Date/Time of Define-XML document generation: 2021-07-28T22:12:18Z

Define-XML version: 2.0.0

Stylesheet version: 2018-11-21

Standard
ADaM-IG 1.1
Study Name
COVE
Study Description
A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older
Protocol Name
mRNA-1273-P301
Metadata Name
Study COVE Data Definitions

Analysis Results Metadata - Summary

Table 14.2.2.1.3.1.1Analysis of Vaccine Efficacy of mRNA-1273 to Prevent COVID-19* Based on Adjudication Committee Assessments Starting 14 Days After Second Injection

The primary efficacy objective will be evaluated by the VE of mRNA-1273 to prevent the first occurrence of COVID-19 starting 14 days after the second injection of IP.

Table 14.2.4.1.1.1.3.1Summary of Binding Antibody Specific to SARS-CoV-2 Spike Protein by MSD by Baseline SARS-CoV-2 Status

The secondary immunogenicity objective will be evaluated by the following endpoints: (a) Geometric mean titer (GMT) of S protein-specific bAb on Day 1, Day 29, Day 57 (b) GMFR of S protein-specific bAb relative to Day 1 on Day 29, Day 57


Analysis Results Metadata - Detail

Table 14.2.2.1.3.1.1
Display See Annotated Table Analysis of Vaccine Efficacy of mRNA-1273 to Prevent COVID-19* Based on Adjudication Committee Assessments Starting 14 Days After Second Injection
Analysis Result The primary efficacy objective will be evaluated by the VE of mRNA-1273 to prevent the first occurrence of COVID-19 starting 14 days after the second injection of IP.
Analysis Parameter(s) PARAMCD = "TTCVDC1"
Analysis Variable(s)

ADTTEA.AVAL (Analysis Value)

ADTTEA.CNSR (Censor)

Analysis Reason SPECIFIED IN SAP
Analysis Purpose Primary Endpoints
Data References (incl. Selection Criteria)
ADTTEA [PARAMCD = "TTCVDC1"]
Documentation
Programming Statements

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Table 14.2.4.1.1.1.3.1
Display See Annotated Table Summary of Binding Antibody Specific to SARS-CoV-2 Spike Protein by MSD by Baseline SARS-CoV-2 Status
Analysis Result The secondary immunogenicity objective will be evaluated by the following endpoints: (a) Geometric mean titer (GMT) of S protein-specific bAb on Day 1, Day 29, Day 57 (b) GMFR of S protein-specific bAb relative to Day 1 on Day 29, Day 57
Analysis Parameter(s) PARAMCD IN (

"S2PIGG",

"LS2PIGG"

)
Analysis Variable(s)

ADIS.AVISIT (Analysis Visit)

ADIS.AVAL (Analysis Value)

ADIS.CRIT1FL (Criterion 1 Evaluation Result Flag)

ADIS.CRIT2FL (Criterion 2 Evaluation Result Flag)

ADIS.CRIT3FL (Criterion 3 Evaluation Result Flag)

ADIS.CRIT4FL (Criterion 4 Evaluation Result Flag)

ADIS.CRIT6FL (Criterion 6 Evaluation Result Flag)

Analysis Reason SPECIFIED IN SAP
Analysis Purpose Secondary Immunogenicity EndPoint
Data References (incl. Selection Criteria)
ADIS [PPSIFL = "Y" and APERIOD = 1 and ADT < EFFCODT and PARAMCD IN ("S2PIGG", "LS2PIGG") and ANL01FL = "Y"]
Documentation
Programming Statements

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Datasets

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
ADSLSF Screen Fail Subj-Level Analysis Dataset SUBJECT LEVEL ANALYSIS DATASET One record per screen failed subject Analysis STUDYID, USUBJID adslsf.xpt
ADAR Solicited AR Analysis Dataset BASIC DATA STRUCTURE One record per subject, per parameter, per analysis timepoint Analysis USUBJID, PARCAT1, PARAMCD, ATPTREF, ATPTN, ADT adar.xpt
ADARP7D Solicited AR post D7 Analysis Dataset BASIC DATA STRUCTURE One record per subject, per parameter, per analysis timepoint Analysis USUBJID, PARCAT1, PARAMCD, ATPTREF, ADT adarp7d.xpt
ADARSUM Solicited AR Summary Analysis Dataset BASIC DATA STRUCTURE One record per subject, per summary parameter, per analysis timepoint Analysis USUBJID, PARCAT1, PARAMCD, ATPTREF adarsum.xpt
ADEFF Efficacy Analysis Dataset BASIC DATA STRUCTURE One record per subject, per parameter, per analysis timepoint Analysis USUBJID, PARAMCD, ADT, PCRDT adeff.xpt
ADEFF2 BOD/BOI Score Analysis Dataset BASIC DATA STRUCTURE One record per subject, per parameter, per time range Analysis USUBJID, PARAMCD, AWRANGEN adeff2.xpt
ADEFF3 Symptom Score Analysis Dataset BASIC DATA STRUCTURE One record per subject, per parameter, per analysis timepoint Analysis USUBJID, PARAMCD, ARELTPT adeff3.xpt
ADIS Immunogenicity Analysis Dataset BASIC DATA STRUCTURE One record per subject, per parameter category, per parameter, per assessment Analysis USUBJID, PARCAT1, PARAMCD, AVISITN, ISDTC, ISSEQ adis.xpt
ADMB Microbiology Analysis Dataset BASIC DATA STRUCTURE One record per subject, per parameter, per analysis timepoint Analysis USUBJID, PARCAT1, PARAMCD, AVISITN, ADT, MBSEQ admb.xpt
ADRISK Risk of Exposure Analysis Dataset BASIC DATA STRUCTURE One record per subject, per parameter Analysis USUBJID, PARAMCD adrisk.xpt
ADSYMP COVID-19 Symptom Analysis Dataset BASIC DATA STRUCTURE One record per subject, per parameter, per analysis timepoint Analysis USUBJID, PARCAT1, PARAMCD, AVISITN, ADT, LNKID, SRCSEQ adsymp.xpt
ADTTE Time to Event Analysis Dataset BASIC DATA STRUCTURE One record per subject, per parameter Analysis USUBJID, PARAMCD adtte.xpt
ADTTEA Time to Adjudication Event Analysis Data BASIC DATA STRUCTURE One record per subject, per parameter Analysis USUBJID, PARAMCD adttea.xpt
ADTTEB Time to Event up to PDV Analysis Dataset BASIC DATA STRUCTURE One record per subject, per parameter Analysis USUBJID, PARAMCD adtteb.xpt
ADTTRE Recurrent of BOD/BOI Analysis Dataset BASIC DATA STRUCTURE One record per subject, per parameter Analysis USUBJID, PARAMCD, EVENTSEQ adttre.xpt
ADTTRE2 Recurrent of Symptom Analysis Dataset BASIC DATA STRUCTURE One record per subject, per parameter, per event occurance Analysis USUBJID, PARAMCD, EVENTSEQ adttre2.xpt
ADVS Vital Signs Analysis Dataset BASIC DATA STRUCTURE One record per subject per parameter per assessment Analysis USUBJID, PARAMCD, AVISITN, ADT, VISITNUM, VSTPT advs.xpt
ADAE Adverse Event Analysis Dataset OCCURRENCE DATA STRUCTURE One record per subject per adverse event Analysis USUBJID, AEBODSYS, AEDECOD, AESTDTC, AEENDTC, AESEQ adae.xpt
ADCM Concomitant Medication Analysis Dataset OCCURRENCE DATA STRUCTURE One record per subject per medication Analysis USUBJID, CMTRT, CMSTDTC, CMENDTC adcm.xpt
ADDV Deviation Analysis Dataset OCCURRENCE DATA STRUCTURE One record per subject per deviation Analysis USUBJID, DVCAT, DVSCAT, DVSTDTC, DVTERM addv.xpt
ADEX Treatment Exposure Analysis Dataset OCCURRENCE DATA STRUCTURE One record per subject per administration Analysis USUBJID, EXSTDTC adex.xpt
ADMH Medical History Analysis Dataset OCCURRENCE DATA STRUCTURE One record per subject per medical history Analysis USUBJID, MHCAT, MHTERM, MHDECOD, MHSTDTC admh.xpt

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Subject-Level Analysis Dataset (ADSL)

ADSL (Subject-Level Analysis Dataset) - SUBJECT LEVEL ANALYSIS DATASET Location: adsl.xpt
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: DM.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: DM.USUBJID
SUBJID Subject Identifier for the Study text 20
Predecessor: DM.SUBJID
SITEID Study Site Identifier text 8
Predecessor: DM.SITEID
COUNTRY Country text 10
Predecessor: DM.COUNTRY
AGE Age integer 8
Predecessor: DM.AGE
AGEU Age Units text 15
Predecessor: DM.AGEU
STRATAR Strata Used for Randomization text 40
Derived
Set to SUPPDM.QVAL where QNAM='COHORT'
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Derived
Based on 'STRATAR': Set to 1 if '>=18 and <65 Years and Not at Risk' Set to 2 if '>=18 and <65 Years and at Risk' Set to 3 if '>=65 Years'
AGEGR1 Pooled Age Group 1 text 40
Derived
Set to '>=18 and <65 Years' if 18<=AGE<65 Set to '>=65 Years' if AGE >=65
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Derived
Based on AGEGR1: Set to 1 if AGEGR1 is '>=18 and <65 Years' Set to 2 if AGEGR1 is '>=65 Years'
AGEGR2 Pooled Age Group 2 text 40
Derived
Set to '>=18 and <65 Years' if 18 <= AGE < 65 Set to '>=65 and <75 Years' if 65 <= AGE < 75 Set to '>=75 if AGE >= 75 Years'
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Derived
Base on AGEGR2: Set to 1 if AGEGR2 is '>=18 and <65 Years' Set to 2 if AGEGR2 is '>=65 and <75 Years' Set to 3 if AGEGR2 is '>=75 Years'
AGEGR3 Pooled Age Group 3 text 40
Derived
Set to '>=18 and <65 Years' if non-missing AGE<65, Set to '>=65 and <75 Years' if 65 <= AGE < 75, Set to '>=75 and <85 Years' if 75 <= AGE < 85, Set to '>=85 Years' if AGE >= 85
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Derived
Set to 1 if AGEGR2 is '>=18 and <65 Years', Set to 2 if AGEGR2 is '>=65 and <75 Years', Set to 3 if AGEGR2 is '>=75 and <85 Years', Set to 4 if AGEGR2 is '>=85 Years'
AGEGR4 Pooled Age Group 4 text 40
Derived
Set to '>=18 and <=25 Years' if 18 <=AGE<=25, Set to '>=26 and <=50 Years' if 26 <= AGE <= 50
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Derived
Set to 1 if AGEGR4 is '>=18 and <=25 Years', Set to 2 if AGEGR4 is '>=26 and <=50 Years'
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: DM.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: DM.RACE
RACESPY Race Specify text 200
Derived
Set to SUPPDM.QVAL where QNAM is RACEOTH if RACE='OTHER', Concatenate SUPPDM.QVAL with ', ' where QNAM is among RACE1 - RACE6 if RACE='MULTIPLE'
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: DM.ETHNIC
PROTVER Protocol Version text 25
Derived
Set to SUPPDM.QVAL where QNAM is PROTVER
CHILDBP Childbearing Potential text 10 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to RP.RPORRES where RPTESTCD is CHILDPOT and VISIT='Screening'
CBNRS Reason for No Childbearing Potential text 200
Derived
Set to SUPPRP.QVAL where QNAM='CBRSN' and VISIT='Screening'
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to 'Y' if both criteria met: 1. USUBJID exists in DS where DSDECOD='RANDOMIZED' and DSSTDTC not missing and DSREFID not missing 2. there is no record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis sets' and DVSTDTC <= AP02SDT (condition of DVSTDTC <= AP02SDT applies only when AP02SDT is not missing) Set to 'N', otherwise
RANDNUM Randomization Number text 20
Derived
Set to DS.DSREFID
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to 'Y' if all criteria met: 1. RANDFL='Y', 2. USUBJID exists in EX with non-missing EXSTDTC, 3. There is no record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis sets', or '2 - Exclude from all efficacy analysis (full analysis set and per-protocol analysis set)' or '8 - Exclude from all analysis sets except for randomization set' and (DVSTDTC <= EFFCODT and DVSTDTC <= AP01EDT and AP01EDT is not missing or DVSTDTC <= EFFCODT if AP01ENDT is missing) Set to 'N', otherwise
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to 'Y' if all criteria met: 1. RANDFL='Y', 2. USUBJID exists in EX with non-missing EXSTDTC, 3. There is no record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis sets', or '8 - Exclude from all analysis sets except for randomization set' and (DVSTDTC <= EFFCODT and DVSTDTC <= AP01EDT and AP01EDT is not missing or DVSTDTC <= EFFCODT if AP01ENDT is missing) Set to 'N', otherwise
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to 'Y' if both criteria met: 1. SAFFL='Y' 2. Have at least one non-missing FAORRES where FATPTREF = 'DOSE 1' in FACE OR have at least one non-missing VSORRES where VSTPTREF = 'DOSE 1' and VSTEST contains "Temperature" where VSCAT contains "REACTOGENICITY" in VS Set to 'N', otherwise
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to 'Y' if all criteria met: 1. SAFFL='Y' 2. Have at least one non-missing FAORRES where FATPTREF = 'DOSE 2' in FACE OR have at least one non-missing VSORRES where VSTPTREF = 'DOSE 2' and VSTEST contains 'Temperature' where VSCAT contains 'REACTOGENICITY' in VS 3. DOSE2FL='Y' Set to 'N', otherwise
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to 'Y' if SAR1FL='Y' or SAR2FL='Y' Set to 'N', otherwise
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to 'Y' if FASFL='Y' and SCOV2BL = 'Negative' Set to 'N', otherwise
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set 'Y' if all criteria met: 1. MITTFL='Y', 2. DOSE2FL='Y' and 21 <= DOSE2DT - TR01SDT <= 42, 3. There is no record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis sets' or '2 - Exclude from all efficacy analysis (full analysis set and per-protocol analysis set)' or '3 - Exclude from per-protocol analysis set only' or '8 - Exclude from all analysis sets except for randomization set' and (DVSTDTC <= EFFCODT and DVSTDTC <= AP01EDT if AP01EDT is not missing or DVSTDTC <= EFFCODT if AP01EDT is missing), 4. There is no record in EX where EXTRT (non-missing) ne TRT01P in any case Set to 'N', otherwise
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to 'Y' if subject is randomized to the ccIAS cohort sampling list (RANDSFL='Y' in ccias_unblinded dataset), Set to 'N', otherwise Note: Use latest ccias_unblinded dataset. Subject eligibilities for sampling are specified in Immune sampling plan
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to 'Y' if all criteria met: 1. RANDIGFL='Y', 2. DOSE2FL='Y' and 21 <= DOSE2DT - TR01SDT <= 42, 3. There is no record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis sets' or '2 - Exclude from all efficacy analysis (full analysis set and per-protocol analysis set)' or '3 - Exclude from per-protocol analysis set only' or '8 - Exclude from all analysis sets except for randomization set' and (DVSTDTC <= EFFCODT and DVSTDTC <= AP01EDT if AP01EDT is not missing or DVSTDTC <= EFFCODT if AP01EDT is missing), 4. There is no records found in EX where EXTRT not missing and EXTRT ne TRT01P in any case, 5. RSKF6 is missing Set to 'N', otherwise
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to 'Y' if RANDFL='Y' and subject is in the ccIAS Cohort sampling list. Set to 'N', otherwise Note: Use latest ccias_unblinded dataset. Subject eligibilities for sampling are specified in Immune sampling plan
COMPLFL Completers Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to 'Y' if USUBJID exists in DS where DSCAT = 'DISPOSITION EVENT' and DS.DSSCAT = 'END OF STUDY' and DSDECOD = 'COMPLETED' Set to 'N' if USUBJID exists in DS where DSCAT = 'DISPOSITION EVENT' and DS.DSSCAT = 'END OF STUDY' and DSDECOD <> 'COMPLETED'
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to 'Y' if USUBJID exists in EX with non-missing EXSTDTC where EX.VISIT contains 'Day 1' Set to 'N', otherwise
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set 'Y' if USUBJID exists in EX with non-missing EXSTDTC where EX.VISIT contains 'Day 29' Set to 'N' otherwise
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to 'Y' if USUBJID exists in EX with non-missing EXSTDTC where EX.VISIT contains 'OL-D1', Set to 'N', otherwise
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to 'Y' if USUBJID exists in EX with non-missing EXSTDTC where EX.VISIT contains 'OL-D29', Set to 'N', otherwise
RTPCRBL Baseline RT-PCR Test text 20
Derived
Set to 'Positive' if USUBJID exists in MB with MBTESTCD='SARSCOV2' and SUPPMB.QVAL is not 'Y' where QNAM is 'LOCALFL' and MBSTRESC='Detected' and date part of non-missing MBDTC<=TR01SDT, otherwise Set to 'Negative' if USUBJID exists MB with MBTESTCD='SARSCOV2' and SUPPMB.QVAL is not 'Y' where QNAM is 'LOCALFL' and MBSTRESC='Not Detected' and date part of non-missing MBDTC<=TR01SDT Note: Use last (only consider date part) non-missing results on/before TR01SDT for derivation
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Derived
Set to 'Positive' if USUBJID exists in IS with ISTESTCD='SARSCOV2', ISORRES='Positive' and non-missing ISDTC<=TR01SDT Set to 'Negative' if USUBJID exists with ISTESTCD='SARSCOV2', ISORRES='Negative' and non-missing ISDTC<=TR01SDT, Otherwise, Set to null. Note: Use last (only consider date part) non-missing results on/before TR01SDT for derivation
SCOV2BL Baseline SARS-CoV-2 Status text 20
Derived
Set to 'Positive' if RTPCRBL='Positive' or ELECSBL='Positive' Set to 'Negative' if RTPCRBL='Negative' and ELECSBL='Negative'
HEIGHTBL Baseline Height (cm) float 8
Derived
Set to the last non-missing VS.VSSTRESN where VSTESTCD = “HEIGHT” and (VSDTC is before the first vaccination (DM.RFXSTDTC) or on the first vaccination date with VSTPT contains 'PRE-DOSE'), if missing use non-missing VS.VSSTRESN where VSTESTCD='HEIGHT' and or VISIT='Screening' with VSTPT^='POST-DOSE'
WEIGHTBL Baseline Weight (kg) float 8
Derived
Set to the last non-missing VS.VSSTRESN where VSTESTCD = “WEIGHT” and (VSDTC is before the first vaccination (DM.RFXSTDTC) or on the first vaccination date with VSTPT contains 'PRE-DOSE'), if missing use non-missing VS.VSSTRESN where VSTESTCD='WEIGHT' and or VISIT='Screening' with VSTPT^='POST-DOSE'
BMIBL Baseline BMI (kg/m2) float 8
Derived
Set to WEIGHTBL/(HEIGHTBL in meters)^2
ARM Description of Planned Arm text 40
Predecessor: DM.ARM
ACTARM Description of Actual Arm text 40
Predecessor: DM.ACTARM
TRT01P Planned Treatment for Period 01 text 25
Derived
Set to 'mRNA-1273' if ARM starts with 'mRNA-1273', Set to 'Placebo' if ARM starts with 'Placebo'
TRT01PN Planned Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Assigned

1 if TRTA='Placebo', 2 if TRTA='mRNA-1273'
TRT01A Actual Treatment for Period 01 text 25
Derived
Set to 'mRNA-1273' if at least one EX.EXTRT='mRNA-1273' where VISIT in ('Visit 1 Day 1' 'Visit 2 Day 29') and EX.EXSTDTC is not missing, Set to 'Placebo' if EX.EXTRT='PLACEBO' where VISIT in ('Visit 1 Day 1' 'Visit 2 Day 29') and EX.EXSTDTC is not missing
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Assigned
TRT02P Planned Treatment for Period 02 text 25
Derived
Set to 'mRNA-1273' where SUPPDM.QVAL='Y' and SUPPDM.QNAM='UNBLMRNA'
TRT02PN Planned Treatment for Period 02 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Assigned
TRT02A Actual Treatment for Period 02 text 25
Derived
Set to 'mRNA-1273' if at least one EX.EXTRT='mRNA-1273' where VISIT in ('Participant Decision Visit / OL-D1', 'OL-D29') and EX.EXSTDTC is not missing, Set to 'Placebo' if EX.EXTRT='PLACEBO' where VISIT in ('Participant Decision Visit / OL-D1', 'OL-D29')) and EX.EXSTDTC is not missing
TRT02AN Actual Treatment for Period 02 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Assigned
TRTSEQP Planned Sequence of Treatments text 30
Derived
Based on TRT01PN and TRT02PN: Set to 'Placebo' if TRT01PN=1 and TRT02PN <> 2, Set to 'Placebo-mRNA-1273' if TRT01PN=1 and TRT02PN=2, Set to 'mRNA-1273' if TRT01PN=2
TRTSEQPN Planned Sequence of Treatments (N) integer 8 Sequence of Treatments Code
  • • 1 = "Placebo"
  • • 2 = "Placebo-mRNA-1273"
  • • 3 = "mRNA-1273"
Assigned
TRTSEQA Actual Sequence of Treatments text 30
Derived
Based on TRT01AN and TRT02AN: Set to 'Placebo' if TRT01AN=1 and TRT02AN <> 2, Set to 'Placebo-mRNA-1273' if TRT01AN=1 and TRT02AN=2, Set to 'mRNA-1273' if TRT01AN=2
TRTSEQAN Actual Sequence of Treatments (N) integer 8 Sequence of Treatments Code
  • • 1 = "Placebo"
  • • 2 = "Placebo-mRNA-1273"
  • • 3 = "mRNA-1273"
Assigned
RFICDT Date of Informed Consent integer DATE9
Derived
Set to date part of DM.RFICDTC in numeric format
RANDDT Date of Randomization integer DATE9
Derived
Set to DS.DSSTDTC where DSTERM='RANDOMIZED' and DSCAT='PROTOCOL MILESTONE'
TRTSDT Date of First Exposure to Treatment integer DATE9
Derived
Convert date part of DM.RFXSTDTC to numeric
TRTEDT Date of Last Exposure to Treatment integer DATE9
Derived
Convert date part of DM.RFXENDTC to numeric
TR01SDT Date of First Exposure in Period 01 integer DATE9
Derived
Convert date part of DM.RFXSTDTC to numeric
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Derived
Convert DM.RFXSTDTC to numeric
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Derived
Convert date part of the latest non-missing EX.EXENDTC where VISIT in ('Visit 1 Day 1', 'Visit 2 Day 29') to numeric
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Derived
Convert the latest non-missing EX.EXENDTC where VISIT in ('Visit 1 Day 1', 'Visit 2 Day 29') to numeric
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Derived
Convert date part of EX.EXSTDTC to numeric where EX.VISIT contains 'Day 29' and EX.EXSTDTC is non-missing
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Derived
Convert EX.EXSTDTC to numeric where EX.VISIT contains 'Day 29' and EX.EXSTDTC is non-missing
TR02SDT Date of First Exposure in Period 02 integer DATE9
Derived
Convert date part of non-missing EXSTDTC where EX.VISIT='Participant Decision Visit / OL-D1') to numeric
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Derived
Convert non-missing EX.EXSTDTC where VISIT='Participant Decision Visit / OL-D1' to numeric
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Derived
Convert date part of latest non-missing EX.EXENDTC where VISIT in ('Participant Decision Visit / OL-D1', 'OL-D29') to numeric
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Derived
Convert latest non-missing EX.EXENDTC where VISIT in ('Participant Decision Visit / OL-D1', 'OL-D29') to numeric
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Derived
Convert date part of non-missing EX.EXSTDTC where EX.VISIT='OL-D29' to numeric
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Derived
Convert non-missing EX.EXSTDTC where EX.VISIT='OL-D29' to numeric.
UICDT Date of Updated Informed Consent integer DATE9
Derived
Covert date part DS.DSSTDTC where DSSCAT='Open Label' and DSDECOD = 'INFORMED CONSENT OBTAINED' to numeric
UBLDDT Date of Unblinding integer DATE9
Derived
Set to date part DS.DSSTDTC where DSDECOD = 'TREATMENT UNBLINDED'
PDVDT Date of Participant Decision Visit integer DATE9
Derived
Convert date part of SV.SVSTDTC where VISIT='Participant Decision Visit / OL-D1'
IRTVISDT Date of Unblinding in IRT integer DATE9
Derived
Convert date part of SUPPDS.QVAL where QNAM = 'IRTVISDT' to numeric
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Derived
See ADSL.EUAVACDT from ADaM-Variable-Definition.pdf

Additional ADaM Variable Definition

EFFCODT Efficacy Date Cutoff Date integer DATE9
Derived
Set to CUTOFFDT or EUAVACDT, whichever is the earliest date after TR01EDT.
AP01SDT Period 01 Start Date integer DATE9
Derived
Set to RANDDT
AP01EDT Period 01 End Date integer DATE9
Derived
Set to AP02SDT-1 if AP02SDT is not missing, Set to the earlier date of EOSDT and DTHDT
AP02SDT Period 02 Start Date integer DATE9
Derived
Set to PDVDT, UBLDDT, or IRTVISDT, whichever is the earliest date after TR01EDT. If AP02SDT is after EOSDT or DTHDT then set AP02SDT as missing.
AP02EDT Period 02 End Date integer DATE9
Derived
Set to the earlier date of EOSDT and DTHDT if AP02SDT is not missing
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Derived
Set to RANDDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Derived
Set to AP02SSDT-1 if AP02SSDT is not missing, Set to the earlier date of EOSDT and DTHDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Derived
Set to TR02SDT if not missing, Set to PDVDT, UBLDDT, or IRTVISDT, whichever is earlier
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Derived
Set to the earlier date of EOSDT and DTHDT if AP02SSDT is not missing
EOSSTT End of Study Status text 20 Disposition Status
  • • "COMPLETED"
  • • "DISCONTINUED"
  • • "ONGOING"
Derived
If RANDFL='Y': Set to 'COMPLETED' if COMPLFL='Y' Set to 'DISCONTINUED' if COMPLFL='N' Set to 'ONGOING' If RANDFL='N' then Set to null
EOSDT End of Study Date integer DATE9
Derived
Convert DS.DSSTDTC where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' to numeric
EOSDY End of Study Relative Day integer 8
Derived
Set to EOSDT-TR01SDT+1 if SAFFL='Y' and EOSDT>=TR01SDT Set to EOSDT-RANDDT+1 if RANDFL='Y' and EOSDT>=RANDDT Set to missing, otherwise
DCSREAS Reason for Discontinuation from Study text 100
Derived
Set to DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' AND DSDECOD not in ('COMPLETED', 'ADVERSE EVENT', 'SAE', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT', 'PROTOCOL DEVIATION', 'OTHER', 'DEATH') Set to 'Adverse Event' if DS.DSDECOD is 'ADVERSE EVENT' Set to 'Serious Adverse Event' if DS.DSDECOD is 'SAE' Set to 'Protocol Deviation' if DS.DSDECOD is 'PROTOCOL DEVIATION' Set to 'Other' if DS.DSDECOD is 'OTHER' Set to 'Physician Decision' if DS.DSDECOD is 'PHYSICIAN DESICION' Set to 'Withdrawal of Consent by Participant' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT' Set to 'Death' if DS.DSDECOD='DEATH'
DCSREASP Reason Spec for Discont from Study text 200
Derived
Set to DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' AND DSDECOD in ('ADVERSE EVENT', 'SAE', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT', 'PROTOCOL DEVIATION', 'OTHER') and DSTERM^=DSDECOD
EOT01STT End of Treatment Status in Period 01 text 20 Disposition Status
  • • "COMPLETED"
  • • "DISCONTINUED"
  • • "ONGOING"
Derived
Set to 'COMPLETED' if DOSE2FL='Y', Set to 'DISCONTINUED' if USUBJID exists in DS where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' and DSDECOD^='COMPLETED' and EPOCH='BLINDED TREATMENT'
EOT01DT End of Treatment Date in Period 01 integer DATE9
Derived
Convert DS.DSSTDTC where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' and EPOCH='BLINDED TREATMENT' to numeric, set to DOSE2DT if EOT01STT is 'COMPLETED'
EOT01DY End of Treatment in Period 01 Rel Day integer 8
Derived
Set to EOT01DT-TR01SDT+1 if EOT01DT>=TR01SDT
DCT01RS Reason for Discont of Treat in Period 01 text 100
Derived
Set to DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' and EPOCH='BLINDED TREATMENT' AND DSDECOD not in ('COMPLETED', 'ADVERSE EVENT', 'SERIOUS ADVERSE EVENT', 'PHYSICIAN DECISION', 'WITHDRAWAL BY SUBJECT', 'PROTOCOL DEVIATION', 'OTHER', 'DEATH', 'COVID'), Set to 'Adverse Event' if DS.DSDECOD is 'ADVERSE EVENT', Set to 'Serious Adverse Event' if DS.DSDECOD is 'SERIOUS ADVERSE EVENT', Set to 'Protocol Deviation' if DS.DSDECOD is 'PROTOCOL DEVIATION', Set to 'Other' if DS.DSDECOD is 'OTHER', Set to 'Physician Decision' if DS.DSDECOD is 'PHYSICIAN DECISION', Set to 'Withdrawal of Consent by Participant' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT', Set ot 'Death' if DS.DSDECOD='DEATH', Set to 'Due to SARS-CoV-2' if DS.DSDECOD='COVID', Set to 'Death' if DS.DSDECOD='DEATH' Set to 'Discontinuation from Study' if EOT01STT='DISCONTINUED' and COMPLFL='N' and no above mentioned record in DS
DCT01RSP Reason Spec for Disc of Trt in Period 01 text 200
Derived
Set to DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' and EPOCH='BLINDED TREATMENT' AND DSDECOD in ('ADVERSE EVENT', 'SERIOUS ADVERSE EVENT', 'PHYSICIAN DECISION', 'WITHDRAWAL BY SUBJECT', 'PROTOCOL DEVIATION', 'OTHER')
EOT02STT End of Treatment Status in Period 02 text 20
Derived
Set to 'COMPLETED' if (OLDOS2FL='Y' and TRT01AN^=2) or (OLDOS1FL='Y' and TRT01AN=2), Set to 'DISCONTINUED' if USUBJID exists in DS where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD^='COMPLETED' and EPOCH='OPEN LABEL TREATMENT ', Set to 'ONGOING' if (TRT02PN=2 and OLDOS1FL^='Y' and OLDOS2FL^='Y') or (TRT01AN^=2 and TRT02PN=2 and OLDOS2FL^='Y')
EOT02DT End of Treatment Date in Period 02 integer DATE9
Derived
Covert DS.DSSTDTC where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' and EPOCH='OPEN LABEL TREATMENT' or 'FOLLOW-UP OPEN LABEL PHASE' to numeric Set to OLDOS2DT if EOT02STT is 'COMPLETED' and (OLDOS2FL='Y' and TRT01AN^=2), or set to TR02EDT if (OLDOS1FL='Y' and TRT01AN=2)
EOT02DY End of Treatment in Period 02 Rel Day integer 8
Derived
EOT02DT-TR02SDT+1 if EOT02DT>=TR02SDT
DCT02RS Reason for Discont of Treat in Period 02 text 100
Derived
Set to DS.DSTERM where DS.DSCAT='DISPOSITION EVENT' and DS.DSSCAT='STUDY TREATMENT' and DS.EPOCH='OPEN LABEL TREATMENT' and DS.DSDECOD not in ('COMPLETED', 'ADVERSE EVENT', 'SERIOUS ADVERSE EVENT', 'PHYSICIAN DECISION', 'WITHDRAWAL BY SUBJECT', 'PROTOCOL DEVIATION', 'OTHER', 'DEATH', 'COVID'), Set to 'Adverse Event' if DS.DSDECOD is 'ADVERSE EVENT', Set to 'Serious Adverse Event' if DS.DSDECOD is 'SERIOUS ADVERSE EVENT', Set to 'Protocol Deviation' if DS.DSDECOD is 'PROTOCOL DEVIATION', Set to 'Other' if DS.DSDECOD is 'OTHER', Set to 'Physician Decision' if DS.DSDECOD is 'PHYSICIAN DESICION', Set to 'Withdrawal of Consent by Participant' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT', Set to 'Death' if DS.DSDECOD='DEATH', Set to 'Due to SARS-CoV-2' if DS.DSDECOD='COVID', Set to 'Discontinuation from Study' if EOT02STT='DISCONTINUED' and COMPLFL='N' and no above mentioned record in DS
DCT02RSP Reason Spec for Disc of Trt in Period 02 text 200
Derived
Set to DS.DSTERM where DS.DSCAT='DISPOSITION EVENT' and DS.DSSCAT='STUDY TREATMENT' and DS.EPOCH='OPEN LABEL TREATMENT' AND DS.DSDECOD in ('ADVERSE EVENT', 'SERIOUS ADVERSE EVENT', 'PHYSICIAN DECISION', 'WITHDRAWAL BY SUBJECT', 'PROTOCOL DEVIATION', 'OTHER')
DTHDT Date of Death integer DATE9
Derived
Convert DD.DDDTC to numeric or Convert AEENDTC where AE.AESDTH='Y' to numeric if DD.DDDTC is missing
DTHCAUS Cause of Death text 200
Derived
Set to DD.DDORRES where DDTESTCD='DTHCAUS'
DSDTHSP Other Main Cause of Death Specification text 200
Derived
Set to SUPPDD.QVAL where SUPPDD.QNAM='DSDTHSP'
DTHAUTOP Was autopsy performed? text 8
Derived
Set to DD.DDORRES where DDTESTCD='AUTOPERF'
TTDTH1 Time to Death from First Injection integer 8
Derived
DTHDT - TR01SDT
TTDTH2 Time to Death from PDV integer 8
Derived
DTHDT - AP02SDT if AP02SDT is not missing
CUTOFFDT Data Cutoff Date integer DATE9
Derived
Set to TS.TSVAL where TS.TSPARMCD='DCUTDTC'
FASEREAS Reason for Full Analysis Set Exclusion text 200
Derived
Only for subjects with RANDFL='Y' 1. Set to 'Did not receive any vaccination' if there is no record exists in EX with non-missing EXSTDTC 2. Set to 'Had major protocol deviations' if there is at least one record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis' or '2 - Exclude from all efficacy analysis (full analysis set and per-protocol analysis set)' or '8 - Exclude from all analysis sets except for randomization and DVSTDTC <= AP01EDT (condition of DVSTDTC <= AP01EDT applies only when AP01EDT is not missing), After above steps, if a subject satisfies more than one of 1-2, then concatenate reason with ',' Set to null, otherwise
SAFEREAS Reason for Safety Set Exclusion text 200
Derived
Only for subjects with RANDFL='Y' 1. Set to 'Did not receive any vaccination' if there is no record exists in EX with non-missing EXSTDTC, 2. Set to 'Had major protocol deviations' if there is at least one record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis' or '8 - Exclude from all analysis sets except for randomization set' and DVSTDTC <= AP01EDT (condition of DVSTDTC <= AP01EDT applies only when AP01EDT is not missing), After above steps, if a subject satisfies more than one of 1-2, then concatenate reason with ',' Set to Null, otherwise
SAR1ERS Reason for 1st Solicited Safety Set Exc text 200
Derived
Only for subjects with RANDFL='Y' 1. Set to 'Did not receive Vaccination' if there is no record exists in EX with non-missing EXSTDTC, 2. Set to 'Had major protocol deviations' If there is at least one record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis' or '8 - Exclude from all analysis sets except for randomization set' and DVSTDTC <= AP01EDT (condition of DVSTDTC <= AP01EDT applies only when AP01EDT is not missing), 3. Set to 'Did not contribute any solicited AR data for Vaccination #1' if SAFFL='Y' and SAR1FL='N', After above steps, if a subject satisfies more than one of 1-3, then concatenate reason with ',' Set to null, otherwise
SAR2ERS Reason for 2nd Solicited Safety Set Exc text 200
Derived
Only for subjects with RANDFL='Y' 1. Set to 'Did not receive Vaccination' if there is no record exists in EX with non-missing EXSTDTC, 2. Set to 'Had major protocol deviations' if there is at least one record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis' or '8 - Exclude from all analysis sets except for randomization set' and DVSTDTC <= AP01EDT (condition of DVSTDTC <= AP01EDT applies only when AP01EDT is not missing), 3. Set to 'Did not receive Vaccination' if SAFFL='Y' and DOSE2FL='N', 4. Set to 'Did not contribute any solicited AR data for Vaccination #2' if SAFFL='Y' and DOSE2FL='Y' and SAR2FL='N', After above steps, if a subject satisfies more than one of 1-4, then concatenate reason with ',' Set to Null, otherwise
MITTERS Reason for Modified ITT Set Exclusion text 200
Derived
Only for subjects with RANDFL='Y'. 1. Set to 'Did not receive any vaccination' if there is no record exists in EX with non-missing EXSTDTC, 2. Set to 'Had major protocol deviations' If there is at least one record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis' or '2 - Exclude from all efficacy analysis (full analysis set and per-protocol analysis set)' or '8 - Exclude from all analysis sets except for randomization set' and DVSTDTC <= EFFCODT and DVSTDTC <= AP01EDT (condition of DVSTDTC <= AP01EDT applies only when AP01EDT is not missing), 3. Set to 'PCR and/or serology positive at baseline' if SCOV2BL='Positive', 4. Set to 'PCR and/or serology missing at baseline' if SCOV2BL='', After above steps, if a subject satisfies more than one of 1-4, then concatenate reason with ',' Set to null, otherwise
PPEREAS Reason for Per-Protocol Set Exclusion text 200
Derived
Only for subjects with RANDFL='Y' 1. Set to 'Excluded from mITT population' if MITTFL='N', 2. Set to 'Did not receive Vaccination #2 per schedule' if DOSE2FL='N' 3. Set to 'Had major protocol deviations' if there is at least one record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis sets' or '2 - Exclude from all efficacy analysis (full analysis set and per-protocol analysis set)' or '3 - Exclude from per-protocol analysis set only' or '8 - Exclude from all analysis sets except for randomization set' and DVSTDTC <= EFFCODT and DVSTDTC <= AP01EDT (condition of DVSTDTC <= AP01EDT applies only when AP01EDT is not missing) 4. Set to 'Received incorrect vaccination' if there is any record in EX where EXTRT (non-missing) ne TRT01P in any case, 5. Set to 'Received Vaccination #2 out of window' if DOSE2FL='Y' and (non-missing DOSE2DT - TR01SDT < 21 or > 42), After above steps, if a subject satisfies more than one of 1-5, then concatenate reason with ',' Set to null otherwise
PREVSCR Was this participant screened previously text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to SUPPDM.QVAL where QNAM='PREVSCR' per USUBJID
RSKF1 Risk Factor 1 text 200
Derived
Set to 'Chronic Lung Disease' if exist record in MH where MHTERM='LUNG DISEASE' and MHOCCUR='Y' and MHCAT='RISK FACTOR FOR COVID-19'
RSKF2 Risk Factor 2 text 200
Derived
Set to 'Significant Cardiac Disease' if exist record in MH where MHTERM='CARDIAC DISEASE' and MHOCCUR='Y' and MHCAT='RISK FACTOR FOR COVID-19'
RSKF3 Risk Factor 3 text 200
Derived
Set to 'Severe Obesity' if exist record in MH where MHTERM='SEVERE OBESITY' and MHOCCUR='Y' and MHCAT='RISK FACTOR FOR COVID-19'
RSKF4 Risk Factor 4 text 200
Derived
Set to 'Diabetes' if exist record in MH where MHTERM='DIABETES' and MHOCCUR='Y' and MHCAT='RISK FACTOR FOR COVID-19'
RSKF5 Risk Factor 5 text 200
Derived
Set to 'Liver Disease' if exist record in MH where MHTERM='LIVER DISEASE' and MHOCCUR='Y' and MHCAT='RISK FACTOR FOR COVID-19'
RSKF6 Risk Factor 6 text 200
Derived
Set to 'Human Immunodeficiency Virus Infection' if exist record in MH where MHTERM='HIV' and MHOCCUR='Y' and MHCAT='RISK FACTOR FOR COVID-19'
STRATAV Strata from Verification Source text 40
Derived
Set to '>=18 and <65 Years and Not at Risk' if AGEGR1N=1 and all of RSKF1--RSKF6 are missing Set to '>=18 and <65 Years and at Risk' if AGEGR1N=1 and at least one of RSKF1--RSKF6 is not missing Set to '>=65 Years' if AGEGR1N=2
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Derived
Based on 'STRATAV': Set to 1 if '>=18 and <65 Years and Not at Risk' Set to 2 if '>=18 and <65 Years and at Risk' Set to 3 if '>=65 Years'
STUDDUR1 Study Duration 1 integer 8
Derived
Derived for subjects with SAFFL='Y': Set to EOSDT-RANDDT+1 if EOSDT not missing Set to CUTOFFDT-RANDDT+1 if EOSDT missing and EOSSTT='ONGOING'
STUDDUR2 Study Duration 2 integer 8
Derived
Derived for subjects with SAFFL='Y': Set to EOSDT-TR01SDT+1 if EOSDT not missing set to CUTOFFDT-TR01SDT+1 if EOSDT missing and EOSSTT='ONGOING'
STUDDUR3 Study Duration 3 integer 8
Derived
Derived for subjects with SAFFL='Y': Set to EOSDT-DOSE2DT+1 if DOSE2FL='Y' and EOSDT not missing Set to CUTOFFDT-DOSE2DT+1 if DOSE2FL='Y' and EOSDT missing and EOSSTT='ONGOING' Set to 0 if DOSE2FL='N'
STUDDUR4 Study Duration 4 integer 8
Derived
DOSE2DT - TR01SDT
STUDDUR5 Study Duration 5 integer 8
Derived
AP02SDT - RANDDT + 1, Note: Use EOSDT if AP02SDT is missing, Use CUTOFFDT if EOSDT is also missing
STUDDUR6 Study Duration 6 integer 8
Derived
Derive for subjects with AP02SDT not missing: EOSDT - AP02SDT + 1, Note: Use CUTOFFDT if EOSDT is missing
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Derived
Only for subjects with (RACE is not missing or not equal to ‘NOT REPORTED’ or ‘UNKNOWN’ ) or (ETHNIC is not missing or not equal to ‘NOT REPORTED’ or ‘UNKNOWN’ ): Set to 'Minority' if ADSL.RACE is equal to ''AMERICAN INDIAN OR ALASKA NATIVE', 'BLACK OR AFRICAN AMERICAN', 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER', or ADSL.ETHNIC= ‘HISPANIC OR LATINO’, Set to 'Non-minority', otherwise
RACEGR1 Pooled Race Group 1 text 40
Derived
Set to 'Caucasian' if RACE='WHITE' Set to 'Non-caucasian' if RACE is not missing or not equal to ‘NOT REPORTED’ or ‘UNKNOWN’
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Derived
Based on RACEGR1: Set to 1 if RACEGR1='Caucasian' Set to 2 if RACEGR1 is 'Non-caucasian'
RISKGR1 Pooled Risk Group 1 text 40
Derived
Only derived for subjects where RANDFL='Y': Set to 'At Risk' if at least one of RSKF1-RSK6 in not missing, otherwise Set to 'Not At Risk'
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Derived
Based on RISKGR1: Set to 1 if RISKGR1='At Risk' Set to 2 if RISKGR1='Not At Risk'
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Derived
Only for subjects with (non-missing RACE not equal to ‘NOT REPORTED’ or ‘UNKNOWN’) or (non-missing ETHNIC not equal to ‘NOT REPORTED’ or ‘UNKNOWN’): Set to 'White' if RACE='WHITE' and ETHNIC ne 'HISPANIC OR LATINO' Set to 'Community of Colors', otherwise
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Derived
Based on RETHGR1 Set to 1 if RETHGR1='White' Set to 2 if RETHGR1='Communities of Color'
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to 'Y' where SUPPCE.QNAM='CEREASOC' and SUPPCE.QVAL containing 'EVENT MEETS THE CHARTER DEFINITION OF COVID-19' and CE.CESTDTC<=EFFCODT, Set to 'N', otherwise
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Derived
Set to 'Y' where SUPPCE.QNAM='CEREASOC' and SUPPCE.QVAL containing 'EVENT MEETS THE CHARTER DEFINITION OF SEVERE COVID-19' and CE.CESTDTC<=EFFCODT, Set to 'N', otherwise
PPSIEREA Reason for PPSI Set Exclusion text 100
Derived
Only for subjects with RANDFL='Y': 1. Set to 'Not in random subcohort for immunogenicity' if RANDIGFL='N', 2. Set to 'Did not receive Vaccination #2 per schedule' if DOSE2FL='N', 3. Set to 'Had major protocol deviations' if there is at least one record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis sets' or '2 - Exclude from all efficacy analysis (full analysis set and per-protocol analysis set)' or '3 - Exclude from per-protocol analysis set only' or '8 - Exclude from all analysis sets except for randomization set' and DVSTDTC <= EFFCODT and DVSTDTC <= AP01EDT (condition of DVSTDTC <= AP01EDT applies only when AP01EDT is not missing), 4. Set to 'Received incorrect vaccination in blinded phase' if there is any dosing error in blinded phase - can find record where iEXTRT (non-missing) ne TRT01P and VISIT in ('Visit 1 Day 1' 'Visit 2 Day 29') and in any case, 5. Set to 'Received Vaccination #2 out of window' if DOSE2FL='Y' and (non-missing DOSE2DT - TR01SDT < 21 or > 42), 6. Set to 'Human Immunodeficiency Virus Infection' if RSKF6 is not missing, Concatenate reason with ',' if a subject satisfies more than one of 1-6
EXTDT Data Extraction Date integer 8
Assigned

