTDTC for Re-vax Informed Consent. | |
| EOTXDCDT | End Of Open Label Treatment D/C Date | integer | DATE9 | Derived EOTXDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and SUPPDS.QNAM='DSPHASE' and SUPPDS.QVAL="OPEN LABEL TREATMENT" and DS.DSDECOD^=“COMPLETED” | |
| EOTXDCRS | End Of Open Label Treatment D/C Reason | text | 21 | Derived EOTXDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and SUPPDS.QNAM='DSPHASE' and SUPPDS.QVAL="OPEN LABEL TREATMENT" and DS.DSDECOD^=“COMPLETED” | |
| BMICAT | Baseline BMI Category | text | 13 | BMI Category
| Derived Carry BMI from SDTM.VS where index(visit, "V1_DAY1") and vstestcd="BMI" and vsdy<=1
if .<vsstresn<18.5 then BMICAT="Underweight";
else if 18.5<=vsstresn<=24.9 then BMICAT="Normal weight";
else if 25<=vsstresn<=29.9 then BMICAT="Overweight";
else if 30<=vsstresn then BMICAT="Obese";
if vsstresn=. then BMICAT="Missing"; |
| BMICATN | Baseline BMI Category (N) | integer | 8 | Numeric Code of BMI Category
| Assigned if BMICAT="Underweight" then BMICATN=1; else if BMICAT="Normal weight" then BMICATN=2; else if BMICAT="Overweight" then BMICATN=3; else if BMICAT="Obese" then BMICATN=4; else if BMICAT="Missing" then BMICATN=5; |
| OBESEFL | Obese Flag for Adolescent | text | 1 | No Yes Response
| Derived "Y" if adolescent with enrolled age 12-15 meets the BMI cut off for obesity with age/sex groups. The standard for obesity is provided in an external file bmi-12-15-scale.xlsx. |
| COMBODFL | Flag for Comorbodities | text | 1 | No Yes Response
| Derived "Y" if subject with Medical History With Comorbodities. Terms were defined in 19 external excel files whose filename contains 'report-cci'. |
| NIGV1FL | N-binding Antibody Neg at Visit 1 Flag | text | 1 | No Yes Response
| Derived Derived from is.istest='N-binding antibody'
if is.isorres="NEG" and index(visit,"V1_DAY1_") and is.isdy<=1 then NIGV1FL="Y";
else if is.isorres="POS" and index(visit,"V1_DAY1_") and is.isdy<=1 then NIGV1FL="N";
Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. |
| NAATNFL | NAAT Negative at Visit 1 Flag | text | 1 | No Yes Response
| Derived if index(mb.visit,"V1_DAY1_") and mb.mbtestcd='RTCOV2NS' and mb.mborres="NEG" and mb.mbdy<=1 then NAATNFL="Y";
else if index(mb.visit,"V1_DAY1_") and mb.mbtestcd='RTCOV2NS' and mb.mborres="POS" and mb.mbdy<=1 then NAATNFL="N"; |
| COVBLST | Baseline SARS-CoV-2 Status | text | 3 | Baseline SARS-CoV-2 Status
| Derived Subjects are considered with COVID-19 history if MH.MHDECOD in ("Asymptomatic COVID-19" "COVID-19" "COVID-19 pneumonia" "COVID-19 treatment" "Suspected COVID-19" "SARS-CoV-2 antibody test positive" "SARS-CoV-2 carrier" "SARS-CoV-2 sepsis" "SARS-CoV-2 test positive" "SARS-CoV-2 viraemia" "Multisystem inflammatory syndrome in children").
if subjects with COVID-19 history or NIGV1FL="N" or NAATNFL="N" then COVBLST="POS";
if subjects without COVID-19 history and NIGV1FL="Y" and NAATNFL="Y" then COVBLST="NEG"; |
| V01DT | Date of Unblinding or Visit at 1MPD2 | integer | DATE9 | Derived Derived BE1DT from CO.CODTC from Visit 7 after second dose for phase 1 and from visit 3 for phase 2/3
Derived BE1DT2 from SV.SVSTDTC from visit 7 after second dose for phase 1 and from visit 3 for phase 2/3
V01DT=COALESCE(VAX10UDT+35, BE1DT, BE1DT2, VAX102DT+35, VAX101DT+58);
Then, for unblinded subjects, compare V01DT with the day before treatment unblinding, set V01DT=min(V01DT,UNBLNDDT-1)
Note: used for AE summary tables to cutoff AEs within 1 month after vax2 | |
| V02DT | Date of Unblinding or Visit at 6MPD2 | integer | DATE9 | Derived Derived BE2DT from CO.CODTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
Derived BE2DT2 from SV.SVSTDTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
V02DT=COALESCE(VAX10UDT+189, BE2DT, BE2DT2, VAX102DT+189, VAX101DT+189+23);
Then, for unblinded subjects, compare V02DT with the day before treatment unblinding, set V02DT=min(V02DT,UNBLNDDT-1)
Note: used for AE summary tables to cutoff AEs within 6 month after vax2. | |
| V02OBDT | Date of Dose 3 or Visit at 6MPD2 | integer | DATE9 | Derived Derived BE2DT from CO.CODTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
Derived BE2DT2 from SV.SVSTDTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
V02DT=COALESCE(VAX10UDT+189, BE2DT, BE2DT2, VAX102DT+189, VAX101DT+189+23);
Then, for subjects took dose 3, compare V02DT with the day before dose 3, set V02DT=min(V02DT, TR02SDT-1)
Note: used for AE summary tables to cutoff AEs within 6 month after vax2 regardless unblinding. | |
| V03DT | Date of Visit at 1M after Vax4 | integer | DATE9 | Derived Derived BE3DT2 from SV.SVSTDTC from 1 month after second dose in open label period visit
V03DT=COALESCE(BE3DT2, VAX202DT+35, VAX201DT+58)
Note: used for AE summary tables to cutoff AEs within 1 month after vax 4 in open label period | |
| V04DT | Date of Visit at 6M after Vax4 | integer | DATE9 | Derived Derived BE4DT2 from SV.SVSTDTC from 6 months after second dose in open label period visit
V04DT=COALESCE(BE4DT2, VAX202DT+189, VAX201DT+189+23)
Note: used for AE summary tables to cutoff AEs within 6 month after vax 4 in open label period | |
| V3C19NIG | C19NIG Result at Visit 3 | text | 3 | Derived The value of N-binding test at 1 Month after Vax 2 Visit. For subjects had Visit 3 recorded as not done, and if there is a convalescent visit or vax3 visit that happened within 28-42 days post dose 2, the convalescent visit/vax3 visit will be used to replace this one. If there are two records fall in the window, the record closed to 30 days after dose 2 will be chosen. | |
| DVSTDT | Start Date of Important PD | integer | DATE9 | Derived The earliest date of important PD | |
| BLDV1FL | Blood Sample Drawn before Vax 1 | text | 1 | No Yes Response
| Derived If non missing blood draw date at Vax 1 Visit then bldv1fl = 'Y''; else bldv1fl = 'N'. |
| BLDV2FL | Blood Sample Drawn 1 Week after Vax 1 | text | 1 | No Yes Response
| Derived If non missing blood draw date at 1 Week after Vax 1 Visit then bldv2fl = 'Y''; else bldv2fl = 'N'. |
| BLDV3FL | Blood Sample Drawn before Vax 2 | text | 1 | No Yes Response
| Derived If non missing blood draw date at Vax 2 Visit then bldv3fl = 'Y''; else bldv3fl = 'N'. |
| BLDV4FL | Blood Sample Drawn 1 Week after Vax 2 | text | 1 | No Yes Response
| Derived If non missing blood draw date at 1 Week after Vax 2 Visit then bldv4fl = 'Y''; else bldv4fl = 'N'. |
| BLDV5FL | Blood Sample Drawn 2 Weeks after Vax 2 | text | 1 | No Yes Response
| Derived If non missing blood draw date at 2 Weeks after Vax 2 Visit then bldv5fl = 'Y''; else bldv5fl = 'N'. |
| BLDV6FL | Blood Sample Drawn 1 Month after Vax 2 | text | 1 | No Yes Response
| Derived If non missing blood draw date at 1 Month after Vax 2 Visit then bldv6fl = 'Y''; else bldv6fl = 'N'. (Only apply to Phase 2/3 to serology: For subjects had Visit 3 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened within 28-42 days post dose 2, the convalescent visit will be used to replace this one, and bldv6fl will be set to "Y".) |
| BLDV7FL | Blood Sample Drawn 6 Months after Vax 2 | text | 1 | No Yes Response
| Derived If non missing blood draw date at 6 Months after Vax 2 Visit then bldv7fl = 'Y''; else bldv7fl = 'N'. (Only apply to Phase 2/3 to serology: For subjects had Visit 4 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened after 42 days post dose 2, the convalescent visit will be used to replace this one, and bldv7fl will be set to "Y".) |
| BLDV1DT | Blood Sample Date before Vax 1 | integer | DATE9 | Derived Blood draw date at Vax 1 Visit | |
| BLDV2DT | Blood Sample Date 1 Week after Vax 1 | integer | DATE9 | Derived Blood draw date at 1 Week after Vax 1 Visit | |
| BLDV3ADT | Additional Bld Sample Date 3W after Vax1 | integer | DATE9 | Derived For 100 ug only, blood draw date at 3 weeks after Vax 1 Visit | |
| BLDV4ADT | Additional Bld Sample Date 4W after Vax1 | integer | DATE9 | Derived For 100 ug only, blood draw date at 4 weeks after Vax 1 Visit | |
| BLDV5ADT | Additional Bld Sample Date 5W after Vax1 | integer | DATE9 | Derived For 100 ug only, blood draw date at 5 weeks after Vax 1 Visit | |
| BLDV6ADT | Additional Bld Sample Date 7W after Vax1 | integer | DATE9 | Derived For 100 ug only, blood draw date at 3 weeks + 1 month after Vax 1 Visit | |
| BLDV3DT | Blood Sample Date before Vax 2 | integer | DATE9 | Derived Blood draw date at Vax 2 Visit | |
| BLDV4DT | Blood Sample Date 1 Week after Vax 2 | integer | DATE9 | Derived Blood draw date at 1 Week after Vax 2 Visit | |
| BLDV5DT | Blood Sample Date 2 Weeks after Vax 2 | integer | DATE9 | Derived Blood draw date at 2 Weeks after Vax 2 Visit | |
| BLDV6DT | Blood Sample Date 1 Month after Vax 2 | integer | DATE9 | Derived Blood draw date at 1 Month after Vax 2 Visit. (Only apply to Phase 2/3 to serology: For subjects had Visit 3 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened within 28-42 days post dose 2, the convalescent visit will be used to replace this one, and bldv6dt will be set to the date of the convalescent visit. If multiple records fall into such window, the one closed to 30 days post dose 2 will be chosen. If multiple records at the same day, the one with available immunogenicity results will be chosen.) | |
| BLDV7DT | Blood Sample Date 6 Months after Vax 2 | integer | DATE9 | Derived Blood draw date at 6 Months after Vax 2 Visit. (Only apply to Phase 2/3 to serology: For subjects had Visit 4 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened after 42 days post dose 2, the convalescent visit will be used to replace this one, and bldv7dt will be set to the date of the convalescent visit. If multiple records fall into such window, the one closed to 190 days post dose 2 will be chosen. If multiple records at the same day, the one with available immunogenicity results will be chosen.) | |
| INCL1FL | Are eligible for the study at rand | text | 1 | No Yes Response
| Derived Assign value 'Y' if meet following criteria; Else Assign value 'N';
1. Signed IC;
2. Randomized;
3. Not screen failure;
4. Meets all inclusion criteria and meets no exclusion criteria; |
| INCL2FL | Have received Vax 1 as randomized | text | 1 | No Yes Response
| Derived Receive the first dose of vaccine to which they are randomly assigned |
| INCL3FL | Have valid and DTM immuno result 1 | text | 1 | No Yes Response
| Derived Will apply to Phase 1 only. Have at least 1 valid and determinate immunogenicity result after Dose 1 but before Dose 2
Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. N-binding is diagnostic assay and not considered as valid and determinate immunogenicity result. |
| INCL4FL | Have valid and DTM immuno result 2 | text | 1 | No Yes Response
| Derived Will apply to Phase 1 only. Have at least 1 valid and determinate immunogenicity result 21 days after Dose 1.
Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. |
| INCL5FL | Have BD within the timeframe 1 | text | 1 | No Yes Response
| Derived Will apply to Phase 1 only. Have blood collection within an appropriate window after Dose 1, with visit window 19-23 days after dose 1. |
| INCL6FL | No important PD determined by clinician | text | 1 | No Yes Response
| Derived Derive from SUPPDV.QNAM.CAPE. 'Y' if the subjects with all records of SUPPDV.QNAM.CAPE is "NO" or missing or CAPE indicates "POP2" only and this date of PD is earlier that VAX102DT+14 |
| INCL7FL | Received 2 doses as rand within window | text | 1 | No Yes Response
| Derived Receive 2 randomized vaccinations within the pre-defined window
Vaccination window – can be 19-42 days after dose 1:
if 19<=VAX102DT-VAX101DT<=42 and ARM ne "" and
((index(upcase(vax102),"BNT162B2") and index(upcase(arm),"BNT162B2")) or (index(upcase(vax102),"PLACEBO") and index(upcase(arm),"PLACEBO")))
and vax101=vax102 then INCL7FL="Y"; else INCL7FL="N"; |
| INCL8FL | Have valid and DTM immuno result 3 | text | 1 | No Yes Response
| Derived Have at least 1 valid and determinate immunogenicity result after Dose 2
Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. N-binding is diagnostic assay and not considered as valid and determinate immunogenicity result. |
| INCL9FL | Have BD within the timeframe 2 | text | 1 | No Yes Response
| Derived Have blood collection within an appropriate window after Dose 2.