Set to 04MAY2021

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Screen Fail Subj-Level Analysis Dataset (ADSLSF)

ADSLSF (Screen Fail Subj-Level Analysis Dataset) - SUBJECT LEVEL ANALYSIS DATASET Location: adslsf.xpt
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: DM.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: DM.USUBJID
SUBJID Subject Identifier for the Study text 20
Predecessor: DM.SUBJID
SITEID Study Site Identifier text 5
Predecessor: DM.SITEID
COUNTRY Country text 3
Predecessor: DM.COUNTRY
AGE Age integer 8
Predecessor: DM.AGE
AGEU Age Units text 6
Predecessor: DM.AGEU
SEX Sex text 1
Predecessor: DM.SEX
RACE Race text 41
Predecessor: DM.RACE
RACESPY Race Specify text 55
Derived
If RACE='OTHER' then set to SUPPDM.QVAL where QNAM is RACEOTH, If RACE='MULTIPLE' then concatenate mixed case of QVAL with ', ' where QNAM is among RACE1 - RACE6
ETHNIC Ethnicity text 22
Predecessor: DM.ETHNIC
PROTVER Protocol Version text 11
Derived
Set to SUPPDM.QVAL where QNAM is PROTVER and VISIT = Screening
CHILDBP Childbearing Potential text 1
Derived
Set to RP.RPORRES where RPTESTCD is CHILDPOTand VISIT=Screening
CBNRS Reason for No Childbearing Potential text 15
Derived
Set to SUPPRP.QVAL where QNAM='CBRSN' and VISIT='Screening'
RFICDT Date of Informed Consent integer Date9.
Derived
Convert date part of DM.RFICDTC
SCFREAS Screen Failure Reason text 19
Derived
Mixed case of DS.DSTERM where DSCAT = 'DISPOSITION EVENT' and DSSCAT='SCREEN FAILURE' and DS.DSDECOD ^= 'OTHER'. Set to 'Other' if DS.DSDECOD = 'OTHER' where DSCAT = 'DISPOSITION EVENT' and DSSCAT = 'SCREEN FAILURE'
SCFREASP Screen Failure Reason Specify text 200
Derived
Set to DS.DSTERM where SCFREAS='Other'
PREVSCR Was this participant screened previously text 1
Derived
Set to SUPPDM.QVAL where QNAM='PREVSCR' per USUBJID

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Solicited AR Analysis Dataset (ADAR)

ADAR (Solicited AR Analysis Dataset) - BASIC DATA STRUCTURE Location: adar.xpt
Variable Where Condition Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
ASEQ Analysis Sequence Number integer 8
Assigned
ADT Analysis Date integer DATE9.
Derived
Convert date part of FACE.FADTC to numeric if source data are from FACE Convert date part of VS.VSDTC to numeric if source data are from VS
ADTM Analysis Datetime integer DATETIME20.
Derived
Convert FACE.FADTC to numeric if source data are from FACE Convert VS.VSDTC to numeric if source data are from VS
ADY Analysis Relative Day integer 8
Derived
Set to FACE.FADY if source data are from FACE Set to VS.VSDY if source data are from VS
ATPT Analysis Timepoint text 100
Derived
If source data are from FACE, set to FACE.FATPT, otherwise If source data are from VS, set to VS.VSTPT Recode 'DAY 1' as 'DAY 1, AFTER VACCINATION (AT HOME)' if FAEVAL='INVESTIGATOR''
ATPTN Analysis Timepoint (N) integer 8
Assigned
ATPTREF Analysis Timepoint Reference text 50
Derived
If source data are from FACE Set to ‘Vaccination 1’ if FACE.FATPTREF contains ‘DOSE1’ Set to ‘Vaccination 2’ if FACE.FATPTREF contains ‘DOSE2’ If source data are from VS Set to 'Vaccination 1' if VS.VSTPTREF contatins 'DOSE1', Set to 'Vaccination 2' if VS.VSTPTREF contains 'DOSE2'
ATPTGR1 Poolded Analysis Timepoint text 50
Derived
Set to 'Day 1' if ATPT contains 'Day 1' Set to ATPT otherwise
ATPTGR1N Poolded Analysis Timepoint (N) integer 8
Assigned
PARCAT1 Parameter Category 1 text 50 Solicited AR within D7, Post D7 and Summary Analysis Dataset Parameter Category
  • • "LOCAL"
  • • "SYSTEMIC"
Derived
For source data are from SDTM.FACE/FAAE: Set to 'LOCAL' if FASCAT=ADMINISTRATION SITE Set to FASCAT For source data are from VS: Set to VSSCAT
PARCAT1N Parameter Category 1 (N) integer 8 Parameter Category 1 (N) in ADAR* datasets
  • • 1 = "LOCAL"
  • • 2 = "SYSTEMIC"
Assigned
PARAMCD Parameter Code text 8 Solicited AR within / Post Day 7 Analysis Dataset Parameter Code

[14 Terms]

Assigned
PARAM Parameter text 200
Derived
If source data are from FACE: If FAOBJ=’Underarm Gland Swelling or Tenderness’ and FATESTCD = 'SEV', then set to 'Underarm Gland Swelling or Tenderness' If FAOBJ=’Nausea/Vomiting’ and FATESTCD = 'SEV', then set to 'Nausea/Vomiting'' If FAOBJ=’Erythema’ or ‘Swelling’ and FATEST contains 'Occurrence' and FAORRES='N', then set to FAOBJ||' Longest Diameter (mm)' and assign AVAL=0 (see specs for AVAL) If FAOBJ= ’Erythema’ or ‘Swelling’ and FATEST contains 'Intensity', then set to FAOBJ||' Longest Diameter (mm)' If FAOBJ=’ Erythema’ or ‘Swelling’ and FATEST='Longest Diameter', set to 'FAOBJ'|| ' '||FATEST|| ' '||'('||FAORRESU||')' If FAOBJ='Pyrexia' or 'Fever', then set to 'Fever (C)' set to FAOBJ, otherwise if source data are from VS and VSTESTCD in ('TEMP' 'VSALL'), set to 'Fever'||'('||VSSTRESU||'). (please add space between the VSTEST and VS unit. If the VSSTRESU is missing, use non-missing VSSTRESU) if there is one record in VS where SUPPVS.QNAM='MEDTAKP' and QVAL='Y', then create one record with PARAM='Prevent Pain or Fever from Occurring'; if there is one record in VS where SUPPVS.QNAM='MEDTAKT' and QVAL='Y', then create one record with PARAM='Treat Pain or Fever already Occurred'; if there is one record in VS where SUPPVS.QNAM='MEDTAK' and QVAL='Y', then create one record with PARAM='Medication Taken Today for Pain or Fever'.
AVALVLM Analysis Value float 20
PARAMCD = "FEVER" (Fever (C)) Fever (C) float 20
Derived
Set to VS.VSSTRESN if source data are from VS
PARAMCD IN (
"ERYTHDIA" (Erythema Longest Diameter (mm)),
"SWELLDIA" (Swelling Longest Diameter (mm))
) 		Erythema/Swelling Longest Diameter (mm) integer 8
Derived
For FACE.FAOBJ = ’Erythema’ or ‘Swelling’ only Set to 0 if FATEST='Occurrence Indicator' and FAORRES='N', otherwise Set to FACE.FASTRESN
PARAMCD NOT IN (
"ERYTHDIA" (Erythema Longest Diameter (mm)),
"SWELLDIA" (Swelling Longest Diameter (mm)),
"FEVER" (Fever (C))
) 		Other Assessment integer 8
Derived
Set to missing
AVALC Analysis Value (C) text 100
Derived
Set to FACE.FASTRESC if source data are from FACE, Set to VS.VSSTRESC if source data are from VS
ATOXGRVLM Analysis Toxicity Grade text 20
PARAMCD IN (
"ERYTHDIA" (Erythema Longest Diameter (mm)),
"SWELLDIA" (Swelling Longest Diameter (mm))
) 		Erythema/Swelling Grade text 20
Derived
Set to 'Grade 0' if .<AVAL < 25 mm or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if AVAL = 25 - 50 mm or FASTRESC contains 'GRADE 1' Set to 'Grade 2' if AVAL = 51 - 100 mm or FASTRESC contains 'GRADE 2' Set to 'Grade 3' if AVAL > 100 mm or FASTRESC contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
PARAMCD = "FEVER" (Fever (C)) Fever (C) Grade text 20
Derived
Grade 0 if .<AVAL < 38.0°C or FASTRESC contains 'GRADE 0' Grade 1 if 38.0<=AVAL<=38.4°C or FASTRESC contains 'GRADE 1' Grade 2 if 38.4<AVAL<=38.9°C or FASTRESC contains 'GRADE 2' Grade 3 if 38.9<AVAL<=40.0°C or FASTRESC contains 'GRADE 3' Grade 4 if AVAL > 40.0°C or FASTRESC contains 'GRADE 4'
PARAM = "PAIN" Pain Symptom Grade text 20
Derived
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC=’DOES NOT INTERFERE WITH ACTIVITY’ or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH ACTIVITY’ or contains 'GRADE 2' Grade 3 if FASTRESC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'; Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
PARAMCD = "LYMPH" (Lymphadenopathy) Lymphadenopathy Symptom Grade text 20
Derived
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC=’DOES NOT INTERFERE WITH ACTIVITY’ or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH SOME ACTIVITY’ or contains 'GRADE 2' Set to 'Grade 3' if FASTRESC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'; Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
PARAMCD = "HEADACHE" (Headache) Headache Symptom Grade text 20
Derived
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC=’NO INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR SOME INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 2'; Set to 'Grade 3' if FASTRESC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
PARAMCD IN (
"FATIGUE" (Fatigue),
"MYALGIA" (Myalgia),
"ARTHRALG" (Arthralgia)
) 		Fatigue, Myalgia and Arthralgia Symptom Grade text 20
Derived
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC= 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘SOME INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 2' Set to 'Grade 3' if FASTRESC= ‘SIGNIFICANT; PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3' Grade 4 if FASTRESC contains 'GRADE 4'
PARAMCD = "NAUSEA" (Nausea/Vomiting) Nausea/Vomiting Symptom Grade text 20
Derived
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC= ‘NO INTERFERENCE WITH ACTIVITY OR 1-2 EPISODES/24 HOURS’ or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘SOME INTERFERENCE WITH ACTIVITY OR >2 EPISODES/24 HOURS’ or contains 'GRADE 2' Set to 'Grade 3' if FASTRESC= ‘PREVENTS DAILY ACTIVITY, REQUIRES OUTPATIENT IV HYDRATION’ or contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
PARAMCD = "CHILLS" (Chills) Chills Symptom Grade text 20
Derived
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC= ‘NO INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘SOME INTERFERENCE WITH ACTIVITY NOT REQUIRING MEDICAL ATTENTION’ or contains 'GRADE 2' Set to 'Grade 3' if FASTRESC= ‘PREVENTS DAILY ACTIVITY AND REQUIRES MEDICAL ATTENTION’ or contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
ATOXGRN Analysis Toxicity Grade (N) integer 8 Solicited AR Toxicity Grade
  • • 0 = "Grade 0"
  • • 1 = "Grade 1"
  • • 2 = "Grade 2"
  • • 3 = "Grade 3"
  • • 4 = "Grade 4"
Assigned
ANL01FL Analysis Flag 01 text 1 Yes Flag
  • • "Y"
Derived
Set 'Y' for the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF) per ATPTGR1 Note: If there are two or more records found, then select the first one where FAEVAL='STUDY SUBJECT' or missing for FEVER
ANL02FL Analysis Flag 02 text 1 Yes Flag
  • • "Y"
Derived
Y for the records where PARAMCD is 'PAIN' or 'ERYTHDIA' or 'SWELLDIA', and ATOXGRN>0
ANL03FL Analysis Flag 03 text 1 Yes Flag
  • • "Y"
Derived
Y for the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF) per ATPT Note: If there are two or more records found, then select the first one where FAEVAL='STUDY SUBJECT' or missing for FEVER
CRIT1 Analysis Criterion 1 text 20
Derived
Set to '> 102.6 degrees F' if CRIT1FL='Y'
CRIT1FL Criterion 1 Evaluation Result Flag text 1
Derived
Set to 'Y' if (9*AVAL/5)+32 > 102.6
CRIT2 Analysis Criterion 2 text 20
Derived
Set to '> 103.1 degrees F' if CRIT2FL='Y'
CRIT2FL Criterion 2 Evaluation Result Flag text 1
Derived
Set to 'Y' if (9*AVAL/5)+32 > 103.1
CRIT3 Analysis Criterion 3 text 20
Derived
Set to '> 103.6 degrees F' if CRIT3FL='Y'
CRIT3FL Criterion 3 Evaluation Result Flag text 1
Derived
Set to 'Y' if (9*AVAL/5)+32 > 103.6
CRIT4 Analysis Criterion 4 text 20
Derived
Set to '> 104.1 degrees F' if CRIT4FL='Y'
CRIT4FL Criterion 4 Evaluation Result Flag text 1
Derived
Set to 'Y' if (9*AVAL/5)+32 > 104.1
SRCDOM Source Data text 20
Derived
FACE.DOMAIN if source data are from FACE; VS.DOMAIN if source data are from VS
SRCSEQ Source Sequence Number integer 8
Derived
FACE.FASEQ if source data are from FACE; VS.VSSEQ if source data are from VS
SRCVAR Source Variable text 50
Derived
Set to 'FASTRESC' if source data are from FACE; Set to 'VSSTRESN' if source data are from VS; Set to "SUPPVS.QVAL where QNAM='MEDTAKP'" if PARAMCD='MEDTAKP'; else set to "SUPPVS.QVAL where QNAM='MEDTAKT'" if PARAMCD='MEDTAKT'; else set to "SUPPVS.QVAL where QNAM='MEDTAK'" if PARAMCD='MEDTAK'.
FAEVAL Evaluator text 40
Predecessor: FACE.FAEVAL
MAAEFL Medically-attended AE Flag text 1
Derived
Set to SUPPFACE.QVAL where SUPPFACE.QNAM='MAAEFL'

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Solicited AR post D7 Analysis Dataset (ADARP7D)

ADARP7D (Solicited AR post D7 Analysis Dataset) - BASIC DATA STRUCTURE Location: adarp7d.xpt
Variable Where Condition Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
ASEQ Analysis Sequence Number integer 8
Assigned
ADT Analysis Date integer DATE9.
Derived
Convert date part of FACE.FADTC to numeric if source data are from FACE Convert date part of FAAE.FADTC to numeric if source data are from FAAE Convert date part of VS.VSDTC to numeric if source data are from VS
ADTM Analysis Datetime integer DATETIME20.
Derived
Convert FACE.FADTC to numeric if source data are from FACE Convert FAAE.FADTC to numeric if source data are from FAAE Convert VS.VSDTC to numeric if source data are from VS
ADY Analysis Relative Day integer 8
Derived
Set to FACE.FADY if source data are from FACE Set to FAAE.FADY if source data are from FAAE Set to VS.VSDY if source data are from VS
ATPTREF Analysis Timepoint Reference text 50
Derived
If source data are from FACE Set to ‘Vaccination 1’ if FACE.FATPTREF contains ‘DOSE1’ Set to ‘Vaccination 2’ if FACE.FATPTREF contains ‘DOSE2’ If source data are from FAAE Set to ‘Vaccination 1’ if FAAE.FATPTREF contains ‘DOSE1’ Set to ‘Vaccination 2’ if FAAE.FATPTREF contains ‘DOSE2’ If source data are from VS Set to 'Vaccination 1' if VS.VSTPTREF contains 'DOSE1', Set to 'Vaccination 2' if VS.VSTPTREF contains 'DOSE2'
ATPT Analysis Timepoint text 100
Derived
If source data are from FACE, set to FACE.FATPT If Source data are from FAAE, set to FAAE.FATPT If source data are from VS, set to VS.VSTPT Recode 'DAY 1' as 'DAY 1, AFTER VACCINATION (AT HOME)' if FAEVAL='INVESTIGATOR''
ATPTN Analysis Timepoint (N) integer 8
Assigned
PARCAT1 Parameter Category 1 text 50 Solicited AR within D7, Post D7 and Summary Analysis Dataset Parameter Category
  • • "LOCAL"
  • • "SYSTEMIC"
Derived
For source data are from SDTM.FACE/FAAE: Set to 'LOCAL' if FASCAT=ADMINISTRATION SITE Set to FASCAT For source data are from VS: Set to VSSCAT
PARCAT1N Parameter Category 1 (N) integer 8 Parameter Category 1 (N) in ADAR* datasets
  • • 1 = "LOCAL"
  • • 2 = "SYSTEMIC"
Assigned
PARAMCD Parameter Code text 8 Solicited AR within / Post Day 7 Analysis Dataset Parameter Code

[14 Terms]

Assigned
PARAM Parameter text 200
Derived
If source data are from FACE/FAAE: If FAOBJ=’Underarm Gland Swelling or Tenderness’ and FATESTCD = 'SEV', then set to FAOBJ, If FAOBJ=’Nausea/Vomiting’ and FATESTCD = 'SEV', then set to 'Nausea/Vomiting', If FAOBJ=’Erythema’ or ‘Swelling’ and FATEST contains 'Occurrence' and FAORRES='N', then set to FAOBJ||' Longest Diameter (mm)' and assign AVAL=0 (see specs for AVAL), If FAOBJ= ’Erythema’ or ‘Swelling’ and FATEST contains 'Intensity', then set to FAOBJ||' Longest Diameter (mm)', If FAOBJ=’ Erythema’ or ‘Swelling’ and FATEST='Longest Diameter', set to 'FAOBJ'|| ' '||FATEST|| ' '||'('||FAORRESU||')', If FAOBJ='Pyrexia' or 'Fever', then set to 'Fever (C)', set to FAOBJ, otherwise If source data are from VS and VSTESTCD in ('TEMP' 'VSALL'), set to 'Fever'||'('||VSSTRESU||'). (please add space between the VSTEST and VS unit. If the VSSTRESU is missing, use non-missing VSSTRESU)" If there is one record in VS where SUPPVS.QNAM='MEDTAKP' and QVAL='Y', then create one record with PARAM='Prevent Pain or Fever from Occurring', If there is one record in VS where SUPPVS.QNAM='MEDTAKT' and QVAL='Y', then create one record with PARAM='Treat Pain or Fever already Occurred', If there is one record in VS where SUPPVS.QNAM='MEDTAK' and QVAL='Y', then create one record with PARAM='Medication Taken Today for Pain or Fever'
AVALVLM Analysis Value float 8
PARAMCD = "FEVER" (Fever (C)) Fever (C) float 20
Derived
If a subject has a least one record found from SDTM.VS where VSCAT="REACTOGENICITY" and VSTPTNUM>=8, then Set to VS.VSSTRESN where VSCAT='REACTOGENICITY'
PARAMCD IN (
"ERYTHDIA" (Erythema Longest Diameter (mm)),
"SWELLDIA" (Swelling Longest Diameter (mm))
) 		Erythema/Swelling Longest Diameter (mm) integer 8
Derived
If data is from SDTM.FACE[1] Set to FACE.FASTRESN where FACE.FAOBJ in ('Erythema', 'Swelling') and FATESTCD='LDIAM' If data is from SDTM.FAAE Set to FAAE.FASTRESN where FAAE.FAOBJ in ('Erythema', 'Swelling') and FAAE.FATESTCE='LDIAM' [1]A least one records should be found from SDTM.FAAE where FAAE.FAOBJ in ('Erythema', 'Swelling') and FATESTCD='LDIAM')
PARAMCD NOT IN (
"ERYTHDIA" (Erythema Longest Diameter (mm)),
"SWELLDIA" (Swelling Longest Diameter (mm)),
"FEVER" (Fever (C))
) 		Other Assessment integer 8
Derived
Set to missing
AVALCVLM Analysis Value (C) text 100
PARAMCD IN (
"MEDTAK" (Medication Taken Today for Pain or Fever),
"MEDTAKP" (Prevent Pain or Fever from Occurring),
"MEDTAKT" (Treat Pain or Fever already Occurred)
) 		Medication Taken Today for Pain or Fever text 1
Derived
Set to SUPPVS.QVAL if SUPPVS.QNAM in ('MEDTAK', 'MEDTAKP', 'MEDTAKT') and QVAL='Y'
PARAMCD NOT IN (
"MEDTAK" (Medication Taken Today for Pain or Fever),
"MEDTAKP" (Prevent Pain or Fever from Occurring),
"MEDTAKT" (Treat Pain or Fever already Occurred)
) 		Symptom Assessment text 100
Derived
Set to FACE.FASTRESC If data is from SDTM.FACE, Set to FAAE.FASTRESC If data is from SDTM.FAAE, Set to VS.VSSTRESC If data is from VS
ATOXGRVLM Analysis Toxicity Grade text 20
PARAMCD IN (
"ERYTHDIA" (Erythema Longest Diameter (mm)),
"SWELLDIA" (Swelling Longest Diameter (mm))
) 		Erythema/Swelling Grade text 20
Derived
Set to 'Grade 0' if .<AVAL < 25 mm or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if AVAL = 25 - 50 mm or FASTRESC contains 'GRADE 1' Set to 'Grade 2' if AVAL = 51 - 100 mm or FASTRESC contains 'GRADE 2' Set to 'Grade 3' if AVAL > 100 mm or FASTRESC contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
PARAMCD = "FEVER" (Fever (C)) Fever (C) Grade text 20
Derived
Grade 0 if .<AVAL < 38.0°C or FASTRESC contains 'GRADE 0' Grade 1 if 38.0<=AVAL<=38.4°C or FASTRESC contains 'GRADE 1' Grade 2 if 38.4<AVAL<=38.9°C or FASTRESC contains 'GRADE 2' Grade 3 if 38.9<AVAL<=40.0°C or FASTRESC contains 'GRADE 3' Grade 4 if AVAL > 40.0°C or FASTRESC contains 'GRADE 4'
PARAM = "PAIN" Pain Symptom Grade text 20
Derived
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC=’DOES NOT INTERFERE WITH ACTIVITY’ or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH ACTIVITY’ or contains 'GRADE 2' Grade 3 if FASTRESC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'; Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
PARAMCD = "LYMPH" (Lymphadenopathy) Lymphadenopathy Symptom Grade text 20
Derived
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC=’DOES NOT INTERFERE WITH ACTIVITY’ or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH SOME ACTIVITY’ or contains 'GRADE 2' Set to 'Grade 3' if FASTRESC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'; Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
PARAMCD = "HEADACHE" (Headache) Headache Symptom Grade text 20
Derived
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC=’NO INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR SOME INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 2'; Set to 'Grade 3' if FASTRESC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
PARAMCD IN (
"FATIGUE" (Fatigue),
"MYALGIA" (Myalgia),
"ARTHRALG" (Arthralgia)
) 		Fatigue, Myalgia and Arthralgia Symptom Grade text 20
Derived
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC= 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘SOME INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 2' Set to 'Grade 3' if FASTRESC= ‘SIGNIFICANT; PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3' Grade 4 if FASTRESC contains 'GRADE 4'
PARAMCD = "NAUSEA" (Nausea/Vomiting) Nausea/Vomiting Symptom Grade text 20
Derived
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC= ‘NO INTERFERENCE WITH ACTIVITY OR 1-2 EPISODES/24 HOURS’ or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘SOME INTERFERENCE WITH ACTIVITY OR >2 EPISODES/24 HOURS’ or contains 'GRADE 2' Set to 'Grade 3' if FASTRESC= ‘PREVENTS DAILY ACTIVITY, REQUIRES OUTPATIENT IV HYDRATION’ or contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
PARAMCD = "CHILLS" (Chills) Chills Symptom Grade text 20
Derived
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC= ‘NO INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘SOME INTERFERENCE WITH ACTIVITY NOT REQUIRING MEDICAL ATTENTION’ or contains 'GRADE 2' Set to 'Grade 3' if FASTRESC= ‘PREVENTS DAILY ACTIVITY AND REQUIRES MEDICAL ATTENTION’ or contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
ATOXGRN Analysis Toxicity Grade (N) integer 8 Solicited AR Toxicity Grade
  • • 0 = "Grade 0"
  • • 1 = "Grade 1"
  • • 2 = "Grade 2"
  • • 3 = "Grade 3"
  • • 4 = "Grade 4"
Assigned
SRCDOM Source Data text 20
Derived
FACE.DOMAIN if source data are from FACE; VS.DOMAIN if source data are from VS
SRCSEQ Source Sequence Number integer 8
Derived
Set to 'FASTRESC' if source data are from FACE; Set to 'VSSTRESN' if source data are from VS; Set to "SUPPVS.QVAL where QNAM='MEDTAKP'" if PARAMCD='MEDTAKP'; else set to "SUPPVS.QVAL where QNAM='MEDTAKT'" if PARAMCD='MEDTAKT'; else set to "SUPPVS.QVAL where QNAM='MEDTAK'" if PARAMCD='MEDTAK'.
SRCVAR Source Variable text 50
Derived
Set to 'FASTRESC' if source data are from FACE; Set to 'VSSTRESN' if source data are from VS; Set to "SUPPVS.QVAL where QNAM='MEDTAKP'" if PARAMCD='MEDTAKP'; else set to "SUPPVS.QVAL where QNAM='MEDTAKT'" if PARAMCD='MEDTAKT'; else set to "SUPPVS.QVAL where QNAM='MEDTAK'" if PARAMCD='MEDTAK'.
ANL01FL Analysis Flag 01 text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' for the records where PARAMCD is 'PAIN' or 'ERYTHDIA' or 'SWELLDIA', or 'LYMPH'
ANL02FL Analysis Flag 02 text 1 Yes Flag
  • • "Y"
Derived
If ANL01FL=Y, per subject per vaccination per symptom, flag all records if there are records at both ATPTN = 7 and ATPTN = 8
ANL03FL Analysis Flag 03 text 1 Yes Flag
  • • "Y"
Derived
If ANL01FL=Y, per subject per vaccination per symptom with min(ATPTN) <=7, flag all records if there are not records at both ATPTN = 7 and ATPTN = 8
ANL04FL Analysis Flag 04 text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' for the records if both criteria met: 1. ANL01FL='Y', 2. If per subject per symptom (PARAMCD) per vaccination (ATPTREF), the smallest ATPTGR1N >=8
ANL05FL Analysis Flag 05 text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' for the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF) per ATPT Note: If there is two records per day and one from investigator and one from subject, select the one from subject (FAEVAL='STUDY SUBJECT' or missing FAEVAL for FEVER)
ANL06FL Analysis Flag 06 text 1 Yes Flag
  • • "Y"
Derived
Per subject per vaccination per symptom, flag all records if the smallest ATPTGR1N<8 and largest ATPTGR1N>=8 where ATOXGRN>0
ATPTGR1 Poolded Analysis Timepoint text 50
Derived
Set to 'Day 1' if ATPT contains 'Day 1' Set to ATPT otherwise
ATPTGR1N Poolded Analysis Timepoint (N) integer 8
Assigned
FAEVAL Evaluator text 40
Derived
Set to FACE/FAAE.FAEVAL
MAAEFL Medically-attended AE Flag text 1
Derived
Set to SUPPFACE/SUPPFAAE.QVAL where SUPPFACE/SUPPFAAE.QNAM='MAAEFL'

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Solicited AR Summary Analysis Dataset (ADARSUM)