Phase 1 – with visit window 6-8 days after dose 2
Phase 2/3 – 28-42 days after dose 2 |
| INCL10FL | Unblinded after 1M post Dose 2 visit | text | 1 | No Yes Response
| Derived "Y" If unblinding date after the visit date of 1 month post dose 2. else "N" for non-missing unblinding date.
Note: not populated for subjects unblnding beyond 14 days after dose 2 but missing both BLDV6DT and SV.V3. ; not populated for missing dose 2. |
| EXCL1FL | Exclusion Flag 1 | text | 1 | Y
| Derived if INCL1FL="N" then EXCL1FL="Y" |
| EXCRIT1 | Exclusion Criterion 1 | text | 43 | Assigned Assign to "not eligible for the study at randomization" when EXCL1FL="Y" | |
| EXCL2FL | Exclusion Flag 2 | text | 1 | Y
| Derived if EXCL1FL ne "Y" and INCL2FL="N" then EXCL2FL="Y" |
| EXCRIT2 | Exclusion Criterion 2 | text | 36 | Assigned Assign to "did not receive Dose 1 as randomized" when EXCL2FL="Y" | |
| EXCL3FL | Exclusion Flag 3 | text | 1 | Y
| Derived Will apply to Phase 1 only. if (VAX101DT>. or vax102dt>.) and INCL3FL="N" then EXCL3FL="Y" |
| EXCRIT3 | Exclusion Criterion 3 | text | 1 | Assigned Will apply to Phase 1 only. Assign to "did not have at least 1 valid and determinate immunogenicity result after Dose 1 but before Dose 2" when EXCL3FL="Y" | |
| EXCL4FL | Exclusion Flag 4 | text | 1 | Y
| Derived Will apply to Phase 1 only. if EXCL2FL ne "Y" and INCL4FL="N" then EXCL4FL="Y" |
| EXCRIT4 | Exclusion Criterion 4 | text | 1 | Assigned Will apply to Phase 1 only. Assign to "did not have at least 1 valid and determinate immunogenicity result 21 days after Dose 1" when EXCL4FL="Y" | |
| EXCL5FL | Exclusion Flag 5 | text | 1 | Y
| Derived Will apply to Phase 1 only. if EXCL2FL ne "Y" and INCL5FL="N" then EXCL5FL="Y" |
| EXCRIT5 | Exclusion Criterion 5 | text | 1 | Assigned Will apply to Phase 1 only. Assign to "did not have blood collection within 19-23 days after Dose 1" when EXCL5FL="Y" | |
| EXCL6FL | Exclusion Flag 6 | text | 1 | Y
| Derived if INCL6FL="N" then EXCL6FL="Y" |
| EXCRIT6 | Exclusion Criterion 6 | text | 149 | Assigned Assign to "had important protocol deviation(s) as determined by the clinician for XXX population(s)" when EXCL6FL="Y" as specified in SUPPDV. POP1=Safety, POP2=Efficacy (within 7 days post Dose 2) if pd start date is before vax102dt +7, POP2=Efficacy (between 7-14 days post Dose 2) if pd start date is on or after vax102dt +7 but before vax102dt+14, POP2=Efficacy (between 14 days - 1 month post Dose 2) if pd start date is on or after vax102dt +14 but before visit 3 date, POP3=Immunogenicity. For visit 3 date, it will be obtained from non-missing BLDV6DT or derived from SV.SVSTDTC from visit 7 after second dose for phase 1 and from visit 3 for phase 2/3 if BLDV6DT is missing. Note: not populated for subjects missing BLDV6DT/SV.V3 | |
| RSEXSAF | Reason for Exclusion from Safety Pop | text | 43 | Derived DV.DVTERM where SUPPDV.QNAM.CAPE contain 'POP5' then RSEXSAF="Unreliable data due to lack of PI oversight"; else if only 'POP1' then RSEXSAF="Did not provide informed consent"; | |
| EXCL7FL | Exclusion Flag 7 | text | 1 | Y
| Derived if EXCL2FL ne "Y" and INCL7FL="N" then EXCL7FL="Y" |
| EXCRIT7 | Exclusion Criterion 7 | text | 129 | Assigned Assign to "did not receive all vaccination(s) as randomized or did not receive Dose 2 within the predefined window (19-42 days after Dose 1)" when EXCL7FL="Y" | |
| EXCL8FL | Exclusion Flag 8 | text | 1 | Y
| Derived if VAX102DT ne . and INCL8FL="N" then EXCL8FL="Y" |
| EXCRIT8 | Exclusion Criterion 8 | text | 80 | Assigned Assign to "did not have at least 1 valid and determinate immunogenicity result after Dose 2" when EXCL8FL="Y" | |
| EXCL9FL | Exclusion Flag 9 | text | 1 | Y
| Derived if VAX102DT ne . and EXCL2FL ne "Y" and INCL9FL="N" then EXCL9FL="Y" |
| EXCRIT9 | Exclusion Criterion 9 | text | 60 | Assigned Assign to "did not have blood collection within 6-8 days after Dose 2" for Phase 1 when EXCL9FL="Y"; assign to "did not have blood collection within 28-42 days after Dose 2" for Phase 2/3 when EXCL9FL="Y" | |
| EXCL10FL | Exclusion Flag 10 | text | 1 | Y
| Derived "Y" if INCL10FL="N" |
| EXCRIT10 | Exclusion Criterion 10 | text | 73 | Derived for INCL10FL="N" and vax102dt not missing:
assign to "unblinded prior to 7 days post Dose 2" for UNBLNDDT<VAX102DT+7;
assign to "unblinded on or after 7 days but prior to 14 days post Dose 2" for VAX102DT+7<=UNBLNDDT<VAX102DT+14;
assign to "unblinded on or after 14 days but no later than 1 month post Dose 2 visit" for VAX102DT+14<=UNBLNDDT<=V3 date; | |
| EVAL01FL | Dose 1 evaluable Immun Popu Flag | text | 1 | No Yes Response
| Derived Will apply to Phase 1 only. If INCL1fl="Y" and INCL2fl="Y" and INCL4fl="Y" and INCL5fl="Y" and (index(SUPPDV.QNAM.CAPE, "POP3")=0 for subjects's all DV records) then EVAL01FL="Y"; else EVAL01FL="N"; |
| EVAL02FL | Dose 2 evaluable Immun Popu Flag | text | 1 | No Yes Response
| Derived If INCL1fl="Y" and INCL2fl="Y" and (INCL7fl="Y" and vax10udt=.) and INCL8fl="Y" and INCL9fl="Y" and (index(SUPPDV.QNAM.CAPE, "POP3")=0 for subjects's all DV records) then EVAL02FL="Y"; else EVAL02FL="N"; |
| AAI01FL | Dose 1 all-available Immun Popu Flag | text | 1 | No Yes Response
| Derived Will apply to Phase 1 only. If SAFFL="Y" and randfl="Y" and (vax101dt>. or vax102dt>.) and INCL3fl="Y" and not (index(SUPPDV.QNAM.CAPE, "POP3") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI01FL="Y"; else AAI01FL="N"; |
| AAI02FL | Dose 2 all-available Immun Popu Flag | text | 1 | No Yes Response
| Derived If SAFFL="Y" and randfl="Y" and vax102dt>. and INCL8fl="Y" and not ((index(SUPPDV.QNAM.CAPE, "POP3") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI02FL="Y"; else AAI02FL="N"; |
| EVALEFFL | Evaluable Efficacy Popu Flag | text | 1 | No Yes Response
| Derived If SAFFL="Y" and RFICDT>. and RANDFL="Y" and ARM ne "SCREEN FAILURE" and INCL1FL="Y" and INCL2fl="Y" and (INCL7fl="Y" and (vax10udt=. or (vax10udt>vax102dt>. and vax10udt>=vax102dt+7))) and VAX102DT>. and (UNBLNDDT=. or (UNBLNDDT>=vax102dt+7>.)) and (index(SUPPDV.QNAM.CAPE, "POP2")=0 for subjects's all DV records or any records with DV date 7 days after Dose 2 and index(SUPPDV.QNAM.CAPE, "POP2")>0 ) and (index(SUPPDV.QNAM.CAPE, "POP3")=0 and index(SUPPDV.QNAM.CAPE, "POP5")=0 for subjects's all DV records)then EVALEFFL="Y"; else EVALEFFL="N"; |
| AAI1EFFL | Dose 1 all-available Efficacy Popu Flag | text | 1 | No Yes Response
| Derived If SAFFL="Y" and randfl="Y" and (vax101dt>. or vax102dt>.) and not((index(SUPPDV.QNAM.CAPE, "POP2") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI1EFFL="Y"; else AAI1EFFL="N"; |
| AAI2EFFL | Dose 2 all-available Efficacy Popu Flag | text | 1 | No Yes Response
| Derived If SAFFL="Y" and randfl="Y" and vax101dt>. and vax102dt>. and (UNBLNDDT=. or (UNBLNDDT>=vax102dt+7>.)) and not((index(SUPPDV.QNAM.CAPE, "POP2") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI2EFFL="Y"; else AAI2EFFL="N"; |
| SCREEN | Screening | text | 1 | Y
| Derived If RFICDT ne . then SCREEN='Y'; |
| DS3KFL | Phase 3 3000 Subjects Flag | text | 1 | No Yes Response
| Derived "Y" for phase 2/3 subjects had follow up 168 days after Dose 2 at the point of EOS or data cutoff and reiceved 2 planned doses of BNT162b2; else "N". |
| DS30KFL | Phase 3 30k Subjects Flag | text | 1 | No Yes Response
| Derived "Y" for non-phase 1 subjects that are randomized on or before 9Oct2020 and obtained IC on or after 27Jul2020. |
| OPBOUFL | Subjects Received Placebo & unblinded | text | 1 | No Yes Response
| Derived “Y” if (tr02sdt>. or UNBLNDDT>.) and actarm in ("Placebo"); else "N" |
| JPNFL | Japanese Subject Flag | text | 1 | No Yes Response
| Derived "Y" if SUPPDM.QNAM = 'RACIALD' and SUPPDM.QVAL = 'JAPANESE' |
| MULENRFL | Multiply Enrolled Subjects | text | 1 | Y
| Derived "Y" for subjects that were multiply enrolled subjests. |
| PEDREAFL | Phase 2/3 Pop for 12-25 Reacto Subset | text | 1 | No Yes Response
| Derived if reactofl="Y" and phasen ne 1 and agegr4n in (1 2) then PEDREAFL="Y"; |
| PEDIMMFL | Pop for Non-inferiority Assessement | text | 1 | No Yes Response
| Derived PEDIMMFL was derived from an external excel file: c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsx (there are 660 subjects in total who are based on an random selection of 280 active+50 placebo from each of the age groups). |
| HIVFL | HIV Positive Subjects Flag | text | 1 | No Yes Response
| Derived "Y" if subject with HIV positive, subjects with HIV were determined by their medical history, HIV related term were defined in an external file: 201114-hiv-preferred-terms.xlsx |
| EV1MD2FL | Subject without Evidence 1MPD2 | text | 1 | No Yes Response
| Derived Subjects will be set to “N” if any of the following conditions are met:
•N-Binding is POS at visit 3.
•Convalescent visit with POS result in the absence of visit 3 and is within 28-42 days PD2.
•Convalescent N-Binding result is POS and is before Visit 3 date or up to 7 days after Visit 3 date.
•Subjects without symptoms and have unscheduled POS swab results within 1MPD2 .
•Subjects with POS swab results at Dose 1/Dose 2 or POS for N-Binding at Dose 1.
•Subjects with presence of symptoms on or after Dose 1 and within 1MPD2 that are without valid NEG swab results.