ADARSUM (Solicited AR Summary Analysis Dataset) - BASIC DATA STRUCTURE Location: adarsum.xpt
Variable Where Condition Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
ATPTREF Analysis Timepoint Reference text 50
Derived
Set to ADAR.ATPTREF if data from ADAR For source data from FAAE: Set to ‘Vaccination 1’ if FAAE.FATPTREF contains ‘DOSE 1’, or Set to ‘Vaccination 2’ if FAAE.FATPTREF contains ‘DOSE 2’ For source data from VS, Set to ‘Vaccination 1’ if VS.VSTPTREF contains ‘DOSE 1’, or Set to ‘Vaccination 2’ if VS.VSTPTREF contains ‘DOSE 2’
PARCAT1 Parameter Category 1 text 50 Solicited AR within D7, Post D7 and Summary Analysis Dataset Parameter Category
  • • "LOCAL"
  • • "SYSTEMIC"
Derived
Set to 'LOCAL' if PARAMCD in (LYMPHDUR, PAINDUR, ERYTHDUR, SWELLDUR, WLYMPH, WPAIN, WERYTH, WSWELL, WSLAR) Set to 'SYSTEMIC' if PARAMCD in (HEADADUR, FATIGDUR, MYALGDUR ARTHRDUR, NAUSEDUR, CHILLDUR, FEVERDUR, WHEAD, WFATIGUE, WMYALGIA, WARTHR, WNAUSEA, WCHILLS,WFEVER, WSSAR)
PARCAT1N Parameter Category 1 (N) integer 8 Parameter Category 1 (N) in ADAR* datasets
  • • 1 = "LOCAL"
  • • 2 = "SYSTEMIC"
Assigned
PARAMCD Parameter Code text 8 Solicited AR Summary Analysis Dataset Parameter Code

[28 Terms]

Assigned
PARAM Parameter text 200
Derived
Create one PARAM per subject per PARCAT1 per ATPTREF by following Solicited AR Summary Analysis Dataset Parameter Code
AVALVLM Analysis Value integer 8
PARAMCD IN (
"ARTHRDUR" (Number of Days for Arthralgia),
"CHILLDUR" (Number of Days for Chills),
"ERYTHDUR FATIGDUR",
"FEVERDUR" (Number of Days for Fever),
"HEADADUR" (Number of Days for Headache),
"LYMPHDUR" (Number of Days for Lymphadenopathy),
"MYALGDUR" (Number of Days for Myalgia),
"NAUSEDUR" (Number of Days for Nausea),
"PAINDUR" (Number of Days for Pain),
"SWELLDUR" (Number of Days for Swelling)
) 		Number of Days of Solicited AR Per Subject, Per Symptom and Per Vaccination integer 8
Derived
1. Get number of days from ADAR: Count total number of records with ATOXGRN>0 per subject, per symptom (ADAR.PARAMCD) and per vaccination (ATPTREF). If there are more than one record within same day (ADAR.ATPTGR1), then count it once only 2. Get number of days from ADARP7D: Count total number of records with ATOXGRN>0 and ADAR.P7D.ATPTGR1N>=8 per subject, per symptom (ADARP7D.PARAMCD) and per vaccination (ATPTREF). If there are more than one record within same day (ADARP7D.ATPTGR1), then count it once only 3. Calculate the sum of the number of records from steps 1 and 2 per subject per, per symptom (PARAMCD) and per vaccination (ATPTREF)
PARAMCD IN (
"LOCDUR" (Number of Days for Local Solicited AR),
"SYSDUR" (Number of Days for Systemic Solicited AR)
) 		Number of Days of Solicited AR Per Symptom Category (Local or Systemic), Per Vaccination integer 8
Derived
1. Get number of days from ADAR: Count total number of records with ATOXGRN>0 per subject, per symptom category (ADAR.PARCAT1) and per vaccination (ATPTREF). If there are more than one record within same day (ADAR.ATPTGR1), then count it once only 2. Get number of days from ADARP7D: Count total number of records with ATOXGRN>0 and ADARP7D.ATPTGR1N>=8 per subject, per symptom category (ADARP7D.PARCAT1) and per vaccination (ATPTREF). If there are more than one record within same day (ADARP7D.ATPTGR1), then count it once only 3. Calculate the sum of the number of records from steps 1 and 2 per subject per, per symptom (PACAT1) and per vaccination (ATPTREF)
PARAMCD = "ANYDUR" (Number of Days for Any Solicited AR) Number of Days of Solicited AR Per Subject and Per Vaccination integer 8
Derived
1. Get number of days from ADAR: Count total number of records with ATOXGRN>0 per subject and per vaccination (ATPTREF). If there are more than one record within same day (ADAR.ATPTGR1), then count it once only 2. Get number of days from ADARP7D: Count total number of records with ATOXGRN>0 and ADARP7D.ATPTGR1N>=8 per subject and per vaccination (ATPTREF). If there are more than one record within same day (ADARP7D.ATPTGR1), then count it once only 3. Calculate the sum of the number of records from steps 1 and 2 per subject per and per vaccination (ATPTREF)
AVALC Analysis Value (C) text 100
Derived
Derived worse case of each AR symptom occurred within 7 days per vaccination (ATPTREF) where PARAMCD in (WLYMPH, WPAIN, WERYTH, WSWELL, WHEAD, WFATIGUE, WMYALGIA, WARTHR, WNAUSEA, WCHILLS, WFEVER): Set to ADAR.AVALC where ADAR.ATOXGR is the worse case per AR symptom within 7 Days per vaccination (ATPTREF) Note: The higher number of ADAR.ATOXGRN, the worse symptom grade
ATOXGRVLM Analysis Toxicity Grade text 20
PARAMCD IN (
"WLYMPH" (Worst Analysis Toxicity Grade for Lymphadenopathy between Day 1 and Day 7),
"WPAIN" (Worst Analysis Toxicity Grade for Pain between Day 1 and Day 7),
"WERYTH" (Worst Analysis Toxicity Grade for Erythema between Day 1 and Day 7),
"WSWELL" (Worst Analysis Toxicity Grade for Swelling between Day 1 and Day 7),
"WHEAD" (Worst Analysis Toxicity Grade for Headache between Day 1 and Day 7),
"WFATIGUE" (Worst Analysis Toxicity Grade for Fatigue between Day 1 and Day 7),
"WMYALGIA" (Worst Analysis Toxicity Grade for Myalgia between Day 1 and Day 7),
"WARTHR" (Worst Analysis Toxicity Grade for Arthralgia between Day 1 and Day 7),
"WNAUSEA" (Worst Analysis Toxicity Grade for Nausea between Day 1 and Day 7),
"WCHILLS" (Worst Analysis Toxicity Grade for Chills between Day 1 and Day 7),
"WFEVER" (Worst Analysis Toxicity Grade for Fever between Day 1 and Day 7)
) 		Worst Analysis Toxicity Grade Per Subject, Per Symptom and Per Vaccination text 20
Derived
Set to the highest ATOXGR by subject, ADAR.PARAMCD, and vaccination (ATPTREF)
PARAMCD IN (
"WSLAR" (Worst Analysis Toxicity Grade for Any Solicited Local AR between Day 1 and Day 7),
"WSSAR" (Worst Analysis Toxicity Grade for Any Solicited Systemic AR between Day 1 and Day 7)
) 		Worst Analysis Toxicity Grade Per Subject, Per Symptom Category (Local or Systemic) and Per Vaccination text 20
Derived
Set to the highest ATOXGR by subject, ADAR.PARCAT1, and vaccination (ATPTREF)
PARAMCD = "WSAR" (Worst Analysis Toxicity Grade for Any Solicited AR between Day 1 and Day 7) Worst Analysis Toxicity Grade Per Subject and Per Vaccination text 20
Derived
Set to the highest ATOXGR by subject, and vaccination (ATPTREF)
ATOXGRN Analysis Toxicity Grade (N) integer 8 Solicited AR Toxicity Grade
  • • 0 = "Grade 0"
  • • 1 = "Grade 1"
  • • 2 = "Grade 2"
  • • 3 = "Grade 3"
  • • 4 = "Grade 4"
Assigned
ANL01FL Analysis Flag 01 text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' for the records that met either of below criteria: 1. ADARSUM.PARAMCD is 'PAINDUR', for the same subject and same vaccination (ATPTREF), the smallest ADARP7D.ATPTGR1N>=8 where ADARP7D.PARAMCD='PAIN' and ATOXGRN>0 2. ADARSUM.PARAMCD is 'ERYTHDUR', for the same subject and same vaccination (ATPTREF), the smallest ADARP7D.ATPTGR1N>=8 where ADARP7D.PARAMCD='ERYTHDIA' and ATOXGRN>0 3. ADARSUM.PARAMCD is 'SWELLDUR', for the same subject and same vaccination (ATPTREF), the smallest ADARP7D.ATPTGR1N>=8 where ADARP7D.PARAMCD='SWELLDIA' and ATOXGRN>0
ANL02FL Analysis Flag 02 text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if PARAMCD in (PAINDUR, ERYTHDUR, SWELLDUR, HEADADUR, LYMPHDUR, FATIGDUR, MYALGDUR, ARTHRDUR, NAUSEDUR, CHILLDUR, FEVERDUR, ANYDUR, LOCDUR, SYSDUR) and no corresponded symptom last beyond day 7 (no any record is found from ADARP7D by ATPTREF)

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Efficacy Analysis Dataset (ADEFF)

ADEFF (Efficacy Analysis Dataset) - BASIC DATA STRUCTURE Location: adeff.xpt
Variable Where Condition Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
ADTVLM Analysis Date integer DATE9
PARAMCD = "COVID" (COVID-19) COVID-19 integer DATE9
Derived
Set to the later date of the following two dates: 1. Date of positive PCR test (MB.MBDTC) meets derivation of PARAM = 'COVID-19' 2. Earliest date from following symptom date: Systemic symptoms: earliest ADSYMP.ADT of the 2nd eligible systemic symptom that occurred within +/-14 days window of positive PCR date Respiratory symptom: earliest ADSYMP.ADT (use ADSYMP.ASTDT for PARAMCD in ('CEPNEU', 'REPNEU') and use ADSYMP.ADT when ADSYMP.ASTDT is missing) of the 1st eligible respiratory symptom that occurred within +/-14 days window of positive PCR date
PARAMCD IN (
"COVIDA" (COVID-19 per Adjudication),
"COVIDSVA" (Severe COVID-19 per Adjudication)
) 		COVID-19, or Severe COVID-19 per Adjudication integer DATE9
Derived
Set to CE.CESDTC where CECAT='ADJUDICATION' and (CESCAT in ('COVID-19', 'SEVERE COVID-19'))
PARAMCD = "COVIDSD" (COVID-19 (Secondary Definition)) COVID-19 (Secondary Definition) integer DATE9
Derived
Set to the later date of the following two dates: 1. Date of positive PCR test (MB.MBDTC) that meets derivation of PARAM = 'COVID-19 (Secondary Definition)' 2. Date of eligible symptom(s), defined as earliest ADSYMP.ADT of the 1st eligible symptom that occurred within +/-14 days window of positive PCR date
PARAMCD = "COVIDSEV" (Severe COVID-19) Severe COVID-19 integer DATE9
Derived
Set to the later date of the following dates: 1. ADT where PARAMCD = 'COVID' 2. Earliest date of first eligible severe symptom, defined as below: a. ADSYMP.ASTDT where ADSYMP.PARAMCD in ('RR30', 'HR125', 'OXYGEN93', 'PAO2F300', 'RF', 'ARDS', 'S90D60', 'VASOPRES', 'ARDYSF', 'HEPDYSF', 'NEURDYSF', 'ICU') with -14/+28 days window of positive PCR date. If ADSYMP.ASTDT is missing or < PCRDT-14 and ADSYMP.AENDT is within the window, use PCRDT-14 as the start date. Use ADSYMP.ADT when ADSYMP.ASTDT and ADSYMP.AENDT are missing b. ADSYMP.ADT where ADSYMP.PARAMCD = 'O2SAT93' with -14/+28 days window of positive PCR date c. ADSL.DTHDT if subject exists in AE with AE.AESDTH = 'Y' and SUPPAE.QNAM = 'AECVDIAG' and QVAL = 'Y' and ADSL.DTHDT within -14/+28 days window of positive PCR date
PARAMCD = "COVIDS" (COVID-19 (Considering Scheduled RT-PCR)) COVID-19 (Considering Scheduled RT-PCR) integer DATE9
Derived
Set to the later date of the following two dates: 1. Date of positive PCR test, ie, MB.MBDTC that meets derivation of PARAM = 'COVID-19 (Considering Scheduled RT-PCR)' 2. Earliest date from following symptom date: Systemic symptoms: earliest ADSYMP.ADT of the 2nd eligible systemic symptom that occurred within +/-14 days window of positive PCR date Respiratory symptom: earliest ADSYMP.ADT (use ADSYMP.ASTDT for PARAMCD 'CEPNEU' and 'REPNEU' and use ADSYMP.ADT when ADSYMP.ASTDT is missing) of the 1st eligible respiratory symptom that occurred within +/-14 days window of positive PCR date
PARAMCD = "COVIDSVS" (Severe COVID-19 (Considering Scheduled RT-PCR)) Severe COVID-19 (Considering Scheduled RT-PCR) integer DATE9
Derived
Set to the later date of the following dates: 1. ADT where PARAMCD = 'COVIDS' 2. Earliest date of first eligible severe symptom, defined as below: a. ADSYMP.ASTDT where ADSYMP.PARAMCD in ('RR30', 'HR125', 'OXYGEN93', 'PAO2F300', 'RF', 'ARDS', 'S90D60', 'VASOPRES', 'ARDYSF', 'HEPDYSF', 'NEURDYSF', 'ICU') with -14/+28 days window of positive PCR date. If ADSYMP.ASTDT is missing or < PCRDT-14 and ADSYMP.AENDT is within the window, use PCRDT-14 as the start date. Use ADSYMP.ADT when ADSYMP.ASTDT and ADSYMP.AENDT are missing b. ADSYMP.ADT where ADSYMP.PARAMCD = 'O2SAT93' with -14/+28 days window of positive PCR date c. ADSL.DTHDT if subject exists in AE with AE.AESDTH = 'Y' and SUPPAE.QNAM = 'AECVDIAG' and QVAL = 'Y' and ADSL.DTHDT within -14/+28 days window of positive PCR date
PARAMCD = "INFECT" (SARS-CoV-2 Infection Regardless of Symptomatology or Severity) SARS-CoV-2 Infection Regardless of Symptomatology or Severity integer DATE9
Derived
Set to earlier date of: 1. Date of positive PCR test, ie, MB.MBDTC that meets derivation of PARAM = "SARS-CoV-2 Infection Regardless of Symptomatology or Severity". 2. Date of seroconversion due to infection, ie, ADIS.ADT where CRIT5FL = "Y".
PARAMCD = "COVIDSDS" (COVID-19 (Secondary Definition and Considering Scheduled RT-PCR)) COVID-19 (Secondary Definition and Considering Scheduled RT-PCR) integer DATE9
Derived
Set to the later date of the following two dates: 1. Date of positive PCR test (MB.MBDTC) that meets derivation of PARAM = 'COVID-19 (Secondary Definition and Considering Scheduled RT-PCR)' 2. Date of eligible symptom(s), defined as earliest ADSYMP.ADT of the 1st eligible symptom that occurred within +/-14 days window of positive PCR date
PARAMCD = "ASYMPINA" (Asymptomatic SARS-CoV-2 Infection per Adjudication) Asymptomatic SARS-CoV-2 Infection per Adjudication integer DATE9
Derived
Set to earlier date of: 1. Date of positive PCR test (MB.MBDTC) meets derivation of PARAM = 'Asymptomatic SARS-CoV-2 Infection per Adjudication' 2. Date of seroconversion due to infection (ADIS.ADT) where CRIT5FL = 'Y' and VISIT doesn't contain 'UNSCH' or 'ILLNESS' or 'CONVALESCENCE'
PARAMCD = "ASYMPINF" (Asymptomatic SARS-CoV-2 Infection) Asymptomatic SARS-CoV-2 Infection integer DATE9
Derived
Set to earlier date of: 1. Date of positive PCR test, ie, MB.MBDTC that meets derivation of PARAM = "Asymptomatic SARS-CoV-2 Infection"; 2. Date of seroconversion due to infection, ie, ADIS.ADT where CRIT5FL = "Y" and VISIT doesn't contain 'UNSCH' or 'ILLNESS' or 'CONVALESCENCE' in upper case.
PARAMCD = "DEATHCVD" (Death Caused by COVID-19) Death Caused by COVID-19 integer DATE9
Derived
Set to ADSL.DTHDT due to COVID-19
ADY Analysis Relative Day integer 8
Derived
Set to ADT - ADSL.TR01SDT + 1 if ADT is on or after ADSL.TR01SDT Set to ADT - ADSL.TR01SDT if ADT is before ADSL.TR01SDT
APERIOD Period integer 8
Derived
Set to 2 if ADT>=AP02SDT>Missing, Otherwise, Set to 1
AVISIT Analysis Visit text 60
Derived
Only apply for PARAMCD in ('ASYMPINF, 'ASYMPINA'): 1. Use MB.VISIT of the RT-PCR result in below derivation if the case is derived based on positive RT-PCR only 2. Use ADIS.AVISIT of the seroconversion if the case is derived based on seroconversion only 3. Use MB.VISIT in below derivation if the case is derived based on both positive RT-PCR and seroconversion If ADY>1, Set to 'Day xx' part of VISIT for VISITNUM=6, 10, 15, 21, 32, Set to VISIT for VISIT = 'Participant Decision Visit / OL-D1', Set to 'Open Label Day 29' if VISIT = 'OL-D29', Set to 'Open Label Day 57' if VISIT = 'OL-D57', Set to null if other PARAMCD,
AVISITN Analysis Visit (N) integer 8 Efficacy Analysis Visit Code

[8 Terms]

Assigned
PARCAT1 Parameter Category 1 text 50
Derived
Set to 'DERIVED PER ADJUDICATION' if PARAMCD in ('COVIDA', 'COVIDSVA', 'ASYMPINA'), otherwise, Set to 'DERIVED PER SAP'
PARAMCD Parameter Code text 8 Covid-19 Symptom Analysis Parameter Code

[12 Terms]

Assigned
PARAMVLM Parameter text 200
PARAMCD = "COVID" (COVID-19) COVID-19 text 100
Derived
Create a record for PARAM = 'COVID-19' for each positive RT-PCR if following conditions are met: 1. RT-PCR is positive (MB.MBTESTCD='SARSCOV2' and MB.MBSTRESC is in ('DETECTED' or ‘POSITIVE’) after first dose (MB.MBDTC > ADSL.TR01SDT (non-missing)) and VISIT is not in ('Visit 2 Day 29', 'Participant Decision Visit / OL-D1') ) 2. if symptom(s) occurred within +/-14 days window of positive PCR date (symptom event found from ADSYMP where ADSYMP.AVALC=Y and MB.MBDTC-14 <= ADSYMP.ADT <= MB.MBDTC+14): (a) at least two systemic symptom events found from ADSYMP where PARAMCD in ('FEVER', 'CHILLS', 'MYALGIA'/'BODYACHE', 'HEADACHE', 'STHROAT', 'NLSMELL'/'NLTASTE') where 'NLSMELL' and/or 'NLTASTE' are considered as one symptom, 'MYALGIA' and/or 'BODYACHE' are considered as one symptom, or (b) at least one respiratory symptom event found from ADSYMP where PARAMCD in ('COUGH', 'SHBREATH', 'DIBREATH', 'CEPNEU', 'REPNEU'). For 'CEPNEU' and 'REPNEU', use ADSYMP.ASTDT in place of ADSYMP.ADT and use ADSYMP.ADT when ADSYMP.ASTDT is missing
PARAMCD = "COVIDS" (COVID-19 (Considering Scheduled RT-PCR)) COVID-19 (Considering Scheduled RT-PCR) text 100
Derived
Create a record for PARAM = 'COVID-19 (Considering Scheduled RT-PCR)' if following conditions are met: 1. RT-PCR is positive (MB.MBTESTCD='SARSCOV2', MB.MBSTRESC is in ('DETECTED', ‘POSITIVE) after first dose (MB.MBDTC > ADSL.TR01SDT (non-missing))) 2. if symptom(s) occurred within +/-14 days window of positive PCR date (symptom event found from ADSYMP where ADSYMP.AVALC=Y and MB.MBDTC-14 <= ADSYMP.ADT <= MB.MBDTC+14): (a) at least two systemic symptom events found from ADSYMP where PARAMCD in ('FEVER', 'CHILLS', 'MYALGIA'/'BODYACHE', 'HEADACHE', 'STHROAT', 'NLSMELL'/'NLTASTE') where 'NLSMELL' and/or 'NLTASTE' are considered as one symptom, 'MYALGIA' and/or 'BODYACHE' are considered as one symptom, or (b) at least one respiratory symptom event found from ADSYMP where PARAMCD in ('COUGH', 'SHBREATH', 'DIBREATH', 'CEPNEU', 'REPNEU'). For 'CEPNEU' and 'REPNEU', use ADSYMP.ASTDT in place of ADSYMP.ADT and use ADSYMP.ADT when ADSYMP.ASTDT is missing
PARAMCD = "COVIDA" (COVID-19 per Adjudication) COVID-19 per Adjudication text 100
Derived
Create a record for PARAM = 'COVID-19 per Adjudication' if subject has SUPPCE.QVAL containing 'EVENT MEETS THE CHARTER DEFINITION OF COVID-19' where QNAM='CEREASOC'
PARAMCD = "COVIDSD" (COVID-19 (Secondary Definition)) COVID-19 (Secondary Definition) text 100
Derived
Create record for PARAM = 'COVID-19' for each RT-PCR is Positive (Secondary Definition)' if following conditions are met: 1. Select all subjects where RT-PCR is Positive (MB.MBSTRESC=DETECTED or POSITIVE due to prompt symptom) after First Dose (MBDTC>ADSL.TR01SDTC) and VISIT is not 'VISIT 2 Day 29' or 'Participant Decision Visit / OL-D1' 2. If a systemic symptom occurred within +/-14 days window of date with detected /positive as test result (a) any systemic symptom event found from ADSYMP where PARAMCD in ('FEVER', 'CHILLS', 'COUGH', 'SHBREATH', 'DIBREATH', 'FATIGUE', 'MYALGIA', 'BODYACHE', 'HEADACHE', 'NLTASTE', 'NLSMELL', 'STHROAT', 'NASALCON', 'RUNNOSE', 'NAUSEA', 'VOMIT', 'DIARRHEA')
PARAMCD = "COVIDSDS" (COVID-19 (Secondary Definition and Considering Scheduled RT-PCR)) COVID-19 (Secondary Definition and Considering Scheduled RT-PCR) text 100
Derived
Create a record for PARAM = 'COVID-19 (Secondary Definition and Considering Scheduled RT-PCR)' for each positive RT-PCR test after first dose if at least one systemic symptom occurred within +/-14 days window of positive PCR date: ADSYMP.PARAMCD in ('FEVER', 'CHILLS', 'COUGH', 'SHBREATH', 'DIBREATH', 'FATIGUE', 'MYALGIA', 'BODYACHE', 'HEADACHE', 'NLTASTE', 'NLSMELL', 'STHROAT', 'NASALCON', 'RUNNOSE', 'NAUSEA', 'VOMIT', 'DIARRHEA') and ADSYMP.AVALC=Y and MB.MBDTC-14 <= ADSYMP.ADT <= MB.MBDTC+14
PARAMCD = "COVIDSEV" (Severe COVID-19) Severe COVID-19 text 100
Derived
Create record for PARAM='Severe COVID-19' if following conditions are met: 1. Subject with PARAMCD='COVID', 2. At least one severe symptom (a) or (b) occurred within -14/+28 days window of positive PCR date (a) ADSYMP.PARAMCD in ('RR30', 'HR125', 'OXYGEN93', 'O2SAT93', 'PAO2F300', 'RF', 'ARDS', 'S90D60', 'VASOPRES', 'ARDYSF', 'HEPDYSF', 'NEURDYSF', 'ICU') and ADSYMP.AVALC='Y' and ((PCRDT-14 <= (ADT, ASTDT, or AENDT) <= PCRDT+28) or (ASTDT < PCRDT-14 and AENDT > PCRDT+28)), (b) AE.AESDTH = 'Y' and SUPPAE.QNAM = 'AECVDIAG' and QVAL = 'Y' and PCRDT-14 <= ADSL.DTHDT <= PCRDT+28
PARAMCD = "COVIDSVA" (Severe COVID-19 per Adjudication) Severe COVID-19 per Adjudication text 100
Derived
Create a record for PARAM = 'Severe COVID-19 per Adjudication' if subject has SUPPCE.QVAL containing 'EVENT MEETS THE CHARTER DEFINITION OF SEVERE COVID-19' where QNAM='CEREASOC'
PARAMCD = "COVIDSVS" (Severe COVID-19 (Considering Scheduled RT-PCR)) Severe COVID-19 (Considering Scheduled RT-PCR) text 100
Derived
Create record for PARAM='Severe COVID-19 (Considering Scheduled RT-PCR)' if following conditions are met: 1. Subject with PARAMCD='COVIDS' and AVALC = 'Y' 2. At least one severe symptom occurred within -14/+28 days window of positive PCR date (a) ADSYMP.PARAMCD in ('RR30', 'HR125', 'OXYGEN93', 'PAO2F300', 'RF', 'ARDS', 'S90D60', 'VASOPRES', 'ARDYSF', 'HEPDYSF', 'NEURDYSF', 'ICU') and ADSYMP.AVALC='Y' and (PCRDT-14 <= ADSYMP.ASTDT<= PCRDT+28, or PCRDT-14 <= ADSYMP.AENDT<= PCRDT+28, or (ADSYMP.ASTDT < PCRDT-14 and ADSYMP.AENDT > PCRDT+28), use PCRDT-14 <= ADSYMP.ADT<= PCRDT+28 when ADSYMP.ASTDT and ADSYMP.AENDT are missing) (b) ADSYMP.PARAMCD = 'O2SAT93' and ADSYMP.AVALC='Y' and PCRDT-14 <= ADSYMP.ADT<= PCRDT+28 (c) AE.AESDTH = 'Y' and SUPPAE.QNAM = 'AECVDIAG' and QVAL = 'Y' and PCRDT-14 <= ADSL.DTHDT <= PCRDT+28
PARAMCD = "INFECT" (SARS-CoV-2 Infection Regardless of Symptomatology or Severity) Asymptomatic SARS-CoV-2 Infection text 100
Derived
Create a record for PARAM = 'Asymptomatic SARS-CoV-2 Infection' and AVALC = 'Y' if no prior COVID-19 symptoms (no record created with PARAMCD='COVIDS' or 'COVIDSDS' and AVALC = 'Y' and ADT on/before the earlier date of 1 and 2) and at least one of the following criteria is met: 1. has positive RT-PCR test at Day 29 or participant decision visit (ie, MB.MBTESTCD='SARSCOV2', MB.MBSTRESC is in ('DETECTED', 'POSITIVE') and VISIT in ('Visit 2 Day 29', 'Participant Decision Visit / OL-D1') 2. has seroconversion due to infection (ADIS.CRIT5FL = 'Y' and VISIT doesn't contain 'UNSCH' or 'ILLNESS' or 'CONVALESCENCE')
PARAMCD = "ASYMPINA" (Asymptomatic SARS-CoV-2 Infection per Adjudication) Asymptomatic SARS-CoV-2 Infection per Adjudication text 100
Derived
Create a record for PARAM = 'Asymptomatic SARS-CoV-2 Infection per Adjudication' and AVALC = 'Y' if no prior COVID-19 symptoms (no record created with PARAMCD='COVIDA' or 'COVIDSDS' and AVALC = 'Y' and ADT on/before the earlier date of 1 and 2) and at least one of the following criteria is met: 1. has positive RT-PCR test at Day 29 or participant decision visit (MB.MBTESTCD='SARSCOV2' and MB.MBSTRESC is in ('DETECTED', ‘POSITIVE') and VISIT = 'Visit 2 Day 29' or 'Participant Decision Visit / OL-D1') 2. has seroconversion due to infection (ADIS.CRIT5FL = 'Y' and VISIT doesn't contain 'UNSCH' or 'ILLNESS' or 'CONVALESCENCE')
PARAMCD = "ASYMPINF" (Asymptomatic SARS-CoV-2 Infection) SARS-CoV-2 Infection Regardless of Symptomatology or Severity text 100
Derived
Create a record for PARAM = 'SARS-CoV-2 Infection Regardless of Symptomatology or Severity' if at least one of the following criteria is met: 1. has seroconversion due to infection (ADIS.CRIT5FL = 'Y') 2. has positive RT-PCR test after first dose (MB.MBTESTCD='SARSCOV2', MB.MBSTRESC is in ('DETECTED', 'POSITIVE’) and MB.MBDTC > ADSL.TR01SDT (non-missing)
PARAMCD = "DEATHCVD" (Death Caused by COVID-19) Death Caused by COVID-19 text 100
Derived
Create a record for PARAM = 'Death Caused by COVID-19' if subject has AE.AESDTH = 'Y' and SUPPAE.QNAM = 'AECVDIAG' and QVAL = 'Y' and ADSL.DTHDT is non-missing
AVALC Analysis Value (C) text 50
Derived
Set to 'Y'
PCRDT Date of Positive RT-PCR integer DATE9
Derived
See derivation of PARAM. For PARAMCD = "COVID", "COVIDSD", "COVIDS", "COVIDSDS", set to the date of positive PCR test that meets derivation of corresponding PARAM; For PARAMCD = "COVIDSEV", set to the date of positive PCR test where PARAMCD = "COVID"; For PARAMCD = "COVIDSVS", set to the date of positive PCR test where PARAMCD = "COVIDS"; For PARAMCD = "INFECT", "ASYMPINF", or "ASYMPINA", set to null if PARAM is created based on seroconversion only (not based on positive RT-PCR), else set to the date of PCR test that meets derivation of corresponding PARAM; For PARAMCD = "DEATHCVD", set to the date of most recent post-baseline positive PCR if available (MB.MBDTC where MB.MBTESTCD="SARSCOV2", MB.MBSTRESC is "DETECTED" or "POSITIVE" in upper case, and MBDTC > ADSL.TR01SDT (non-missing)). Otherwise, null.
PCRD29FL Flag for Case Using Positive D29 RT-PCR text 1
Derived
Set to 'Y' if the case is derived using positive RT-PCR at Day 29 ( MB.MBTESTCD = 'SARSCOV2', MB.MBSTRESC is in ('DETECTED' or 'POSITIVE' ), MB.VISIT = 'Visit 2 Day 29', and MB.MBDTC=PCRDT (non-missing)
EVIDINF Evidence for Infection text 15
Derived
For PARAMCD = 'INFECT', 'ASYMPINF', or 'ASYMPINA' Set to 'Virology' if the case is derived based on positive RT-PCR only, Set to 'Serology' if the case is derived based on seroconversion only, Set to 'Virology and Serology' if the case is derived based on both positive RT-PCR and seroconversion
ANL01FL Analysis Flag 01 text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' for the record with AVALC = 'Y' and earliest ADT per PARAMCD
EUAVACFL Post-EUA Off-Study Vaccine Flag text 1 Yes Flag
  • • "Y"
Derived
See ADSL.EUAVACDT from ADaM-Variable-Definition.pdf

Additional ADaM Variable Definition

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BOD/BOI Score Analysis Dataset (ADEFF2)

ADEFF2 (BOD/BOI Score Analysis Dataset) - BASIC DATA STRUCTURE Location: adeff2.xpt
Variable Where Condition Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
RANDDT Date of Randomization integer DATE9.
Predecessor: ADSL.RANDDT
ADTVLM Analysis Date integer DATE9.
PARAMCD IN (
"BOD28D"
) 		Analysis Date integer 8
Derived
Set to the first ADEFF.ADT where PARAMCD = 'COVIDA' and APERIOD = 1 and . < ADT <= EFFCODT per USUBJID, Set to missing, otherwise
PARAMCD IN (
"BOI28D"
) 		Analysis Date integer 8
Derived
Set to the first ADEFF.ADT where PARAMCD='COVIDA' and APERIOD = 1 and . < ADT <= EFFCODT, Set to ADEFF.ADT where PARAMCD = 'ASYMPINF' and APERIOD = 1 and . < ADT <= EFFCODT if ADEFF.ADT where PARAMCD='COVIDA' per USUBJID is missing, Set to missing, otherwise
PARAMCD Parameter Code text 8
Assigned

BOD7D if PARAM = 'Burden of Disease Score in 7 Days', BOI7D if PARAM = 'Burden of Infection Score in 7 Days', BOD28D if PARAM = 'Burden of Disease Score in 28 Days', BOI28D if PARAM = 'Burden of Infection Score in 28 Days'
PARAM Parameter text 40 BOD/BOI Score Analysis Parameter Code
  • • "BOD7D" = "Burden of Disease Score in 7 Days"
  • • "BOD28D" = "Burden of Disease Score in 28 Days"
  • • "BOI7D" = "Burden of Infection Score in 7 Days"
  • • "BOI28D" = "Burden of Infection Score in 28 Days"
Assigned

Assign 'Burden of Disease Score in 7 Days', 'Burden of Infection Score in 7 Days', 'Burden of Disease Score in 28 Days', and 'Burden of Infection Score in 28 Days' to each subject who is in ADSL.
AWRANGEVLM Analysis Window Valid Relative Range text 40
PARAMCD IN (
"BOD28D"
) 		Burden of Disease Score text 40
Derived
Set EVENTMO = ADT - RANDDT+1)/30.4375 and create # of records per USUBJID per PARAMCD based on EVENTMO: Create 4 records if EVENTMO >= 18: AWRANGE = 'Randomization through 6 Months', ' After 6 Months through 12 Months', ' After 12 Months through 18 Months', ' After 18 Months through Completion' Create 3 records if EVENTMO >= 12: AWRANGE = 'Randomization through 6 Months', ' After 6 Months through 12 Months', ' After 12 Months through 18 Months' Create 2 records if EVENTMO >= 6: AWRANGE = 'Randomization through 6 Months', ' After 6 Months through 12 Months' Create 1 records, otherwise: AWRANGE = 'Randomization through 6 Months'
PARAMCD IN (
"BOI28D"
) 		Burden of Infection Score text 40
Derived
Set EVENTMO = ADT - RANDDT+1)/30.4375 and create # of records per USUBJID per PARAMCD based on EVENTMO: Create 5 records If EVENTMO >=13 or ADT is missing: AWRANGE= 'Baseline through Month 1', 'After Month 1 through Month 2', 'After Month 2 through Month 7', 'After Month 7 through Month 13', and 'After Month 13 through Month 25' Create 4 records if EVENTMO >=7: AWRANGE= 'Baseline through Month 1', 'After Month 1 through Month 2', 'After Month 2 through Month 7', and 'After Month 7 through Month 13' Create 3 records if EVENTMO >=2: AWRANGE='Baseline through Month 1', 'After Month 1 through Month 2', and 'After Month 2 through Month 7' Create 2 records if EVENTMO >=1: AWRANGE = 'Baseline through Month 1' and 'After Month 1 through Month 2'. Create 1 record, otherwise: AWRANGE = 'Baseline through Month 1'
AWRANGENVLM Analysis Window Valid Relative Range (N) integer 8
PARAMCD IN (
"BOD28D"
) 		Burden of Disease Score integer 8
Derived
Set to 1 if AWRANGE='Randomization through 6 Months'; Set to 2 if AWRANGE='After 6 Months through 12 Months'; Set to 3 if AWRANGE='After 12 Months through 18 Months'; Set to 4 if AWRANGE='After 18 Months through Completion';
PARAMCD IN (
"BOI28D"
) 		Burden of Infection Score integer 8
Derived
Set to 1 if AWRANGE='Baseline through Month 1'; Set to 2 if AWRANGE='After Month 1 through Month 2'; Set to 3 if AWRANGE='After Month 2 through Month 7'; Set to 4 if AWRANGE='After Month 7 through Month 13'; Set to 5 if AWRANGE='After Month 13 through Month 25';
AVALVLM Analysis Value float 8
PARAMCD IN (
"BOD28D"
) 		Burden of Disease Score integer 8
Derived
For PARAMCD = “BOD7D”: Set to 0 if EVENTMO > AWRANGEN or ADT=missing Set to 3 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' and not missing (ADSL.DTHDT) and (DTHDT - ADT + 1) <= 7. Set to 2 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' and USUBJID is in HO and 1 <= (any non-missing numeric HO.HOSTDTC – ADT + 1) <= 7 Set to 1 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' For PARAMCD = “BOD28D”: Set to 0 if EVENTMO > AWRANGEN or ADT=missing Set to 3 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' and not missing (ADSL.DTHDT) and (DTHDT - ADT + 1) <= 28. Set to 2 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' and USUBJID is in HO and 1 <= (any non-missing numeric HO.HOSTDTC – ADT + 1) <= 28 Set to 1 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA'
PARAMCD IN (
"BOI28D"
) 		Burden of Infection Score float 8
Derived
For PARAMCD = “BOI7D”: Set to 0 if EVENTMO > AWRANGEN or ADT=missing Set to 3 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' and not missing (ADSL.DTHDT) and (DTHDT-ADT+1) <= 7. Set to 2 if ADEFF.AVALC = 'Y' where PARAMCD='COVIDA' and USUBJID is in HO and 1<=(any non-missing numeric HO.HOSTDTC - ADT + 1) <= 7 Set to 1 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' Set to 0.5 if ADEFF.AVALC = 'Y' where PARAMCD = 'ASYMPINF' For PARAMCD = “BOI28D”: Set to 0 if EVENTMO > AWRANGEN or ADT=missing Set to 3 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' and not missing (ADSL.DTHDT) and (DTHDT-ADT+1) <= 28 Set to 2 if ADEFF.AVALC = 'Y' where PARAMCD='COVIDA' and USUBJID is in HO and 1<=(any non-missing numeric HO.HOSTDTC - ADT + 1) <= 28 Set to 1 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' Set to 0.5 if ADEFF.AVALC = 'Y' where PARAMCD = 'ASYMPINF'
ANL01FLVLM Analysis Flag 01 text 1
PARAMCD IN (
"BOD28D"
) 		Burden of Disease Score text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' to the record with maximum of AVAL where paramcd = BOD28D per USUBJID
PARAMCD IN (
"BOI28D"
) 		Burden of Infection Score text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' to the record with maximum of AVAL where paramcd = BOI28D per USUBJID