Else "Y". |
| BDCSRDT | Double Blinded Follow-up Censor Date | integer | DATE9 | Derived if randfl="Y" then do;
if (tr02sdt>. or UNBLNDDT>. ) and boostfl ne "Y" then do;
if .<tr02sdt-1<"&cutoff2"d then BDCSRDT=tr02sdt-1;
else BDCSRDT="&cutoff2"d;
if .<UNBLNDDT-1<=BDCSRDT then BDCSRDT=UNBLNDDT-1;
end;
else do;
if .<UNBLNDDT-1<="&cutoff2"d then BDCSRDT=UNBLNDDT-1;
else BDCSRDT="&cutoff2"d;
if .<eosdcdt<=BDCSRDT then BDCSRDT=eosdcdt;
end;
end;
Note: &cutoff2 will be the data cutoff date which specified in the table footnote. | |
| X1CSRDT | Crossover Dose1 Censor Date | integer | DATE9 | Derived X1CSRDT=min(eosdcdt, "&cutoff2"d) for subjects with ranfl="Y" and non-missing tr02sdt or non-missing UNBLNDDT and boostfl ne "Y" | |
| STCSRDT | Study Censor Date | integer | DATE9 | Derived STCSRDT=min(eosdcdt, "&cutoff2"d) for subjects with ranfl="Y" | |
| FUP2CUT | PD2 FU Time in Days: to Cutoff | integer | 8 | Derived if randfl="Y" then do;
if vax102dt=. then FUP2CUT=0;
else if not missing(eosdcdt) then do;
FUP2CUT=eosdcdt-vax102dt+1;
if vax10udt>. then FUP2CUT=eosdcdt-vax10udt+1;
end;
else do;
FUP2CUT="&cutoff2"d-vax102dt+1;
if vax10udt>. then FUP2CUT="&cutoff2"d-vax10udt+1;
end;
end; | |
| FUP2UNB | PD2 FU Time in Days: to Unblinding | integer | 8 | Derived if randfl="Y" then do;
if vax102dt=. then FUP2UNB=0;
else if not missing(BDCSRDT) then do;
FUP2UNB=BDCSRDT-vax102dt+1;
if vax10udt>. then FUP2UNB=BDCSRDT-vax10udt+1;
end;
end; | |
| FPX1CUT | Post Xover D1 FUTM in Days: to Cutoff | integer | 8 | Derived if (UNBLNDDT>. or tr02sdt>. ) and boostfl ne "Y" then do;
if tr02sdt=. then FPX1CUT=0;
else if not missing(eosdcdt) and eosdcdt>=tr02sdt then FPX1CUT=eosdcdt-tr02sdt+1;
else FPX1CUT="&cutoff2"d-tr02sdt+1;
end;
Note: only populate for subjects unblinded or received cross over doses | |
| FUNBCUT | Unblinding FUTM in Days: to Cutoff | integer | 8 | Derived if (UNBLNDDT>. or tr02sdt>. ) and boostfl ne "Y" then do;
if UNBLNDDT=. then FUNBCUT=0;
else if not missing(eosdcdt) then FUNBCUT=eosdcdt-UNBLNDDT+1;
else FUNBCUT="&cutoff2"d-UNBLNDDT+1;
end; | |
| FUP1CUT | PD1 FU Time in Days: to Cutoff | integer | 8 | Derived if randfl="Y" then do;
if vax101dt=. then FUP1CUT=0;
else if not missing(eosdcdt) then FUP1CUT=eosdcdt-vax101dt+1;
else FUP1CUT="&cutoff2"d-vax101dt+1;
end; | |
| FUP1UNB | PD1 FU Time in Days: to Unblinding | integer | 8 | Derived if randfl="Y" then do;
if vax101dt=. then FUP1UNB=0;
else if not missing(BDCSRDT) then FUP1UNB=BDCSRDT-vax101dt+1;
end; | |
| FUP2CAT1 | PD2 FU Time Cat 1: to Cutoff | text | 12 | FUP2CAT1 [11 Terms] | Derived "0-1 Month" for FUP2CA1N=1;
"1-2 Months" for FUP2CA1N=2;
"2-3 Months" for FUP2CA1N=3;
"3-4 Months" for FUP2CA1N=4;
etc. |
| FUP2CA1N | PD2 FU Time Cat 1 (N): to Cutoff | integer | 8 | FUP2CA1N [11 Terms] | Derived 1 for 0<=FUP2CUT/28<1;
2 for 1<=FUP2CUT/28<2;
3 for 2<=FUP2CUT/28<3;
4 for 3<=FUP2CUT/28<4;
etc. |
| FUP2CAT2 | PD2 FU Time Cat 2: to Unblinding | text | 11 | FUP2CAT2 [10 Terms] | Derived "0-1 Month" for FUP2CA2N=1;
"1-2 Months" for FUP2CA2N=2;
"2-3 Months" for FUP2CA2N=3;
"3-4 Months" for FUP2CA2N=4;
etc. |
| FUP2CA2N | PD2 FU Time Cat 2 (N): to Unblinding | integer | 8 | FUP2CA2N [10 Terms] | Derived 1 for 0<=FUP2UNB/28<1;
2 for 1<=FUP2UNB/28<2;
3 for 2<=FUP2UNB/28<3;
4 for 3<=FUP2UNB/28<4;
etc." |
| FPX1CAT1 | Post Xover D1 FUTM Cat 1: to Cutoff | text | 10 | FPX1CAT1
| Derived "0-1 Month" for FPX1CA1N=1;
"1-2 Months" for FPX1CA1N=2;
"2-3 Months" for FPX1CA1N=3;
"3-4 Months" for FPX1CA1N=4;
etc. |
| FPX1CA1N | Post Xover D1 FUTM Cat 1 (N): to Cutoff | integer | 8 | FPX1CA1N
| Derived 1 for 0<=FPX1CUT/28<1;
2 for 1<=FPX1CUT/28<2;
3 for 2<=FPX1CUT/28<3;
4 for 3<=FPX1CUT/28<4;
etc. |
| FUP1CAT1 | PD1 FU Time Cat 1: to Cutoff | text | 12 | FUP1CAT1 [12 Terms] | Derived "0-1 Month" for FUP1CA1N=1;
"1-2 Months" for FUP1CA1N=2;
"2-3 Months" for FUP1CA1N=3;
"3-4 Months" for FUP1CA1N=4;
etc. |
| FUP1CA1N | PD1 FU Time Cat 1 (N): to Cutoff | integer | 8 | FUP1CA1N [12 Terms] | Derived 1 for 0<=FUP1CUT/28<1;
2 for 1<=FUP1CUT/28<2;
3 for 2<=FUP1CUT/28<3;
4 for 3<=FUP1CUT/28<4;
etc. |
| RNACAT | HIV RNA Category | text | 4 | RNACAT
| Derived Derived numeric value from LB.LBORRES where LB.LBTESTCD="HIVR_US". Assigned as "<50" if subject's LBORRES does not contain any numeric value and not equal to positive. If derived numeric value is less than 50 then assigned as "<50"; if derived numeric value is equal to or greater than 50 then assigned as ">=50". |
| RNACATN | HIV RNA Category (N) | integer | 8 | RNACATN
| Derived 1="<50"
2=">=50" |
| CD4CAT | CD4 Category for HIV-positive | text | 7 | CD4CAT
| Derived if .<LB.LBSTRESN*1000<200 then assigned as "<200"; else if 200<=LB.LBSTRESN*1000<=500 then assigned as "200-500"; else if LB.LBSTRESN*1000>500 then assigned as ">500"; where LB.LBTESTCD="CD4" and LBSTRESU="10^9/L" and LB.LBSTAT ne "NOT DONE" and index(visit, "V1_DAY1_VAX1") and LBDY<=1 |
| CD4CATN | CD4 Category for HIV-positive (N) | integer | 8 | CD4CATN
| Derived 1="<200"
2="200-500"
3=">500" |
| SAF1FL | Safety - excld Multi-Enrolloer&HIV&IND | text | 1 | No Yes Response
| Derived if SAFFL="Y" and MULENRFL^="Y" and HIVFL^="Y" and trt01a ne "" then SAF1FL="Y"; else SAF1FL="N"; |
| SAF2FL | Safety - exclude Multi-Enrolloer&IND | text | 1 | No Yes Response
| Derived if SAFFL="Y" and MULENRFL^="Y" and trt01a ne "" then SAF2FL="Y"; else SAF2FL="N"; |
| RAND1FL | Random - exclude Multi-Enrolloer | text | 1 | No Yes Response
| Derived if RANDFL="Y" and MULENRFL^="Y" and then RAND1FL="Y"; else RAND1FL="N"; |
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Sequencing Analysis Dataset (ADXB)
| 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 | ||
| AGEGR1N | Pooled Age Group 1 (N) | integer | 8 | Pooled Age Group 1 (N)
| Predecessor: ADSL.AGEGR1N | |
| AGEGR1 | Pooled Age Group 1 | text | 11 | Pooled Age Group 1
| Predecessor: ADSL.AGEGR1 | |
| SEX | Sex | text | 1 | Sex
| Predecessor: ADSL.SEX | |
| RACE | Race | text | 41 | Race [7 Terms] | Predecessor: ADSL.RACE | |
| ETHNIC | Ethnicity | text | 22 | Ethnic Group
| Predecessor: ADSL.ETHNIC | |
| COUNTRY | Country | text | 3 | Predecessor: ADSL.COUNTRY | ||
| STATE | State | text | 14 | Derived Derive from Pfizer Corporate Registry Database (based on Investigator ID)
If we have Abbreviation for the States in USA, then update them to get full Text of the State.
if State="AK" then state="ALASKA";
if State="AL" then state="ALABAMA";
if State="AR" then state="ARKANSAS";
if State="AZ" then state="ARIZONA";
if State="CA" then state="CALIFORNIA";
if State="CO" then state="COLORADO";
if State="CT" then state="CONNECTICUT";
if State="DE" then state="DELAWARE";
if State="FL" then state="FLORIDA";
if State="GA" then state="GEORGIA";
if State="HI" then state="HAWAII";
if State="IA" then state="IOWA";
if State="ID" then state="IDAHO";
if State="IL" then state="ILLINOIS";
if State="IN" then state="INDIANA";
if State="KS" then state="KANSAS";
if State="KY" then state="KENTUCKY";
if State="LA" then state="LOUISIANA";
if State="MA" then state="MASSACHUSETTS";
if State="MD" then state="MARYLAND";
if State="ME" then state="MAINE";
if State="MI" then state="MICHIGAN";
if State="MN" then state="MINNESOTA";
if State="MO" then state="MISSOURI";
if State="MS" then state="MISSISSIPPI";
if State="MT" then state="MONTANA";
if State="NC" then state="NORTH CAROLINA";
if State="ND" then state="NORTH DAKOTA";
if State="NE" then state="NEBRASKA";
if State="NH" then state="NEW HAMPSHIRE";
if State="NJ" then state="NEW JERSEY";
if State="NM" then state="NEW MEXICO";
if State="NV" then state="NEVADA";
if State="NY" then state="NEW YORK";
if State="OH" then state="OHIO";
if State="OK" then state="OKLAHOMA";
if State="OR" then state="OREGON";
if State="PA" then state="PENNSYLVANIA";
if State="RI" then state="RHODE ISLAND";
if State="SC" then state="SOUTH CAROLINA";
if State="SD" then state="SOUTH DAKOTA";
if State="TN" then state="TENNESSEE";
if State="TX" then state="TEXAS";
if State="UT" then state="UTAH";
if State="VA" then state="VIRGINIA";
if State="VT" then state="VERMONT";
if State="WA" then state="WASHINGTON";
if State="WI" then state="WISCONSIN";
if State="WV" then state="WEST VIRGINIA";
if State="WY" then state="WYOMING"; | ||
| ARMCD | Planned Arm Code | text | 9 | Planned Arm Code [11 Terms] | Predecessor: ADSL.ARMCD | |
| ARM | Description of Planned Arm | text | 27 | Description of Planned Arm [11 Terms] | Predecessor: ADSL.ARM | |
| ACTARMCD | Actual Arm Code | text | 9 | Actual Arm Code [12 Terms] | Predecessor: ADSL.ACTARMCD | |
| ACTARM | Description of Actual Arm | text | 27 | Description of Planned Arm [11 Terms] | Predecessor: ADSL.ACTARM | |
| 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 | ||
| TRT01A | Actual Treatment for Period 01 | text | 27 | ADXB.TRT01A
| Predecessor: ADSL.TRT01A | |
| TRT01AN | Actual Treatment for Period 01 (N) | integer | 8 | ADXB.TRT01AN
| Predecessor: ADSL.TRT01AN | |
| TRT01P | Planned Treatment for Period 01 | text | 27 | ADXB.TRT01P
| Predecessor: ADSL.TRT01P | |
| TRT01PN | Planned Treatment for Period 01 (N) | integer | 8 | ADXB.TRT01PN
| Predecessor: ADSL.TRT01PN | |
| VAX101DT | Vaccination Date 01 | integer | DATE9 | Predecessor: ADSL.VAX101DT | ||
| VAX102DT | Vaccination Date 02 | integer | DATE9 | Predecessor: ADSL.VAX102DT | ||
| DVSTDT | Start Date of Important PD | integer | DATE9 | Predecessor: ADSL.DVSTDT | ||
| UNBLNDDT | Treatment Unblinded Date | integer | DATE9 | Predecessor: ADSL.UNBLNDDT | ||
| RANDFL | Randomized Population Flag | text | 1 | Y
| Predecessor: ADSL.RANDFL | |
| EVALEFFL | Evaluable Efficacy Popu Flag | text | 1 | No Yes Response
| Predecessor: ADSL.EVALEFFL | |
| AAI1EFFL | Dose 1 all-available Efficacy Popu Flag | text | 1 | Y
| Predecessor: ADSL.AAI1EFFL | |
| AAI2EFFL | Dose 2 all-available Efficacy Popu Flag | text | 1 | No Yes Response
| Predecessor: ADSL.AAI2EFFL | |
| MULENRFL | Multiply Enrolled Subjects | text | 1 | Predecessor: ADSL.MULENRFL | ||
| PHASE | Study Phase | text | 20 | Study Phase
| Predecessor: ADSL.PHASE | |
| PHASEN | Study Phase (N) | integer | 8 | Numeric Code of Study Phase
| Predecessor: ADSL.PHASEN | |
| HIVFL | HIV Positive Subjects Flag | text | 1 | N
| Predecessor: ADSL.HIVFL | |
| PARAMN | Parameter (N) | integer | 8 | Parameter (N)
| Derived if XB.XBTESTCD="WGSCLINE" then PARAMN=1; | |
| PARAMCD | Parameter Code | text | 8 | ADXB Parameter Code
| Predecessor: XB.XBTESTCD | |
| PARAM | Parameter | text | 39 | ADXB Parameter
| Predecessor: XB.XBTEST | |
| PARCAT1 | Parameter Category 1 | text | 8 | Parameter Category 1
| Predecessor: XB.XBCAT | |
| AVAL | Analysis Value | float | 8 | Derived set to null | ||
| AVALCVLM | Analysis Value (C) | text | 13 | Predecessor: XB.XBSTRESC | ||
| PARAMCD = "WGSCLINE" (SARS CoV2 lineage phylogenetic analysis) | SARS CoV2 lineage phylogenetic analysis | text | 13 | Predecessor: XB.XBSTRESC | ||
| AVISITN | Analysis Visit (N) | integer | 8 | ADXB Analysis Visit (N) [8 Terms] | Predecessor: XB.VISITNUM | |
| AVISIT | Analysis Visit | text | 11 | ADXB Analysis Visit [8 Terms] | Predecessor: XB.VISIT | |
| ADT | Analysis Date | integer | DATE9 | Derived ADT = input(xbdtc, ?? yymmdd10.) | ||
| ADY | Analysis Relative Day | integer | 8 | Derived Set as following:
ADY = ADT - TRTSDT.
If ADT >= TRTSDT, ADY = ADT - TRTSDT + 1. | ||
| PDP27FL | VE Prot Def Pop Incl 7D Post D2 Flag | text | 1 | No Yes Response
| Predecessor: ADC19EF.PDP27FL | |
| FC19D27 | First COVID Onset 7D Post D2 (PD) | text | 1 | No Yes Response
| Derived Set "Y" for records with swabs within the same illness visits for the first COVID-19 episode for a subject based on following condition
ADC19EF.paramcd in ("C19ONST") and ADC19EF.FILOCRFL= "Y" and ADC19EF.AVALC="POS" and ADC19EF.ILD27FL="Y" and ((not missing(DVSTDT) and ADC19EF.adt <= DVSTDT) or missing(DVSTDT)) and ADC19EF.PDRMUPFL = "N" and ADC19EF.EVALEFFL='Y'
else "N" | |
| FSEVPD27 | First Sev COVID Onset 7D Post D2 (PD) | text | 1 | No Yes Response
| Derived Set "Y" for records with swabs within the same illness visits for the first severe COVID-19 episode based on Protocol defined symptoms for a subject based on following condition
ADC19EF.paramcd in ("SEVCONST") and ADC19EF.FILOCRFL= "Y" and ADC19EF.AVALC="POS" and ADC19EF.ILD27FL="Y" and ((not missing(DVSTDT) and ADC19EF.adt <= DVSTDT) or missing(DVSTDT)) and ADC19EF.PDRMUPFL = "N" and ADC19EF.EVALEFFL='Y'
else "N" | |
| FSEVCD27 | First Sev COVID Onset 7D Post D2 (CDC) | text | 1 | No Yes Response
| Derived Set "Y" for records with swabs within the same illness visits for the first severe COVID-19 episode based on CDC defined symptoms for a subject based on following condition
ADC19EF.paramcd in ("CDCSONST") and ADC19EF.FILOCRFL= "Y" and ADC19EF.AVALC="POS" and ADC19EF.ILD27FL="Y" and ((not missing(DVSTDT) and ADC19EF.adt <= DVSTDT) or missing(DVSTDT)) and ADC19EF.CDRMUPFL = "N" and ADC19EF.EVALEFFL='Y'
else "N" | |
| FSEVPD1 | First Sev COVID Onset Post D1 (PD) | text | 1 | No Yes Response
| Derived Set "Y" for records with swabs within the same illness visits for the first severe COVID-19 episode based on Protocol defined symptoms for a subject based on following condition
ADC19EF.paramcd in ("SEVCONST") and ADC19EF.FILOCRFL= "Y" and ADC19EF.AVALC="POS" and ADC19EF.adt >= ADC19EF.VAX101DT and ADC19EF.PDRMUPFL = "N" and ADC19EF.aai1effl='Y'
else "N" | |
| FSEVCD1 | First Sev COVID Onset Post D1 (CDC) | text | 1 | No Yes Response
| Derived Set "Y" for records with swabs within the same illness visits for the first severe COVID-19 episode based on CDC defined symptoms for a subject based on following condition
ADC19EF.paramcd in ("CDCSONST") and ADC19EF.FILOCRFL= "Y" and ADC19EF.AVALC="POS" and ADC19EF.adt >= ADC19EF.VAX101DT and ADC19EF.CDRMUPFL = "N" and ADC19EF.aai1effl='Y'
else "N" |
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CodeLists
Description of Actual Arm
| Permitted Value (Code) |
|---|
| BNT162b1 Phase 1 (10 mcg) |
| BNT162b1 Phase 1 (20 mcg) |
| BNT162b1 Phase 1 (30 mcg) |
| BNT162b1 Phase 1 (100/10 mcg) |
| BNT162b2 Phase 1 (10 mcg) |
| BNT162b2 Phase 1 (20 mcg) |
| BNT162b2 Phase 1 (30 mcg) |
| BNT162b2 Phase 2/3 (30 mcg) |
| NOT ASSIGNED |
| Not Treated |
| Placebo |
| SCREEN FAILURE |
Actual Arm Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| B1_10 | BNT162b1 Phase 1 (10 mcg) |
| B1_20 | BNT162b1 Phase 1 (20 mcg) |
| B1_30 | BNT162b1 Phase 1 (30 mcg) |
| B1_100 | BNT162b1 Phase 1 (100/10 mcg) |
| B2_10 | BNT162b2 Phase 1 (10 mcg) |
| B2_20 | BNT162b2 Phase 1 (20 mcg) |
| B2_30 | BNT162b2 Phase 1 (30 mcg) |
| B2_P23_30 | BNT162b2 Phase 2/3 (30 mcg) |
| NOTASSGN | NOT ASSIGNED |
| NOTTRT | Not Treated |
| PLACEBO | Placebo |
| SCRNFAIL | SCREEN FAILURE |
Pooled Age Group 1 (N)
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 12-15 Years |
| 2 | 16-55 Years |
| 5 | >55 Years |
ADXB Analysis Visit
| Permitted Value (Code) |
|---|
| COVID_A |
| COVID_B |
| COVID_C |
| COVID_D |
| COVID_AR1 |
| COVID_BR1 |
| SSWAB_WEEK2 |
| SSWAB_WEEK4 |
ADXB Analysis Visit (N)
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | COVID_A |
| 2 | COVID_B |
| 3 | COVID_C |
| 4 | COVID_D |
| 1001 | COVID_AR1 |
| 2001 | COVID_BR1 |
| 20202 | SSWAB_WEEK2 |
| 20204 | SSWAB_WEEK4 |
ADXB Parameter
| Permitted Value (Code) |
|---|
| SARS CoV2 lineage phylogenetic analysis |
ADXB Parameter Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| WGSCLINE | SARS CoV2 lineage phylogenetic analysis |
Parameter (N)
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | SARS CoV2 lineage phylogenetic analysis |
Parameter Category 1
| Permitted Value (Code) |
|---|
| VIROLOGY |
Study Phase
| Permitted Value (Code) |
|---|
| Phase 2_ds360/ds6000 |
| Phase 3_ds6000 |
| Phase 3 |
Numeric Code of Study Phase
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 2 | Phase 2_ds360/ds6000 |
| 3 | Phase 3_ds6000 |
| 4 | Phase 3 |
ADXB.TRT01A
| Permitted Value (Code) |
|---|
| BNT162b2 Phase 2/3 (30 mcg) |
| Placebo |
ADXB.TRT01AN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 8 | BNT162b2 Phase 2/3 (30 mcg) |
| 9 | Placebo |
ADXB.TRT01P
| Permitted Value (Code) |
|---|
| BNT162b2 Phase 2/3 (30 mcg) |
| Placebo |
ADXB.TRT01PN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 8 | BNT162b2 Phase 2/3 (30 mcg) |
| 9 | Placebo |
Pooled Age Group 1
| Permitted Value (Code) |
|---|
| 12-15 Years |
| 16-55 Years |
| 18-55 Years |
| 65-85 Years |
| >55 Years |
Numeric Code of Pooled Age Group 1
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 12-15 Years |
| 2 | 16-55 Years |
| 3 | 18-55 Years |
| 4 | 65-85 Years |
| 5 | >55 Years |
Pooled Age Group 2
| Permitted Value (Code) |
|---|
| <65 Years |
| >=65 Years |
Numeric Code of Pooled Age Group 2
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | <65 Years |
| 2 | >=65 Years |
Pooled Age Group 3
| Permitted Value (Code) |
|---|
| 16-17 Years |
| 18-55 Years |
| >55 Years |
Numeric Code of Pooled Age Group 3
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 16-17 Years |
| 2 | 18-55 Years |
| 3 | >55 Years |
Pooled Age Group 4
| Permitted Value (Code) |
|---|
| 12-15 Years |
| 16-25 Years |
Numeric Code of Pooled Age Group 4
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 12-15 Years |
| 2 | 16-25 Years |
Age Group at Vaccination 03
| Permitted Value (Code) |
|---|
| 16-55 Years |
| >55 Years |
Numeric Code of Age Group at Vaccination 03
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 16-55 Years |
| 2 | >55 Years |
Age Unit [C66781]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| YEARS [C29848] | Year |
Analysis Race
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| WHITE [C41261] | White |
| BLACK OR AFRICAN AMERICAN [C16352] | Black or african american |
| AMERICAN INDIAN OR ALASKA NATIVE [C41259] | American indian or alaska native |
| ASIAN [C41260] | Asian |
| NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER [C41219] | Native hawaiian or other pacific islander |
| MULTIRACIAL | Multiple |
| NOT REPORTED [C43234] | Not reported |
Numeric Code of Analysis Race
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | WHITE |
| 2 | BLACK OR AFRICAN AMERICAN |
| 3 | AMERICAN INDIAN OR ALASKA NATIVE |
| 4 | ASIAN |
| 5 | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER |
| 6 | MULTIRACIAL |
| 7 | NOT REPORTED |
Description of Planned Arm
| Permitted Value (Code) |
|---|
| BNT162b1 Phase 1 (10 mcg) |
| BNT162b1 Phase 1 (20 mcg) |
| BNT162b1 Phase 1 (30 mcg) |
| BNT162b1 Phase 1 (100/10 mcg) |
| BNT162b2 Phase 1 (10 mcg) |
| BNT162b2 Phase 1 (20 mcg) |
| BNT162b2 Phase 1 (30 mcg) |
| BNT162b2 Phase 2/3 (30 mcg) |
| NOT ASSIGNED |
| Placebo |
| SCREEN FAILURE |
Planned Arm Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| B1_10 | BNT162b1 Phase 1 (10 mcg) |
| B1_20 | BNT162b1 Phase 1 (20 mcg) |
| B1_30 | BNT162b1 Phase 1 (30 mcg) |
| B1_100 | BNT162b1 Phase 1 (100/10 mcg) |
| B2_10 | BNT162b2 Phase 1 (10 mcg) |
| B2_20 | BNT162b2 Phase 1 (20 mcg) |
| B2_30 | BNT162b2 Phase 1 (30 mcg) |
| B2_P23_30 | BNT162b2 Phase 2/3 (30 mcg) |
| NOTASSGN | NOT ASSIGNED |
| PLACEBO | Placebo |
| SCRNFAIL | SCREEN FAILURE |
BMI Category
| Permitted Value (Code) |
|---|
| Underweight |
| Normal weight |
| Overweight |
| Obese |
| Missing |
Numeric Code of BMI Category
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | Underweight |
| 2 | Normal weight |
| 3 | Overweight |
| 4 | Obese |
| 5 | Missing |
CD4CAT
| Permitted Value (Code) |
|---|
| <200 |
| 200-500 |
| >500 |
CD4CATN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | <200 |
| 2 | 200-500 |
| 3 | >500 |
Cohort
| Permitted Value (Code) |
|---|
| Stage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) |
| Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO) |
| Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) |
| Stage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) |
| Stage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) |
| Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO) |
| Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) |
| Stage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) |
| Stage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO) |
| Stage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) |
| Stage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) |
| Stage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO) |
| Stage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) |
Numeric Code of Cohort
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1.14 | Stage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) |
| 1.145 | Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO) |
| 1.15 | Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) |
| 1.16 | Stage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) |
| 1.17 | Stage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) |
| 1.175 | Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO) |
| 1.18 | Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) |
| 1.34 | Stage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) |
| 1.345 | Stage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO) |
| 1.35 | Stage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) |
| 1.37 | Stage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) |
| 1.375 | Stage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO) |
| 1.38 | Stage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) |
Baseline SARS-CoV-2 Status
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| NEG | Negative |
| POS | Positive |
Date Imputation Flag [C81223]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| D [C81212] | Day Imputed |
| M [C81211] | Month Day Imputed |
Actual Dosing Level
| Permitted Value (Code) |