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Symptom Score Analysis Dataset (ADEFF3)

ADEFF3 (Symptom Score Analysis Dataset) - BASIC DATA STRUCTURE Location: adeff3.xpt
Variable Where Condition Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
COVIDADT Date of COVID-19 per Adjudication integer DATE9.
Derived
Set to first ADEFF.ADT where PARAMCD='COVIDA' and APERIOD = 1 and . < ADT <= EFFCODT per subject
ADT Analysis Date integer DATE9.
Derived
Step 1: Convert date part of FADTC to numeric if source data are from FAEF Convert date part of VSDTC to numeric if source data are from VS Step 2: Keep all records that occurred on or after COVID-19 (ADT from step 1 >= COVIDADT)
ARELTPTN Analysis Relative Timepoint (N) integer 8
Derived
Set to ADT - COVIDADT + 1
ARELTPT Analysis Relative Timepoint text 20
Derived
Set to 'Day ' || ARELTPTN
ARELTPG1 Pooled Analysis Relative Timepoint 1 text 100
Derived
Set to '<= 14 Days after COVID-19 Onset Date' if 1 <= ARELTPTN <= 15 Set to '> 14 Days after COVID-19 Onset Date' if ARELTPTN > 15
ARELTG1N Pooled Analysis Relative Timepoint 1 (N) integer 8
Assigned
ARELTPG2 Pooled Analysis Relative Timepoint 2 text 100
Derived
Set to '<= 28 Days after COVID-19 Onset Date' if 1 <= ARELTPTN <= 29 Set to '> 28 Days after COVID-19 Onset Date' if ARELTPTN > 29
ARELTG2N Pooled Analysis Relative Timepoint 1 (N) integer 8
Assigned
PARCAT1 Parameter Category 1 text 50
Derived
Set to 'Oxygen Saturation or Temperature' if PARAMCD = 'TEMP' or 'OXYSAT' Set to 'Non Oxygen Saturation and Temperature'
PARCAT1N Parameter Category 1 (N) integer 8
Assigned
PARAMCD Parameter Code text 8
Assigned
PARAM Parameter text 50 Symptom Score Analysis Parameter Code

[18 Terms]

Derived
Set to VS.VSTEST || ' ( ||VSSTRESU|| ')' if source data from VS. Please add space between VSTEST and VSSTRESU Set to FAEF.FAOBJ if source data from FAEF. If FAOBJ='Myalgia', re-code it as 'Muscle Aches (Myalgia)' and if FAOBJ='Rhinorrhea', re-code it as 'Runny Nose (Rhinorrhea)'
AVALVLM Analysis Value float 5
PARAMCD IN (
"TEMP",
"OXYSAT"
) 		Oxygen Saturation or Temperature float 5
Derived
Set to VS.VSSTRESN
PARAMCD NOT IN (
"TEMP",
"OXYSAT"
) 		Non Oxygen Saturation and Temperature integer 8
Derived
Set to 0 if AVALC = 'NONE' 1 if AVALC = 'MILD' 2 if AVALC = 'MODERATE' 3 if AVALC = 'SEVERE'
AVALCVLM Analysis Value (C) text 50
PARAMCD IN (
"TEMP",
"OXYSAT"
) 		Oxygen Saturation or Temperature text 20
Derived
Set to Null
PARAMCD NOT IN (
"TEMP",
"OXYSAT"
) 		Non Oxygen Saturation and Temperature text 20
Derived
Set to FAEF.FASTRESC
HOSPFL Hospitalization Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' per subject (USUBJID) if HO.HOOCCUR = 'Y' and .z < COVIDADT <= HOSTDTC where HOTERM = 'HOSPITAL' or 'ADMITTED TO ICU'
AGAPFL Analysis Symptom Gap Flag text 1 Yes Flag
  • • "Y"
Derived
1) Sort the data by subject (SUBJID) and ADT 2) Set to 'Y' if ADT - last ADT > 28 and set 'Y' to all records on or after the ADT per subject
ANL01FL Analysis Flag 01 text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if HOSPFL ne 'Y' and ARELTG2N = 1 and AGAPFL ne 'Y'
FASYMPFL First Any Symptom Occur Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' to the first ADT where PARAMCD ne (TEMP or OXYSAT) and AVAL > 0
SRCDOM Source Data text 6
Derived
Set to 'FAEF' if source data are from FAEF Set to 'VS' if source data are from VS
SRCSEQ Source Sequence Number integer 8
Derived
FAEF.FASEQ if source data are from FAEF VS.VSSEQ if source data are from VS
SRCVAR Source Variable text 6
Derived
Set to 'FASTRESC' if source data are from FAEF Set to 'VSSTRESN' if source data are from VS

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Immunogenicity Analysis Dataset (ADIS)

ADIS (Immunogenicity Analysis Dataset) - BASIC DATA STRUCTURE Location: adis.xpt
Variable Where Condition Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
TRTA Actual Treatment text 50
Derived
If ADTM>TR01SDTM>. and (ADTM<=DOS2DTM or TR01SDTM is the last dose date time): Set to 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 1', Set to 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'Day 1' If ADTM> ADSL.DOS2DTM>. and (ADTM<ADSL.TR02SDTM or ADSL.DOS2DTM is the last dose date time): Set to 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 29', Set to 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'Day 29' If ADTM >ADSL.TR02SDTM>. and (ADTM<ADSL.OLDO2DTM or TR02SDTM is the last dose date time): Set to 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'OL-D1', Set to 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'OL-D1' If .<ADSL.OLDO2DTM<=ADTM: Set to 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'OL-D29', Set to 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'OL-D29' Note: If time part of ADTM, TR01SDTM, DOS2DTM, TR02SDTM, or OLDO2DTM is missing, use ADT, TR01SDT, DOSE2DT, TR02SDT, and OLDOS2DT to replace ADTM, TR01SDTM, DOS2DTM, TR02SDTM, and OLDO2DTM, respectively
TRTAN Actual Treatment (N) integer 8 Actual Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Assigned

1 if TRTA='Placebo', 2 if TRTA='mRNA-1273'
ISSEQ Sequence Number integer 8
Predecessor: IS.ISSEQ
ISDTC Date/Time of Collection datetime ISO 8601
Predecessor: IS.ISDTC
ADT Analysis Date integer DATE9
Derived
Convert date part of IS.ISDTC to numeric
ATM Analysis Time integer TIME5
Derived
Convert time part of IS.ISDTC to numeric
ADTM Analysis Datetime integer DATETIME20
Derived
Convert IS.ISDTC to numeric
ADY Analysis Relative Day integer 8
Derived
Set to ADT - ADSL.TR01SDT if ADT is before ADSL.TR01SDT, otherwise, Set to ADT - ADSL.TR01SDT + 1 if ADT is on or after ADSL.TR01SDT
APERIOD Period integer 8
Derived
Set to 2 if ADT>=AP02SDT>Missing, Otherwise, Set to 1
VISIT Visit Name text 100
Predecessor: IS.VISIT
VISITNUM Visit Number float 8
Predecessor: IS.VISITNUM
AVISIT Analysis Visit text 50
Derived
See ADIS.AVISIT from Additional ADaM Variable Definition Doc.

Additional ADaM Variable Definition

AVISITN Analysis Visit (N) integer 8
Assigned
ATPT Analysis Timepoint text 20
Derived
Set to 'Day x' If AVISIT='Illness Visit Day x' or 'Illness Visit y Day x' (See ADIS.AVISIT from Additional ADaM Variable Definition Doc). Otherwise, set to null

Additional ADaM Variable Definition

ATPTN Analysis Timepoint (N) float 8
Assigned
PARCAT1 Parameter Category 1 text 50
Derived
Set to IS.ISCAT
PARCAT2 Parameter Category 2 text 50
Derived
Set to 'Keep Actual Values Beyond ULOQ' if PARAMCD ne 'SARSCOV2'
PARAMCD Parameter Code text 8
Derived
Set to ISTESTCD and create follow PARAMCDs if AVAL is not missing and PARAM ne 'Elecsys SARS Cov-2 assay': L10PVN50, L10PVN80, L10MN50, LV65IGGS, LV66IGGN, LS2PIGG, LRBDIGG, LNPIGG
PARAM Parameter text 50 Immunogenicity Analysis Dataset Parameter Code

[15 Terms]

Derived
For PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies', Set to ISTEST For PARCAT1='Serum SARS-CoV-2 Binding Antibodies': Set to ISTEST " (" ||ISSTRESU|| ")" if PARAMCD does not contain 'L10' and ISSTRESU is non-missing, or ISTEST if ISSTRESU is not available for the test If PARAMCD contains 'L10' then assign PARAM based on PARAMCD: Set to 'LOG10(PsVNT50)' if PARAMCD='L10PVN50' Set to 'LOG10(PsVNT80)' if PARAMCD='L10PVN80' Set to 'LOG10(MN50)' if PARAMCD='L10MN50' Set to 'LOG10(VAC65 Spike IgG Antibody)' if PARAMCD='LV65IGGS' Set to 'LOG10(VAC66 Nucleocapsid IgG Antibody)' if PARAMCD='LV66IGGN' Set to 'LOG10(SARSCOV2S2P IgG Antibody)' if PARAMCD='LS2PIGG' Set to 'LOG10(SARSCOV2RBD IgG Antibody)' if PARAMCD='LRBDIGG' Set to 'LOG10(SARSCOV2NP IgG Antibody)' if PARAMCD='LNPIGG'.
PARAMTYP Parameter Type text 7
Derived
Set to 'DERIVED' if PARAMCD contains 'L10' or 'LV58' or 'LV65' or 'LV66'
AVALVLM Analysis Value float 20
PARAMCD IN (
"NPIGG",
"PSVNT50",
"PSVNT80",
"RBDIGG",
"S2PIGG",
"V65IGGS",
"V66IGGN"
) 		Original Antibody Test Results float 20
Derived
Set to 0.5 times ISLLOQ if ISSTRESC contains '<' or 'BQL' or ISSTRESN<ISLLOQ, Set to ISULQ if ISSTRSC contains ">", Set to IS.ISSTRESN, Otherwise
PARAMCD IN (
"L10PVN50",
"L10PVN80",
"LNPIGG",
"LRBDIGG",
"LS2PIGG",
"LV65IGGS",
"LV66IGGN"
) 		LOG10(Original Antibody Test Results) float 20
Derived
Set to LOG10(0.5* times ISLLOQ) if ISSTRESC contains '<' or 'BQL' or ISSTRESN<ISLLOQ, Set to LOG10(ISULOQ) if ISSTRESC contains '>', Set to LOG10(IS.ISSTRESN), Otherwise
PARAMCD = "SARSCOV2" Elecsys Sars Cov-2 assay float 20
Derived
Set to null
AVALC Analysis Value (C) text 20
Derived
Set to IS.ISSTRESC if PARAMCD='SARSCOV2'
BASE Baseline Value float 8
Derived
Set to AVAL where ABLFL = 'Y' for each SUBJID, PARCAT1 and PARAMCD
CHG Change from Baseline float 8
Derived
Set to AVAL - BASE for post-baseline records
R2BASE Ratio to Baseline float 8
Derived
Set to AVAL/BASE if both are available and BASE is not 0 for post-baseline records and baseline result does not contain '<' or 'BQL' or ISSTRESN<ISLLOQ
AWRANGE Analysis Window Valid Relative Range text 50
Assigned
AWTARGET Analysis Window Target integer 8
Assigned
AWTDIFF Analysis Window Diff from Target integer 8
Derived
Set to absolute value of (ADY - AWTARGET)
ABLFL Baseline Record Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' for the latest (ADT) non-missing AVAL on or before ADSL.TR01SDT for each SUBJID, PARCAT1 and PARAMCD. Use ADT and TR01SDT if time is not available
ANL01FL Analysis Flag 01 text 1 Yes Flag
  • • "Y"
Derived
If ABLFL='Y', then set to 'Y' For post-baseline assessments where AVISITN is non-missing and result (AVAL) is non-missing, per subject per parameter and per AVISIT: Within an AVISIT, set to ‘Y’ for the assessment at scheduled visit (i.e., VISIT doesn't contain "Unsched"). If there are 2 or more assessments at scheduled visit, set ‘Y’ to the latest assessment. If there are 2 or more assessments with non-missing AVAL on the latest assessment date, use the smaller AVAL, If there is no scheduled visit, set to 'Y' for the assessment closest to the target study day (record with minimum AWTDIFF) in the visit window. If there are 2 or more assessments equal distance to the target study day (AWTDIFFs are same), set to the latest assessment. If there are 2 or more assessments with non-missing AVAL on the latest assessment date, use the smaller AVAL
EUAVACFL Post-EUA Off-Study Vaccine Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if .< ADSL.EUAVACDT < ADT
CRIT1 Analysis Criterion 1 text 100
Derived
Set to '>=2-fold Increase from Baseline' if CRIT1FL='Y'
CRIT1FL Criterion 1 Evaluation Result Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if baseline result contains ('<', 'BQL') or ISSTRESN<ISLLOQ, and post-baseline >= 2 x ISLLOQ (AVAL>=2 * ISLLOQ) or baseline result does not contains ('<' , 'BQL') and not <ISLLOQ and post-baseline increase 2 times from the baseline value (R2BASE>=2)
CRIT2 Analysis Criterion 2 text 100
Derived
Set to '>=3-fold Increase from Baseline' if CRIT2FL='Y'
CRIT2FL Criterion 2 Evaluation Result Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if baseline result contains ('<', 'BQL') or ISSTRESN<ISLLOQ, and post-baseline >= 2 x ISLLOQ (AVAL>=3 * ISLLOQ) or baseline result does not contain ('<' , 'BQL') and not <ISLLOQ and post-baseline increase 3 times from the baseline value (R2BASE>=3)
CRIT3 Analysis Criterion 3 text 100
Derived
Set to '>=4-fold Increase from Baseline' if CRIT3FL='Y'
CRIT3FL Criterion 3 Evaluation Result Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if baseline result contains '<xxx' or ISSTRESN<ISLOD or ISSTRESN<ISLLOQ, and post-baseline >= 4 x ISLLOQ (AVAL>=4 * ISLLOQ) or baseline result does not contain '<' and not <ISLOD and not <ISLLOQ and post-baseline increase 4 times from the baseline value (R2BASE>=4)
CRIT4 Analysis Criterion 4 text 100
Derived
Set to 'Seroconversion Due to Vaccination' if CRIT4FL='Y'
CRIT4FL Criterion 4 Evaluation Result Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if baseline result ISSTRESC contains ('<', 'BQL') or ISSTRESN<ISLLOQ and post-baseline >= ISLLOQ, or baseline result does not contain ('<' , 'BQL') and not < ISLLOQ and post-baseline increase 4 times from the baseline value (R2BASE>=4)
CRIT5 Analysis Criterion 5 text 100
Derived
Set to 'Seroconversion Due to Infection if CRIT5FL='Y'
CRIT5FL Criterion 5 Evaluation Result Flag text 1
Derived
For ADSL.ELECSBL= 'Negative': Set to 'Y' if PARAMCD='SARSCOV2' and post-baseline ISSTRESC='Positive' For ADSL.ELECSBL = 'Positive': Set to 'Y' if PARAMCD='V66IGGEN' and post-baseline result increased 4 times from the baseline (R2BASE>=4)
CRIT6 Analysis Criterion 6 text 100
Derived
Set to 'Seroconversion' if CRIT6FL='Y'
CRIT6FL Criterion 6 Evaluation Result Flag text 1
Derived
Set to 'Y' if baseline result contains ('<', 'BQL') or ISSTRESN<ISLLOQ and post-baseline >= ISLLOQ (AVAL>=ISLLOQ) or baseline result does not contain ('<', 'BQL') and >= ISLLOQ and post-baseline increase x times from the baseline value (R2BASE>=x) where x=3.3 for PARAMCD='PSVNT50', x=2.3 for PARAMCD='PSVNT80', x=4.6 for PARAMCD='V65IGGS', x=1.9 for PARAMCD='S2PIGG', and x=4 for other PARAMCD
ISSTRESC Result or Finding in Standard Format text 50
Predecessor: IS.ISSTRESC
ISSTRESN Numeric Results/Findings in Std. Units float 20
Predecessor: IS.ISSTRESN
ISLLOQ Lower Limit of Quantitation float 8
Derived
SUPPIS.QVAL where QNAM is 'ISLLOQ'
ISULOQ Upper Limit of Quantification float 8
Derived
Set to SUPPIS.QVAL where QNAM is 'ISULOQ'
ISLOD Limit of Detection float 8
Derived
Set to SUPPIS.QVAL where QNAM is 'ISLOD'
ISNAM Vendor Name text 40
Predecessor: IS.ISNAM
ISSPEC Specimen Type text 25
Predecessor: IS.ISSPEC
ISMETHOD Method of Test or Examination text 40
Predecessor: IS.ISMETHOD
ISORNRLO Reference Range Lower Limit-Std Units text 20
Predecessor: IS.ISORNRLO
ISORNRHI Reference Range Upper Limit-Std Units text 20
Predecessor: IS.ISORNRHI
RANGE Range Indicator text 40
Derived
Set to SUPPIS.QVAL where QNAM is 'RANGE'
DTYPE Derivation Type text 20
Derived
Set to 'HALFLLOQ' if ISSTRESN<LLOQ or ISSTRESC contains '<' or 'BQL' Set to 'ULOQ' if ISSTRESC contains '>'

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Microbiology Analysis Dataset (ADMB)

ADMB (Microbiology Analysis Dataset) - BASIC DATA STRUCTURE Location: admb.xpt
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
MBSEQ Sequence Number integer 8
Predecessor: MB.MBSEQ
MBDTC Date/Time of Specimen Collection text 20
Predecessor: MB.MBDTC
MBMETHOD Method of Test or Examination text 40
Predecessor: MB.MBMETHOD
ADT Analysis Date integer DATE9
Derived
Convert date part of MB.MBDTC to numeric
ATM Analysis Time integer TIME5
Derived
Convert time part of MB.MBDTC to numeric
ADTM Analysis Datetime integer DATETIME20
Derived
Convert MB.MBDTC to numeric
ADY Analysis Relative Day integer 8
Derived
Set to ADT - ADSL.TR01SDT if ADT is before ADSL.TR01SDT Set to ADT - ADSL.TR01SDT + 1 if ADT is on or after ADSL.TR01SDT
APERIOD Period integer 8
Derived
Set to 2 if ADT>=AP02SDT>Missing, Otherwise, Set to 1
VISIT Visit Name text 100
Predecessor: MB.VISIT
VISITNUM Visit Number integer 8
Predecessor: MB.VISITNUM
MBTPT Planned Time Point Name text 40
Predecessor: MB.MBTPT
AVISIT Analysis Visit text 50
Derived
See ADMB.AVISIT from Additional ADaM Variable Difinition Doc.

Additional ADaM Variable Definition

AVISITN Analysis Visit (N) integer 8 Microbiology Analysis Visit Code

[10 Terms]

Assigned
ATPT Analysis Timepoint text 20
Derived
Set to MB.MBTPT if MB.MBTPT is not missing or Set ATPT='Day x' if original AVISIT='Illness Visit Day x' or 'Illness Visit y Day x'
ATPTN Analysis Timepoint (N) integer 8
Assigned
PARCAT1 Parameter Category 1 text 50 Microbiology Analysis Dataset Parameter Category
  • • "BIOFIRE"
  • • "SARS-CoV-2"
Derived
Set to MB.MBCAT
PARAMCD Parameter Code text 8 Microbiology Analysis Dataset Parameter Code

[23 Terms]

Derived
Set to MB.MBTESTCD
PARAM Parameter text 50
Derived
Set to MB.MBTEST
AVALC Analysis Value (C) text 50
Derived
Set to 'Negative' if upcase(MBSTRESC) is 'NOT DETECTED' or 'NEGATIVE' or Set to 'Positive' if upcase(MBSTRESC) is 'DETECTED' or 'POSITIVE' Set to MBSTRESC, Otherwise
BASEC Baseline Value (C) text 50
Derived
Set to AVALC where ABLFL = 'Y' for each SUBJID, PARCAT1 and PARAMCD
AWRANGE Analysis Window Valid Relative Range text 50
Derived
See ADMB.AWRANGE from Additional ADaM Variable Difinition Doc.

Additional ADaM Variable Definition

AWTARGET Analysis Window Target integer 8
Derived
See ADMB.AWTARGET from Additional ADaM Variable Difinition Doc.

Additional ADaM Variable Definition

AWTDIFF Analysis Window Diff from Target integer 8
Derived
Set to absolute value of (ADY - AWTARGET)
ABLFL Baseline Record Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' for last ADT on or before ADSL.TR01SDT with AVALC = 'Negative'/'Positive' for each SUBJID, PARCAT1 and PARAMCD. If there are multiple tests on the same date, select AVALC in the order of Positive > Negative
ANL01FL Analysis Flag 01 text 1 Yes Flag
  • • "Y"
Derived
See ADMB.ANL01FL from Additional ADaM Variable Difinition Doc

Additional ADaM Variable Definition

EUAVACFL Post-EUA Off-Study Vaccine Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if .< ADSL.EUAVACDT < ADT
MBSCAT Subcategory for Microbiology Finding text 40 Microbiology Analysis Dataset Parameter Sub-Category
  • • "Nasal Swab"
  • • "Nasopharyngeal Swab"
  • • "Saliva"
  • • "Swab"
  • • "Other"
Predecessor: MB.MBSCAT
MBSPEC Specimen Type text 40
Predecessor: MB.MBSPEC
MBSTAT Completion Status text 10
Predecessor: MB.MBSTAT
LDTCLIA CLIA Certified text 200
Derived
Set to SUPPMB.QVAL where QNAM is 'LDTCLIA'
LOCALFL From Covid Diag Test text 200
Derived
Set to SUPPMB.QVAL where QNAM is 'LOCALFL'

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Risk of Exposure Analysis Dataset (ADRISK)

ADRISK (Risk of Exposure Analysis Dataset) - BASIC DATA STRUCTURE Location: adrisk.xpt
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
ASEQ Analysis Sequence Number integer 8
Assigned
PARCAT1 Parameter Category 1 text 50 Risk of Exposure Analysis Dataset Parameter Category
  • • "OCCUPATIONAL RISK"
  • • "LOCATION AND LIVING CIRCUMSTANCES RISK"
Derived
Set to SC.SCSCAT
PARCAT1N Parameter Category 1 (N) integer 8 Parameter Category 1 (N) in ADRISK dataset
  • • 1 = "OCCUPATIONAL RISK"
  • • 2 = "LOCATION AND LIVING CIRCUMSTANCES RISK"
Assigned
PARAMCD Parameter Code text 8 Risk of Exposure Analysis Dataset Parameter Code

[19 Terms]

Assigned
PARAM Parameter text 200
Derived
Set to mixed case of SC.SCTEST if SC.SCTEST not in ('Other', 'High density housing', 'Low density, multi-family setting', 'Multi-family dwelling', 'Nursing Home or Assisted Living Facility', 'Single family home') or Set to 'Resides in High Density Housing' if SC.SCTEST='High density housing' or Set to 'Resides in Low Density, Multi-Family Setting' if SC.SCTEST='Low density, multi-family setting' or Set to 'Resides in Multi-Family Dwelling'if SC.SCTEST='Multi-family dwelling' or Set to 'Resides in Nursing Home or Assisted Living Facility' if SC.SCTEST='Nursing Home or Assisted Living Facility' or Set to 'Resides in a Single Family Home' if SC.SCTEST='Single family home' or Set to 'Other Occupational Risk' if SC.SCTEST='Other' and PARCAT1='OCCUPATIONAL RISK' or Set to 'Other Location And Living Circumstances Risk' if SC.SCTEST='Other' and PARCAT1='LOCATION AND LIVING CIRCUMSTANCES RISK'
AVALC Analysis Value (C) text 50
Derived
For PARAMCD='OTHERLOC' or 'OTHEROCC', set to 'N' if SC.SCSTRESC='N', else set to 'Y' if SCSTRESC is not missing. For other PARAMCD, set to SC.SCSTRESC.
OTHSPY Other Specify text 200
Derived
If PARAMCD='OTHEROCC' or 'OTHERLOC', set to SCSTRESC. Otherwise, set to null.

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COVID-19 Symptom Analysis Dataset (ADSYMP)

ADSYMP (COVID-19 Symptom Analysis Dataset) - BASIC DATA STRUCTURE Location: adsymp.xpt
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
ASEQ Analysis Sequence Number integer 8
Assigned
ADT Analysis Date integer DATE9
Derived
Convert date part of --DTC to numeric
ADY Analysis Relative Day integer 8
Derived
Set to ADT - ADSL.TR01SDT + 1 if ADT is on or after ADSL.TR01SDT, Set to ADT - ADSL.TR01SDT if ADT is before ADSL.TR01SDT
ASTDT Analysis Start Date integer DATE9
Derived
For source data are from FAEF: Convert date part of SUPPFAEF.QVAL where SUPPFAEF.QNAM='FAEVDTC' to numeric For source data are from PR: Convert date part of PR.PRSTDTC to numeric For source data are from HO: Convert date part of HO.HOSTDTC to numeric
ASTDY Analysis Start Relative Day integer 8
Derived
Set to ASTDT - ADSL.TR01SDT + 1 if ASTDT is on or after ADSL.TR01SDT, Set to ASTDT - ADSL.TR01SDT if ASTDT is before ADSL.TR01SDT
AENDT Analysis End Date integer DATE9
Derived
Convert date part of FAENDTC to numeric if source data are from FAEF, Convert date part of PR.PRENDTC to numeric if source data are from PR, Convert date part of HO.HOENDTC to numeric if For source data are from HO
AENDY Analysis End Relative Day integer 8
Derived
Set to AENDT - ADSL.TR01SDT + 1 if AENDT is on or after ADSL.TR01SDT, Set to AENDT - ADSL.TR01SDT if AENDT is before ADSL.TR01SDT
APERIOD Period integer 8
Derived
Set to 2 if ADT>=AP02SDT>Missing, Otherwise, Set to 1
AVISIT Analysis Visit text 50
Derived
Set to 'Illness Visit'. For subject with multiple Illness Visit Day 1 (FA.FATPT='Day 1') on different dates, if ADT is on/after the 2nd Illness Visit Day 1 and prior to the 3rd Illness Visit Day 1 (if available), then set to 'Illness Visit 2', and so on
AVISITN Analysis Visit (N) integer 8
Assigned
ATPT Analysis Timepoint text 20
Derived
Set to FAEF.FATPT if source data are from FAEF, Set to VS.VSTPT if source data are from VS, Set to null, Otherwise
PARCAT1 Parameter Category 1 text 50 COVID-19 Symptom Analysis Dataset Parameter Category
  • • "COVID-19 SYMPTOM"
  • • "COVID-19 SEVERITY"
Derived
Set to 'COVID-19 SEVERITY' if source data are from HO, else set to --SCAT in individual source data Re-code 'COVID-19' to 'COVID-19 SYMPTOM'
PARAMCD Parameter Code text 8 COVID-19 Symptom Analysis Dataset Parameter Code

[36 Terms]

Assigned
PARAM Parameter text 200
Derived
Set to PR.PRTRT if source data are from PR Set to HO.HOTERM if source data are from HO and re-code 'ADMITTED TO ICU' to 'Admission to an intensive care unit due to SARS-CoV-2' For SDTM.FAEF as source data: Set to FAEF.FAOBJ and recode follwing symptom terms - Recode to 'Vasopressors Required' if FAEF.FAOBJ='Evidence of Shock Requires Vasopressors' Recode to 'Muscle Aches (Myalgia)' if FAEF.FAOBJ='Myalgia' Recode to 'Runny Nose (Rhinorrhea)' if FAEF.FAOBJ='Rhinorrhea' For SDTM.VS as source data: Set to 'O2 Saturation <=93%' if VSSCAT='COVID-19' and VSTESTCD='OXYSAT' and VSSTRESN is not missing and VSSTRESN<=93 Set to 'Fever' if VSSCAT='COVID-19' and VSTESTCD='TEMP' and VSSTRESN is not missing and VSSTRESN>=38
AVALC Analysis Value (C) text 100
Derived
Set to PR.PROCCUR if source data are from PR Set to HO.HOOCCUR if source data are from HO For SDTM.FAEF as source data: Set to 'Y' if FAEF.FASCAT='COVID-19' and FAEF.FASTRESC in ('MILD', 'MODERATE', 'SEVERE') Set to 'N' if FAEF.FASCAT='COVID-19' and FAEF.FASTRESC = 'NONE' Set to FAEF.FASTRESC if FAEF.FASCAT='COVID-19 SEVERITY' For SDTM.VS as source data: Set to 'Y' if VSTESTCD='OXYSAT' and non-missing VSSTRESN<=93 Set to 'Y' if VSTESTCD='TEMP' and non-missing VSSTRESN>=38 and VSSTRESU='C'
SEV Severity/Intensity text 20
Derived
For SDTM.FAEF as source data: Set to FAEF.FASTRESC if FAEF.FASCAT = 'COVID-19' and FASTRESC in ('MILD', 'MODERATE', 'SEVERE') Set to null, Otherwise
LNKID Link ID text 40
Derived
Set to PRLNKID if source data are from PR, or Set to --SPID in individual source data
SRCDOM Source Data text 20
Derived
Set to FAEF.DOMAIN if source data are from FAEF Set to VS.DOMAIN if source data are from VS Set to PR.DOMAIN if source data are from PR Set to HO.DOMAIN if source data are from HO
SRCSEQ Source Sequence Number integer 8
Derived
Set to FAEF.FASEQ if source data are from FAEF Set to VS.CESEQ if source data are from VS Set to PR.PRSEQ if source data are from PR Set to HO.HOSEQ if source data are from HO
SRCVAR Source Variable text 50
Derived
Set to 'FASTRESC' if source data are from FAEF Set to 'VSSTRESN' if source data are from VS Set to 'PROCCUR' if source data are from PR Set to 'HOOCCUR' if source data are from HO
EUAVACFL Post-EUA Off-Study Vaccine Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if .< ADSL.EUAVACDT < ADT

Go to the top of the Define-XML document


Time to Event Analysis Dataset (ADTTE)

ADTTE (Time to Event Analysis Dataset) - BASIC DATA STRUCTURE Location: adtte.xpt
Variable Where Condition Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
PARCAT1 Parameter Category 1 text 15
Derived
Set to ADEFF.PARCAT1
PARAM Parameter text 200 Time to Event Analysis Data Set Parameter Code

[51 Terms]

Derived
See controlled terms. Create one PARAM per subject for all full analysis subjects (FASFL = 'Y')
PARAMCD Parameter Code text 8
Assigned
STARTDT Time-to-Event Origin Date for Subject integer DATE9
Derived
Set to ADSL.RANDDT if PARAMCD not in (TTCVDC9, TCVDSVC9, TCVDSDC9, TTASYMP9, TTASYCR9, TTINF9, TTDTHCV9, TTDEATH9), Otherwise, Set to ADSL.AP02SDT
ADTVLM Analysis Date integer DATE9
PARAMCD IN (
"TTCVDC1",
"TTCVDC2",
"TTCVDC3",
"TTCVDC4",
"TTCVDC5",
"TTCVDC6"
) 		Time to COVID-19 (Considering Scheduled RT-PCR) integer Date9
Derived
See ADTTE.ADT where PARAMCD in 'TTCVDC1', 'TTCVDC2', 'TTCVDC3', 'TTCVDC4', 'TTCVDC5', 'TTCVDC6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TCVDSVC1",
"TCVDSVC2",
"TCVDSVC3",
"TCVDSVC4",
"TCVDSVC5",
"TCVDSVC6"
) 		Time to Severe COVID-19 (Considering Scheduled RT-PCR) integer Date9
Derived
See ADTTE.ADT where PARAMCD in (('TCVDSVC1', 'TCVDSVC2', 'TCVDSVC3', 'TCVDSVC4', 'TCVDSVC5', 'TCVDSVC6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TCVDSDC1",
"TCVDSDC2",
"TCVDSDC3",
"TCVDSDC4",
"TCVDSDC5",
"TCVDSDC6"
) 		Time to COVID-19 (Secondary Definition) (Considering Scheduled RT-PCR) integer Date9
Derived
See ADTTE.ADT where PARAMCD in ('TCVDSDC1', 'TCVDSDC2', 'TCVDSDC3','TCVDSDC4', 'TCVDSDC5', 'TCVDSDC6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TTASYMP1",
"TTASYMP2",
"TTASYMP3",
"TTASYMP4",
"TTASYMP5",
"TTASYMP6",
"TTASYCR1",
"TTASYCR2",
"TTASYCR3",
"TTASYCR4",
"TTASYCR5",
"TTASYCR6"
) 		Asymptomatic SARS-CoV-2 Infection integer Date9
Derived
See ADTTE.ADT where PARAMCD in 'TTASYMP1', 'TTASYMP2', 'TTASYMP3', 'TTASYMP4', 'TTASYMP5', 'TTASYMP6', 'TTASYCR1', 'TTASYCR2', 'TTASYCR3', 'TTASYCR4', 'TTASYCR5', 'TTASYCR6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TTINF1",
"TTINF2",
"TTINF3",
"TTINF4",
"TTINF5",
"TTINF6"
) 		Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity integer Date9
Derived
See ADTTE.ADT where PARAMCD in ('TTINF1', 'TTINF2', 'TTINF3','TTINF4','TTINF5','TTINF6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TTDTHCV1",
"TTDTHCV2",
"TTDTHCV3",
"TTDTHCV4",
"TTDTHCV5",
"TTDTHCV6"
) 		Time to Death Caused by COVID-19 integer Date9
Derived
See ADTTE.ADT where PARAMCD in ('TTDTHCV1', 'TTDTHCV2', 'TTDTHCV3', 'TTDTHCV4', 'TTDTHCV5', 'TTDTHCV6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTDEATH" Time to All-Cause Death after Randomization (Days) integer Date9
Derived
See ADTTE.ADT where PARAMCD = 'TTDEATH' from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTCVDC9" Time to COVID-19 (Considering Scheduled RT-PCR) in Open Label Phase (Days) integer Date9
Derived
See ADTTE.ADT where PARAMCD=TTCVDC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TCVDSVC9" Time to Severe COVID-19 (Considering Scheduled RT-PCR) in Open Label Phase (Days) integer Date9
Derived
See ADTTE.ADT where PARAMCD=TCVDSVC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TCVDSDC9" Time to COVID-19 (Secondary Definition) (Considering Scheduled RT-PCR) - Open Label integer Date9
Derived
See ADTTE.ADT where PARAMCD=TCVDSDC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TTASYMP9",
"TTASYCR9"
) 		Asymptomatic SARS-CoV-2 Infection in Open Label Phase (Days) integer Date9
Derived
See ADTTE.ADT where PARAMCD=TTASYMP9 or PARAMCD = TTASYCR9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTINF9" Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity in Open Label Phase (Days) integer Date9
Derived
See ADTTE.ADT where PARAMCD=TTINF9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTDTHCV9" Time to Death Caused by COVID-19 in Open Label Phase (Days) integer Date9
Derived
See ADTTE.ADT where PARAMCD=TTDTHCV9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTDEATH9" Time to All-Cause Death after Randomization (Days) in Open Label Phase (Days) integer Date9
Derived
See ADTTE.ADT where PARAMCD=TTDEATH9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