|---|
| 10 (*ESC*){unicode 03BC}g |
| 20 (*ESC*){unicode 03BC}g |
| 30 (*ESC*){unicode 03BC}g |
| 100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}g |
| Placebo |
Numeric Code of Actual Dosing Level
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 10 (*ESC*){unicode 03BC}g |
| 2 | 20 (*ESC*){unicode 03BC}g |
| 3 | 30 (*ESC*){unicode 03BC}g |
| 5 | 100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}g |
| 6 | Placebo |
Planned Dosing Level
| Permitted Value (Code) |
|---|
| 10 (*ESC*){unicode 03BC}g |
| 20 (*ESC*){unicode 03BC}g |
| 30 (*ESC*){unicode 03BC}g |
| 100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}g |
| Placebo |
Numeric Code of Planned Dosing Level
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 10 (*ESC*){unicode 03BC}g |
| 2 | 20 (*ESC*){unicode 03BC}g |
| 3 | 30 (*ESC*){unicode 03BC}g |
| 5 | 100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}g |
| 6 | Placebo |
Ethnic Group [C66790]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| HISPANIC OR LATINO [C17459] | Hispanic or Latino |
| NOT HISPANIC OR LATINO [C41222] | Not Hispanic or Latino |
| NOT REPORTED [C43234] | Not Reported |
Numeric Code of Ethnic Group
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | HISPANIC OR LATINO |
| 2 | NOT HISPANIC OR LATINO |
| 3 | NOT REPORTED |
FPX1CA1N
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 0-1 month |
| 2 | 1-2 months |
| 3 | 2-3 months |
| 4 | 3-4 months |
FPX1CAT1
| Permitted Value (Code) |
|---|
| 0-1 month |
| 1-2 months |
| 2-3 months |
| 3-4 months |
FUP1CA1N
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 0-1 month |
| 2 | 1-2 months |
| 3 | 2-3 months |
| 4 | 3-4 months |
| 5 | 4-5 months |
| 6 | 5-6 months |
| 7 | 6-7 months |
| 8 | 7-8 months |
| 9 | 8-9 months |
| 10 | 9-10 months |
| 11 | 10-11 months |
| 12 | 11-12 months |
FUP1CAT1
| Permitted Value (Code) |
|---|
| 0-1 month |
| 1-2 months |
| 2-3 months |
| 3-4 months |
| 4-5 months |
| 5-6 months |
| 6-7 months |
| 7-8 months |
| 8-9 months |
| 9-10 months |
| 10-11 months |
| 11-12 months |
FUP2CA1N
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 0-1 month |
| 2 | 1-2 months |
| 3 | 2-3 months |
| 4 | 3-4 months |
| 5 | 4-5 months |
| 6 | 5-6 months |
| 7 | 6-7 months |
| 8 | 7-8 months |
| 9 | 8-9 months |
| 10 | 9-10 months |
| 11 | 10-11 months |
FUP2CA2N
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 0-1 month |
| 2 | 1-2 months |
| 3 | 2-3 months |
| 4 | 3-4 months |
| 5 | 4-5 months |
| 6 | 5-6 months |
| 7 | 6-7 months |
| 8 | 7-8 months |
| 9 | 8-9 months |
| 10 | 9-10 months |
FUP2CAT1
| Permitted Value (Code) |
|---|
| 0-1 month |
| 1-2 months |
| 2-3 months |
| 3-4 months |
| 4-5 months |
| 5-6 months |
| 6-7 months |
| 7-8 months |
| 8-9 months |
| 9-10 months |
| 10-11 months |
FUP2CAT2
| Permitted Value (Code) |
|---|
| 0-1 month |
| 1-2 months |
| 2-3 months |
| 3-4 months |
| 4-5 months |
| 5-6 months |
| 6-7 months |
| 7-8 months |
| 8-9 months |
| 9-10 months |
N [C66742]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| N [C49487] | No |
No Yes Response [C66742]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| N [C49487] | No |
| Y [C49488] | Yes |
Study Phase
| Permitted Value (Code) |
|---|
| Phase 1 |
| Phase 2_ds360/ds6000 |
| Phase 3_ds6000 |
| Phase 3 |
Numeric Code of Study Phase
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | Phase 1 |
| 2 | Phase 2_ds360/ds6000 |
| 3 | Phase 3_ds6000 |
| 4 | Phase 3 |
Race [C74457]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| WHITE [C41261] | White |
| BLACK OR AFRICAN AMERICAN [C16352] | Black or african american |
| AMERICAN INDIAN OR ALASKA NATIVE [C41259] | American indian or alaska native |
| ASIAN [C41260] | Asian |
| NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER [C41219] | Native hawaiian or other pacific islander |
| MULTIPLE [*] | Multiple |
| NOT REPORTED [C43234] | Not reported |
* Extended Value
Pooled Race Group 1
| Permitted Value (Code) |
|---|
| WHITE |
| BLACK OR AFRICAN AMERICAN |
| ALL OTHERS |
Numeric Code of Pooled Race Group 1
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | WHITE |
| 2 | BLACK OR AFRICAN AMERICAN |
| 3 | ALL OTHERS |
Numeric Code of Race
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | WHITE |
| 2 | BLACK OR AFRICAN AMERICAN |
| 3 | AMERICAN INDIAN OR ALASKA NATIVE |
| 4 | ASIAN |
| 5 | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER |
| 6 | MULTIPLE |
| 7 | NOT REPORTED |
RACIALD
| Permitted Value (Code) |
|---|
| JAPANESE |
| OTHER |
Numeric Code of RACIALD
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 5 | JAPANESE |
| 999 | OTHER |
RNACAT
| Permitted Value (Code) |
|---|
| <50 |
| >=50 |
RNACATN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | <50 |
| 2 | >=50 |
Sex [C66731]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| F [C16576] | Female |
| M [C20197] | Male |
Numeric Code of Sex
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | M |
| 2 | F |
TRT01A
| Permitted Value (Code) |
|---|
| BNT162b1 Phase 1 (10 mcg) |
| BNT162b1 Phase 1 (20 mcg) |
| BNT162b1 Phase 1 (30 mcg) |
| BNT162b1 Phase 1 (100/10 mcg) |
| BNT162b2 Phase 1 (10 mcg) |
| BNT162b2 Phase 1 (20 mcg) |
| BNT162b2 Phase 1 (30 mcg) |
| BNT162b2 Phase 2/3 (30 mcg) |
| Placebo |
TRT01AN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | BNT162b1 Phase 1 (10 mcg) |
| 2 | BNT162b1 Phase 1 (20 mcg) |
| 3 | BNT162b1 Phase 1 (30 mcg) |
| 4 | BNT162b1 Phase 1 (100/10 mcg) |
| 5 | BNT162b2 Phase 1 (10 mcg) |
| 6 | BNT162b2 Phase 1 (20 mcg) |
| 7 | BNT162b2 Phase 1 (30 mcg) |
| 8 | BNT162b2 Phase 2/3 (30 mcg) |
| 9 | Placebo |
TRT01P
| Permitted Value (Code) |
|---|
| BNT162b1 Phase 1 (10 mcg) |
| BNT162b1 Phase 1 (20 mcg) |
| BNT162b1 Phase 1 (30 mcg) |
| BNT162b1 Phase 1 (100/10 mcg) |
| BNT162b2 Phase 1 (10 mcg) |
| BNT162b2 Phase 1 (20 mcg) |
| BNT162b2 Phase 1 (30 mcg) |
| BNT162b2 Phase 2/3 (30 mcg) |
| Placebo |
TRT01PN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | BNT162b1 Phase 1 (10 mcg) |
| 2 | BNT162b1 Phase 1 (20 mcg) |
| 3 | BNT162b1 Phase 1 (30 mcg) |
| 4 | BNT162b1 Phase 1 (100/10 mcg) |
| 5 | BNT162b2 Phase 1 (10 mcg) |
| 6 | BNT162b2 Phase 1 (20 mcg) |
| 7 | BNT162b2 Phase 1 (30 mcg) |
| 8 | BNT162b2 Phase 2/3 (30 mcg) |
| 9 | Placebo |
TRT02A
| Permitted Value (Code) |
|---|
| BNT162b2 Phase 1 (30 mcg) |
| BNT162b2 Phase 2/3 (30 mcg) |
TRT02AN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 7 | BNT162b2 Phase 1 (30 mcg) |
| 8 | BNT162b2 Phase 2/3 (30 mcg) |
TRT02P
| Permitted Value (Code) |
|---|
| BNT162b2 Phase 1 (30 mcg) |
| BNT162b2 Phase 2/3 (30 mcg) |
TRT02PN
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 7 | BNT162b2 Phase 1 (30 mcg) |
| 8 | BNT162b2 Phase 2/3 (30 mcg) |
Y [C66742]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| Y [C49488] | Yes |
Go to the top of the Define-XML document
Methods
| Method | Type | Description |
|---|---|---|
| Algorithm: ADSL.AAI01FL | Computation | Will apply to Phase 1 only. If SAFFL="Y" and randfl="Y" and (vax101dt>. or vax102dt>.) and INCL3fl="Y" and not (index(SUPPDV.QNAM.CAPE, "POP3") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI01FL="Y"; else AAI01FL="N"; |
| Algorithm: ADSL.AAI02FL | Computation | If SAFFL="Y" and randfl="Y" and vax102dt>. and INCL8fl="Y" and not ((index(SUPPDV.QNAM.CAPE, "POP3") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI02FL="Y"; else AAI02FL="N"; |
| Algorithm: ADSL.AAI1EFFL | Computation | If SAFFL="Y" and randfl="Y" and (vax101dt>. or vax102dt>.) and not((index(SUPPDV.QNAM.CAPE, "POP2") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI1EFFL="Y"; else AAI1EFFL="N"; |
| Algorithm: ADSL.AAI2EFFL | Computation | If SAFFL="Y" and randfl="Y" and vax101dt>. and vax102dt>. and (UNBLNDDT=. or (UNBLNDDT>=vax102dt+7>.)) and not((index(SUPPDV.QNAM.CAPE, "POP2") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI2EFFL="Y"; else AAI2EFFL="N"; |
| Algorithm: ADSL.ACTARM | Computation | Based on the actual vaccinations taken by subjects. Same as ARM if no medication error for the vaccinated subjects
ACTARM=' NOT ASSIGNED ' for not assigned subjects;
ACTARM=' SCREEN FAILURE ' for screen failure subjects;
ACTARM='Not Treated' for not treated subjets or subjects without determined treatment; |
| Algorithm: ADSL.ACTARMCD | Computation | Based on the actual vaccinations taken by subjects. Same as ARMCD if no medication error for the vaccinated subjects.
ACTARM=' NOTASSGN ' for not assigned subjects;
ACTARM=' SCRNFAIL ' for screen failure subjects;
ACTARMCD='NOTTRT' for not treated subjets or subjects without determined treatment; |
| Algorithm: ADSL.AGEGR1 | Computation | Derived using following derivations:
if 12<=agetr01<=15 then AGEGR1='12-15 Years';(Phase 2/3 cohort)
if 18<=agetr01<=55 then AGEGR1='18-55 Years';(Phase 1 cohort)
if 16<=agetr01<=55 then AGEGR1='16-55 Years';(Phase 2/3 cohort)
if 65<=agetr01 then AGEGR1='65-85 Years'; (Phase 1 cohort)
if 56<=agetr01 then AGEGR1='>55 Years'; (Phase 2/3 cohort) |
| Algorithm: ADSL.AGEGR2 | Computation | Derived using following derivations:
if 65<=agetr01 then AGEGR2='>=65 Years';
if agetr01<65 then AGEGR2='<65 Years'; |
| Algorithm: ADSL.AGEGR3 | Computation | Derived using following derivations:
if 16<=agetr01<=17 then AGEGR3='16-17 Years';
if 18<=agetr01<=55 then AGEGR3='18-55 Years';
if 55<agetr01 then AGEGR3='>55 Years'; |
| Algorithm: ADSL.AGEGR4 | Computation | Derived using following derivations for Phase 3 subjects only:
if 12<=agetr01<=15 then AGEGR4='12-15 Years';
if 16<=agetr01<=25 then AGEGR4='16-25 Years'; |
| Algorithm: ADSL.AGETGR3 | Computation | Derived using following derivations:
if 16<=agetr03<=55 then AGETGR3='16-55 Years';
if 56<=agetr03 then AGETGR3='>55 Years'; |
| Algorithm: ADSL.AGETR01 | Computation | Derive AGETR01 from BIRTHDT (after applying imputation for partial date) and date of vaccination1. For participants who were randomized but not vaccinated, the randomization date will be used in place of the date of vaccination at Dose 1 for the age calculation. If the randomization date is also missing, then the informed consent date will be used for the age calculation.
Note: For example: If the vaccination 1 date is one day before the subject's 19th birthday, the subject is 18 years old. |
| Algorithm: ADSL.AGETR03 | Computation | Derive AGETR03 from BIRTHDT (after applying imputation for partial date) and date of first dose of crossover period.