APERIOD Period integer 8
Derived
Set to 2 if ADT>=AP02SDT>Missing, Otherwise, Set to 1
AVAL Analysis Value integer 8
Derived
Set to Event date or censor date (ADT) - STARTDT+1
CNSRVLM Censor integer 8
PARAMCD IN (
"TTCVDC1",
"TTCVDC2",
"TTCVDC3",
"TTCVDC4",
"TTCVDC5",
"TTCVDC6"
) 		Time to COVID-19 (Considering Scheduled RT-PCR) integer 1
Derived
See ADTTE.CNSR where PARAMCD in (TTCVDC1, TTCVDC2, TTCVDC3, TTCVDC4, TTCVDC5, TTCVDC6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TCVDSVC1",
"TCVDSVC2",
"TCVDSVC3",
"TCVDSVC4",
"TCVDSVC5",
"TCVDSVC6"
) 		Time to Severe COVID-19 (Considering Scheduled RT-PCR) integer 1
Derived
See ADTTE.CNSR where PARAMCD in (TCVDSVC1, TCVDSVC2, TCVDSVC3, TCVDSVC4, TCVDSVC5, TCVDSVC6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TCVDSDC1",
"TCVDSDC2",
"TCVDSDC3",
"TCVDSDC4",
"TCVDSDC5",
"TCVDSDC6"
) 		Time to COVID-19 (Secondary Definition) (Considering Scheduled RT-PCR) integer 1
Derived
See ADTTE.CNSR where PARAMCD in (TCVDSDC1, TCVDSDC2, TCVDSDC3,TCVDSDC4, TCVDSDC5, TCVDSDC6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TTASYMP1",
"TTASYMP2",
"TTASYMP3",
"TTASYMP4",
"TTASYMP5",
"TTASYMP6"
) 		Asymptomatic SARS-CoV-2 Infection integer 1
Derived
See ADTTE.CNSR where PARAMCD in (TTASYMP1, TTASYMP2, TTASYMP3, TTASYMP4, TTASYMP5, TTASYMP6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TTASYCR1",
"TTASYCR2",
"TTASYCR3",
"TTASYCR4",
"TTASYCR5",
"TTASYCR6"
) 		Asymptomatic SARS-CoV-2 Infection (Competing Risk) integer 1
Derived
See ADTTE.CNSR where PARAMCD in (TTASYCR1, TTASYCR2, TTASYCR3, TTASYCR4, TTASYCR5, TTASYCR6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TTINF1",
"TTINF2",
"TTINF3",
"TTINF4",
"TTINF5",
"TTINF6"
) 		Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity integer 1
Derived
See ADTTE.CNSR where PARAMCD in (TTINF1, TTINF2, TTINF3, TTINF4, TTINF5, TTINF6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TTDTHCV1",
"TTDTHCV2",
"TTDTHCV3",
"TTDTHCV4",
"TTDTHCV5",
"TTDTHCV6"
) 		Time to Death Caused by COVID-19 integer 1
Derived
See ADTTE.CNSR where PARAMCD in (TTDTHCV1, TTDTHCV2, TTDTHCV3, TTDTHCV4, TTDTHCV5, TTDTHCV6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTDEATH" Time to All-Cause Death after Randomization (Days) integer 1
Derived
See ADTTE.CNSR where PARAMCD = TTDEATH from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTCVDC9" Time to COVID-19 (Considering Scheduled RT-PCR) in Open Label Phase (Days) integer 1
Derived
See ADTTE.CNSR where PARAMCD=TTCVDC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TCVDSVC9" Time to Severe COVID-19 (Considering Scheduled RT-PCR) in Open Label Phase (Days) integer 1
Derived
See ADTTE.CNSR where PARAMCD = TCVDSVC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TCVDSDC9" Time to COVID-19 (Secondary Definition) (Considering Scheduled RT-PCR) - Open Label integer 1
Derived
See ADTTE.CNSR where PARAMCD = TCVDSDC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTASYMP9" Asymptomatic SARS-CoV-2 Infection in Open Label Phase (Days) integer 1
Derived
See ADTTE.CNSR where PARAMCD=TTASYMP9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTASYCR9" Asymptomatic SARS-CoV-2 Infection (Competing Risk) in Open Label Phase (Days) integer 1
Derived
See ADTTE.CNSR where PARAMCD=TTASYCR9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTINF9" Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity in Open Label Phase (Days) integer 1
Derived
See ADTTE.CNSR where PARAMCD=TTINF9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTDTHCV9" Time to Death Caused by COVID-19 in Open Label Phase (Days) integer 1
Derived
See ADTTE.CNSR where PARAMCD=TTDTHCV9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTDEATH9" Time to All-Cause Death after Randomization (Days) in Open Label Phase (Days) integer 1
Derived
See ADTTE.CNSR where PARAMCD=TTDEATH9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

EVNTDESCVLM Event or Censoring Description text 200
PARAMCD IN (
"TTCVDC1",
"TTCVDC2",
"TTCVDC3",
"TTCVDC4",
"TTCVDC5",
"TTCVDC6"
) 		Time to COVID-19 (Considering Scheduled RT-PCR) text 200
Derived
See ADTTE.EVNTDESC where PARAMCD in (TTCVDC1, TTCVDC2, TTCVDC3, TTCVDC4, TTCVDC5, TTCVDC6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TCVDSVC1",
"TCVDSVC2",
"TCVDSVC3",
"TCVDSVC4",
"TCVDSVC5",
"TCVDSVC6"
) 		Time to Severe COVID-19 (Considering Scheduled RT-PCR) text 200
Derived
See ADTTE.EVNTDESC where PARAMCD in (TCVDSVC1, TCVDSVC2, TCVDSVC3, TCVDSVC4, TCVDSVC5, TCVDSVC6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TCVDSDC1",
"TCVDSDC2",
"TCVDSDC3",
"TCVDSDC4",
"TCVDSDC5",
"TCVDSDC6"
) 		Time to COVID-19 (Secondary Definition) (Considering Scheduled RT-PCR) text 200
Derived
See ADTTE.EVNTDESC where PARAMCD in (TCVDSDC1, TCVDSDC2, TCVDSDC3,TCVDSDC4, TCVDSDC5, TCVDSDC6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TTASYMP1",
"TTASYMP2",
"TTASYMP3",
"TTASYMP4",
"TTASYMP5",
"TTASYMP6"
) 		Asymptomatic SARS-CoV-2 Infection text 200
Derived
See ADTTE.EVNTDESC where PARAMCD in (TTASYMP1, TTASYMP2, TTASYMP3, TTASYMP4, TTASYMP5, TTASYMP6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TTASYCR1",
"TTASYCR2",
"TTASYCR3",
"TTASYCR4",
"TTASYCR5",
"TTASYCR6"
) 		Asymptomatic SARS-CoV-2 Infection (Competing Risk) text 200
Derived
See ADTTE.EVNTDESC where PARAMCD in (TTASYCR1, TTASYCR2, TTASYCR3, TTASYCR4, TTASYCR5, TTASYCR6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TTINF1",
"TTINF2",
"TTINF3",
"TTINF4",
"TTINF5",
"TTINF6"
) 		Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity text 200
Derived
See ADTTE.EVNTDESC where PARAMCD in (TTINF1, TTINF2, TTINF3, TTINF4, TTINF5, TTINF6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TTDTHCV1",
"TTDTHCV2",
"TTDTHCV3",
"TTDTHCV4",
"TTDTHCV5",
"TTDTHCV6"
) 		Time to Death Caused by COVID-19 text 200
Derived
See ADTTE.EVNTDESC where PARAMCD in (TTDTHCV1, TTDTHCV2, TTDTHCV3, TTDTHCV4, TTDTHCV5, TTDTHCV6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTDEATH" Time to All-Cause Death after Randomization (Days) text 200
Derived
Set to 'All-Cause Death' if ADSL.DTHDT is not missing and ADSL.AP02SDT is not missing, Set to 'No All-Cause Death'

Additional ADaM Variable Definition

PARAMCD = "TTCVDC9" Time to COVID-19 (Considering Scheduled RT-PCR) in Open Label Phase (Days) text 200
Derived
See ADTTE.EVNTDESC where PARAMCD=TTCVDC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TCVDSVC9" Time to Severe COVID-19 (Considering Scheduled RT-PCR) in Open Label Phase (Days) text 200
Derived
See ADTTE.EVNTDESC where PARAMCD=TCVDSVC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TCVDSDC9" Time to COVID-19 (Secondary Definition) (Considering Scheduled RT-PCR) - Open Label text 200
Derived
See ADTTE.EVNTDESC where PARAMCD=TCVDSDC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTASYMP9" Asymptomatic SARS-CoV-2 Infection in Open Label Phase (Days) text 200
Derived
See ADTTE.EVNTDESC where PARAMCD=TTASYMP9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTASYCR9" Asymptomatic SARS-CoV-2 Infection (Competing Risk) in Open Label Phase (Days) text 200
Derived
See ADTTE.EVNTDESC where PARAMCD=TTASYCR9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTINF9" Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity in Open Label Phase (Days) text 200
Derived
See ADTTE.EVNTDESC where PARAMCD=TTINF9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTDTHCV9" Time to Death Caused by COVID-19 in Open Label Phase (Days) text 200
Derived
See ADTTE.EVNTDESC where PARAMCD=TTDTHCV9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTDEATH9" Time to All-Cause Death after Randomization (Days) in Open Label Phase (Days) text 200
Derived
See ADTTE.EVNTDESC where PARAMCD=TTDEATH9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

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Time to Adjudication Event Analysis Data (ADTTEA)

ADTTEA (Time to Adjudication Event Analysis Data) - BASIC DATA STRUCTURE Location: adttea.xpt
Variable Where Condition Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
PARCAT1 Parameter Category 1 text 24
Derived
Set to ADEFF.PARCAT1
PARAM Parameter text 200 Time to Adjudication Event Analysis Data Set Parameter Code

[14 Terms]

Derived
See controlled terms. Create one PARAM per subject for all full analysis subjects (FASFL = 'Y')
PARAMCD Parameter Code text 8
Assigned
STARTDT Time-to-Event Origin Date for Subject integer DATE9.
Derived
Set to ADSL.RANDDT if PARAMCD not in (TTCVDC9, TCVDSVC9), Otherwise, Set to ADSL.AP02SDT
APERIOD Period integer 8
Derived
Set to 2 if ADT>=AP02SDT>Missing, Otherwise, Set to 1
ADTVLM Analysis Date integer DATE9.
PARAMCD IN (
"TTCVDC1",
"TTCVDC2",
"TTCVDC3",
"TTCVDC4",
"TTCVDC5",
"TTCVDC6"
) 		Time to COVID-19 (Prior Infection Censoring) integer 8
Derived
See ADTTEA.ADT where in ('TTCVDC1', 'TTCVDC2', 'TTCVDC3', 'TTCVDC4', 'TTCVDC5', 'TTCVDC6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TCVDSVC1",
"TCVDSVC2",
"TCVDSVC3",
"TCVDSVC4",
"TCVDSVC5",
"TCVDSVC6"
) 		Time to Severe COVID-19 (Prior Infection Censoring) integer 8
Derived
See ADTTEA.ADT where PARAMCD in ('TCVDSVC1', 'TCVDSVC2', 'TCVDSVC3', 'TCVDSVC4', 'TCVDSVC5', 'TCVDSVC6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTCVDC9" Time to COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) in Open Label Phase (Days) integer 8
Derived
See ADTTEA.ADT where PARAMCD = 'TTCVDC9' from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TCVDSVC9" Time to Severe COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) in Open Label Phase (Days) integer 8
Derived
See ADTTEA.ADT where PARAMCD = 'TCVDSVC9' from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

AVAL Analysis Value integer 8
Derived
Set to Event date or censor date (ADT) - STARTDT+1
CNSRVLM Censor integer 8
PARAMCD IN (
"TTCVDC1",
"TTCVDC2",
"TTCVDC3",
"TTCVDC4",
"TTCVDC5",
"TTCVDC6"
) 		Time to COVID-19 (Prior Infection Censoring) integer 1
Derived
See ADTTEA.CNSR where in ('TTCVDC1', 'TTCVDC2', 'TTCVDC3', 'TTCVDC4', 'TTCVDC5', 'TTCVDC6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TCVDSVC1",
"TCVDSVC2",
"TCVDSVC3",
"TCVDSVC4",
"TCVDSVC5",
"TCVDSVC6"
) 		Time to Severe COVID-19 (Prior Infection Censoring) integer 1
Derived
See ADTTEA.ENVTDESC where PARAMCD in ('TCVDSVC1', 'TCVDSVC2', 'TCVDSVC3', 'TCVDSVC4', 'TCVDSVC5', 'TCVDSVC') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTCVDC9" Time to COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) in Open Label Phase (Days) integer 1
Derived
See ADTTE.CNSR where PARAMCD = 'TTCVDC9' from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TCVDSVC9" Time to Severe COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) in Open Label Phase (Days) integer 1
Derived
See ADTTE.CNSR where PARAMCD = 'TCVDSVC9' from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

EVNTDESCVLM Event or Censoring Description text 200
PARAMCD IN (
"TTCVDC1",
"TTCVDC2",
"TTCVDC3",
"TTCVDC4",
"TTCVDC5",
"TTCVDC6"
) 		Time to COVID-19 (Prior Infection Censoring) text 200
Derived
See ADTTEA.ENVTDESC where in ('TTCVDC1', 'TTCVDC2', 'TTCVDC3', 'TTCVDC4', 'TTCVDC5', 'TTCVDC6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TCVDSVC1",
"TCVDSVC2",
"TCVDSVC3",
"TCVDSVC4",
"TCVDSVC5",
"TCVDSVC6"
) 		Time to Severe COVID-19 (Prior Infection Censoring) text 200
Derived
See ADTTEA.EVNTDESC where PARAMCD in ('TCVDSVC1', 'TCVDSVC2', 'TCVDSVC3', 'TCVDSVC4', 'TCVDSVC5', 'TCVDSVC6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TTCVDC9" Time to COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) in Open Label Phase (Days) text 200
Derived
See ADTTEA.ENVTDESC where PARAMCD = 'TCVDSVC9' from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD = "TCVDSVC9" Time to Severe COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) in Open Label Phase (Days) text 200
Derived
See ADTTE.EVNTDESC where PARAMCD=TCVDSVC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

CVD53DT Date of 53rd COVID-19 Case integer DATE9.
Assigned

Record Date of 53rd COVID-19 Case
CDCCD CDC Classification Code text 19
Derived
Set to SDTM.XQ.XQCAT
LGROUP Location of the First Detected text 10
Derived
Set to SDTM.XQ.XQGRPID
LINEAGES Lineage Based on Mutations in S text 10
Derived
Set to SDTM.XQ.XQSTRESC if XQSTRESC ne "Empty"

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Time to Event up to PDV Analysis Dataset (ADTTEB)

ADTTEB (Time to Event up to PDV Analysis Dataset) - BASIC DATA STRUCTURE Location: adtteb.xpt
Variable Where Condition Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
PARCAT1 Parameter Category 1 text 15
Derived
Set to ADEFF.PARCAT1
PARAM Parameter text 200 Time to Event up to PDV Analysis Data Set Parameter Code

[10 Terms]

Derived
See controlled terms. Create one PARAM per subject for all full analysis subjects (FASFL = 'Y')
PARAMCD Parameter Code text 8
Assigned
STARTDT Time-to-Event Origin Date for Subject integer Date9.
Derived
Set to ADSL.RANDDT
ADTVLM Analysis Date integer Date9.
PARAMCD IN (
"TASYCRB1",
"TASYCRB2",
"TASYCRB3",
"TASYCRB4",
"TASYCRB5"
) 		Time to Asymptomatic SARS-CoV-2 Infection integer 8
Derived
See ADTTEB.ADT where PARAMCD in 'TASYCRB1', 'TASYCRB2', 'TASYCRB3', 'TASYCRB4', 'TASYCRB5') rom Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TTINFB1",
"TTINFB2",
"TTINFB3",
"TTINFB4",
"TTINFB5)"
) 		Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity integer 8
Derived
See ADTTEB.ADT where PARAMCD in 'TTINFB1', 'TTINFB2', 'TTINFB3', 'TTINFB4', 'TTINFB5') rom Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

APERIOD Period integer 8
Derived
Set to 2 if ADT>=AP02SDT>Missing, Otherwise, Set to 1
AVAL Analysis Value integer 8
Derived
Set to Event date or censor date (ADT) - STARTDT+1
CNSRVLM Censor integer 8
PARAMCD IN (
"TASYCRB1",
"TASYCRB2",
"TASYCRB3",
"TASYCRB4",
"TASYCRB5"
) 		Time to Asymptomatic SARS-CoV-2 Infection integer 1
Derived
See ADTTE.CNSR where PARAMCD in 'TASYCRB1', 'TASYCRB2', 'TASYCRB3', 'TASYCRB4', 'TASYCRB5') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TTINFB1",
"TTINFB2",
"TTINFB3",
"TTINFB4",
"TTINFB5)"
) 		Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity integer 1
Derived
See ADTTE.CNSR where PARAMCD in 'TTINFB1', 'TTINFB2', 'TTINFB3', 'TTINFB4', 'TTINFB5') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

EVNTDESCVLM Event or Censoring Description text 200
PARAMCD IN (
"TASYCRB1",
"TASYCRB2",
"TASYCRB3",
"TASYCRB4",
"TASYCRB5"
) 		Time to Asymptomatic SARS-CoV-2 Infection text 100
Derived
See ADTTE.EVNTDESC where PARAMCD in 'TASYCRB1', 'TASYCRB2', 'TASYCRB3', 'TASYCRB4', 'TASYCRB5') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAMCD IN (
"TTINFB1",
"TTINFB2",
"TTINFB3",
"TTINFB4",
"TTINFB5)"
) 		Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity text 100
Derived
See ADTTE.EVNTDESC where PARAMCD in 'TTINFB1', 'TTINFB2', 'TTINFB3', 'TTINFB4', 'TTINFB5') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

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Recurrent of BOD/BOI Analysis Dataset (ADTTRE)

ADTTRE (Recurrent of BOD/BOI Analysis Dataset) - BASIC DATA STRUCTURE Location: adttre.xpt
Variable Where Condition Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
PARAM Parameter text 50
Derived
Create # of records based on ADEFF2.PARAMCD and ADEFF2.AVAL: Set to "Burden of Disease Score" if data is derived from ADEFF2.PARAMCD in (BOD7D, BOD28D) Set to 'Burden of Infection Score' if data is derived from ADEFF2.PARAMCD in (BOI7D, BOI28D)
PARAMCD Parameter Code text 8
Assigned
EVENTSEQVLM Event Sequence Number integer 8
PARAMCD = "BOD" Burden of Disease Score Sequence integer 8
Derived
Derive based on the records with ADEFF2.ANL01FL='Y': If ADEFF2.AVAL=0 or 1 where PARAMCD contains 'BOD', assign one record/row with EVENTSEQ=1, If ADEFF2.AVAL=2 where PARAMCD contains 'BOD', assign one record/row with EVENTSEQ=1 and one record/row with EVENTSEQ=2, If ADEFF2.AVAL=3 where PARAMCD contains 'BOD', assign one record/row with EVENTSEQ=1 and one record/row with EVENTSEQ=2 and one record/row with EVENTSEQ=3
PARAMCD = "BOI" Burden of Infection Score Sequence integer 8
Derived
Derive based on the records with ADEFF2.ANL01FL='Y': If ADEFF2.AVAL=0 or 0.5 where PARAMCD contains 'BOI', assign one record/row with EVENTSEQ=1, If ADEFF2.AVAL=1 where PARAMCD contains 'BOI', assign one record/row with EVENTSEQ=1 and one record/row with EVENTSEQ=2, If ADEFF2.AVAL=2 where PARAMCD contains 'BOI', assign one record/row with EVENTSEQ=1 and one record/row with EVENTSEQ=2 and one record/row with EVENTSEQ=3 and one record/row with EVENTSEQ=4, If ADEFF2.AVAL=3 where PARAMCD contains 'BOI', assign one record/row with EVENTSEQ=1 and one record/row with EVENTSEQ=2 and one record/row with EVENTSEQ=3 and one record/row with EVENTSEQ=4 and one record/row with EVENTSEQ=5 and one record/row with EVENTSEQ=6
CNSRVLM Censor integer 8
PARAMCD = "BOD" Burden of Infection Score Censor integer 8
Derived
If EVENTSEQ=1, then do: 1)Set to 1 If ADEFF2.AVAL=0 where PARAMCD contains 'BOD', 2)Set to 0 If ADEFF2.AVAL>=1 where PARAMCD contains 'BOD', If EVENTSEQ=2 or 3, then set to 0 Note: (1 for censor; 0 for event)
PARAMCD = "BOI" Burden of Infection Score Censor integer 8
Derived
If EVENTSEQ=1, then do: 1)Set to 1 If ADEFF2.AVAL=0 where PARAMCD contains 'BOI', 2)Set to 0 If ADEFF2.AVAL>=0.5 where PARAMCD contains 'BOI', If EVENTSEQ>=2, then set to 0 Note: (1 for censor; 0 for event)
EVNTDESCVLM Event or Censoring Description text 100
PARAMCD = "BOD" Burden of Infection Score Censor Description text 100
Derived
For each USUBJID, Set to 'Without COVID-19' if ADEFF2.AVAL=0 where PARAMCD contains 'BOD', Set to 'COVID-19 without hospitalization' if ADEFF2.AVAL= 1 where PARAMCD contains 'BOD', Set to 'COVID-19 with hospitalization' if ADEFF2.AVAL=2 where PARAMCD contains 'BOD', Set to 'Death' if ADEFF2.AVAL=3 where PARAMCD contains 'BOD'
PARAMCD = "BOI" Burden of Infection Score Censor Description text 100
Derived
For each USUBJID, Set to 'No infection’ if ADEFF2.AVAL=0 where PARAMCD contains 'BOI', Set to 'Asymptomatic infection' if ADEFF2.AVAL=0.5 where PARAMCD contains 'BOI', Set to 'COVID-19 without hospitalization' if ADEFF2.AVAL=1 where PARAMCD contains 'BOI', Set to 'COVID-19 with hospitalization' if ADEFF2.AVAL=2 where PARAMCD contains 'BOI', Set to 'Death' if ADEFF2.AVAL=3 where PARAMCD contains 'BOI'
STARTVALVLM Analysis Start Value integer 8
PARAMCD = "BOD" Burden of Disease Score Analysis Start Value integer 8
Derived
Set to 0 if EVENTSEQ=1, Set to the (ADEFF2.ADT- ADSL.RANDDT) if EVENTSEQ=2, Set to the (ADEFF2.ADT- ADSL.RANDDT)+(1e-10) if EVENTSEQ=3
PARAMCD = "BOI" Burden of Infection Score Analysis Start Value integer 8
Derived
Set to 0 if EVENTSEQ=1, set to the (ADEFF2.ADT-ADSL.TR01SDT) if EVENTSEQ=2, Set to the (ADEFF2.ADT-ADSL.TR01SDT) +(1e-10) if EVENTSEQ=3, Set to the (ADEFF2.ADT-ADSL.TR01SDT) +(2e-10) if EVENTSEQ=4, Set to the (ADEFF2.ADT-ADSL.TR01SDT) +(3e-10) if EVENTSEQ=5, Set to the (ADEFF2.ADT-ADSL.TR01SDT) +(4e-10) if EVENTSEQ=6
AVALVLM Analysis Value float 20
PARAMCD = "BOD" Burden of Disease Score Analysis Value float 20
Derived
If where ADEFF2.PARAMCD contains 'BOD' : If ADEFF2.AVAL=0: Set to the earliest date of (ADSL.DTHDT, ADSL.EOSDT, ADSL.EFFCODT, ADSL.AP01EDT) - ADSL.RANDDT if and EVENTSEQ=1, Else: Set to the ADEFF2.ADT- ADSL.RANDDT where EVENTSEQ=1, Set to the ADEFF2.ADT- ADSL.RANDDT+(1e-10) where EVENTSEQ=2 Set to the ADEFF2.ADT- ADSL.RANDDT +(2e-10) where EVENTSEQ=3
PARAMCD = "BOI" Burden of Infection Score Analysis Value float 20
Derived
Set to the earliest date of (ADSL.DTHDT, ADSL.EOSDT, ADSL.EFFCODT, ADSL.AP01EDT) - TR01SDT if ADEFF2.AVAL=0 and EVENTSEQ=1, Set to the ADEFF2.ADT- TR01SDT if EVENTSEQ=1, Set to the ADEFF2.ADT- TR01SDT +(1e-10) if EVENTSEQ=2, Set to the ADEFF2.ADT- TR01SDT +(2e-10) if EVENTSEQ=3, Set to the ADEFF2.ADT- TR01SDT +(3e-10) if EVENTSEQ=4, Set to the ADEFF2.ADT- TR01SDT +(4e-10) if EVENTSEQ=5, Set to the ADEFF2.ADT- TR01SDT +(5e-10) if EVENTSEQ=6

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Recurrent of Symptom Analysis Dataset (ADTTRE2)

ADTTRE2 (Recurrent of Symptom Analysis Dataset) - BASIC DATA STRUCTURE Location: adttre2.xpt
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
PARAM Parameter text 50
Assigned

Assign 'Total COVID-19 Symptoms Score' to each subject
PARAMCD Parameter Code text 8
Assigned
EVENTSEQ Event Sequence Number integer 8
Derived
Derive based on the records with ADEFF3.ANL01FL='Y' and PARCAT1N = 1 and PPROTFL = ’Y’. Step 1. Calculate temporary variable SUM = sum of AVAL per subject (SUBJID). Step 2. Calcalate min, max, Q1 and Q3 of SUM. Step 3. Assgin EVENTSEQ as follows: If SUM = 0 or 0 < SUM < Q1, assign one record/row with EVENTSEQ = 1; if Q1 <= SUM < Median, assign one record/row with EVENTSEQ = 1 and one record/row with EVENTSEQ = 2; if Median <= SUM < Q3, assign one record/row with EVENTSEQ = 1 and one record/row with EVENTSEQ = 2 and one record/row with EVENTSEQ = 3; if Q3 <= SUM, assign one record/row with EVENTSEQ = 1 and one record/row with EVENTSEQ = 2 and one record/row with EVENTSEQ = 3 and one record/row with EVENTSEQ = 4;
CNSR Censor integer 8
Derived
If EVENTSEQ = 1, then do: 1) Set to 1 If temporary variable SUM (see derivation of EVENTSEQ) = 0, 2) Set to 0 If temporary variable SUM (see derivation of EVENTSEQ) > 0, if EVENTSEQ = 2 or 3 or 4, then set to 0 Note: (1 for censor; 0 for event)
EVNTDESC Event or Censoring Description text 50
Derived
For each USUBJID, Set to ‘No symptom’ if temporary variable SUM (see derivation of EVENTSEQ) = 0, Set to ‘0 < Total COVID-19 Symptoms Score < Q1’ if 0 < temporary variable SUM (see derivation of EVENTSEQ) < Q1, Set to ‘Q1 <= Total COVID-19 Symptoms Score < Median’ if Q1 <= temporary variable SUM (see derivation of EVENTSEQ) < Median, Set to ‘Median <= Total COVID-19 Symptoms Score < Q3’ if Median <= temporary variable SUM (see derivation of EVENTSEQ) < Q3, Set to ‘Q3 <= Total COVID-19 Symptoms Score’ if Q3 <= temporary variable SUM (see derivation of EVENTSEQ).
STARTVAL Analysis Start Value integer 8
Derived
Derive based on the date of first symtom occure per subject (ADEFF3.ADT where FASYMPFL = 'Y') If EVENTSEQ = 1, set to 0. if EVENTSEQ = 2, set to the (ADT - ADSL.TR01SDT). if EVENTSEQ = 3, set to the (ADT - ADSL.TR01SDT) + (1e-10). if EVENTSEQ = 4, set to the (ADT - ADSL.TR01SDT) + (2e-10).
AVAL Analysis Value float 20
Derived
Derive based on the temporary variable SUM (see derivation of EVENTSEQ) and date of first symtom occure per subject (ADEFF3.ADT where FASYMPFL = 'Y') If SUM = 0 where EVENTSEQ = 1, set to the earliest date of (ADSL.DTHDT, ADSL.EOSDT, ADSL.CUTOFFDT) - TR01SDT. if 0 < SUM <= Q1 where EVENTSEQ = 1, set to the ADT - TR01SDT. if Q1 <= SUM < Median , then do: 1) if EVENTSEQ = 1, set to the ADT - TR01SDT. 2) if EVENTSEQ = 2, set to the ADT - TR01SDT + (1e-10). if Median <= SUM < Q3, then do: 1) if EVENTSEQ = 1, set to the ADT - TR01SDT. 2) if EVENTSEQ = 2, set to the ADT - TR01SDT + (1e-10). 3) if EVENTSEQ = 3, set to the ADT - TR01SDT + (2e-10). if Q3 <= SUM, then do: 1) if EVENTSEQ = 1, set to the ADT - TR01SDT. 2) if EVENTSEQ = 2, set to the ADT - TR01SDT + (1e-10). 3) if EVENTSEQ = 3, set to the ADT - TR01SDT + (2e-10). 4) if EVENTSEQ = 4, set to the ADT - TR01SDT + (3e-10).

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Vital Signs Analysis Dataset (ADVS)

ADVS (Vital Signs Analysis Dataset) - BASIC DATA STRUCTURE Location: advs.xpt
Variable Where Condition Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
TRTA Actual Treatment text 50
Derived
If MDOSREF='Vaccination 1', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 1', 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'Day 1', if MDOSREF='Vaccination 2', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 29', 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'Day 29', If MDOSREF='OL Vaccination 1', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'OL-D1', 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'OL-D1', if MDOSREF='OL Vaccination 2', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'OL-D29', 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'OL-D29'
TRTAN Actual Treatment (N) integer 8 Actual Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Assigned
APERIOD Period integer 8
Derived
Set to 2 if non-missing AP02SSDT<=ADT, Otherwise, Set to 1
VSDTC Date/Time of Measurements text 20
Predecessor: VS.VSDTC
ADT Analysis Date integer DATE9.
Derived
Convert date part of VS.VSDTC to numeric
ADTM Analysis Datetime integer DATETIME20.
Derived
Convert VS.VSDTC to numeric
ADY Analysis Relative Day integer 8
Derived
Set to ADT - ADSL.TR01SDT + 1 if ADT is on or after ADSL.TR01SDT, or Set to ADT - ADSL.TR01SDT if ADT is before ADSL.TR01SDT
MDOSREF Most Recent Dose Reference text 25
Derived
Set to 'Vaccination 1' if ( . < ADSL.TR01SDTM <= ADTM < ADSL.DOS2DTM ) or ( .< ADSL.TR01SDTM <= ADTM and ADSL.DOS2DTM is missing and (TR02SDTM is missing or .<ASTDTM<ADSL.TR02SDTM)), Set to 'Vaccination 2' if ( .< ADSL.DOS2DTM <= ADTM < ADSL.TR02SDTM ) or ( .< ADSL.DOS2DTM <= ADTM and ADSL.TR02SDTM is missing), Set to 'OL Vaccination 1' if (.<ADSL.TR02SDTM<=ADTM<ADSL.OLDO2DTM) or (.<ADSL.TR02SDTM<=ADTM and ADSL.OLDO2DTM is missing), Set to 'OL Vaccination 2' if .<ADSL.OLDO2DTM<=ADTM Note: using date variables for comparison when time part is not available
MRDDY Relative Day from Most Recent Dose integer 8
Derived
Set to ADT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1', Set to ADT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2', Set to ADT – ADSL.TR02SDT+ 1 If MDOSREF='OL Vaccination 1', Set to ADT – ADSL.OLDO2SDT+ 1 If MDOSREF='OL Vaccination 2'
VISIT Visit Name text 100
Predecessor: VS.VISIT
VISITNUM Visit Number integer 8
Predecessor: VS.VISITNUM
AVISIT Analysis Visit text 50
Derived
See ADVS.AVISIT from Additional ADaM Variable Definition Doc.

Additional ADaM Variable Definition

AVISITN Analysis Visit (N) integer 8
Assigned
ATPT Analysis Timepoint text 20
Derived
Set to ‘Day x’ if AVISIT='Illness Visit Day x' or 'Illness Visit y Day x' (see derivation of AVISIT)
ATPTN Analysis Timepoint (N) integer 8
Assigned
VSTPT Planned Time Point Name text 100
Predecessor: VS.VSTPT
ASTAGE Stage text 30 Stage
  • • "Vaccination stage"
  • • "Follow up stage"
Derived
Only derive for post baseline records where DOSE1FL='Y': For APERIOD=1: If DOSE2FL='Y' then set TEMP to date of VISIT 3 (i.e. SV.SVSTDTC where SV.VISIT = 'Visit 3 Day 57') else if DOSE2FL ne 'Y' then set TEMP to date of VISIT 2 (i.e. SV.SVSTDTC where SV.VISIT = 'Visit 2 Day 29') Then do following: set to ‘Vaccination stage’ If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of (TEMP, ADSL.EOSDT, ADSL.DTHDT) Set to 'Follow-Up Analysis Period' if ADT > non-missing TEMP. If TEMP, ADSL.EOSDT, and ADSL.DTHDT are all unavailable, set to ‘Vaccination stage’ For APERIOD=2: If OLDOS2FL ='Y' then set TEMP to date of OL-Day57 (i.e. SV.SVSTDTC where SV.VISIT = 'OL-Day 57') else if OLDOS2FL ne 'Y' then set TEMP to date of OL-Day29 (i.e. SV.SVSTDTC where SV.VISIT = 'OL-Day 29') Then do following: set to ‘Vaccination stage’ If .< ADSL.TR02SDTM <=ADTM and ADT<=earliest date of (TEMP, ADSL.EOSDT, ADSL.DTHDT) Set to 'Follow-Up Analysis Period' if ADT > non-missing TEMP. If TEMP, ADSL.EOSDT, and ADSL.DTHDT are all unavailable, set to ‘Vaccination stage’ Else Set to missing
ASTAGEN Stage (N) integer 8 Stage Code
  • • 1 = "Vaccination stage"
  • • 2 = "Follow up stage"
Assigned
PARAMCD Parameter Code text 8 Vital Signs Analysis Dataset Parameter Code

[8 Terms]

Assigned
PARAM Parameter text 50
Derived
VS.VSTEST ' (' ||VSSTRESU|| ')' if VSSTRESU is non-missing, if VSSTRESU is missing, use the non-missing VSSTRESU from the same VSTEST
AVAL Analysis Value float 8
Derived
Set to VS.VSSTRESN
VSSTRESC Character Result/Finding in Std Format text 25
Predecessor: VS.VSSTRESC
ABLFL Baseline Record Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' for the latest (consider both ADT and ATM) non-missing assessment (AVAL>. or non-missing AVALC) on or before TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID and PARAMCD Note: exclude records where ADT is the same as TR01SDT and VSTPT^='PRE-DOSE'
BASE Baseline Value float 8
Derived
Merge value of nonmissing AVAL where ABLFL = 'Y' by USUBJID and PARAMCD, then Set to AVAL where ABLFL = 'Y'
CHG Change from Baseline float 8
Derived
For post baseline records only, if AVAL and BASE are both non-missing, set to AVAL - BASE Note: post-baseline records are defined as any result where ADTM > TR01SDTM or (ADTM=TR01SDTM and VSTPT^='PRE-DOSE') if time is available, if time is not available use (ADY=1 and VSTPT^='PRE-DOSE') or ADY > 1)
PCHG Percent Change from Baseline float 8
Derived
Set to (CHG/BASE)*100 if BASE ne 0
ATOXGRLVLM Analysis Toxicity Grade Low text 10
PARAMCD = "PULSE" (Pulse Rate (beats/min)) Pulse Rate (beats/min) text 8
Derived
Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 50 – 54 Set to 'Grade 2' if 45 – 49 Set to 'Grade 3' if <45 Grade 4 is based on medical input Otherwise, set to 'Grade 0'
PARAMCD = "SYSBP" (Systolic Blood Pressure (mmHg)) Systolic Blood Pressure (mmHg) text 8
Derived
Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 85 – 89 Set to 'Grade 2' if 80 – 84 Set to 'Grade 3' if <80 Grade 4 is based on medical input Otherwise, set to Grade '0'
ATOXGRLN Analysis Toxicity Grade Low (N) integer 8 Solicited AR Toxicity Grade
  • • 0 = "Grade 0"
  • • 1 = "Grade 1"
  • • 2 = "Grade 2"
  • • 3 = "Grade 3"
  • • 4 = "Grade 4"
Assigned
ATOXGRHVLM Analysis Toxicity Grade High text 10
PARAMCD = "PULSE" (Pulse Rate (beats/min)) Pulse Rate (beats/min) text 8
Derived
Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 101 – 115 Set to 'Grade 2' if 116 – 130 Set to 'Grade 3' if >130 Grade 4 is based on medical input Otherwise, set to 'Grade 0'
PARAMCD = "TEMP" (Temperature (C)) Temperature (C) text 8
Derived
Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 38.0 – 38.4 Set to 'Grade 2' if >38.4 – 38.9 Set to 'Grade 3' if >38.9 – 40.0 Set to 'Grade 4' if >40.0 Otherwise, set to 'Grade 0'
PARAMCD = "DIABP" (Diastolic Blood Pressure (mmHg)) Diastolic Blood Pressure (mmHg) text 8
Derived
Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 91 – 95 Set to 'Grade 2' if 96 – 100 Set to 'Grade 3' if >100 Grade 4 is based on medical input Otherwise, set to 'Grade 0'
PARAMCD = "SYSBP" (Systolic Blood Pressure (mmHg)) Systolic Blood Pressure (mmHg) text 8
Derived
Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 141 – 150 Set to 'Grade 2' if 151 – 155 Set to 'Grade 3' if >155 Grade 4 is based on medical input Otherwise, set to 'Grade 0'
PARAMCD = "RESP" (Respiratory Rate (breaths/min)) Respiratory Rate (breaths/min) text 8
Derived
Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 17 – 20 Set to 'Grade 2' if 21 – 25 Set to 'Grade 3' if >25 Grade 4 is based on medical input Otherwise, set to 'Grade 0'
ATOXGRHN Analysis Toxicity Grade High (N) integer 8 Solicited AR Toxicity Grade
  • • 0 = "Grade 0"
  • • 1 = "Grade 1"
  • • 2 = "Grade 2"
  • • 3 = "Grade 3"
  • • 4 = "Grade 4"
Assigned
BTOXGRL Baseline Toxicity Grade Low text 10
Derived
Merge value of nonmissing ATOXGRL where ABLFL = 'Y' by USUBJID and PARAMCD
BTOXGRLN Baseline Toxicity Grade Low (N) integer 8 Solicited AR Toxicity Grade
  • • 0 = "Grade 0"
  • • 1 = "Grade 1"
  • • 2 = "Grade 2"
  • • 3 = "Grade 3"
  • • 4 = "Grade 4"
Assigned
BTOXGRH Baseline Toxicity Grade High text 10
Derived
Merge value of nonmissing ATOXGRH where ABLFL = 'Y' by USUBJID and PARAMCD
BTOXGRHN Baseline Toxicity Grade High (N) integer 8 Solicited AR Toxicity Grade
  • • 0 = "Grade 0"
  • • 1 = "Grade 1"
  • • 2 = "Grade 2"
  • • 3 = "Grade 3"
  • • 4 = "Grade 4"
Assigned
ATOXDSCL Analysis Toxicity Description Low text 30
Derived
Set to 'Bradycardia' if PARAMCD = 'PULSE' Hypotension' if PARAMCD = 'SYSBP'
ATOXDSCH Analysis Toxicity Description High text 30
Derived
Set to: 'Fever' if PARAMCD = 'TEMP' 'Tachycardia' if PARAMCD = 'PULSE' 'Systolic Hypertension' if PARAMCD = 'SYSBP' 'Diastolic Hypertension' if PARAMCD = 'DIABP' 'Respiratory Rate Increased' if PARAMCD = 'RESP'
SHIFT1 Shift 1 text 20
Derived
Only populate for post-baseline records where PARAMCD in ('PULSE', 'SYSBP') Set to BTOXGRL || ' to ' ||ATOXGRL if both of BTOXGRL and ATOXGRL are not missing If either BTOXGRL or ATOXGRL is missing: Set the missing BTOXGRL or ATOXGRL to 'UNK', then Set to BTOXGRL || ' to ' || ATOXGRL
SHIFT2 Shift 2 text 20
Derived
Only populate for post-baseline records Set to BTOXGRH || ' to '|| ATOXGRH if both of BTOXGRH and ATOXGRH are not missing If either BTOXGRH or ATOXGRH is missing: Set the missing BTOXGRH and ATOXGRH to 'UNK' Set to BTOXGRH || ' to ' || ATOXGRH
AWRANGE Analysis Window Valid Relative Range text 50
Derived
Set to '<=1 Pre-dose' for 'Baseline' 'Day 1 Post-dose' for 'Day 1' 'Day 2 - Day 43' for 'Day 29' 'Day 44 - Day 133' for 'Day 57' 'Day 134 – Day 301' for 'Day 209' 'Day 302 – Day 576' for 'Day 394' 'Day 577 - Day 773' for 'Day 759' 'Participant Decision Visit / OL-D1' for 'Participant Decision Visit / OL-D1' 'Day 2 – Day 43 Relative to Participant Decision Visit / OL-D1' for 'Open Label Day 29' 'Day 44 – Day 71 Relative to Participant Decision Visit / OL-D1' for 'Open Label Day 57' 'Illness Visit Day 1' for 'Illness Visit” and ATPT='Day 1' 'Illness Visit y Day 1' for 'Illness Visit y' and ATPT='Day 1' 'Illness Visit Day 2 - Illness Visit Day 35' for 'Illness Visit' and ATPT='Day 28' 'Illness Visit y Day 2 - Illness Visit y Day 35' for 'Illness Visit y' and ATPT='Day 28'
AWTARGET Analysis Window Target integer 8
Derived
Set to 1 if AVISIT = 'Baseline' Set to 1 if AVISIT = 'Day 1' Set to 29 if AVISIT = 'Day 29' Set to 57 if AVISIT = 'Day 57' Set to 209 if AVISIT = 'Day 209' Set to 394 if AVISIT = 'Day 394' Set to 759 if AVISIT = 'Day 759' Set to ADY where AVISIT='Participant Decision Visit / OL-D1' for 'Participant Decision Visit / OL-D1' Set to ADY + 28 where AVISIT='Participant Decision Visit / OL-D1' for 'Open Label Day 29' Set to ADY + 56 where AVISIT='Participant Decision Visit / OL-D1' for 'Open Label Day 57' Set to ADY where AVISIT='Illness Visit' for 'Illness Visit' and ATPT='Day 1' Set to ADY where AVISIT='Illness Visit y' for 'Illness Visit y' and ATPT='Day 1' Set to ADY + 27 where AVISIT='Illness Visit' for 'Illness Visit' and ATPT='Day 28' Set to ADY + 27 where AVISIT='Illness Visit y' for 'Illness Visit y' and ATPT='Day 28'
AWTDIFF Analysis Window Diff from Target integer 8
Derived
Set to absolute value of ( ADY - AWTARGET )
ANL01FL Analysis Flag 01 text 1 Yes Flag
  • • "Y"
Derived
If ABLFL='Y', then set to 'Y'; for post-baseline assessments where AVISITN is non-missing and result (AVAL) is non-missing, per subject per parameter and per AVISIT per ATPT, Within an AVISIT and ATPT, set to ‘Y’ for the assessment at scheduled visit (i.e., VISIT doesn't contain "UNSCHED"). If there are 2 or more assessments at same visit, set to the last assessment. If there is no scheduled visit, set to 'Y' for the assessment closest to the target study day (record with minimum AWTDIFF) in the visit window. If there are 2 or more assessments equal distance to the target study day (AWTDIFFs are same), set to the last assessment.
ANL02FL Analysis Flag 02 text 1 Yes Flag
  • • "Y"
Derived
For post baseline records where PARAMCD in ('PULSE', 'SYSBP'), per subject per parameter per AVISIT per ATPT where AVISIT NE 'Baseline': Set to 'Y' for the worst toxicity grade (ATOXGRL) where ATOXDSCL is not missing using the following order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0. If there are more than one worst toxicity grades, then set to the first record
ANL03FL Analysis Flag 03 text 1 Yes Flag
  • • "Y"
Derived
For post baseline records, per subject per parameter per AVISIT where AVISIT NE 'Baseline' Set to 'Y' for the worst toxicity grade (ATOXGRH) where ATOXDSCH is not missing using the following order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0.If there are more than one worst toxicity grades, then set to the first record
VSLOC Location of Vital Signs Measurement text 20
Predecessor: VS.VSLOC
VSLOCSP Other Location, specify text 200
Derived
Set to SUPPCM.QVAL where QNAM='VSLOCSP'

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Adverse Event Analysis Dataset (ADAE)

ADAE (Adverse Event Analysis Dataset) - OCCURRENCE DATA STRUCTURE Location: adae.xpt
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
TRTA Actual Treatment text 50
Derived
If MDOSREF='Vaccination 1', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 1', 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'Day 1', if MDOSREF='Vaccination 2', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 29', 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'Day 29', If MDOSREF='OL Vaccination 1', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'OL-D1', 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'OL-D1', if MDOSREF='OL Vaccination 2', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'OL-D29', 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'OL-D29'
TRTAN Actual Treatment (N) integer 8 Actual Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Assigned

1 if TRTA='Placebo', 2 if TRTA='mRNA-1273'
AESPID Sponsor-Defined Identifier text 40
Predecessor: AE.AESPID
AESEQ Sequence Number integer 8
Predecessor: AE.AESEQ
AECAT Category for Adverse Event text 25
Predecessor: AE.AECAT
AETERM Reported Term for the Adverse Event text 200
Predecessor: AE.AETERM
AEDECOD Dictionary-Derived Term text 200
Predecessor: AE.AEDECOD
AEBODSYS Body System or Organ Class text 200
Predecessor: AE.AEBODSYS
AEBDSYCD Body System or Organ Class Code integer 8
Predecessor: AE.AEBDSYCD
AELLT Lowest Level Term text 200
Predecessor: AE.AELLT
AELLTCD Lowest Level Term Code integer 8
Predecessor: AE.AELLTCD
AEPTCD Preferred Term Code integer 8
Predecessor: AE.AEPTCD
AEHLT High Level Term text 200
Predecessor: AE.AEHLT
AEHLTCD High Level Term Code integer 8
Predecessor: AE.AEHLTCD
AEHLGT High Level Group Term text 200
Predecessor: AE.AEHLGT
AEHLGTCD High Level Group Term Code integer 8
Predecessor: AE.AEHLGTCD
AESOC Primary System Organ Class text 200
Predecessor: AE.AESOC
AESOCCD Primary System Organ Class Code integer 8
Predecessor: AE.AESOCCD
AESTDTC Start Date/Time of Adverse Event text 20
Predecessor: AE.AESTDTC
AEENDTC End Date/Time of Adverse Event text 20
Predecessor: AE.AEENDTC
AESTDY Study Day of Start of Adverse Event integer 8
Predecessor: AE.AESTDY
AEENDY Study Day of End of Adverse Event integer 8
Predecessor: AE.AEENDY
AEENRF End Relative to Reference Period text 20
Predecessor: AE.AEENRF
ASTDT Analysis Start Date integer DATE9
Derived
Convert date part of AESTDTC convert to numeric See ADAE.ASTDT from ADaM Variable definition doc. for the date imputation rule

Additional ADaM Variable Definition

ASTDTM Analysis Start Date/Time integer DATETIME20
Derived
Concatenate ASTDT and ASTTM if both are non-missing
ASTDTF Analysis Start Date Imputation Flag text 1
Derived
Set to 'M' if year is present and month is imputed, or Set to 'D' if only day is imputed
ASTDY Analysis Start Relative Day integer 8
Derived
Set to ASTDT – ADSL.TR01SDT + 1 if ASTDT >= TR01SDT Set to ASTDT – ADSL.TR01SDT if ASTDT< TR01SDT
AENDT Analysis End Date integer DATE9
Derived
Converted date part of AEENDTC to numeric
AENTM Analysis End Time integer TIME5
Derived
Converted time part of AEENDTC to numeric
AENDTM Analysis End Date/Time integer DATETIME20
Derived
Concatenate AENDT and AENTM if both are non-missing
AEDUR Duration of Adverse Event text 20
Predecessor: AE.AEDUR
APERIOD Period integer 8
Derived
Set to 2 if ASTDTM>=ADSL.TR02SDTM (or ASTDT>=ADSL.AP02SSDT if ASTDTM or TR02SDTM has time part missing), otherwise, Set to 1
ASTAGE Stage text 30
Derived
Set to 'Vaccination stage' if (.< ADSL.TR01SDTM <=ASTDTM and ASTDT<= ADSL.TR01EDT+27) or (.< ADSL.TR02SDTM <=ASTDTM and ASTDT<= ADSL.TR02EDT+27), Note: If time part of TR01SDTM or time part of ASTDTM is missing,then use TR01SDT and ASTDT, if time part of TR02SDTM or time part of ASTDTM is missing, then use TR02SDT and ASTDT Set to 'Follow-Up stage' if (APERIOD=1 and ASTDT> ADSL.TR01EDT+27) or ASTDT> ADSL.TR02EDT+27
ASTAGEN Stage (N) integer 8 Stage Code
  • • 1 = "Vaccination stage"
  • • 2 = "Follow up stage"
Assigned
MDOSREF Most Recent Dose Reference text 50
Derived
Set to 'Vaccination 1' if (missing < ADSL.TR01SDTM <= ASTDTM < ADSL.DOSE2DTM) or ( missing < ADSL.TR01SDTM <= ASTDTM and ADSL.DOSE2DTM is missing and (TR02SDTM is missing or missing < ASTDTM < ADSL.TR02SDTM)) Set to 'Vaccination 2' if ( missing < ADSL.DOS2DTM <= ASTDTM < ADSL.TR02SDTM) or ( missing < ADSL.DOS2DTM <= ASTDTM and ADSL.TR02SDTM is missing) Set to 'OL Vaccination 1' if ( missing <ADSL.TR02SDTM <= ASTDTM < ADSL.OLDO2DTM) or ( missing < ADSL.TR02SDTM <= ASTDTM and ADSL.OLDO2DTM is missing) Set to 'OL Vaccination 2' if missing < ADSL.OLDO2DTM <= ASTDTM Note: Using date variables for comparison when time part is not available
MRDSTDY Relative Start Day from Most Recent Dose integer 8
Derived
Set to (the largest integer less than or equal to (ASTDTM – ADSL.TR01SDTM)/(24*60*60)) +1 if MDOSREF='Vaccination 1', Set to (the largest integer less than or equal to (ASTDTM – ADSL.DOS2DTM)/(24*60*60)) +1 if MDOSREF='Vaccination 2,' Set to (the largest integer less than or equal to (ASTDTM – ADSL.TR02SDTM)/(24*60*60)) +1 if MDOSREF='OL Vaccination 1', Set to (the largest integer less than or equal to (ASTDTM – ADSL.OLDO2DTM)/(24*60*60)) +1 if MDOSREF='OL Vaccination 2' Note: If time part of ASTDTM is missing, use ASTDT to replace ASTDTM and calculate as follows: Set to ASTDT – ADSL.TR01SDT + 1 if MDOSREF='Vaccination 1', Set to ASTDT – ADSL.DOSE2DT + 1 if MDOSREF='Vaccination 2', Set to ASTDT – ADSL.TR02SDT + 1 if MDOSREF='OL Vaccination 1', Set to ASTDT – ADSL.OLDOS2DT + 1 if MDOSREF='OL Vaccination 2'
MRDENDY Relative End Day from Most Recent Dose integer 8
Derived
Set to (the largest integer less than or equal to (AENDTM – ADSL.TR01SDTM)/(24*60*60)) + 1 if MDOSREF='Vaccination 1', Set to (the largest integer less than or equal to (AENDTM – ADSL.DOS2DTM)/(24*60*60)) + 1 if MDOSREF='Vaccination 2', Set to (the largest integer less than or equal to (AENDTM – ADSL.TR02SDTM)/(24*60*60)) + 1 If MDOSREF='OL Vaccination 1', Set to (the largest integer less than or equal to (AENDTM – ADSL.OLDO2DTM)/(24*60*60)) + 1 If MDOSREF='OL Vaccination 2' If time part of AENDTM is missing, use AENDT to replace AEENDTM and calculate as follows: AENDT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1', AENDT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2', AENDT – ADSL.TR02SDT+ 1 If MDOSREF='OL Vaccination 1', AENDT – ADSL.OLDOS2DT+ 1 If MDOSREF='OL Vaccination 2'
TRTEMFL Treatment Emergent Analysis Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if .< ADSL.TR01SDTM <= ASTDTM, or (if ASTDT missing and .< ADSL.TR01SDTM <= AENDTM) or both ASTDT and AENDT missing. Note: If time is not available, use TR01SDT, ASTDT and AENDT
AEMAFL Medically-Attended Flag text 20
Derived
Set to SUPPAE.QVAL where SUPPAE.QNAM=MAAEFL
D28FL AE Through 28 Days Analysis Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if non-missing MRDSTDY<=28
AEDISFL Leading to Study Discontinuation Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if either of the two conditions below is met: 1) If subject with DS.DSDECOD countians 'SERIOUS ADVERSE EVENT' or 'ADVERSE EVENT' and the specified adverse event number (numeric part of SUPPDS.QVAL where SUPPDS.QNAM='AESPIDX') match the numeric part of AE.AEGRPID where DSCAT = DISPOSITION EVENT and DS.DSSCAT='END OF STUDY' 2). If subject has record with AEOUT='FATAL' or AETERM contains 'DEATH'
AESER Serious Event text 9
Predecessor: AE.AESER
AESCONG Congenital Anomaly or Birth Defect text 8
Predecessor: AE.AESCONG
AESDISAB Persist or Signif Disability/Incapacity text 8
Predecessor: AE.AESDISAB
AESDTH Results in Death text 8
Predecessor: AE.AESDTH
AESHOSP Requires or Prolongs Hospitalization text 8
Predecessor: AE.AESHOSP
AESLIFE Is Life Threatening text 8
Predecessor: AE.AESLIFE
AESMIE Other Medically Important Serious Event text 8
Predecessor: AE.AESMIE
AEREL Causality text 60
Predecessor: AE.AEREL
AERELNST Relationship to Non-Study Treatment text 25
Predecessor: AE.AERELNST
AREL Analysis Causality text 20
Derived
Set to AEREL
ARELN Analysis Causality (N) integer 8 Analysis Causality (N)
  • • 1 = "NOT RELATED"
  • • 2 = "RELATED"
  • • 3 = "NOT APPLICABLE"
Assigned
AETOXGR Standard Toxicity Grade text 20
Predecessor: AE.AETOXGR
AESEV Severity/Intensity text 60 Severity/Intensity
  • • "MILD"
  • • "MODERATE"
  • • "SEVERE"
Predecessor: AE.AESEV
ATOXGR Analysis Toxicity Grade text 20
Derived
Set to 'Grade 1' if AETOXGR='1', Set to 'Grade 2’ if AETOXGR='2', Set to ‘Grade 3’ if AETOXGR='3', Set to ‘Grade 4’ if AETOXGR='4', Set to ‘Grade 5’ if AEOUT='FATAL' or AETERM contains 'DEATH'
ATOXGRN Analysis Toxicity Grade (N) integer 8 Toxicity Grade Code
  • • 1 = "Grade 1"
  • • 2 = "Grade 2"
  • • 3 = "Grade 3"
  • • 4 = "Grade 4"
  • • 5 = "Grade 5"
Assigned
ASEV Analysis Severity/Intensity text 20
Derived
Concatenate ATOXGR and Mixed case of AESEV with '/', eg, Grade 1/Mild; Set to ATOXGR if ATOXGR is 'Grade 4' or 'Grade 5'
ASEVN Analysis Severity/Intensity (N) integer 8 Analysis Severity/Intensity Code
  • • 1 = "Grade 1/Mild"
  • • 2 = "Grade 2/Moderate"
  • • 3 = "Grade 3/Severe"
  • • 4 = "Grade 4"
  • • 5 = "Grade 5"
Assigned
TOXGGR1 Pooled Toxicity Grade Group 1 text 20
Derived
Pooled grouping of toxicity grade for analysis: Set to '<3' when .<ATOXGRN <3, or Set to '>=3' when ATOXGRN >=3
TOXGGR1N Pooled Toxicity Grade 1 (N) integer 8 Pooled Toxicity Grade Code
  • • 1 = "<3"
  • • 2 = ">=3"
Assigned
AEACN Action Taken with Study Treatment text 99
Predecessor: AE.AEACN
AEACNOTH Other Action Taken text 200
Predecessor: AE.AEACNOTH
AEOUT Outcome of Adverse Event text 105
Predecessor: AE.AEOUT
AEOUTSP Recovered/Resolved with Sequelae,Spec text 200
Derived
Set to SUPPAE.QVAL where SUPPAE.QNAM=AEOUTSP
AEHENDTC Hospital Discharge Date text 20
Derived
Set to SUPPAE.QVAL where QNAM='AEHOSPEN'
AEHSTDTC Hospital Admission Date text 20
Derived
Set to SUPPAE.QVAL where QNAM='AEHOSPST'
ICUAD Admitted to ICU text 20
Derived
Set to HO.HOOCCUR where HODECOD='ICU' based on SUPPAE.QVAL where QNAM='HOSPIDX' and SUPPHO.QVAL where QNAM='HOSPIDX'
ICUDAY Number of Days in ICU integer 8
Derived
Set to HO.HODUR where HODECOD='ICU' based on SUPPAE.QVAL where QNAM='HOSPIDX' and SUPPHO.QVAL where QNAM='HOSPIDX'
AECVDIAG confirmed diagnosis Symptom Covid-19 text 200
Derived
Set to SUPPAE.QVAL where QNAM='AECVDIAG'
ADURSDT Analysis Duration Start Date integer 8
Derived
Set to ASTDT if ASTDT is not missing, Set to TR01SDT if TRTEMFL='Y'
ADUREDT Analysis Duration End Date integer DATE9
Derived
First set to AENDT, then if 1) missing, set to the earlier of (cutoff date, non missing ADSL.EOSDT) 2) if partial AENDT: If only day is missing, set to the earlier of (the last date of that month, cutoff date, non missing ADSL.EOSDT) If both month and day are missing, set to the earlier of (the last date of the yeatr, cutoff date, non missing ADSL.EOSDT)
ADURN Analysis Duration (N) integer 8
Derived
For records where SMQ01FL - SMQ14FL='Y' or ARTERM is not missing, do the following: per SUBJID per AEDECOD per MDOSREF, calculate the duration days: ADUREDT-ADURSDT+1 if there are multiple events, sum the duration of each event excluding the overlapping periods
CQ01NAM Customized Query 01 Name text 100
Derived
Set to 'Autoimmune' if AEDECOD is in import.CMQ where CMQNAME='AUTOIMMUNE'
CQ01FL Customized Query 01 Flag text 1 Yes Flag
  • • "Y"
Derived
Set ''Y' if CQ01NAM is not missing
CQ02NAM Customized Query 02 Name text 100
Derived
Set to 'Dermal Filler Reaction Post Vaccination' if AEDECOD is in import.CMQ where CMQNAME='DERMAL FILLER REACTION POST VACCINATION'
CQ02FL Customized Query 02 Flag text 1 Yes Flag
  • • "Y"
Derived
Set ''Y' if CQ02NAM is not missing
CQ03NAM Customized Query 03 Name text 100
Derived
Set to 'Bell's Palsy' if AELLT is in ('Bell's palsy', 'Palsy Bells', 'Facial palsy', and 'Facial paralysis')
CQ03FL Customized Query 03 Flag text 1 Yes Flag
  • • "Y"
Derived
Y' if CQ03NAM is not missing
SMQ01NAM SMQ 01 Name text 100
Derived
Set to 'Anaphylactic Reaction' if AEDECOD is in import.SMQ where SMQNAME='ANAPHYLACTIC REACTION'
SMQ01SC SMQ 01 Scope text 20
Derived
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='ANAPHYLACTIC REACTION'
SMQ01FL SMQ 01 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ01NAM is not missing
SMQ02NAM SMQ 02 Name text 100
Derived
Set to 'Angioedema' if AEDECOD is in import.SMQ where SMQNAME='ANGIOEDEMA'
SMQ02SC SMQ 02 Scope text 20
Derived
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='ANGIOEDEMA'
SMQ02FL SMQ 02 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ02NAM is not missing and SMQ02SC is 'Narrow'
SMQ03NAM SMQ 03 Name text 100
Derived
Set to 'Arthritis' if AEDECOD is in import.SMQ where SMQNAME='ARTHRITIS'
SMQ03SC SMQ 03 Scope text 20
Derived
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='ARTHRITIS'
SMQ03FL SMQ 03 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ03NAM is not missing and SMQ03SC is 'Narrow'
SMQ04NAM SMQ 04 Name text 100
Derived
Set to 'Convulsions' if AEDECOD is in import.SMQ where SMQNAME='CONVULSIONS'
SMQ04SC SMQ 04 Scope text 20
Derived
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='CONVULSIONS'
SMQ04FL SMQ 04 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ04NAM is not missing and SMQ04SC is 'Narrow'
SMQ05NAM SMQ 05 Name text 100
Derived
Set to 'Demyelinating Disease of Central Nervous System' if AEDECOD is in import.SMQ where SMQNAME='DEMYELINATION'
SMQ05SC SMQ 05 Scope text 20
Derived
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='DEMYELINATION'
SMQ05FL SMQ 05 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ05NAM is not missing and SMQ05SC is 'Narrow'
SMQ06NAM SMQ 06 Name text 100
Derived
Set to 'Hypersensitivity' if AEDECOD is in import.SMQ where SMQNAME='HYPERSENSITIVITY
SMQ06SC SMQ 06 Scope text 20
Derived
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='HYPERSENSITIVITY'
SMQ06FL SMQ 06 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ06NAM is not missing and SMQ06SC is 'Narrow'
SMQ07NAM SMQ 07 Name text 100
Derived
Set to 'Peripheral Neuropathy' if AEDECOD is in import.SMQ where SMQNAME='PERIPHERAL NEUROPATHY'
SMQ07SC SMQ 07 Scope text 20
Derived
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='PERIPHERAL NEUROPATHY'
SMQ07FL SMQ 07 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ07NAM is not missing and SMQ07SC is 'Narrow'
SMQ08NAM SMQ 08 Name text 100
Derived
Set to 'Vasculitis' if AEDECOD is in import.SMQ where SMQNAME='VASCULITIS'
SMQ08SC SMQ 08 Scope text 20
Derived
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='VASCULITIS'
SMQ08FL SMQ 08 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ08NAM is not missing and SMQ08SC is 'Narrow'
SMQ09NAM SMQ 09 Name text 100
Derived
Set to 'Central Nervous System Haemorrhages and Cerebrovascular Conditions' if AEDECOD is in import.SMQ where SMQNAME='CENTRAL NERVOUS SYSTEM HAEMORRHAGES AND CEREBROVASCULAR CONDITIONS'
SMQ09SC SMQ 09 Scope text 20
Derived
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='CENTRAL NERVOUS SYSTEM HAEMORRHAGES AND CEREBROVASCULAR CONDITIONS'
SMQ09FL SMQ 09 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ09NAM is not missing and SMQ09SC is 'Narrow'
SMQ10NAM SMQ 10 Name text 100
Derived
Set to 'Embolic and Thrombotic Events' if AEDECOD is in import.SMQ where SMQNAME='EMBOLIC AND THROMBOTIC EVENTS'
SMQ10SC SMQ 10 Scope text 20
Derived
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='EMBOLIC AND THROMBOTIC EVENTS'
SMQ10FL SMQ 10 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ10NAM is not missing and SMQ10SC is 'Narrow'
SMQ11NAM SMQ 11 Name text 100
Derived
Set to 'Hearing and Vestibular Disorders' if AEDECOD is in import.SMQ where SMQNAME='HEARING AND VESTIBULAR DISORDERS'
SMQ11SC SMQ 11 Scope text 20
Derived
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='HEARING AND VESTIBULAR DISORDERS'
SMQ11FL SMQ 11 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ11NAM is not missing and SMQ11SC is 'Narrow'
SMQ12NAM SMQ 12 Name text 100
Derived
Set to 'Thrombophlebitis' if AEDECOD is in import.SMQ where SMQNAME='THROMBOPHLEBITIS'
SMQ12SC SMQ 12 Scope text 20
Derived
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='THROMBOPHLEBITIS'
SMQ12FL SMQ 12 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ12NAM is not missing and SMQ12SC is 'Narrow'
SMQ13NAM SMQ 13 Name text 100
Derived
Set to 'Haematopoietic Cytopenias' if AEDECOD is in import.SMQ where SMQNAME='HAEMATOPOIETIC CYTOPENIAS'
SMQ13SC SMQ 13 Scope text 20
Derived
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='HAEMATOPOIETIC CYTOPENIAS'
SMQ13FL SMQ 13 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ13NAM is not missing and SMQ13SC is 'Narrow'
SMQ14NAM SMQ 14 Name text 100
Derived
Set to 'Cardiomyopathy' if AEDECOD is in import.SMQ where SMQNAME='CARDIOMYOPATHY'
SMQ14SC SMQ 14 Scope text 20
Derived
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='CARDIOMYOPATHY'
SMQ14FL SMQ 14 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ14NAM is not missing and SMQ14SC is 'Narrow'
ARTERM Collected Term for Adverse Reaction text 40
Derived
Set to import.symp.CETERM where ADAE.AEDECOD = import.symp.CEDECOD
AESOFL Solicited Adverse Reaction? text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if ARTERM is not missing
APLFL Anaphylaxis Flag text 1 Yes Flag
  • • "Y"
Derived
Subject level flag based on import.SMQ where SMQNAME='ANAPHYLACTIC REACTION': Set to 'Y' if one of the conditions below is met: 1) AEDECOD in import.SMQ where SMQ.Scope='Narrow' or SMQ.Category = 'A' 2) One AEDECOD in import.SMQ where SMQ.Category = 'B' and One AEDECOD in import.SMQ where SMQ.Category = 'C'. The two identified events should occur within 24 hours based on AESTDTC 3) One AEDECOD in import.SMQ where SMQ.Category = 'D' and [One AEDECOD in import.SMQ where SMQ.Category = 'B' or One AEDECOD in import.SMQ where SMQ.Category = 'C]. The two identified events should occur within 24 hours based on AESTDTC. Note: Use date part to compare if time part is missing, and no date or time imputation
APLREAS Reason for Anaphylaxis text 200
Derived
Refer to the 3 conditions for APLFL: If condition 1 is met, APLREAS = "A narrow term or a term from Category A", If condition 2 is met, APLREAS = "A term from Category B and a term from Category C ", If condition 3 is met, APLREAS = "A term from Category D and [a term from Category B or a term from Category C] " Note: If multiple reasons, concatenate and seperate by '; '
ANL01FL Analysis Flag 01 text 1 Yes Flag
  • • "Y"
Derived
Set to Y if all the conditions below are met: 1) ARTERM in ('Pain', 'Erythema', 'Swelling', 'Underarm Gland Swelling or Tenderness'), 2) MRDSTDY>=8
ANL02FL Analysis Flag 02 text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if ANL01FL='Y' and: MRDSTDY=8 and it exists in SDTM.FACE where FATPTNUM=7 by SUBJID, MDOSREF/FATPTREF, ARTERM/FAOBJ
ANL03FL Analysis Flag 03 text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if all the conditions below are met: 1) ANL01FL='Y' 2) It exists in SDTM.FACE by SUBJID, MDOSREF/FATPTREF, ARTERM/FAOBJ. That is, subject's events happen in the same period in SDTM.FACE, link ADAE and SDTM.FACE by SUBJID, match the events and corresponding period by ADAE.MDOSREF=FACE.FATPTREF, and ADAE.ARTERM=FACE.FAOBJ 3) If MRDSTDY = 8, the event identified in FACE in step 2) should have max(FATPTNUM) < 7 4) It does not exist in FAAE by SUBJID - MDOSREF/FATPTREF - ARTERM/FAOBJ. Similar linking rule as in Step 2
ANL04FL Analysis Flag 04 text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if all the conditions below are met: 1) ANL01FL='Y' 2) It does not exist in FACE by SUBJID - MDOSREF/FATPTREF - ARTERM/FAOBJ

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Concomitant Medication Analysis Dataset (ADCM)

ADCM (Concomitant Medication Analysis Dataset) - OCCURRENCE DATA STRUCTURE Location: adcm.xpt
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
CMSEQ Sequence Number integer 8
Predecessor: CM.CMSEQ
CMCAT Category for Medication text 200
Predecessor: CM.CMCAT
CMTRT Reported Name of Drug, Med, or Therapy text 200
Predecessor: CM.CMTRT
CMTRTO1 Name of Medication text 200
Derived
Set to SUPPCM.QVAL where QNAM='CMTRTO1'
CMDECOD Standardized Medication Name text 200
Predecessor: CM.CMDECOD
CMDECOD1 Standardized Medication Name 1 text 200
Derived
Set to SUPPCM.QVAL where QNAM='CMDECOD1'
CMDECOD2 Standardized Medication Name 2 text 200
Derived
Set to SUPPCM.QVAL where QNAM='CMDECOD2'
CMDECOD3 Standardized Medication Name 3 text 200
Derived
Set to SUPPCM.QVAL where QNAM='CMDECOD3'
CMINDC Indication text 200
Predecessor: CM.CMINDC
CMDOSE Dose per Administration integer 8
Predecessor: CM.CMDOSE
CMDOSU Dose Units text 90
Predecessor: CM.CMDOSU
CMUOTHSP Dose Unit Other Specficiation text 200
Derived
Set to SUPPCM.QVAL where QNAM='CMUOTHSP'
CMDOSFRQ Dosing Frequency per Interval text 75
Predecessor: CM.CMDOSFRQ
CMFOTHSP Dose Frequency Specification text 200
Derived
Set to SUPPCM.QVAL where QNAM='CMFOTHSP'
CMROUTE Route of Administration text 90
Predecessor: CM.CMDOSFRQ
CMROTHSP Dose Route Other Specification text 200
Derived
Set to SUPPCM.QVAL where QNAM='CMROTHSP'
CMSTDTC Start Date/Time of Medication text 20
Predecessor: CM.CMSTDTC
CMENDTC End Date/Time of Medication text 20
Predecessor: CM.CMENDTC
CMSTDY Study Day of Start of Medication integer 8
Predecessor: CM.CMSTDY
CMENDY Study Day of End of Medication integer 8
Predecessor: CM.CMENDY
CMENRF End Relative to Reference Period text 200
Predecessor: CM.CMENRTPT
CMSOLFL Medication Taken for Solicited Event text 1
Derived
Set to SUPPCM.QVAL when QNAM='CMSOL'
ASTDT Analysis Start Date integer DATE9.
Derived
Convert date part of CM.CMSTDTC to numeric if day, month, and year are all present See ADCM.ASTDT from Additional ADaM Variable Definition Doc for partial date imputation rules