Note: For example: If dose 3 date is one day before the subject's 19th birthday, the subject is 18 years old. |
| Algorithm: ADSL.ARACE | Computation | if RACEN=1 then ARACE='WHITE';
if RACEN=2 then ARACE='BLACK OR AFRICAN AMERICAN';
if RACEN=3 then ARACE='AMERICAN INDIAN OR ALASKA NATIVE';
if RACEN=4 then ARACE='ASIAN';
if RACEN=5 then ARACE='NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER';
if RACEN=6 then ARACE='MULTIRACIAL';
if RACEN=7 then ARACE='NOT REPORTED'; |
| Algorithm: ADSL.ARM | Computation | if armcd="B1_10" then arm="BNT162b1 Phase 1 (10 mcg)"
if armcd="B1_100" then arm="BNT162b1 Phase 1 (100/10 mcg)"
if armcd="B1_20" then arm="BNT162b1 Phase 1 (20 mcg)"
if armcd="B1_30" then arm="BNT162b1 Phase 1 (30 mcg)"
if armcd="B2_10" then arm="BNT162b2 Phase 1 (10 mcg)"
if armcd="B2_20" then arm="BNT162b2 Phase 1 (20 mcg)"
if armcd="B2_30" then arm="BNT162b2 Phase 1 (30 mcg)"
if armcd="B2_P23_30" then arm="BNT162b2 Phase 2/3 (30 mcg)"
if armcd="NOTASSGN" then arm="NOT ASSIGNED"
if armcd="NOTTRT" then arm="Not Treated"
if armcd="PLACEBO" then arm="Placebo"
if armcd="SCRNFAIL" then arm="SCREEN FAILURE" |
| Algorithm: ADSL.BDCSRDT | Computation | if randfl="Y" then do;
if (tr02sdt>. or UNBLNDDT>. ) and boostfl ne "Y" then do;
if .<tr02sdt-1<"&cutoff2"d then BDCSRDT=tr02sdt-1;
else BDCSRDT="&cutoff2"d;
if .<UNBLNDDT-1<=BDCSRDT then BDCSRDT=UNBLNDDT-1;
end;
else do;
if .<UNBLNDDT-1<="&cutoff2"d then BDCSRDT=UNBLNDDT-1;
else BDCSRDT="&cutoff2"d;
if .<eosdcdt<=BDCSRDT then BDCSRDT=eosdcdt;
end;
end;
Note: &cutoff2 will be the data cutoff date which specified in the table footnote. |
| Algorithm: ADSL.BLDV1DT | Computation | Blood draw date at Vax 1 Visit |
| Algorithm: ADSL.BLDV1FL | Computation | If non missing blood draw date at Vax 1 Visit then bldv1fl = 'Y''; else bldv1fl = 'N'. |
| Algorithm: ADSL.BLDV2DT | Computation | Blood draw date at 1 Week after Vax 1 Visit |
| Algorithm: ADSL.BLDV2FL | Computation | If non missing blood draw date at 1 Week after Vax 1 Visit then bldv2fl = 'Y''; else bldv2fl = 'N'. |
| Algorithm: ADSL.BLDV3ADT | Computation | For 100 ug only, blood draw date at 3 weeks after Vax 1 Visit |
| Algorithm: ADSL.BLDV3DT | Computation | Blood draw date at Vax 2 Visit |
| Algorithm: ADSL.BLDV3FL | Computation | If non missing blood draw date at Vax 2 Visit then bldv3fl = 'Y''; else bldv3fl = 'N'. |
| Algorithm: ADSL.BLDV4ADT | Computation | For 100 ug only, blood draw date at 4 weeks after Vax 1 Visit |
| Algorithm: ADSL.BLDV4DT | Computation | Blood draw date at 1 Week after Vax 2 Visit |
| Algorithm: ADSL.BLDV4FL | Computation | If non missing blood draw date at 1 Week after Vax 2 Visit then bldv4fl = 'Y''; else bldv4fl = 'N'. |
| Algorithm: ADSL.BLDV5ADT | Computation | For 100 ug only, blood draw date at 5 weeks after Vax 1 Visit |
| Algorithm: ADSL.BLDV5DT | Computation | Blood draw date at 2 Weeks after Vax 2 Visit |
| Algorithm: ADSL.BLDV5FL | Computation | If non missing blood draw date at 2 Weeks after Vax 2 Visit then bldv5fl = 'Y''; else bldv5fl = 'N'. |
| Algorithm: ADSL.BLDV6ADT | Computation | For 100 ug only, blood draw date at 3 weeks + 1 month after Vax 1 Visit |
| Algorithm: ADSL.BLDV6DT | Computation | Blood draw date at 1 Month after Vax 2 Visit. (Only apply to Phase 2/3 to serology: For subjects had Visit 3 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened within 28-42 days post dose 2, the convalescent visit will be used to replace this one, and bldv6dt will be set to the date of the convalescent visit. If multiple records fall into such window, the one closed to 30 days post dose 2 will be chosen. If multiple records at the same day, the one with available immunogenicity results will be chosen.) |
| Algorithm: ADSL.BLDV6FL | Computation | If non missing blood draw date at 1 Month after Vax 2 Visit then bldv6fl = 'Y''; else bldv6fl = 'N'. (Only apply to Phase 2/3 to serology: For subjects had Visit 3 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened within 28-42 days post dose 2, the convalescent visit will be used to replace this one, and bldv6fl will be set to "Y".) |
| Algorithm: ADSL.BLDV7DT | Computation | Blood draw date at 6 Months after Vax 2 Visit. (Only apply to Phase 2/3 to serology: For subjects had Visit 4 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened after 42 days post dose 2, the convalescent visit will be used to replace this one, and bldv7dt will be set to the date of the convalescent visit. If multiple records fall into such window, the one closed to 190 days post dose 2 will be chosen. If multiple records at the same day, the one with available immunogenicity results will be chosen.) |
| Algorithm: ADSL.BLDV7FL | Computation | If non missing blood draw date at 6 Months after Vax 2 Visit then bldv7fl = 'Y''; else bldv7fl = 'N'. (Only apply to Phase 2/3 to serology: For subjects had Visit 4 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened after 42 days post dose 2, the convalescent visit will be used to replace this one, and bldv7fl will be set to "Y".) |
| Algorithm: ADSL.BMICAT | Computation | Carry BMI from SDTM.VS where index(visit, "V1_DAY1") and vstestcd="BMI" and vsdy<=1
if .<vsstresn<18.5 then BMICAT="Underweight";
else if 18.5<=vsstresn<=24.9 then BMICAT="Normal weight";
else if 25<=vsstresn<=29.9 then BMICAT="Overweight";
else if 30<=vsstresn then BMICAT="Obese";
if vsstresn=. then BMICAT="Missing"; |
| Algorithm: ADSL.BRTHDT | Computation | Datepart of DM.BRTHDTC
Imputation of Partial Dates:
If Day is missing, 1st day of Month
If Month is missing, 1st month of Year. |
| Algorithm: ADSL.BRTHDTF | Computation | BRTHDTF = 'M' if Month and Day are imputed in BRTHDT
BRTHDTF = 'D' if only Day is imputed in BRTHDT |
| Algorithm: ADSL.CD4CAT | Computation | if .<LB.LBSTRESN*1000<200 then assigned as "<200"; else if 200<=LB.LBSTRESN*1000<=500 then assigned as "200-500"; else if LB.LBSTRESN*1000>500 then assigned as ">500"; where LB.LBTESTCD="CD4" and LBSTRESU="10^9/L" and LB.LBSTAT ne "NOT DONE" and index(visit, "V1_DAY1_VAX1") and LBDY<=1 |
| Algorithm: ADSL.CD4CATN | Computation | 1="<200"
2="200-500"
3=">500" |
| Algorithm: ADSL.COHORT | Computation | For Phase 1 only: SUPPDS.QVAL where SUPPDS.QNAM=’ DSRANGRP’ |
| Algorithm: ADSL.COMBODFL | Computation | "Y" if subject with Medical History With Comorbodities. Terms were defined in 19 external excel files whose filename contains 'report-cci'. |
| Algorithm: ADSL.COVBLST | Computation | Subjects are considered with COVID-19 history if MH.MHDECOD in ("Asymptomatic COVID-19" "COVID-19" "COVID-19 pneumonia" "COVID-19 treatment" "Suspected COVID-19" "SARS-CoV-2 antibody test positive" "SARS-CoV-2 carrier" "SARS-CoV-2 sepsis" "SARS-CoV-2 test positive" "SARS-CoV-2 viraemia" "Multisystem inflammatory syndrome in children").
if subjects with COVID-19 history or NIGV1FL="N" or NAATNFL="N" then COVBLST="POS";
if subjects without COVID-19 history and NIGV1FL="Y" and NAATNFL="Y" then COVBLST="NEG"; |
| Algorithm: ADSL.DOSALVL | Computation | For Phase 1 only:
Assign actual dose level. eg: 10 ug, 20 ug, 30 ug, 100 ug/10 ug
For Placebo: Assign 'Placebo' |
| Algorithm: ADSL.DOSPLVL | Computation | For Phase 1 only:
Assign planned dose level. eg: 10 ug, 20 ug, 30 ug,100 ug/10 ug
For Placebo: Assign 'Placebo' |
| Algorithm: ADSL.DS30KFL | Computation | "Y" for non-phase 1 subjects that are randomized on or before 9Oct2020 and obtained IC on or after 27Jul2020. |
| Algorithm: ADSL.DS3KFL | Computation | "Y" for phase 2/3 subjects had follow up 168 days after Dose 2 at the point of EOS or data cutoff and reiceved 2 planned doses of BNT162b2; else "N". |
| Algorithm: ADSL.DTHDT | Computation | If DM.DTHDTC is not missing and not partial then DTHDT=Datepart of DM.DTHDTC;
Else if DM.DTHDTC is partial then impute DTHDT using imputation START rules.
Partial Death Dates Imputation Rules:
If day (DD) and month (MMM) are missing in DM.DTHDTC, then use first day (01) and first month (JAN) for DD and MMM respectively.
If day (DD) missing then use first day (01) of the month for DD.
It is recommended that the database be designed to mandate a complete death date. If there is a record for death, but the date is missing or is partial, it will be imputed based on the last contact date.
If the entire death date DM.DTHDTC is missing OR If imputed Death Date (DTHDT) is ON or PRIOR to Last Know Alive Date then reset DTHDT=(Last Known Alive Date) +1 |
| Algorithm: ADSL.DTHDTF | Computation | If DTHDT was imputed, DTHDTF must be populated and is required.
DTHDTF = 'Y' if Year is imputed
DTHDTF = 'M' if Year is present and Month is imputed
DTHDTF = 'D' if only day is imputed |
| Algorithm: ADSL.DVSTDT | Computation | The earliest date of important PD |
| Algorithm: ADSL.ENRLFL | Computation | Assign 'Y' for participants who have a signed ICD. |
| Algorithm: ADSL.EOSDCDT | Computation | EOSDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and DSPHASE="FOLLOW-UP" and DS.DSDECOD^=“COMPLETED” |
| Algorithm: ADSL.EOSDCRS | Computation | EOSDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and DSPHASE="FOLLOW-UP" and DS.DSDECOD^=“COMPLETED” |
| Algorithm: ADSL.EOTDCDT | Computation | EOTDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and index(SUPPDS.QNAM.DSPHASE, "VACCINATION")>0 and DS.DSDECOD^=“COMPLETED” |
| Algorithm: ADSL.EOTDCRS | Computation | EOTDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and SUPPDS.QNAM.DSPHASE="VACCINATION" and DS.DSDECOD^=“COMPLETED” |
| Algorithm: ADSL.EOTXDCDT | Computation | EOTXDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and SUPPDS.QNAM='DSPHASE' and SUPPDS.QVAL="OPEN LABEL TREATMENT" and DS.DSDECOD^=“COMPLETED” |
| Algorithm: ADSL.EOTXDCRS | Computation | EOTXDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and SUPPDS.QNAM='DSPHASE' and SUPPDS.QVAL="OPEN LABEL TREATMENT" and DS.DSDECOD^=“COMPLETED” |
| Algorithm: ADSL.EV1MD2FL | Computation | Subjects will be set to “N” if any of the following conditions are met:
•N-Binding is POS at visit 3.
•Convalescent visit with POS result in the absence of visit 3 and is within 28-42 days PD2.
•Convalescent N-Binding result is POS and is before Visit 3 date or up to 7 days after Visit 3 date.
•Subjects without symptoms and have unscheduled POS swab results within 1MPD2 .
•Subjects with POS swab results at Dose 1/Dose 2 or POS for N-Binding at Dose 1.
•Subjects with presence of symptoms on or after Dose 1 and within 1MPD2 that are without valid NEG swab results.
Else "Y". |
| Algorithm: ADSL.EVAL01FL | Computation | Will apply to Phase 1 only. If INCL1fl="Y" and INCL2fl="Y" and INCL4fl="Y" and INCL5fl="Y" and (index(SUPPDV.QNAM.CAPE, "POP3")=0 for subjects's all DV records) then EVAL01FL="Y"; else EVAL01FL="N"; |
| Algorithm: ADSL.EVAL02FL | Computation | If INCL1fl="Y" and INCL2fl="Y" and (INCL7fl="Y" and vax10udt=.) and INCL8fl="Y" and INCL9fl="Y" and (index(SUPPDV.QNAM.CAPE, "POP3")=0 for subjects's all DV records) then EVAL02FL="Y"; else EVAL02FL="N"; |
| Algorithm: ADSL.EVALEFFL | Computation | If SAFFL="Y" and RFICDT>. and RANDFL="Y" and ARM ne "SCREEN FAILURE" and INCL1FL="Y" and INCL2fl="Y" and (INCL7fl="Y" and (vax10udt=. or (vax10udt>vax102dt>. and vax10udt>=vax102dt+7))) and VAX102DT>. and (UNBLNDDT=. or (UNBLNDDT>=vax102dt+7>.)) and (index(SUPPDV.QNAM.CAPE, "POP2")=0 for subjects's all DV records or any records with DV date 7 days after Dose 2 and index(SUPPDV.QNAM.CAPE, "POP2")>0 ) and (index(SUPPDV.QNAM.CAPE, "POP3")=0 and index(SUPPDV.QNAM.CAPE, "POP5")=0 for subjects's all DV records)then EVALEFFL="Y"; else EVALEFFL="N"; |
| Algorithm: ADSL.EXCL10FL | Computation | "Y" if INCL10FL="N" |
| Algorithm: ADSL.EXCL1FL | Computation | if INCL1FL="N" then EXCL1FL="Y" |
| Algorithm: ADSL.EXCL2FL | Computation | if EXCL1FL ne "Y" and INCL2FL="N" then EXCL2FL="Y" |
| Algorithm: ADSL.EXCL3FL | Computation | Will apply to Phase 1 only. if (VAX101DT>. or vax102dt>.) and INCL3FL="N" then EXCL3FL="Y" |
| Algorithm: ADSL.EXCL4FL | Computation | Will apply to Phase 1 only. if EXCL2FL ne "Y" and INCL4FL="N" then EXCL4FL="Y" |
| Algorithm: ADSL.EXCL5FL | Computation | Will apply to Phase 1 only. if EXCL2FL ne "Y" and INCL5FL="N" then EXCL5FL="Y" |
| Algorithm: ADSL.EXCL6FL | Computation | if INCL6FL="N" then EXCL6FL="Y" |
| Algorithm: ADSL.EXCL7FL | Computation | if EXCL2FL ne "Y" and INCL7FL="N" then EXCL7FL="Y" |
| Algorithm: ADSL.EXCL8FL | Computation | if VAX102DT ne . and INCL8FL="N" then EXCL8FL="Y" |
| Algorithm: ADSL.EXCL9FL | Computation | if VAX102DT ne . and EXCL2FL ne "Y" and INCL9FL="N" then EXCL9FL="Y" |
| Algorithm: ADSL.EXCRIT10 | Computation | for INCL10FL="N" and vax102dt not missing:
assign to "unblinded prior to 7 days post Dose 2" for UNBLNDDT<VAX102DT+7;
assign to "unblinded on or after 7 days but prior to 14 days post Dose 2" for VAX102DT+7<=UNBLNDDT<VAX102DT+14;
assign to "unblinded on or after 14 days but no later than 1 month post Dose 2 visit" for VAX102DT+14<=UNBLNDDT<=V3 date; |
| Algorithm: ADSL.FPX1CA1N | Computation | 1 for 0<=FPX1CUT/28<1;
2 for 1<=FPX1CUT/28<2;
3 for 2<=FPX1CUT/28<3;
4 for 3<=FPX1CUT/28<4;
etc. |
| Algorithm: ADSL.FPX1CAT1 | Computation | "0-1 Month" for FPX1CA1N=1;
"1-2 Months" for FPX1CA1N=2;
"2-3 Months" for FPX1CA1N=3;
"3-4 Months" for FPX1CA1N=4;
etc. |
| Algorithm: ADSL.FPX1CUT | Computation | if (UNBLNDDT>. or tr02sdt>. ) and boostfl ne "Y" then do;
if tr02sdt=. then FPX1CUT=0;
else if not missing(eosdcdt) and eosdcdt>=tr02sdt then FPX1CUT=eosdcdt-tr02sdt+1;
else FPX1CUT="&cutoff2"d-tr02sdt+1;
end;
Note: only populate for subjects unblinded or received cross over doses |
| Algorithm: ADSL.FUNBCUT | Computation | if (UNBLNDDT>. or tr02sdt>. ) and boostfl ne "Y" then do;
if UNBLNDDT=. then FUNBCUT=0;
else if not missing(eosdcdt) then FUNBCUT=eosdcdt-UNBLNDDT+1;
else FUNBCUT="&cutoff2"d-UNBLNDDT+1;
end; |
| Algorithm: ADSL.FUP1CA1N | Computation | 1 for 0<=FUP1CUT/28<1;
2 for 1<=FUP1CUT/28<2;
3 for 2<=FUP1CUT/28<3;
4 for 3<=FUP1CUT/28<4;
etc. |
| Algorithm: ADSL.FUP1CAT1 | Computation | "0-1 Month" for FUP1CA1N=1;
"1-2 Months" for FUP1CA1N=2;
"2-3 Months" for FUP1CA1N=3;
"3-4 Months" for FUP1CA1N=4;
etc. |
| Algorithm: ADSL.FUP1CUT | Computation | if randfl="Y" then do;
if vax101dt=. then FUP1CUT=0;
else if not missing(eosdcdt) then FUP1CUT=eosdcdt-vax101dt+1;
else FUP1CUT="&cutoff2"d-vax101dt+1;
end; |
| Algorithm: ADSL.FUP1UNB | Computation | if randfl="Y" then do;
if vax101dt=. then FUP1UNB=0;
else if not missing(BDCSRDT) then FUP1UNB=BDCSRDT-vax101dt+1;
end; |
| Algorithm: ADSL.FUP2CA1N | Computation | 1 for 0<=FUP2CUT/28<1;
2 for 1<=FUP2CUT/28<2;
3 for 2<=FUP2CUT/28<3;
4 for 3<=FUP2CUT/28<4;
etc. |
| Algorithm: ADSL.FUP2CA2N | Computation | 1 for 0<=FUP2UNB/28<1;
2 for 1<=FUP2UNB/28<2;
3 for 2<=FUP2UNB/28<3;
4 for 3<=FUP2UNB/28<4;
etc." |
| Algorithm: ADSL.FUP2CAT1 | Computation | "0-1 Month" for FUP2CA1N=1;
"1-2 Months" for FUP2CA1N=2;
"2-3 Months" for FUP2CA1N=3;
"3-4 Months" for FUP2CA1N=4;
etc. |
| Algorithm: ADSL.FUP2CAT2 | Computation | "0-1 Month" for FUP2CA2N=1;
"1-2 Months" for FUP2CA2N=2;
"2-3 Months" for FUP2CA2N=3;
"3-4 Months" for FUP2CA2N=4;
etc. |
| Algorithm: ADSL.FUP2CUT | Computation | if randfl="Y" then do;
if vax102dt=. then FUP2CUT=0;
else if not missing(eosdcdt) then do;
FUP2CUT=eosdcdt-vax102dt+1;
if vax10udt>. then FUP2CUT=eosdcdt-vax10udt+1;
end;
else do;
FUP2CUT="&cutoff2"d-vax102dt+1;
if vax10udt>. then FUP2CUT="&cutoff2"d-vax10udt+1;
end;
end; |
| Algorithm: ADSL.FUP2UNB | Computation | if randfl="Y" then do;
if vax102dt=. then FUP2UNB=0;
else if not missing(BDCSRDT) then do;
FUP2UNB=BDCSRDT-vax102dt+1;
if vax10udt>. then FUP2UNB=BDCSRDT-vax10udt+1;
end;
end; |
| Algorithm: ADSL.HIVFL | Computation | "Y" if subject with HIV positive, subjects with HIV were determined by their medical history, HIV related term were defined in an external file: 201114-hiv-preferred-terms.xlsx |
| Algorithm: ADSL.INCL10FL | Computation | "Y" If unblinding date after the visit date of 1 month post dose 2. else "N" for non-missing unblinding date.
Note: not populated for subjects unblnding beyond 14 days after dose 2 but missing both BLDV6DT and SV.V3. ; not populated for missing dose 2. |
| Algorithm: ADSL.INCL1FL | Computation | Assign value 'Y' if meet following criteria; Else Assign value 'N';
1. Signed IC;
2. Randomized;
3. Not screen failure;
4. Meets all inclusion criteria and meets no exclusion criteria; |
| Algorithm: ADSL.INCL2FL | Computation | Receive the first dose of vaccine to which they are randomly assigned |
| Algorithm: ADSL.INCL3FL | Computation | Will apply to Phase 1 only. Have at least 1 valid and determinate immunogenicity result after Dose 1 but before Dose 2
Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. N-binding is diagnostic assay and not considered as valid and determinate immunogenicity result. |
| Algorithm: ADSL.INCL4FL | Computation | Will apply to Phase 1 only. Have at least 1 valid and determinate immunogenicity result 21 days after Dose 1.
Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. |
| Algorithm: ADSL.INCL5FL | Computation | Will apply to Phase 1 only. Have blood collection within an appropriate window after Dose 1, with visit window 19-23 days after dose 1. |
| Algorithm: ADSL.INCL6FL | Computation | Derive from SUPPDV.QNAM.CAPE. 'Y' if the subjects with all records of SUPPDV.QNAM.CAPE is "NO" or missing or CAPE indicates "POP2" only and this date of PD is earlier that VAX102DT+14 |
| Algorithm: ADSL.INCL7FL | Computation | Receive 2 randomized vaccinations within the pre-defined window
Vaccination window – can be 19-42 days after dose 1:
if 19<=VAX102DT-VAX101DT<=42 and ARM ne "" and
((index(upcase(vax102),"BNT162B2") and index(upcase(arm),"BNT162B2")) or (index(upcase(vax102),"PLACEBO") and index(upcase(arm),"PLACEBO")))
and vax101=vax102 then INCL7FL="Y"; else INCL7FL="N"; |
| Algorithm: ADSL.INCL8FL | Computation | Have at least 1 valid and determinate immunogenicity result after Dose 2
Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. N-binding is diagnostic assay and not considered as valid and determinate immunogenicity result. |
| Algorithm: ADSL.INCL9FL | Computation | Have blood collection within an appropriate window after Dose 2.
Phase 1 – with visit window 6-8 days after dose 2
Phase 2/3 – 28-42 days after dose 2 |
| Algorithm: ADSL.JPNFL | Computation | "Y" if SUPPDM.QNAM = 'RACIALD' and SUPPDM.QVAL = 'JAPANESE' |
| Algorithm: ADSL.MULENRFL | Computation | "Y" for subjects that were multiply enrolled subjests. |
| Algorithm: ADSL.NAATNFL | Computation | if index(mb.visit,"V1_DAY1_") and mb.mbtestcd='RTCOV2NS' and mb.mborres="NEG" and mb.mbdy<=1 then NAATNFL="Y";
else if index(mb.visit,"V1_DAY1_") and mb.mbtestcd='RTCOV2NS' and mb.mborres="POS" and mb.mbdy<=1 then NAATNFL="N"; |
| Algorithm: ADSL.NIGV1FL | Computation | Derived from is.istest='N-binding antibody'
if is.isorres="NEG" and index(visit,"V1_DAY1_") and is.isdy<=1 then NIGV1FL="Y";
else if is.isorres="POS" and index(visit,"V1_DAY1_") and is.isdy<=1 then NIGV1FL="N";
Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. |
| Algorithm: ADSL.OBESEFL | Computation | "Y" if adolescent with enrolled age 12-15 meets the BMI cut off for obesity with age/sex groups. The standard for obesity is provided in an external file bmi-12-15-scale.xlsx. |
| Algorithm: ADSL.OPBOUFL | Computation | “Y” if (tr02sdt>. or UNBLNDDT>.) and actarm in ("Placebo"); else "N" |
| Algorithm: ADSL.PEDIMMFL | Computation | PEDIMMFL was derived from an external excel file: c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsx (there are 660 subjects in total who are based on an random selection of 280 active+50 placebo from each of the age groups). |
| Algorithm: ADSL.PEDREAFL | Computation | if reactofl="Y" and phasen ne 1 and agegr4n in (1 2) then PEDREAFL="Y"; |
| Algorithm: ADSL.PHASE | Computation | "Phase 1" for subjects from Phase 1, who were picked from an external excel file: c4591001-phase-1-subjects-from-dmw.xlsx;
"Phase 2_ds360/ds6000" for subjects from Phase 2, who were picked from an external excel file: first-c4591001-360-participants-enrolled-v1-13aug2020-update.xlsx;
"Phase 3_ds6000" for subjects from Phase 3 and included in DS6000, who were picked from an external excel file: newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsx;
"Phase 3" for other subjects from Phase 3 |
| Algorithm: ADSL.RACEGR1 | Computation | if RACE='WHITE' then RACEGR1="WHITE";
else if RACE='BLACK OR AFRICAN AMERICAN' then RACEGR1="BLACK OR AFRICAN AMERICAN";
else RACEGR1="ALL OTHERS" |
| Algorithm: ADSL.RAND1FL | Computation | if RANDFL="Y" and MULENRFL^="Y" and then RAND1FL="Y"; else RAND1FL="N"; |
| Algorithm: ADSL.RANDDT | Computation | [Protocol]
Randomization Date is defined usually those who have been randomized the study. (For study design where subject gets randomized multiple time then RANDDT will be derive based on 1st Randomization Date)
RANDDT = MIN of DS.DSSTDTC where DS.DSDECOD = "RANDOMIZED" |
| Algorithm: ADSL.RANDFL | Computation | Assign 'Y' for participants who are assigned a randomization number and with non-missing randomization date. |
| Algorithm: ADSL.REVXICDT | Computation | DS.DSSTDTC for Re-vax Informed Consent. |
| Algorithm: ADSL.RFENDT | Computation | Datepart of DM.RFENDTC |
| Algorithm: ADSL.RFENTM | Computation | Timepart of DM.RFENDTC |
| Algorithm: ADSL.RFSTDT | Computation | Datepart of DM.RFSTDTC |
| Algorithm: ADSL.RFSTTM | Computation | Timepart of DM.RFSTDTC |
| Algorithm: ADSL.RNACAT | Computation | Derived numeric value from LB.LBORRES where LB.LBTESTCD="HIVR_US". Assigned as "<50" if subject's LBORRES does not contain any numeric value and not equal to positive. If derived numeric value is less than 50 then assigned as "<50"; if derived numeric value is equal to or greater than 50 then assigned as ">=50". |
| Algorithm: ADSL.RNACATN | Computation | 1="<50"
2=">=50" |
| Algorithm: ADSL.RSEXSAF | Computation | DV.DVTERM where SUPPDV.QNAM.CAPE contain 'POP5' then RSEXSAF="Unreliable data due to lack of PI oversight"; else if only 'POP1' then RSEXSAF="Did not provide informed consent"; |
| Algorithm: ADSL.SAF1FL | Computation | if SAFFL="Y" and MULENRFL^="Y" and HIVFL^="Y" and trt01a ne "" then SAF1FL="Y"; else SAF1FL="N"; |
| Algorithm: ADSL.SAF2FL | Computation | if SAFFL="Y" and MULENRFL^="Y" and trt01a ne "" then SAF2FL="Y"; else SAF2FL="N"; |
| Algorithm: ADSL.SAFFL | Computation | If RANDFL='Y' and (VAX101DT ne . or VAX102DT ne . ) and (index(SUPPDV.QNAM.CAPE, "POP1")=0 for subjects's all DV records) then SAFFL='Y', else SAFFL='N' |
| Algorithm: ADSL.SCREEN | Computation | If RFICDT ne . then SCREEN='Y'; |
| Algorithm: ADSL.STCSRDT | Computation | STCSRDT=min(eosdcdt, "&cutoff2"d) for subjects with ranfl="Y" |
| Algorithm: ADSL.TR01EDT | Computation | Datepart of EX.EXENDTC for last vaccination of double blinded period. The last vaccination is defined as latest vaccination for subjects without Vaccination 3 or as last vaccination before Vaccination 3. |
| Algorithm: ADSL.TR01EDTM | Computation | Datetime of EX.EXENDTC for last vaccination of double blinded period. The last vaccination is defined as latest vaccination for subjects without Vaccination 3 or as last vaccination before Vaccination 3. |
| Algorithm: ADSL.TR01ETM | Computation | Timepart of EX.EXENDTC for last vaccination of double blinded period. The last vaccination is defined as latest vaccination for subjects without Vaccination 3 or as last vaccination before Vaccination 3. |
| Algorithm: ADSL.TR01SDT | Computation | Datepart of EX.EXSTDTC for Vaccination 1 |
| Algorithm: ADSL.TR01SDTM | Computation | Datetime of EX.EXSTDTC for Vaccination 1 |
| Algorithm: ADSL.TR01STM | Computation | Timepart of EX.EXSTDTC for Vaccination 1 |
| Algorithm: ADSL.TR02EDT | Computation | Datepart of EX.EXENDTC for last vaccination for subjects with Vaccination 3/4. |
| Algorithm: ADSL.TR02EDTM | Computation | Datetime of EX.EXENDTC for last vaccination for subjects with Vaccination 3/4. |
| Algorithm: ADSL.TR02ETM | Computation | Timepart of EX.EXENDTC for last vaccination for subjects with Vaccination 3/4. |
| Algorithm: ADSL.TR02SDT | Computation | Datepart of EX.EXSTDTC for the first Vaccination for subjects with Vaccination 3/4. |
| Algorithm: ADSL.TR02SDTM | Computation | Datetime of EX.EXSTDTC for the first Vaccination for subjects with Vaccination 3/4. |
| Algorithm: ADSL.TR02STM | Computation | Timepart of EX.EXSTDTC for the first Vaccination for subjects with Vaccination 3/4. |
| Algorithm: ADSL.TRT01A | Computation | Derived from DM.ACTARM. If subject received any of doses as BNT162b2, then the subject will be assigned as 'BNT162b2 Phase 1 (30 mcg)' for phase 1 subject and 'BNT162b2 Phase 2/3 (30 mcg)' for phase 2/3 subject. If the subject received 1 or 2 doses of placebo and no BNT, the subject will be assigned as "Placebo". If subject with all indeterminate vaccinations, set TRT01A to missing. |
| Algorithm: ADSL.TRT01P | Computation | Obtained from DM.ARM directly. |
| Algorithm: ADSL.TRT02A | Computation | Derived from EX.EXTRT where EXTPTREF in ("Vaccination 3" "Vaccination 4"). If subject received any of these 2 doses as BNT162b2, then the subject will be assigned as 'BNT162b2 Phase 1 (30 mcg)' for phase 1 subject and 'BNT162b2 Phase 2/3 (30 mcg)' for phase 2/3 subject. If subject with all indeterminate vaccinations, set TRT02A to missing. |
| Algorithm: ADSL.TRT02P | Computation | assign as "BNT162b2 Phase 1 (30 mcg)" for Phase 1 subjects and "BNT162b2 Phase 2/3 (30 mcg)" for Phase 2/3 subjects if EX.EXDOSE and EX.EXSTDTC are not missing when EX.EXTPTREF='VACCINATION 3' or 'VACCINATION 4' |
| Algorithm: ADSL.TRTEDT | Computation | Datepart of max(EX.EXENDTC) by subject level |
| Algorithm: ADSL.TRTEDTM | Computation | Max (EX.EXSTDTC) by subject level |
| Algorithm: ADSL.TRTETM | Computation | Timepart of max(EX.EXENDTC) by subject level |
| Algorithm: ADSL.TRTSDT | Computation | Datepart of min(EX.EXSTDTC) by subject level |
| Algorithm: ADSL.TRTSDTM | Computation | Min (EX.EXSTDTC) by subject level |
| Algorithm: ADSL.TRTSEQA | Computation | combination of TRT01A and TRT02A for treated subject |