Additional ADaM Variable Definition

ASTDTF Analysis Start Date Imputation Flag text 1
Derived
Set to 'D' if only the day is imputed, or Set to 'M' if the day and the month are imputed
ASTDY Analysis Start Relative Day integer 8
Derived
Set to ASTDT - TR01SDT + 1 if ASTDT >= TR01SDT, or Set to ASTDT - TR01SDT if ASTDT < TR01SDT
AENDT Analysis End Date integer DATE9.
Derived
Converted date part of CM.CMENDTC to numeric if day, month, and year are all present If day and month are both missing, AENDT is whichever is earliest of the following: 31DECYYYY, EOSDT, or DTHDT If only day is missing, AENDT is whichiever is earliest of the following: EOSDT, DTHDT, or xxMMMYYYY where xx is the last day of the month
AENDTF Analysis End Date Imputation Flag text 1
Derived
Set to 'D' if only the day is imputed, or Set to 'M' if the day and the month are imputed
AENDY Analysis End Relative Day integer 8
Derived
Set to AENDT - TR01SDT + 1 if AENDT >= TR01SDT, or Set to AENDT - TR01SDT if AENDT < TR01SDT
MDOSREF Most Recent Dose Reference text 50
Derived
Set to 'Vaccination 1' if 1. missing < ADSL.TR01SDT <= ASTDT < ADSL.DOSE2DT or 2. missing < ADSL.TR01SDT <= ASTDT and ADSL.DOS2DT is missing and (ADSL.TR02SDT is missing or missing < ASTDT < ADSL.TR02SDT), Set to 'Vaccination 2' if 1. missing < ADSL.DOS2DT <= ASTDT < ADSL.TR02SDT or 2. missing < ADSL.DOS2DT <= ASTDT and ADSL.TR02SDT is missing, Set to 'OL Vaccination 1' if 1. missing < ADSL.TR02SDT <= ASTDT<ADSL.OLDOS2DT or 2. missing < ADSL.TR02SDT <= ASTDT and ADSL.OLDOS2DT is missing, Set to 'OL Vaccination 2' if missing < ADSL.OLDOS2DT <= ASTDT
APERIOD Period integer 8
Derived
Set to 2 if ASTDTM>=ADSL.TR02SDTM (or ASTDT>=ADSL.AP02SSDT if ASTDTM or TR02SDTM has time part missing), otherwise, Set to 1
MRDSTDY Relative Start Day from Most Recent Dose integer 8
Derived
Set to ASTDT – TR01SDT + 1 if MDOSREF='Vaccination 1', Set to ASTDT – DOS2DT + 1 if MDOSREF='Vaccination 2', Set to ASTDT – TR02SDT + 1 if MDOSREF='OL Vaccination 1', Set to ASTDT – OLDOS2DT + 1 if MDOSREF='OL Vaccination 2'
CMMOI1FL Modified Indication 1 Result Flag text 1
Derived
Y' if SUPPCM.QVAL='Y' where  QNAM='CMPLX'
CMMOI2FL Modified Indication 4 Result Flag text 1
Derived
Set to 'Y' if the first 8 digits of SUPPCM.QVAL (where SUPPCM.QNAM="CMPROTCD") is in the first 8 digits of import.pain_drugcode.DRUGCODE
CMMOI3FL Modified Indication 3 Result Flag text 1
Derived
Y' if ATCLEV4T='INFLUENZA VACCINES'
PREFL Pre-treatment Flag text 1
Derived
"Y" if ASTDT < TR01SDT or ASTDT is missing; missing otherwise
ONTRTFL On Treatment Record Flag text 1
Derived
Set to 'Y' if APERIOD=1 and (ASTDT <= TR01EDT + 27 days) and (AENDT >= TR01SDT or AENDT is missing); or if ASTDT is missing and (AENDT >= TR01SDT or AENDT is missing); or if APERIOD=2 and (ASTDT <= TR02EDT + 27 days) and (AENDT >= TR02SDT or AENDT is missing); or if ASTDT is missing and (AENDT >= TR02SDT or AENDT is missing); or missing otherwise
FUPFL Follow-up Flag text 1
Derived
Set to 'Y' if APERIOD=1 and (AENDT > TR01EDT + 27 days or AENDT is missing); or if APERIOD=2 and (AENDT > TR02EDT + 27 days or AENDT is missing); missing otherwise
ATCLEV1T ATC Level 1 text 200
Derived
Set to SUPPCM.QVAL where QNAM='ATCLEV1T'
ATCLEV2T ATC Level 2 text 200
Derived
Set to CM.CMCLAS
ATCLEV3T ATC Level 3 text 200
Derived
Set to SUPPCM.QVAL where QNAM='ATCLEV3T'
ATCLEV4T ATC Level 4 text 200
Derived
Set to SUPPCM.QVAL where QNAM='ATCLEV4T'
CMPROTCD Name of MedicationPRODUCT_CODE text 20
Derived
Set to SUPPCM.QVAL where QNAM='CMPROTCD'

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Deviation Analysis Dataset (ADDV)

ADDV (Deviation Analysis Dataset) - OCCURRENCE DATA STRUCTURE Location: addv.xpt
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
DVSEQ Sequence Number integer 8
Predecessor: DV.DVSEQ
DVCAT Category for Protocol Deviation text 40 Category for Protocol Deviation
  • • "ICH/GCP Deviation"
  • • "Protocol Deviation"
Predecessor: DV.DVCAT
DVSCAT Subcategory for Protocol Deviation text 40 Subcategory for Protocol Deviation

[24 Terms]

Predecessor: DV.DVSCAT
DVSTDTC Start Date/Time of Deviation date ISO 8601
Predecessor: DV.DVSTDTC
DVSTDY Study Day of Start of Deviation integer 8
Predecessor: DV.DVSTDY
APERIOD Period integer 8
Derived
Set to 2 if non-missing AP02SSDT<=DVSTDTC, Otherwise, Set to 1
DVTERM Protocol Deviation Term text 200
Predecessor: DV.DVTERM
DVTERM1 Protocol Deviation Term text 200
Derived
Set to SUPPDV.QVAL where SUPPDV.QNAM='DVTERM1'
DVSIG Significant Protocol Deviation text 20
Derived
Set to SUPPDV.QVAL where SUPPDV.QNAM='DVSIG'

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Treatment Exposure Analysis Dataset (ADEX)

ADEX (Treatment Exposure Analysis Dataset) - OCCURRENCE DATA STRUCTURE Location: adex.xpt
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
ASEQ Analysis Sequence Number integer 8
Derived
Sort by USUBJID, VISIT, EX.EXSEQ, EX.ECSEQ and start from 1, increase by 1 for records within each subject
EXTRT Name of Treatment text 150 Treatment Exposure Analysis Dataset Treatment Group
  • • "PLACEBO"
  • • "mRNA-1273"
Predecessor: EX.EXTRT
EXDOSE Dose integer 8
Predecessor: EX.EXDOSE
EXDOSU Dose Units text 20
Predecessor: EX.EXDOSU
EXDOSFRM Dose Form text 20
Predecessor: EX.EXDOSFRM
EXDOSFRQ Dosing Frequency per Interval text 8
Predecessor: EX.EXDOSFRQ
EXROUTE Route of Administration text 39
Predecessor: EX.EXROUTE
EXLOC Location of Dose Administration text 20
Predecessor: EX.EXLOC
EXLAT Laterality text 25 Laterality
  • • "LEFT"
  • • "RIGHT"
Predecessor: EX.EXLAT
EXSTDTC Start Date/Time of Treatment datetime ISO 8601
Predecessor: EX.EXSTDTC
EXENDTC End Date/Time of Treatment datetime ISO 8601
Predecessor: EX.EXENDTC
EXSTDY Study Day of Start of Treatment integer 8
Predecessor: EX.EXSTDY
VISIT Visit Name text 25
Predecessor: EX.VISIT
VISITNUM Visit Number integer 8
Predecessor: EX.VISITNUM
ASTDT Analysis Start Date integer DATE9
Derived
Convert date part of EX.EXSTDTC to numeric
ASTDTM Analysis Start Date/Time integer DATETIME20
Derived
Convert EXSTDTC to numeric
AENDT Analysis End Date integer DATE9
Derived
Converted date part of EX.EXENDTC to numeric
APERIOD Period integer 8
Derived
Set to 2 if ASTDTM>=ADSL.TR02SDTM (or ASTDT>=ADSL.AP02SSDT if ASTDTM or TR02SDTM has time part missing), otherwise, Set to 1
DOSEYNFL Study Treatment Occurrence Flag text 1
Derived
Set to 'Y' if EXSTDTC is not missing. Set to 'N' if EXSTDTC is missing and EC.ECOCCUR='N'
NDOSERS Reason Study Treatment not Given text 200
Derived
Set to EC.ECREASOC
NDOSRSP Reason Study Treatment not Given Specify text 200
Derived
Set to SUPPEC.QVAL where QNAM='EXREASSP'
NDOSRSP1 Reason Study Trt not Given Specify 1 text 200
Derived
Set to SUPPEC.QVAL where QNAM='EXREASP1'
NDOSRSP2 Reason Study Trt not Given Specify 2 text 200
Derived
Set to SUPPEC.QVAL where QNAM='EXREASP2'
SRCDOM Source Data text 20
Derived
Set to EX.DOMAIN if source data are from EX or Set to EC.DOMAIN if source data are from EC
SRCSEQ Source Sequence Number integer 8
Derived
Set to EX.EXSEQ if source data are from EX or Set to EC.ECSEQ if source data are from EC

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Medical History Analysis Dataset (ADMH)

ADMH (Medical History Analysis Dataset) - OCCURRENCE DATA STRUCTURE Location: admh.xpt
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 20
Predecessor: ADSL.STUDYID
USUBJID Unique Subject Identifier text 50
Predecessor: ADSL.USUBJID
SUBJID Subject Identifier for the Study text 20
Assigned
SITEID Study Site Identifier text 8
Predecessor: ADSL.SITEID
COUNTRY Country text 10
Predecessor: ADSL.COUNTRY
AGE Age integer 8
Predecessor: ADSL.AGE
AGEU Age Units text 15
Predecessor: ADSL.AGEU
STRATAR Strata Used for Randomization text 40
Predecessor: ADSL.STRATAR
STRATARN Strata Used for Randomization (N) integer 8 Strata Used for Randomization Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAR
AGEGR1 Pooled Age Group 1 text 40
Predecessor: ADSL.STRATARN
AGEGR1N Pooled Age Group 1 (N) integer 8 Pooled Age Group 1 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 Years"
Predecessor: ADSL.AGEGR1
AGEGR2 Pooled Age Group 2 text 40
Predecessor: ADSL.AGEGR2
AGEGR2N Pooled Age Group 2 (N) integer 8 Pooled Age Group 2 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 Years"
Predecessor: ADSL.AGEGR2N
AGEGR3 Pooled Age Group 3 text 40
Predecessor: ADSL.AGEGR3
AGEGR3N Pooled Age Group 3 (N) integer 8 Pooled Age Group 3 Code
  • • 1 = ">=18 and <65 Years"
  • • 2 = ">=65 and <75 Years"
  • • 3 = ">=75 and <85 Years"
  • • 4 = ">=85 Years"
Predecessor: ADSL.AGEGR3N
AGEGR4 Pooled Age Group 4 text 40
Predecessor: ADSL.AGEGR4
AGEGR4N Pooled Age Group 4 (N) integer 8 Pooled Age Group 4 Code
  • • 1 = ">=18 and <=25 Years"
  • • 2 = ">=26 and <=50 Years"
Predecessor: ADSL.AGEGR4N
SEX Sex text 18 Sex
  • • "F" = "Female"
  • • "M" = "Male"
Predecessor: ADSL.SEX
RACE Race text 50 Race

[9 Terms]

Predecessor: ADSL.RACE
RACESPY Race Specify text 200
Predecessor: ADSL.RACESPY
ETHNIC Ethnicity text 75 Ethnicity
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
  • • "NOT REPORTED"
  • • "UNKNOWN"
Predecessor: ADSL.ETHNIC
RANDFL Randomized Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDFL
FASFL Full Analysis Set Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.FASFL
SAFFL Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAFFL
SAR1FL First Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR1FL
SAR2FL Second Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SAR2FL
SARAFL Solicited Safety Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.SARAFL
MITTFL Modified Intent to Treat Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.MITTFL
PPROTFL Per-Protocol Population Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPROTFL
RANDIGFL Random Immunogenicity Subcohort Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.RANDIGFL
PPSIFL Per-Protocol Random Subcohort for IG text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.PPSIFL
CCIASFL Case-Cohort IG Analysis Set Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CCIASFL
DOSE1FL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE1FL
DOSE2FL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.DOSE2FL
OLDOS1FL OL Vaccination 1 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS1FL
OLDOS2FL OL Vaccination 2 Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.OLDOS2FL
RTPCRBL Baseline RT-PCR Test text 20
Predecessor: ADSL.RTPCRBL
ELECSBL Baseline Elecsys Sars Cov-2 Assay text 20
Predecessor: ADSL.ELECSBL
SCOV2BL Baseline SARS-CoV-2 Status text 20
Predecessor: ADSL.SCOV2BL
TRT01P Planned Treatment for Period 01 text 25
Predecessor: ADSL.TRT01P
TRT01PN Planned Treatment for Period 01 (N) integer 8
Predecessor: ADSL.TRT01PN
TRT01A Actual Treatment for Period 01 text 25
Predecessor: ADSL.TRT01A
TRT01AN Actual Treatment for Period 01 (N) integer 8 Period 01/02 Treatment Code
  • • 1 = "Placebo"
  • • 2 = "mRNA-1273"
Predecessor: ADSL.TRT01AN
TRT02P Planned Treatment for Period 02 text 25
Predecessor: ADSL.TRT02P
TRT02PN Planned Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02PN
TRT02A Actual Treatment for Period 02 text 25
Predecessor: ADSL.TRT02A
TRT02AN Actual Treatment for Period 02 (N) integer 8
Predecessor: ADSL.TRT02AN
TR01SDT Date of First Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01SDT
TR01SDTM Datetime of First Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01SDTM
TRTSEQP Planned Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQP
TRTSEQPN Planned Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQPN
TRTSEQA Actual Sequence of Treatments text 30
Predecessor: ADSL.TRTSEQA
TRTSEQAN Actual Sequence of Treatments (N) integer 8
Predecessor: ADSL.TRTSEQAN
TRTSDT Date of First Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment integer DATE9
Predecessor: ADSL.TRTEDT
TR01EDT Date of Last Exposure in Period 01 integer DATE9
Predecessor: ADSL.TR01EDT
TR01EDTM Datetime of Last Exposure in Period 01 integer DATETIME20
Predecessor: ADSL.TR01EDTM
DOSE2DT Date of Dose 2 in Blinded Phase integer DATE9
Predecessor: ADSL.DOSE2DT
DOS2DTM Datetime of Dose 2 in Blinded Phase integer DATETIME20
Predecessor: ADSL.DOS2DTM
TR02SDT Date of First Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02SDT
TR02SDTM Datetime of First Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02SDTM
TR02EDT Date of Last Exposure in Period 02 integer DATE9
Predecessor: ADSL.TR02EDT
TR02EDTM Datetime of Last Exposure in Period 02 integer DATETIME20
Predecessor: ADSL.TR02EDTM
OLDOS2DT Date of Dose 2 in Open Label Phase integer DATE9
Predecessor: ADSL.OLDOS2DT
OLDO2DTM Datetime of Dose 2 in Open Label Phase integer DATETIME20
Predecessor: ADSL.OLDO2DTM
EUAVACDT Date of Post-EUA Off-Study COVID Vaccine integer DATE9
Predecessor: ADSL.EUAVACDT
EFFCODT Efficacy Date Cutoff Date integer DATE9
Predecessor: ADSL.EFFCODT
AP01SDT Period 01 Start Date integer DATE9
Predecessor: ADSL.AP01SDT
AP01EDT Period 01 End Date integer DATE9
Predecessor: ADSL.AP01EDT
AP02SDT Period 02 Start Date integer DATE9
Predecessor: ADSL.AP02SDT
AP02EDT Period 02 End Date integer DATE9
Predecessor: ADSL.AP02EDT
AP01SSDT Period 01 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SSDT
AP01SEDT Period 01 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP01SEDT
AP02SSDT Period 02 Start Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SSDT
AP02SEDT Period 02 End Date for Safety Analysis integer DATE9
Predecessor: ADSL.AP02SEDT
RSKF1 Risk Factor 1 text 200
Predecessor: ADSL.RSKF1
RSKF2 Risk Factor 2 text 200
Predecessor: ADSL.RSKF2
RSKF3 Risk Factor 3 text 200
Predecessor: ADSL.RSKF3
RSKF4 Risk Factor 4 text 200
Predecessor: ADSL.RSKF4
RSKF5 Risk Factor 5 text 200
Predecessor: ADSL.RSKF5
RSKF6 Risk Factor 6 text 200
Predecessor: ADSL.RSKF6
STRATAV Strata from Verification Source text 40
Predecessor: ADSL.STRATAV
STRATAVN Strata from Verification Source (N) integer 8 Strata from Verification Source Code
  • • 1 = ">=18 and <65 Years and Not at Risk"
  • • 2 = ">=18 and <65 Years and at Risk"
  • • 3 = ">=65 Years"
Predecessor: ADSL.STRATAVN
STUDDUR3 Study Duration 3 integer 8
Predecessor: ADSL.STUDDUR3
MINORITY Minority text 20 Minority
  • • "Minority"
  • • "Non-minority"
Predecessor: ADSL.MINORITY
RACEGR1 Pooled Race Group 1 text 40
Predecessor: ADSL.RACEGR1
RACEGR1N Pooled Race Group 1 (N) integer 8 Pooled Race Group 1 Code
  • • 1 = "Caucasian"
  • • 2 = "Non-caucasian"
Predecessor: ADSL.RACEGR1N
RISKGR1 Pooled Risk Group 1 text 40
Predecessor: ADSL.RISKGR1
RISKGR1N Pooled Risk Group 1 (N) integer 8 Pooled Risk Group 1 Code
  • • 1 = "At Risk"
  • • 2 = "Not At Risk"
Predecessor: ADSL.RISKGR1N
RETHGR1 Pooled Race and Ethnicity Group 1 text 40
Predecessor: ADSL.RETHGR1
RETHGR1N Pooled Race and Ethnicity Group 1 (N) integer 8 Pooled Race and Ethnicity Group 1 Code
  • • 1 = "White"
  • • 2 = "Communities of Color"
Predecessor: ADSL.RETHGR1N
COVIDAFL COVID-19 Based on Adjudication Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.COVIDAFL
CVDSVAFL Severe COVID-19 Based on Adj Flag text 1 No/Yes Flag
  • • "Y"
  • • "N"
Predecessor: ADSL.CVDSVAFL
MHSEQ Sequence Number integer 8
Predecessor: MH.MHSEQ
MHCAT Category for Medical History text 40
Predecessor: MH.MHCAT
MHTERM Reported Term for the Medical History text 200
Predecessor: MH.MHTERM
MHBODSYS Body System or Organ Class text 67
Predecessor: MH.MHBODSYS
MHDECOD Dictionary-Derived Term text 61
Predecessor: MH.MHDECOD
MHPTCD Preferred Term Code integer 12
Predecessor: MH.MHPTCD
MHSTDTC Start Date/Time of Medical History Event text 20
Predecessor: MH.MHSTDTC
MHENDTC End Date/Time of Medical History Event text 20
Predecessor: MH.MHENDTC
MHENRTPT End Relative to Reference Time Point text 10
Predecessor: MH.MHENRTPT
MHSTDY Study Day of Start of Observation integer 8
Predecessor: MH.MHSTDY
MHENDY Study Day of End of Observation integer 8
Predecessor: MH.MHENDY
SMQ01NAM SMQ 01 Name text 100
Derived
Set to 'Anaphylactic Reaction' if AEDECOD is in import.SMQ where SMQNAME='ANAPHYLACTIC REACTION'
SMQ01SC SMQ 01 Scope text 40
Derived
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='ANAPHYLACTIC REACTION'
SMQ01FL SMQ 01 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ01NAM is not missing
SMQ02NAM SMQ 02 Name text 100
Derived
Set to 'Angioedema' if MHDECOD is in import.SMQ where SMQNAME='ANGIOEDEMA'
SMQ02SC SMQ 02 Scope text 40
Derived
Set to SMQ.SCOPE if MHDECOD is in import.SMQ where SMQNAME='ANGIOEDEMA'
SMQ02FL SMQ 02 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ02NAM is not missing and SMQ02SC is 'Narrow'
SMQ06NAM SMQ 06 Name text 100
Derived
Set to 'Hypersensitivity' if AEDECOD is in import.SMQ where SMQNAME='HYPERSENSITIVITY'
SMQ06SC SMQ 06 Scope text 40
Derived
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='HYPERSENSITIVITY'
SMQ06FL SMQ 06 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if SMQ06NAM is not missing and SMQ06SC is 'Narrow'
CQ01NAM Customized Query 01 Name text 100
Derived
Set to 'Autoimmune' if MHDECOD is in import.CMQ where CMQNAME='AUTOIMMUNE'
CQ01FL Customized Query 01 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if CQ01NAM is not missing
CQ02NAM Customized Query 02 Name text 100
Derived
Set to 'Dermal Filler Reaction Post Vaccination' if MHDECOD is in import.CMQ where CMQNAME='DERMAL FILLER REACTION POST VACCINATION'
CQ02FL Customized Query 02 Flag text 1 Yes Flag
  • • "Y"
Derived
Set to 'Y' if CQ02NAM is not missing

Go to the top of the Define-XML document


CodeLists

Severity/Intensity [C66769]
Permitted Value (Code)
MILD [C41338]
MODERATE [C41339]
SEVERE [C41340]
Solicited AR within D7, Post D7 and Summary Analysis Dataset Parameter Category
Permitted Value (Code)
LOCAL
SYSTEMIC
Parameter Category 1 (N) in ADAR* datasets
Permitted Value (Code) Display Value (Decode)
1 LOCAL
2 SYSTEMIC
Solicited AR within / Post Day 7 Analysis Dataset Parameter Code
Permitted Value (Code) Display Value (Decode)
ERYTHDIA Erythema Longest Diameter (mm)
SWELLDIA Swelling Longest Diameter (mm)
PAIN Pain
LYMPH Lymphadenopathy
ARTHRALG Arthralgia
CHILLS Chills
FATIGUE Fatigue
FEVER Fever (C)
HEADACHE Headache
MYALGIA Myalgia
NAUSEA Nausea/Vomiting
MEDTAK Medication Taken Today for Pain or Fever
MEDTAKT Treat Pain or Fever already Occurred
MEDTAKP Prevent Pain or Fever from Occurring
Solicited AR Summary Analysis Dataset Parameter Code
Permitted Value (Code) Display Value (Decode)
ANYDUR Number of Days for Any Solicited AR
LOCDUR Number of Days for Local Solicited AR
SYSDUR Number of Days for Systemic Solicited AR
WSAR Worst Analysis Toxicity Grade for Any Solicited AR between Day 1 and Day 7
ERYTHDUR Number of Days for Erythema
LYMPHDUR Number of Days for Lymphadenopathy
PAINDUR Number of Days for Pain
SWELLDUR Number of Days for Swelling
WERYTH Worst Analysis Toxicity Grade for Erythema between Day 1 and Day 7
WLYMPH Worst Analysis Toxicity Grade for Lymphadenopathy between Day 1 and Day 7
WPAIN Worst Analysis Toxicity Grade for Pain between Day 1 and Day 7
WSLAR Worst Analysis Toxicity Grade for Any Solicited Local AR between Day 1 and Day 7
WSWELL Worst Analysis Toxicity Grade for Swelling between Day 1 and Day 7
ARTHRDUR Number of Days for Arthralgia
CHILLDUR Number of Days for Chills
FATIGDUR Number of Days for Fatigue
FEVERDUR Number of Days for Fever
HEADADUR Number of Days for Headache
MYALGDUR Number of Days for Myalgia
NAUSEDUR Number of Days for Nausea
WARTHR Worst Analysis Toxicity Grade for Arthralgia between Day 1 and Day 7
WCHILLS Worst Analysis Toxicity Grade for Chills between Day 1 and Day 7
WFATIGUE Worst Analysis Toxicity Grade for Fatigue between Day 1 and Day 7
WFEVER Worst Analysis Toxicity Grade for Fever between Day 1 and Day 7
WHEAD Worst Analysis Toxicity Grade for Headache between Day 1 and Day 7
WMYALGIA Worst Analysis Toxicity Grade for Myalgia between Day 1 and Day 7
WNAUSEA Worst Analysis Toxicity Grade for Nausea between Day 1 and Day 7
WSSAR Worst Analysis Toxicity Grade for Any Solicited Systemic AR between Day 1 and Day 7
Category for Protocol Deviation
Permitted Value (Code)
ICH/GCP Deviation
Protocol Deviation
Subcategory for Protocol Deviation
Permitted Value (Code)
Data Privacy
ICF Process/Timing
Inv Adequate Resources
Inv Communication with Ethics
Inv Oversight
Inv Qualifications/Agreements
Inv Randomization/Unblinding
Inv Record Keeping CRF
Inv Record Keeping Esntl Docs
Inv Record Keeping Source Docs
Inv Safety Reporting (CRF)
Inv Safety Rptg (Reg/Sponsor)
Inv Subject Medical Care
Local Regulatory Compliance
Accidental Unblinding
Concomitant Medication
Exclusion Criteria
Inclusion Criteria
Missing Endpoint Assessments
Study Procedures/Assessments
Study Treatment Admin/Dispense
Study Treatment Randomization
Visit Scheduling
Withdrawal/Term Criteria
Efficacy Analysis Visit Code
Permitted Value (Code) Display Value (Decode)
3 Day 29
4 Day 57
6 Day 209
7 Day 394
8 Day 759
10 Participant Decision Visit / OL-D1
11 Open Label Day 29
12 Open Label Day 57
Covid-19 Symptom Analysis Parameter Code
Permitted Value (Code) Display Value (Decode)
ASYMPINA Asymptomatic SARS-CoV-2 Infection per Adjudication
ASYMPINF Asymptomatic SARS-CoV-2 Infection
COVID COVID-19
COVIDA COVID-19 per Adjudication
COVIDS COVID-19 (Considering Scheduled RT-PCR)
COVIDSD COVID-19 (Secondary Definition)
COVIDSDS COVID-19 (Secondary Definition and Considering Scheduled RT-PCR)
COVIDSEV Severe COVID-19
COVIDSVA Severe COVID-19 per Adjudication
COVIDSVS Severe COVID-19 (Considering Scheduled RT-PCR)
DEATHCVD Death Caused by COVID-19
INFECT SARS-CoV-2 Infection Regardless of Symptomatology or Severity
BOD/BOI Score Analysis Parameter Code
Permitted Value (Code) Display Value (Decode)
BOD7D Burden of Disease Score in 7 Days
BOD28D Burden of Disease Score in 28 Days
BOI7D Burden of Infection Score in 7 Days
BOI28D Burden of Infection Score in 28 Days
Symptom Score Analysis Parameter Code
Permitted Value (Code) Display Value (Decode)
TEMP Temperature (C)
OXYSAT Oxygen Saturation (%)
CHILLS Chills
COUGH Cough
SHBREATH Shortness of Breath
DIBREATH Difficulty Breathing
FATIGUE Fatigue
MYALGIA Muscle Aches (Myalgia)
BODYACHE Body Aches
HEADACHE Headache
NLTASTE New Loss of Taste
NLSMELL New Loss of Smell
NASALCON Nasal Congestion
RUNNOSE Runny Nose (Rhinorrhea)
NAUSEA Nausea
VOMIT Vomiting
DIARRHEA Diarrhea
STHROAT Sore Throat
Laterality [C99073]
Permitted Value (Code)
LEFT [C25229]
RIGHT [C25228]
Treatment Exposure Analysis Dataset Treatment Group
Permitted Value (Code)
PLACEBO
mRNA-1273
Immunogenicity Analysis Dataset Parameter Code
Permitted Value (Code) Display Value (Decode)
L10PVN50 LOG10(PsVNT50)
L10PVN80 LOG10(PsVNT80)
LNPIGG LOG10(SARSCOV2NP IgG Antibody)
LRBDIGG LOG10(SARSCOV2RBD IgG Antibody)
LS2PIGG LOG10(SARSCOV2S2P IgG Antibody)
LV65IGGS LOG10(VAC65 Spike IgG Antibody)
LV66IGGN LOG10(VAC66 Nucleocapsid IgG Antibody)
NPIGG SARSCOV2NP IgG Antibody (AU/mL) by MSD MULTIPLEX
PSVNT50 Pseudovirus Neutralizing Antibody ID50 Titers
PSVNT80 Pseudovirus Neutralizing Antibody ID80 Titers
RBDIGG SARSCOV2RBD IgG Antibody (AU/mL) by MSD MULTIPLEX
S2PIGG SARSCOV2S2P IgG Antibody (AU/mL) by MSD MULTIPLEX
SARSCOV2 Elecsys Anti-SARS-CoV-2
V65IGGS VAC65 Spike IgG Antibody (AU/mL) by ELISA
V66IGGN VAC66 Nucleocapsid IgG Antibody (AU/mL) by ELISA
Microbiology Analysis Visit Code
Permitted Value (Code) Display Value (Decode)
1 Baseline
3 Day 29
10 Participant Decision Visit / OL-D1
100 Illness Visit
200 Illness Visit 2
300 Illness Visit 3
400 Illness Visit 4
500 Illness Visit 5
600 Illness Visit 6
700 Illness Visit 7
Microbiology Analysis Dataset Parameter Sub-Category
Permitted Value (Code)
Nasal Swab
Nasopharyngeal Swab
Saliva
Swab
Other
Microbiology Analysis Dataset Parameter Code
Permitted Value (Code) Display Value (Decode)
B41080 Coronavirus 229E
B41081 Parainfluenza Virus 1
B41082 Parainfluenza Virus 2
B41083 Chlamydophila pneumoniae
B41084 Mycoplasma pneumoniae
B41099 Adenovirus
B41100 Coronavirus HKU1
B41101 Human metapneumovirus
B41119 Coronavirus NL63
B41120 Influenza A subtype H1
B41121 Influenza A subtype H1/2009
B41122 Influenza B
B41123 Parainfluenza Virus 4
B41124 Bordetella pertussis
B41139 Coronavirus OC43
B41140 Human Rhinovirus/Enterovirus
B41141 Influenza A
B41142 Influenza A subtype H3
B41143 Parainfluenza Virus 3
B41144 Respiratory Syncytial Virus
SARSCOV2 Severe Acute Resp Syndrome Coronavirus 2
MPN Mycoplasma pneumoniae
RSV Respiratory Syncytial Virus
Microbiology Analysis Dataset Parameter Category
Permitted Value (Code)
BIOFIRE
SARS-CoV-2
Risk of Exposure Analysis Dataset Parameter Code
Permitted Value (Code) Display Value (Decode)
EDUSTDT Educators and Students
EMERGRES Emergency Response
HIGHDEN Resides in High Density Housing
HLTHWRKR Healthcare Workers
HPTLTY Hospitality and Tourism Workers
LOWDEN Resides in Low Density, Multi-Family Setting
MFGOP Manufacturing and Production Operations
MILITARY Border Protection and Military Personnel
MULTIFAM Resides in Multi-Family Dwelling
NORISK No Risk Identified
NURSHOM Resides in Nursing Home or Assisted Living Facility
OTHERLOC Other Location And Living Circumstances Risk
OTHEROCC Other Occupational Risk
PASTWRKR Pastoral, Social or Public Health Workers
PCIHS Personal Care and In-Home Services
RETAIL Retail or Restaurant Operations
SINFAM Resides in a Single Family Home
TRANS Transportation and Delivery Services
WHSSHIP Warehouse Shipping and Fulfillment Centers
Risk of Exposure Analysis Dataset Parameter Category
Permitted Value (Code)
OCCUPATIONAL RISK
LOCATION AND LIVING CIRCUMSTANCES RISK
Parameter Category 1 (N) in ADRISK dataset
Permitted Value (Code) Display Value (Decode)
1 OCCUPATIONAL RISK
2 LOCATION AND LIVING CIRCUMSTANCES RISK
Pooled Age Group 1 Code
Permitted Value (Code) Display Value (Decode)
1 >=18 and <65 Years
2 >=65 Years
Pooled Age Group 2 Code
Permitted Value (Code) Display Value (Decode)
1 >=18 and <65 Years
2 >=65 and <75 Years
3 >=75 Years
Pooled Age Group 3 Code
Permitted Value (Code) Display Value (Decode)
1 >=18 and <65 Years
2 >=65 and <75 Years
3 >=75 and <85 Years
4 >=85 Years
Pooled Age Group 4 Code
Permitted Value (Code) Display Value (Decode)
1 >=18 and <=25 Years
2 >=26 and <=50 Years
Disposition Status
Permitted Value (Code)
COMPLETED
DISCONTINUED
ONGOING
Ethnicity
Permitted Value (Code)
HISPANIC OR LATINO
NOT HISPANIC OR LATINO
NOT REPORTED
UNKNOWN
Minority
Permitted Value (Code)
Minority
Non-minority
Race [C74457]
Permitted Value (Code)
AMERICAN INDIAN OR ALASKA NATIVE [C41259]
ASIAN [C41260]
BLACK OR AFRICAN AMERICAN [C16352]
MULTIPLE [*]
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER [C41219]
WHITE [C41261]
OTHER [*]
NOT REPORTED [C43234]
UNKNOWN [C17998]