| Algorithm: ADSL.TRTSEQP | Computation | combination of TRT01P and TRT02P for randomized subject |
| Algorithm: ADSL.TRTSTM | Computation | Timepart of min(EX.EXSTDTC) by subject level |
| Algorithm: ADSL.UNBLNDDT | Computation | DS.DSSTDTC when DSDECOD="TREATMENT UNBLINDED" |
| Algorithm: ADSL.V01DT | Computation | Derived BE1DT from CO.CODTC from Visit 7 after second dose for phase 1 and from visit 3 for phase 2/3
Derived BE1DT2 from SV.SVSTDTC from visit 7 after second dose for phase 1 and from visit 3 for phase 2/3
V01DT=COALESCE(VAX10UDT+35, BE1DT, BE1DT2, VAX102DT+35, VAX101DT+58);
Then, for unblinded subjects, compare V01DT with the day before treatment unblinding, set V01DT=min(V01DT,UNBLNDDT-1)
Note: used for AE summary tables to cutoff AEs within 1 month after vax2 |
| Algorithm: ADSL.V02DT | Computation | Derived BE2DT from CO.CODTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
Derived BE2DT2 from SV.SVSTDTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
V02DT=COALESCE(VAX10UDT+189, BE2DT, BE2DT2, VAX102DT+189, VAX101DT+189+23);
Then, for unblinded subjects, compare V02DT with the day before treatment unblinding, set V02DT=min(V02DT,UNBLNDDT-1)
Note: used for AE summary tables to cutoff AEs within 6 month after vax2. |
| Algorithm: ADSL.V02OBDT | Computation | Derived BE2DT from CO.CODTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
Derived BE2DT2 from SV.SVSTDTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3
V02DT=COALESCE(VAX10UDT+189, BE2DT, BE2DT2, VAX102DT+189, VAX101DT+189+23);
Then, for subjects took dose 3, compare V02DT with the day before dose 3, set V02DT=min(V02DT, TR02SDT-1)
Note: used for AE summary tables to cutoff AEs within 6 month after vax2 regardless unblinding. |
| Algorithm: ADSL.V03DT | Computation | Derived BE3DT2 from SV.SVSTDTC from 1 month after second dose in open label period visit
V03DT=COALESCE(BE3DT2, VAX202DT+35, VAX201DT+58)
Note: used for AE summary tables to cutoff AEs within 1 month after vax 4 in open label period |
| Algorithm: ADSL.V04DT | Computation | Derived BE4DT2 from SV.SVSTDTC from 6 months after second dose in open label period visit
V04DT=COALESCE(BE4DT2, VAX202DT+189, VAX201DT+189+23)
Note: used for AE summary tables to cutoff AEs within 6 month after vax 4 in open label period |
| Algorithm: ADSL.V3C19NIG | Computation | The value of N-binding test at 1 Month after Vax 2 Visit. For subjects had Visit 3 recorded as not done, and if there is a convalescent visit or vax3 visit that happened within 28-42 days post dose 2, the convalescent visit/vax3 visit will be used to replace this one. If there are two records fall in the window, the record closed to 30 days after dose 2 will be chosen. |
| Algorithm: ADSL.VAX101 | Computation | Dose 1: combined form the vaccination at dose 1 and the corresponding dosage; set to missing if the dose is INDETERMINATE. |
| Algorithm: ADSL.VAX101DT | Computation | Date of the vaccination 1 (first vaccination date) |
| Algorithm: ADSL.VAX101TM | Computation | Time of the vaccination 1 (first vaccination date) |
| Algorithm: ADSL.VAX102 | Computation | Dose 2: combined form the vaccination at dose 2 and the corresponding dosage; set to missing if the dose is INDETERMINATE. |
| Algorithm: ADSL.VAX102DT | Computation | Date of the vaccination 2 (2nd vaccination date) |
| Algorithm: ADSL.VAX102TM | Computation | Time of the vaccination 2 (2nd vaccination date) |
| Algorithm: ADSL.VAX10U | Computation | Unplanned Dose 2: combined form the vaccination at unplanned dose 2 and the corresponding dosage; set to missing if the dose is INDETERMINATE. |
| Algorithm: ADSL.VAX10UDT | Computation | Date of the unplanned vaccination 2 (3rd vaccination date in the first period) |
| Algorithm: ADSL.VAX10UTM | Computation | Time of the unplanned vaccination 2 (3rd vaccination date in the first period) |
| Algorithm: ADSL.VAX201 | Computation | If EX.EXTRT='BNT162b2' when EX.VISIT in ('V101_VAX3' 'V8A_VAX3'), then VAX201='BNT162b2 (30 (*ESC*){unicode 03BC}g)'; set to missing if the dose is INDETERMINATE. |
| Algorithm: ADSL.VAX201DT | Computation | Date of the vaccination at Visit 101 (3rd vaccination date), Datepart of EX.EXSTDTC where EX.VISIT in ('V101_VAX3' 'V8A_VAX3'). |
| Algorithm: ADSL.VAX201TM | Computation | Time of the vaccination at Visit 101 (3rd vaccination date), timepart of EX.EXSTDTC where EX.VISIT in ('V101_VAX3' 'V8A_VAX3'). |
| Algorithm: ADSL.VAX202 | Computation | If EX.EXTRT='BNT162b2' when EX.VISIT='V102_VAX4', then VAX202='BNT162b2 (30 (*ESC*){unicode 03BC}g)'; set to missing if the dose is INDETERMINATE. |
| Algorithm: ADSL.VAX202DT | Computation | Date of the vaccination at Visit 102 (4th vaccination date), Datepart of EX.EXSTDTC where EX.VISIT='V102_VAX4'. |
| Algorithm: ADSL.VAX202TM | Computation | Time of the vaccination at Visit 102 (4th vaccination date), timepart of EX.EXSTDTC where EX.VISIT='V102_VAX4'. |
| Algorithm: ADSL.VAX20U | Computation | Unplanned Dose in open label period: combined form the vaccination at unplanned dose after the first dose after crossover period and the corresponding dosage; set to missing if the dose is INDETERMINATE. |
| Algorithm: ADSL.VAX20UDT | Computation | Date of the unplanned vaccination 1 in open label period. |
| Algorithm: ADSL.VAX20UTM | Computation | Time of the unplanned vaccination 1 in open label period. |
| Algorithm: ADSL.X1CSRDT | Computation | X1CSRDT=min(eosdcdt, "&cutoff2"d) for subjects with ranfl="Y" and non-missing tr02sdt or non-missing UNBLNDDT and boostfl ne "Y" |
| Algorithm: ADXB.ADT | Computation | ADT = input(xbdtc, ?? yymmdd10.) |
| Algorithm: ADXB.ADY | Computation | Set as following:
ADY = ADT - TRTSDT.
If ADT >= TRTSDT, ADY = ADT - TRTSDT + 1. |
| Algorithm: ADXB.AVAL | Computation | set to null |
| Algorithm:ADXB.FC19D27 | Computation | Set "Y" for records with swabs within the same illness visits for the first COVID-19 episode for a subject based on following condition
ADC19EF.paramcd in ("C19ONST") and ADC19EF.FILOCRFL= "Y" and ADC19EF.AVALC="POS" and ADC19EF.ILD27FL="Y" and ((not missing(DVSTDT) and ADC19EF.adt <= DVSTDT) or missing(DVSTDT)) and ADC19EF.PDRMUPFL = "N" and ADC19EF.EVALEFFL='Y'
else "N" |
| Algorithm:ADXB.FSEVCD1 | Computation | Set "Y" for records with swabs within the same illness visits for the first severe COVID-19 episode based on CDC defined symptoms for a subject based on following condition
ADC19EF.paramcd in ("CDCSONST") and ADC19EF.FILOCRFL= "Y" and ADC19EF.AVALC="POS" and ADC19EF.adt >= ADC19EF.VAX101DT and ADC19EF.CDRMUPFL = "N" and ADC19EF.aai1effl='Y'
else "N" |
| Algorithm:ADXB.FSEVCD27 | Computation | Set "Y" for records with swabs within the same illness visits for the first severe COVID-19 episode based on CDC defined symptoms for a subject based on following condition
ADC19EF.paramcd in ("CDCSONST") and ADC19EF.FILOCRFL= "Y" and ADC19EF.AVALC="POS" and ADC19EF.ILD27FL="Y" and ((not missing(DVSTDT) and ADC19EF.adt <= DVSTDT) or missing(DVSTDT)) and ADC19EF.CDRMUPFL = "N" and ADC19EF.EVALEFFL='Y'
else "N" |
| Algorithm:ADXB.FSEVPD1 | Computation | Set "Y" for records with swabs within the same illness visits for the first severe COVID-19 episode based on Protocol defined symptoms for a subject based on following condition
ADC19EF.paramcd in ("SEVCONST") and ADC19EF.FILOCRFL= "Y" and ADC19EF.AVALC="POS" and ADC19EF.adt >= ADC19EF.VAX101DT and ADC19EF.PDRMUPFL = "N" and ADC19EF.aai1effl='Y'
else "N" |
| Algorithm:ADXB.FSEVPD27 | Computation | Set "Y" for records with swabs within the same illness visits for the first severe COVID-19 episode based on Protocol defined symptoms for a subject based on following condition
ADC19EF.paramcd in ("SEVCONST") and ADC19EF.FILOCRFL= "Y" and ADC19EF.AVALC="POS" and ADC19EF.ILD27FL="Y" and ((not missing(DVSTDT) and ADC19EF.adt <= DVSTDT) or missing(DVSTDT)) and ADC19EF.PDRMUPFL = "N" and ADC19EF.EVALEFFL='Y'
else "N" |
| Algorithm:ADXB.PARAMN | Computation | if XB.XBTESTCD="WGSCLINE" then PARAMN=1; |
| Algorithm:ADXB.STATE | Computation | Derive from Pfizer Corporate Registry Database (based on Investigator ID)
If we have Abbreviation for the States in USA, then update them to get full Text of the State.
if State="AK" then state="ALASKA";
if State="AL" then state="ALABAMA";
if State="AR" then state="ARKANSAS";
if State="AZ" then state="ARIZONA";
if State="CA" then state="CALIFORNIA";
if State="CO" then state="COLORADO";
if State="CT" then state="CONNECTICUT";
if State="DE" then state="DELAWARE";
if State="FL" then state="FLORIDA";
if State="GA" then state="GEORGIA";
if State="HI" then state="HAWAII";
if State="IA" then state="IOWA";
if State="ID" then state="IDAHO";
if State="IL" then state="ILLINOIS";
if State="IN" then state="INDIANA";
if State="KS" then state="KANSAS";
if State="KY" then state="KENTUCKY";
if State="LA" then state="LOUISIANA";
if State="MA" then state="MASSACHUSETTS";
if State="MD" then state="MARYLAND";
if State="ME" then state="MAINE";
if State="MI" then state="MICHIGAN";
if State="MN" then state="MINNESOTA";
if State="MO" then state="MISSOURI";
if State="MS" then state="MISSISSIPPI";
if State="MT" then state="MONTANA";
if State="NC" then state="NORTH CAROLINA";
if State="ND" then state="NORTH DAKOTA";
if State="NE" then state="NEBRASKA";
if State="NH" then state="NEW HAMPSHIRE";
if State="NJ" then state="NEW JERSEY";
if State="NM" then state="NEW MEXICO";
if State="NV" then state="NEVADA";
if State="NY" then state="NEW YORK";
if State="OH" then state="OHIO";
if State="OK" then state="OKLAHOMA";
if State="OR" then state="OREGON";
if State="PA" then state="PENNSYLVANIA";
if State="RI" then state="RHODE ISLAND";
if State="SC" then state="SOUTH CAROLINA";
if State="SD" then state="SOUTH DAKOTA";
if State="TN" then state="TENNESSEE";
if State="TX" then state="TEXAS";
if State="UT" then state="UTAH";
if State="VA" then state="VIRGINIA";
if State="VT" then state="VERMONT";
if State="WA" then state="WASHINGTON";
if State="WI" then state="WISCONSIN";
if State="WV" then state="WEST VIRGINIA";
if State="WY" then state="WYOMING"; |
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