* Extended Value

Pooled Race Group 1 Code
Permitted Value (Code) Display Value (Decode)
1 Caucasian
2 Non-caucasian
Pooled Race and Ethnicity Group 1 Code
Permitted Value (Code) Display Value (Decode)
1 White
2 Communities of Color
Pooled Risk Group 1 Code
Permitted Value (Code) Display Value (Decode)
1 At Risk
2 Not At Risk
Strata Used for Randomization Code
Permitted Value (Code) Display Value (Decode)
1 >=18 and <65 Years and Not at Risk
2 >=18 and <65 Years and at Risk
3 >=65 Years
Strata from Verification Source Code
Permitted Value (Code) Display Value (Decode)
1 >=18 and <65 Years and Not at Risk
2 >=18 and <65 Years and at Risk
3 >=65 Years
COVID-19 Symptom Analysis Dataset Parameter Code
Permitted Value (Code) Display Value (Decode)
ARDS Acute Respiratory Distress Syndrome (ARDS)
ARDYSF Acute Renal Dysfunction
BODYACHE Body Aches
CEPNEU Clinical Evidence of Pneumonia
CHILLS Chills
COUGH Cough
DIARRHEA Diarrhea
DIBREATH Difficulty Breathing
ECMO ECMO
FATIGUE Fatigue
FEVER Fever
HEADACHE Headache
HEPDYSF Hepatic Dysfunction
HFOXYGEN High-Flow Oxygen
HR125 Heart Rate >= 125 per Minute
ICU Admission to an intensive care unit due to SARS-CoV-2
MVENT Mechanical Ventilation
MYALGIA Muscle Aches (Myalgia)
NASALCON Nasal Congestion
NAUSEA Nausea
NEURDYSF Neurologic Dysfunction
NIVENT Non-Invasive Ventilation
NLSMELL New Loss of Smell
NLTASTE New Loss of Taste
O2SAT93 O2 Saturation <=93%
OXYGEN93 Oxygen Saturation of SpO2 <=93% on room air at sea level
PAO2F300 PaO2/FIO2 Ratio < 300 mmHg
REPNEU Radiographical Evidence of Pneumonia
RF Respiratory Failure
RR30 Respiratory Rates >= 30 per Minute
RUNNOSE Runny Nose (Rhinorrhea)
S90D60 Systolic Blood Pressure < 90 mmHg, Diastolic Blood Pressure < 60 mmHg
SHBREATH Shortness of Breath
STHROAT Sore Throat
VASOPRES Vasopressors Required
VOMIT Vomiting
COVID-19 Symptom Analysis Dataset Parameter Category
Permitted Value (Code)
COVID-19 SYMPTOM
COVID-19 SEVERITY
Time to Event Analysis Data Set Parameter Code
Permitted Value (Code) Display Value (Decode)
TCVDSDC1 Time to COVID-19 (Secondary Definition, Considering Scheduled RT-PCR and Prior Infection Censoring) 14 Days after Dose 2 (Days)
TCVDSDC2 Time to COVID-19 (Secondary Definition, Considering Scheduled RT-PCR and Prior Infection Censoring) after Dose 2 (Days)
TCVDSDC3 Time to COVID-19 (Secondary Definition, Considering Scheduled RT-PCR and Prior Infection Censoring) 14 Days after Dose 1 (Days)
TCVDSDC4 Time to COVID-19 (Secondary Definition, Considering Scheduled RT-PCR and Prior Infection Censoring) after Dose 1 (Days)
TCVDSDC5 Time to COVID-19 (Secondary Definition, Considering Scheduled RT-PCR and Prior Infection Censoring) after Randomization (Days)
TCVDSDC6 Time to COVID-19 (Secondary Definition, Considering Scheduled RT-PCR and Prior Infection Censoring) 35 Days after Dose 2 (Days)
TCVDSDC9 Time to COVID-19 (Secondary Definition, Considering Scheduled RT-PCR and Prior Infection Censoring) in Open Label Phase (Days)
TCVDSVC1 Time to Severe COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) 14 Days after Dose 2 (Days)
TCVDSVC2 Time to Severe COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) after Dose 2 (Days)
TCVDSVC3 Time to Severe COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) 14 Days after Dose 1 (Days)
TCVDSVC4 Time to Severe COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) after Dose 1 (Days)
TCVDSVC5 Time to Severe COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) after Randomization (Days)
TCVDSVC6 Time to Severe COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) 35 Days after Dose 2 (Days)
TCVDSVC9 Time to Severe COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) in Open Label Phase (Days)
TTASYCR1 Time to Asymptomatic SARS-CoV-2 Infection (Competing Risk) 14 Days after Dose 2 (Days)
TTASYCR2 Time to Asymptomatic SARS-CoV-2 Infection (Competing Risk) after Dose 2 (Days)
TTASYCR3 Time to Asymptomatic SARS-CoV-2 Infection (Competing Risk) 14 Days after Dose 1 (Days)
TTASYCR4 Time to Asymptomatic SARS-CoV-2 Infection (Competing Risk) after Dose 1 (Days)
TTASYCR5 Time to Asymptomatic SARS-CoV-2 Infection (Competing Risk) after Randomization (Days)
TTASYCR6 Time to Asymptomatic SARS-CoV-2 Infection (Competing Risk) 35 Days after Dose 2 (Days)
TTASYCR9 Time to Asymptomatic SARS-CoV-2 Infection (Competing Risk) in Open Label Phase (Days)
TTASYMP1 Time to Asymptomatic SARS-CoV-2 Infection 14 Days after Dose 2 (Days)
TTASYMP2 Time to Asymptomatic SARS-CoV-2 Infection after Dose 2 (Days)
TTASYMP3 Time to Asymptomatic SARS-CoV-2 Infection 14 Days after Dose 1 (Days)
TTASYMP4 Time to Asymptomatic SARS-CoV-2 Infection after Dose 1 (Days)
TTASYMP5 Time to Asymptomatic SARS-CoV-2 Infection after Randomization (Days)
TTASYMP6 Time to Asymptomatic SARS-CoV-2 Infection 35 Days after Dose 2 (Days)
TTASYMP9 Time to Asymptomatic SARS-CoV-2 Infection in Open Label Phase (Days)
TTCVDC1 Time to COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) 14 Days after Dose 2 (Days)
TTCVDC2 Time to COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) after Dose 2 (Days)
TTCVDC3 Time to COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) 14 Days after Dose 1 (Days)
TTCVDC4 Time to COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) after Dose 1 (Days)
TTCVDC5 Time to COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) after Randomization (Days)
TTCVDC6 Time to COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) 35 Days after Dose 2 (Days)
TTCVDC9 Time to COVID-19 (Considering Scheduled RT-PCR and Prior Infection Censoring) in Open Label Phase (Days)
TTDEATH Time to All-Cause Death after Randomization (Days)
TTDEATH9 Time to All-Cause Death in Open Label Phase (Days)
TTDTHCV1 Time to Death Caused by COVID-19 14 Days after Dose 2 (Days)
TTDTHCV2 Time to Death Caused by COVID-19 after Dose 2 (Days)
TTDTHCV3 Time to Death Caused by COVID-19 14 Days after Dose 1 (Days)
TTDTHCV4 Time to Death Caused by COVID-19 after Dose 1 (Days)
TTDTHCV5 Time to Death Caused by COVID-19 after Randomization (Days)
TTDTHCV6 Time to Death Caused by COVID-19 35 Days after Dose 2 (Days)
TTDTHCV9 Time to Death Caused by COVID-19 in Open Label Phase (Days)
TTINF1 Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity 14 Days after Dose 2 (Days)
TTINF2 Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity after Dose 2 (Days)
TTINF3 Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity 14 Days after Dose 1 (Days)
TTINF4 Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity after Dose 1 (Days)
TTINF5 Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity after Randomization (Days)
TTINF6 Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity 35 Days after Dose 2 (Days)
TTINF9 Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity in Open Label Phase (Days)
Time to Adjudication Event Analysis Data Set Parameter Code
Permitted Value (Code) Display Value (Decode)
TCVDSVC1 Time to Severe COVID-19 (Prior Infection Censoring) 14 Days after Dose 2 (Days)
TCVDSVC2 Time to Severe COVID-19 (Prior Infection Censoring) after Dose 2 (Days)
TCVDSVC3 Time to Severe COVID-19 (Prior Infection Censoring) 14 Days after Dose 1 (Days)
TCVDSVC4 Time to Severe COVID-19 (Prior Infection Censoring) after Dose 1 (Days)
TCVDSVC5 Time to Severe COVID-19 (Prior Infection Censoring) after Randomization (Days)
TCVDSVC6 Time to Severe COVID-19 (Prior Infection Censoring) 35 Days after Dose 2 (Days)
TCVDSVC9 Time to Severe COVID-19 (Prior Infection Censoring) in Open Label Phase (Days)
TTCVDC1 Time to COVID-19 (Prior Infection Censoring) 14 Days after Dose 2 (Days)
TTCVDC2 Time to COVID-19 (Prior Infection Censoring) after Dose 2 (Days)
TTCVDC3 Time to COVID-19 (Prior Infection Censoring) 14 Days after Dose 1 (Days)
TTCVDC4 Time to COVID-19 (Prior Infection Censoring) after Dose 1 (Days)
TTCVDC5 Time to COVID-19 (Prior Infection Censoring) after Randomization (Days)
TTCVDC6 Time to COVID-19 (Prior Infection Censoring) 35 Days after Dose 2 (Days)
TTCVDC9 Time to COVID-19 (Prior Infection Censoring) in Open Label Phase (Days)
Time to Event up to PDV Analysis Data Set Parameter Code
Permitted Value (Code) Display Value (Decode)
TASYCRB1 Time to Asymptomatic SARS-CoV-2 Infection (Competing Risk) 14 Days after Dose 2 Including PDV (Days)
TASYCRB2 Time to Asymptomatic SARS-CoV-2 Infection (Competing Risk) after Dose 2 Including PDV (Days)
TASYCRB3 Time to Asymptomatic SARS-CoV-2 Infection (Competing Risk) 14 Days after Dose 1 Including PDV (Days)
TASYCRB4 Time to Asymptomatic SARS-CoV-2 Infection (Competing Risk) after Dose 1 Including PDV (Days)
TASYCRB5 Time to Asymptomatic SARS-CoV-2 Infection (Competing Risk) after Randomization Including PDV (Days)
TTINFB1 Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity 14 Days after Dose 2 Including PDV (Days)
TTINFB2 Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity after Dose 2 Including PDV (Days)
TTINFB3 Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity 14 Days after Dose 1 Including PDV (Days)
TTINFB4 Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity after Dose 1 Including PDV (Days)
TTINFB5 Time to SARS-CoV-2 Infection Regardless of Symptomatology or Severity after Randomization Including PDV (Days)
Vital Signs Analysis Dataset Parameter Code
Permitted Value (Code) Display Value (Decode)
BMI Body Mass Index (kg/m2)
DIABP Diastolic Blood Pressure (mmHg)
HEIGHT Height (cm)
PULSE Pulse Rate (beats/min)
RESP Respiratory Rate (breaths/min)
SYSBP Systolic Blood Pressure (mmHg)
TEMP Temperature (C)
WEIGHT Weight (kg)
Analysis Causality (N)
Permitted Value (Code) Display Value (Decode)
1 NOT RELATED
2 RELATED
3 NOT APPLICABLE
Solicited AR Toxicity Grade
Permitted Value (Code) Display Value (Decode)
0 Grade 0
1 Grade 1
2 Grade 2
3 Grade 3
4 Grade 4
Analysis Severity/Intensity Code
Permitted Value (Code) Display Value (Decode)
1 Grade 1/Mild
2 Grade 2/Moderate
3 Grade 3/Severe
4 Grade 4
5 Grade 5
Stage Code
Permitted Value (Code) Display Value (Decode)
1 Vaccination stage
2 Follow up stage
No/Yes Flag [C66742]
Permitted Value (Code)
Y [C49488]
N [C49487]
Sex [C66731]
Permitted Value (Code) Display Value (Decode)
F [C16576] Female
M [C20197] Male
Pooled Toxicity Grade Code
Permitted Value (Code) Display Value (Decode)
1 <3
2 >=3
Toxicity Grade Code
Permitted Value (Code) Display Value (Decode)
1 Grade 1
2 Grade 2
3 Grade 3
4 Grade 4
5 Grade 5
Actual Treatment Code
Permitted Value (Code) Display Value (Decode)
1 Placebo
2 mRNA-1273
Sequence of Treatments Code
Permitted Value (Code) Display Value (Decode)
1 Placebo
2 Placebo-mRNA-1273
3 mRNA-1273
Period 01/02 Treatment Code
Permitted Value (Code) Display Value (Decode)
1 Placebo
2 mRNA-1273
Stage
Permitted Value (Code)
Vaccination stage
Follow up stage
Yes Flag [C66742]
Permitted Value (Code)
Y [C49488]

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External Dictionaries

External Dictionaries
Reference Name External Dictionary Dictionary Version
Medical Dictionary for Regulatory Activities MedDRA 23.0

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Methods

Methods
Method Type Description
ADUREDT Computation
First set to AENDT, then if 1) missing, set to the earlier of (cutoff date, non missing ADSL.EOSDT) 2) if partial AENDT: If only day is missing, set to the earlier of (the last date of that month, cutoff date, non missing ADSL.EOSDT) If both month and day are missing, set to the earlier of (the last date of the yeatr, cutoff date, non missing ADSL.EOSDT)
ADURN Computation
For records where SMQ01FL - SMQ14FL='Y' or ARTERM is not missing, do the following: per SUBJID per AEDECOD per MDOSREF, calculate the duration days: ADUREDT-ADURSDT+1 if there are multiple events, sum the duration of each event excluding the overlapping periods
ADURSDT Computation
Set to ASTDT if ASTDT is not missing, Set to TR01SDT if TRTEMFL='Y'
AECVDIAG Computation
Set to SUPPAE.QVAL where QNAM='AECVDIAG'
AEDISFL Computation
Set to 'Y' if either of the two conditions below is met: 1) If subject with DS.DSDECOD countians 'SERIOUS ADVERSE EVENT' or 'ADVERSE EVENT' and the specified adverse event number (numeric part of SUPPDS.QVAL where SUPPDS.QNAM='AESPIDX') match the numeric part of AE.AEGRPID where DSCAT = DISPOSITION EVENT and DS.DSSCAT='END OF STUDY' 2). If subject has record with AEOUT='FATAL' or AETERM contains 'DEATH'
AEHENDTC Computation
Set to SUPPAE.QVAL where QNAM='AEHOSPEN'
AEHSTDTC Computation
Set to SUPPAE.QVAL where QNAM='AEHOSPST'
AEMAFL Computation
Set to SUPPAE.QVAL where SUPPAE.QNAM=MAAEFL
AENDT Computation
Converted date part of AEENDTC to numeric
AENDTM Computation
Concatenate AENDT and AENTM if both are non-missing
AENTM Computation
Converted time part of AEENDTC to numeric
AEOUTSP Computation
Set to SUPPAE.QVAL where SUPPAE.QNAM=AEOUTSP
AESOFL Computation
Set to 'Y' if ARTERM is not missing
ANL01FL Computation
Set to Y if all the conditions below are met: 1) ARTERM in ('Pain', 'Erythema', 'Swelling', 'Underarm Gland Swelling or Tenderness'), 2) MRDSTDY>=8
ANL02FL Computation
Set to 'Y' if ANL01FL='Y' and: MRDSTDY=8 and it exists in SDTM.FACE where FATPTNUM=7 by SUBJID, MDOSREF/FATPTREF, ARTERM/FAOBJ
ANL03FL Computation
Set to 'Y' if all the conditions below are met: 1) ANL01FL='Y' 2) It exists in SDTM.FACE by SUBJID, MDOSREF/FATPTREF, ARTERM/FAOBJ. That is, subject's events happen in the same period in SDTM.FACE, link ADAE and SDTM.FACE by SUBJID, match the events and corresponding period by ADAE.MDOSREF=FACE.FATPTREF, and ADAE.ARTERM=FACE.FAOBJ 3) If MRDSTDY = 8, the event identified in FACE in step 2) should have max(FATPTNUM) < 7 4) It does not exist in FAAE by SUBJID - MDOSREF/FATPTREF - ARTERM/FAOBJ. Similar linking rule as in Step 2
ANL04FL Computation
Set to 'Y' if all the conditions below are met: 1) ANL01FL='Y' 2) It does not exist in FACE by SUBJID - MDOSREF/FATPTREF - ARTERM/FAOBJ
APERIOD Computation
Set to 2 if ASTDTM>=ADSL.TR02SDTM (or ASTDT>=ADSL.AP02SSDT if ASTDTM or TR02SDTM has time part missing), otherwise, Set to 1
APLFL Computation
Subject level flag based on import.SMQ where SMQNAME='ANAPHYLACTIC REACTION': Set to 'Y' if one of the conditions below is met: 1) AEDECOD in import.SMQ where SMQ.Scope='Narrow' or SMQ.Category = 'A' 2) One AEDECOD in import.SMQ where SMQ.Category = 'B' and One AEDECOD in import.SMQ where SMQ.Category = 'C'. The two identified events should occur within 24 hours based on AESTDTC 3) One AEDECOD in import.SMQ where SMQ.Category = 'D' and [One AEDECOD in import.SMQ where SMQ.Category = 'B' or One AEDECOD in import.SMQ where SMQ.Category = 'C]. The two identified events should occur within 24 hours based on AESTDTC. Note: Use date part to compare if time part is missing, and no date or time imputation
APLREAS Computation
Refer to the 3 conditions for APLFL: If condition 1 is met, APLREAS = "A narrow term or a term from Category A", If condition 2 is met, APLREAS = "A term from Category B and a term from Category C ", If condition 3 is met, APLREAS = "A term from Category D and [a term from Category B or a term from Category C] " Note: If multiple reasons, concatenate and seperate by '; '
AREL Computation
Set to AEREL
ASEV Computation
Concatenate ATOXGR and Mixed case of AESEV with '/', eg, Grade 1/Mild; Set to ATOXGR if ATOXGR is 'Grade 4' or 'Grade 5'
ASTAGE Computation
Set to 'Vaccination stage' if (.< ADSL.TR01SDTM <=ASTDTM and ASTDT<= ADSL.TR01EDT+27) or (.< ADSL.TR02SDTM <=ASTDTM and ASTDT<= ADSL.TR02EDT+27), Note: If time part of TR01SDTM or time part of ASTDTM is missing,then use TR01SDT and ASTDT, if time part of TR02SDTM or time part of ASTDTM is missing, then use TR02SDT and ASTDT Set to 'Follow-Up stage' if (APERIOD=1 and ASTDT> ADSL.TR01EDT+27) or ASTDT> ADSL.TR02EDT+27
ASTDT Computation
Convert date part of AESTDTC convert to numeric See ADAE.ASTDT from ADaM Variable definition doc. for the date imputation rule

Additional ADaM Variable Definition

ASTDTF Computation
Set to 'M' if year is present and month is imputed, or Set to 'D' if only day is imputed
ASTDTM Computation
Concatenate ASTDT and ASTTM if both are non-missing
ASTDY Computation
Set to ASTDT – ADSL.TR01SDT + 1 if ASTDT >= TR01SDT Set to ASTDT – ADSL.TR01SDT if ASTDT< TR01SDT
ATOXGR Computation
Set to 'Grade 1' if AETOXGR='1', Set to 'Grade 2’ if AETOXGR='2', Set to ‘Grade 3’ if AETOXGR='3', Set to ‘Grade 4’ if AETOXGR='4', Set to ‘Grade 5’ if AEOUT='FATAL' or AETERM contains 'DEATH'
CMQ01FL Computation
Set ''Y' if CQ01NAM is not missing
CQ01NAM Computation
Set to 'Autoimmune' if AEDECOD is in import.CMQ where CMQNAME='AUTOIMMUNE'
CMQ01FL Computation
Set ''Y' if CQ02NAM is not missing
CQ01NAM Computation
Set to 'Dermal Filler Reaction Post Vaccination' if AEDECOD is in import.CMQ where CMQNAME='DERMAL FILLER REACTION POST VACCINATION'
CMQ03FL Computation
Y' if CQ03NAM is not missing
CQ03NAM Computation
Set to 'Bell's Palsy' if AELLT is in ('Bell's palsy', 'Palsy Bells', 'Facial palsy', and 'Facial paralysis')
D28FL Computation
Set to 'Y' if non-missing MRDSTDY<=28
ICUAD Computation
Set to HO.HOOCCUR where HODECOD='ICU' based on SUPPAE.QVAL where QNAM='HOSPIDX' and SUPPHO.QVAL where QNAM='HOSPIDX'
ICUDAY Computation
Set to HO.HODUR where HODECOD='ICU' based on SUPPAE.QVAL where QNAM='HOSPIDX' and SUPPHO.QVAL where QNAM='HOSPIDX'
MDOSREF Computation
Set to 'Vaccination 1' if (missing < ADSL.TR01SDTM <= ASTDTM < ADSL.DOSE2DTM) or ( missing < ADSL.TR01SDTM <= ASTDTM and ADSL.DOSE2DTM is missing and (TR02SDTM is missing or missing < ASTDTM < ADSL.TR02SDTM)) Set to 'Vaccination 2' if ( missing < ADSL.DOS2DTM <= ASTDTM < ADSL.TR02SDTM) or ( missing < ADSL.DOS2DTM <= ASTDTM and ADSL.TR02SDTM is missing) Set to 'OL Vaccination 1' if ( missing <ADSL.TR02SDTM <= ASTDTM < ADSL.OLDO2DTM) or ( missing < ADSL.TR02SDTM <= ASTDTM and ADSL.OLDO2DTM is missing) Set to 'OL Vaccination 2' if missing < ADSL.OLDO2DTM <= ASTDTM Note: Using date variables for comparison when time part is not available
MRDENDY Computation
Set to (the largest integer less than or equal to (AENDTM – ADSL.TR01SDTM)/(24*60*60)) + 1 if MDOSREF='Vaccination 1', Set to (the largest integer less than or equal to (AENDTM – ADSL.DOS2DTM)/(24*60*60)) + 1 if MDOSREF='Vaccination 2', Set to (the largest integer less than or equal to (AENDTM – ADSL.TR02SDTM)/(24*60*60)) + 1 If MDOSREF='OL Vaccination 1', Set to (the largest integer less than or equal to (AENDTM – ADSL.OLDO2DTM)/(24*60*60)) + 1 If MDOSREF='OL Vaccination 2' If time part of AENDTM is missing, use AENDT to replace AEENDTM and calculate as follows: AENDT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1', AENDT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2', AENDT – ADSL.TR02SDT+ 1 If MDOSREF='OL Vaccination 1', AENDT – ADSL.OLDOS2DT+ 1 If MDOSREF='OL Vaccination 2'
MRDSTDY Computation
Set to (the largest integer less than or equal to (ASTDTM – ADSL.TR01SDTM)/(24*60*60)) +1 if MDOSREF='Vaccination 1', Set to (the largest integer less than or equal to (ASTDTM – ADSL.DOS2DTM)/(24*60*60)) +1 if MDOSREF='Vaccination 2,' Set to (the largest integer less than or equal to (ASTDTM – ADSL.TR02SDTM)/(24*60*60)) +1 if MDOSREF='OL Vaccination 1', Set to (the largest integer less than or equal to (ASTDTM – ADSL.OLDO2DTM)/(24*60*60)) +1 if MDOSREF='OL Vaccination 2' Note: If time part of ASTDTM is missing, use ASTDT to replace ASTDTM and calculate as follows: Set to ASTDT – ADSL.TR01SDT + 1 if MDOSREF='Vaccination 1', Set to ASTDT – ADSL.DOSE2DT + 1 if MDOSREF='Vaccination 2', Set to ASTDT – ADSL.TR02SDT + 1 if MDOSREF='OL Vaccination 1', Set to ASTDT – ADSL.OLDOS2DT + 1 if MDOSREF='OL Vaccination 2'
SMQ01FL Computation
Set to 'Y' if SMQ01NAM is not missing
SMQ01NAM Computation
Set to 'Anaphylactic Reaction' if AEDECOD is in import.SMQ where SMQNAME='ANAPHYLACTIC REACTION'
SMQ01SC Computation
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='ANAPHYLACTIC REACTION'
SMQ02FL Computation
Set to 'Y' if SMQ02NAM is not missing and SMQ02SC is 'Narrow'
SMQ02NAM Computation
Set to 'Angioedema' if AEDECOD is in import.SMQ where SMQNAME='ANGIOEDEMA'
SMQ02SC Computation
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='ANGIOEDEMA'
SMQ03FL Computation
Set to 'Y' if SMQ03NAM is not missing and SMQ03SC is 'Narrow'
SMQ03NAM Computation
Set to 'Arthritis' if AEDECOD is in import.SMQ where SMQNAME='ARTHRITIS'
SMQ03SC Computation
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='ARTHRITIS'
SMQ04FL Computation
Set to 'Y' if SMQ04NAM is not missing and SMQ04SC is 'Narrow'
SMQ04NAM Computation
Set to 'Convulsions' if AEDECOD is in import.SMQ where SMQNAME='CONVULSIONS'
SMQ04SC Computation
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='CONVULSIONS'
SMQ05FL Computation
Set to 'Y' if SMQ05NAM is not missing and SMQ05SC is 'Narrow'
SMQ05NAM Computation
Set to 'Demyelinating Disease of Central Nervous System' if AEDECOD is in import.SMQ where SMQNAME='DEMYELINATION'
SMQ05SC Computation
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='DEMYELINATION'
SMQ06FL Computation
Set to 'Y' if SMQ06NAM is not missing and SMQ06SC is 'Narrow'
SMQ06NAM Computation
Set to 'Hypersensitivity' if AEDECOD is in import.SMQ where SMQNAME='HYPERSENSITIVITY
SMQ06SC Computation
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='HYPERSENSITIVITY'
SMQ07FL Computation
Set to 'Y' if SMQ07NAM is not missing and SMQ07SC is 'Narrow'
SMQ07NAM Computation
Set to 'Peripheral Neuropathy' if AEDECOD is in import.SMQ where SMQNAME='PERIPHERAL NEUROPATHY'
SMQ07SC Computation
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='PERIPHERAL NEUROPATHY'
SMQ08FL Computation
Set to 'Y' if SMQ08NAM is not missing and SMQ08SC is 'Narrow'
SMQ08NAM Computation
Set to 'Vasculitis' if AEDECOD is in import.SMQ where SMQNAME='VASCULITIS'
SMQ08SC Computation
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='VASCULITIS'
SMQ09FL Computation
Set to 'Y' if SMQ09NAM is not missing and SMQ09SC is 'Narrow'
SMQ09NAM Computation
Set to 'Central Nervous System Haemorrhages and Cerebrovascular Conditions' if AEDECOD is in import.SMQ where SMQNAME='CENTRAL NERVOUS SYSTEM HAEMORRHAGES AND CEREBROVASCULAR CONDITIONS'
SMQ09SC Computation
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='CENTRAL NERVOUS SYSTEM HAEMORRHAGES AND CEREBROVASCULAR CONDITIONS'
SMQ10FL Computation
Set to 'Y' if SMQ10NAM is not missing and SMQ10SC is 'Narrow'
SMQ10NAM Computation
Set to 'Embolic and Thrombotic Events' if AEDECOD is in import.SMQ where SMQNAME='EMBOLIC AND THROMBOTIC EVENTS'
SMQ10SC Computation
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='EMBOLIC AND THROMBOTIC EVENTS'
SMQ11FL Computation
Set to 'Y' if SMQ11NAM is not missing and SMQ11SC is 'Narrow'
SMQ11NAM Computation
Set to 'Hearing and Vestibular Disorders' if AEDECOD is in import.SMQ where SMQNAME='HEARING AND VESTIBULAR DISORDERS'
SMQ11SC Computation
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='HEARING AND VESTIBULAR DISORDERS'
SMQ12FL Computation
Set to 'Y' if SMQ12NAM is not missing and SMQ12SC is 'Narrow'
SMQ12NAM Computation
Set to 'Thrombophlebitis' if AEDECOD is in import.SMQ where SMQNAME='THROMBOPHLEBITIS'
SMQ12SC Computation
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='THROMBOPHLEBITIS'
SMQ13FL Computation
Set to 'Y' if SMQ13NAM is not missing and SMQ13SC is 'Narrow'
SMQ13NAM Computation
Set to 'Haematopoietic Cytopenias' if AEDECOD is in import.SMQ where SMQNAME='HAEMATOPOIETIC CYTOPENIAS'
SMQ13SC Computation
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='HAEMATOPOIETIC CYTOPENIAS'
SMQ14FL Computation
Set to 'Y' if SMQ14NAM is not missing and SMQ14SC is 'Narrow'
SMQ14NAM Computation
Set to 'Cardiomyopathy' if AEDECOD is in import.SMQ where SMQNAME='CARDIOMYOPATHY'
SMQ14SC Computation
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='CARDIOMYOPATHY'
TOXGGR1 Computation
Pooled grouping of toxicity grade for analysis: Set to '<3' when .<ATOXGRN <3, or Set to '>=3' when ATOXGRN >=3
TRTA Computation
If MDOSREF='Vaccination 1', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 1', 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'Day 1', if MDOSREF='Vaccination 2', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 29', 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'Day 29', If MDOSREF='OL Vaccination 1', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'OL-D1', 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'OL-D1', if MDOSREF='OL Vaccination 2', set to: 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'OL-D29', 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'OL-D29'
TRTEMFL Computation
Set to 'Y' if .< ADSL.TR01SDTM <= ASTDTM, or (if ASTDT missing and .< ADSL.TR01SDTM <= AENDTM) or both ASTDT and AENDT missing. Note: If time is not available, use TR01SDT, ASTDT and AENDT
ADT Computation
Convert date part of FACE.FADTC to numeric if source data are from FACE Convert date part of VS.VSDTC to numeric if source data are from VS
ADTM Computation
Convert FACE.FADTC to numeric if source data are from FACE Convert VS.VSDTC to numeric if source data are from VS
ADY Computation
Set to FACE.FADY if source data are from FACE Set to VS.VSDY if source data are from VS
ANL01FL Computation
Set 'Y' for the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF) per ATPTGR1 Note: If there are two or more records found, then select the first one where FAEVAL='STUDY SUBJECT' or missing for FEVER
ANL02FL Computation
Y for the records where PARAMCD is 'PAIN' or 'ERYTHDIA' or 'SWELLDIA', and ATOXGRN>0
ANL03FL Computation
Y for the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF) per ATPT Note: If there are two or more records found, then select the first one where FAEVAL='STUDY SUBJECT' or missing for FEVER
ARTERM Computation
Set to import.symp.CETERM where ADAE.AEDECOD = import.symp.CEDECOD
ATPT Computation
If source data are from FACE, set to FACE.FATPT, otherwise If source data are from VS, set to VS.VSTPT Recode 'DAY 1' as 'DAY 1, AFTER VACCINATION (AT HOME)' if FAEVAL='INVESTIGATOR''
ATPTGR1 Computation
Set to 'Day 1' if ATPT contains 'Day 1' Set to ATPT otherwise
ATPTREF Computation
If source data are from FACE Set to ‘Vaccination 1’ if FACE.FATPTREF contains ‘DOSE1’ Set to ‘Vaccination 2’ if FACE.FATPTREF contains ‘DOSE2’ If source data are from VS Set to 'Vaccination 1' if VS.VSTPTREF contatins 'DOSE1', Set to 'Vaccination 2' if VS.VSTPTREF contains 'DOSE2'
AVALC Computation
Set to FACE.FASTRESC if source data are from FACE, Set to VS.VSSTRESC if source data are from VS
FAVER Computation
Set to VS.VSSTRESN if source data are from VS
ERYTHDIA, SWELLDIA Computation
For FACE.FAOBJ = ’Erythema’ or ‘Swelling’ only Set to 0 if FATEST='Occurrence Indicator' and FAORRES='N', otherwise Set to FACE.FASTRESN
OTHER Computation
Set to missing
CRIT1 Computation
Set to '> 102.6 degrees F' if CRIT1FL='Y'
CRIT1FL Computation
Set to 'Y' if (9*AVAL/5)+32 > 102.6
CRIT2 Computation
Set to '> 103.1 degrees F' if CRIT2FL='Y'
CRIT2FL Computation
Set to 'Y' if (9*AVAL/5)+32 > 103.1
CRIT3 Computation
Set to '> 103.6 degrees F' if CRIT3FL='Y'
CRIT3FL Computation
Set to 'Y' if (9*AVAL/5)+32 > 103.6
CRIT4 Computation
Set to '> 104.1 degrees F' if CRIT4FL='Y'
CRIT4FL Computation
Set to 'Y' if (9*AVAL/5)+32 > 104.1
MAAEFL Computation
Set to SUPPFACE.QVAL where SUPPFACE.QNAM='MAAEFL'
ADT Computation
Convert date part of FACE.FADTC to numeric if source data are from FACE Convert date part of FAAE.FADTC to numeric if source data are from FAAE Convert date part of VS.VSDTC to numeric if source data are from VS
ADTM Computation
Convert FACE.FADTC to numeric if source data are from FACE Convert FAAE.FADTC to numeric if source data are from FAAE Convert VS.VSDTC to numeric if source data are from VS
ADY Computation
Set to FACE.FADY if source data are from FACE Set to FAAE.FADY if source data are from FAAE Set to VS.VSDY if source data are from VS
ANL01FL Computation
Set to 'Y' for the records where PARAMCD is 'PAIN' or 'ERYTHDIA' or 'SWELLDIA', or 'LYMPH'
ANL02FL Computation
If ANL01FL=Y, per subject per vaccination per symptom, flag all records if there are records at both ATPTN = 7 and ATPTN = 8
ANL03FL Computation
If ANL01FL=Y, per subject per vaccination per symptom with min(ATPTN) <=7, flag all records if there are not records at both ATPTN = 7 and ATPTN = 8
ANL04FL Computation
Set to 'Y' for the records if both criteria met: 1. ANL01FL='Y', 2. If per subject per symptom (PARAMCD) per vaccination (ATPTREF), the smallest ATPTGR1N >=8
ANL05FL Computation
Set to 'Y' for the first record with maximum non-missing ATOXGRN per subject per PARAM per vaccination (ATPTREF) per ATPT Note: If there is two records per day and one from investigator and one from subject, select the one from subject (FAEVAL='STUDY SUBJECT' or missing FAEVAL for FEVER)
ANL06FL Computation
Per subject per vaccination per symptom, flag all records if the smallest ATPTGR1N<8 and largest ATPTGR1N>=8 where ATOXGRN>0
ATPT Computation
If source data are from FACE, set to FACE.FATPT If Source data are from FAAE, set to FAAE.FATPT If source data are from VS, set to VS.VSTPT Recode 'DAY 1' as 'DAY 1, AFTER VACCINATION (AT HOME)' if FAEVAL='INVESTIGATOR''
ATPTREF Computation
If source data are from FACE Set to ‘Vaccination 1’ if FACE.FATPTREF contains ‘DOSE1’ Set to ‘Vaccination 2’ if FACE.FATPTREF contains ‘DOSE2’ If source data are from FAAE Set to ‘Vaccination 1’ if FAAE.FATPTREF contains ‘DOSE1’ Set to ‘Vaccination 2’ if FAAE.FATPTREF contains ‘DOSE2’ If source data are from VS Set to 'Vaccination 1' if VS.VSTPTREF contains 'DOSE1', Set to 'Vaccination 2' if VS.VSTPTREF contains 'DOSE2'
AVALC1 Computation
Set to SUPPVS.QVAL if SUPPVS.QNAM in ('MEDTAK', 'MEDTAKP', 'MEDTAKT') and QVAL='Y'
AVALC2 Computation
Set to FACE.FASTRESC If data is from SDTM.FACE, Set to FAAE.FASTRESC If data is from SDTM.FAAE, Set to VS.VSSTRESC If data is from VS
FEVER Computation
If a subject has a least one record found from SDTM.VS where VSCAT="REACTOGENICITY" and VSTPTNUM>=8, then Set to VS.VSSTRESN where VSCAT='REACTOGENICITY'
ERYTHDIA, SWELLDIA Computation
If data is from SDTM.FACE[1] Set to FACE.FASTRESN where FACE.FAOBJ in ('Erythema', 'Swelling') and FATESTCD='LDIAM' If data is from SDTM.FAAE Set to FAAE.FASTRESN where FAAE.FAOBJ in ('Erythema', 'Swelling') and FAAE.FATESTCE='LDIAM' [1]A least one records should be found from SDTM.FAAE where FAAE.FAOBJ in ('Erythema', 'Swelling') and FATESTCD='LDIAM')
OTHER Computation
Set to missing
FAEVAL Computation
Set to FACE/FAAE.FAEVAL
MAAEFL Computation
Set to SUPPFACE/SUPPFAAE.QVAL where SUPPFACE/SUPPFAAE.QNAM='MAAEFL'
PARAM Computation
If source data are from FACE/FAAE: If FAOBJ=’Underarm Gland Swelling or Tenderness’ and FATESTCD = 'SEV', then set to FAOBJ, If FAOBJ=’Nausea/Vomiting’ and FATESTCD = 'SEV', then set to 'Nausea/Vomiting', If FAOBJ=’Erythema’ or ‘Swelling’ and FATEST contains 'Occurrence' and FAORRES='N', then set to FAOBJ||' Longest Diameter (mm)' and assign AVAL=0 (see specs for AVAL), If FAOBJ= ’Erythema’ or ‘Swelling’ and FATEST contains 'Intensity', then set to FAOBJ||' Longest Diameter (mm)', If FAOBJ=’ Erythema’ or ‘Swelling’ and FATEST='Longest Diameter', set to 'FAOBJ'|| ' '||FATEST|| ' '||'('||FAORRESU||')', If FAOBJ='Pyrexia' or 'Fever', then set to 'Fever (C)', set to FAOBJ, otherwise If source data are from VS and VSTESTCD in ('TEMP' 'VSALL'), set to 'Fever'||'('||VSSTRESU||'). (please add space between the VSTEST and VS unit. If the VSSTRESU is missing, use non-missing VSSTRESU)" If there is one record in VS where SUPPVS.QNAM='MEDTAKP' and QVAL='Y', then create one record with PARAM='Prevent Pain or Fever from Occurring', If there is one record in VS where SUPPVS.QNAM='MEDTAKT' and QVAL='Y', then create one record with PARAM='Treat Pain or Fever already Occurred', If there is one record in VS where SUPPVS.QNAM='MEDTAK' and QVAL='Y', then create one record with PARAM='Medication Taken Today for Pain or Fever'
PARAM Computation
If source data are from FACE: If FAOBJ=’Underarm Gland Swelling or Tenderness’ and FATESTCD = 'SEV', then set to 'Underarm Gland Swelling or Tenderness' If FAOBJ=’Nausea/Vomiting’ and FATESTCD = 'SEV', then set to 'Nausea/Vomiting'' If FAOBJ=’Erythema’ or ‘Swelling’ and FATEST contains 'Occurrence' and FAORRES='N', then set to FAOBJ||' Longest Diameter (mm)' and assign AVAL=0 (see specs for AVAL) If FAOBJ= ’Erythema’ or ‘Swelling’ and FATEST contains 'Intensity', then set to FAOBJ||' Longest Diameter (mm)' If FAOBJ=’ Erythema’ or ‘Swelling’ and FATEST='Longest Diameter', set to 'FAOBJ'|| ' '||FATEST|| ' '||'('||FAORRESU||')' If FAOBJ='Pyrexia' or 'Fever', then set to 'Fever (C)' set to FAOBJ, otherwise if source data are from VS and VSTESTCD in ('TEMP' 'VSALL'), set to 'Fever'||'('||VSSTRESU||'). (please add space between the VSTEST and VS unit. If the VSSTRESU is missing, use non-missing VSSTRESU) if there is one record in VS where SUPPVS.QNAM='MEDTAKP' and QVAL='Y', then create one record with PARAM='Prevent Pain or Fever from Occurring'; if there is one record in VS where SUPPVS.QNAM='MEDTAKT' and QVAL='Y', then create one record with PARAM='Treat Pain or Fever already Occurred'; if there is one record in VS where SUPPVS.QNAM='MEDTAK' and QVAL='Y', then create one record with PARAM='Medication Taken Today for Pain or Fever'.
PARCAT1 Computation
For source data are from SDTM.FACE/FAAE: Set to 'LOCAL' if FASCAT=ADMINISTRATION SITE Set to FASCAT For source data are from VS: Set to VSSCAT
SRCDOM Computation
FACE.DOMAIN if source data are from FACE; VS.DOMAIN if source data are from VS
SRCSEQ Computation
FACE.FASEQ if source data are from FACE; VS.VSSEQ if source data are from VS
SRCVAR Computation
Set to 'FASTRESC' if source data are from FACE; Set to 'VSSTRESN' if source data are from VS; Set to "SUPPVS.QVAL where QNAM='MEDTAKP'" if PARAMCD='MEDTAKP'; else set to "SUPPVS.QVAL where QNAM='MEDTAKT'" if PARAMCD='MEDTAKT'; else set to "SUPPVS.QVAL where QNAM='MEDTAK'" if PARAMCD='MEDTAK'.
ANL01FL Computation
Set to 'Y' for the records that met either of below criteria: 1. ADARSUM.PARAMCD is 'PAINDUR', for the same subject and same vaccination (ATPTREF), the smallest ADARP7D.ATPTGR1N>=8 where ADARP7D.PARAMCD='PAIN' and ATOXGRN>0 2. ADARSUM.PARAMCD is 'ERYTHDUR', for the same subject and same vaccination (ATPTREF), the smallest ADARP7D.ATPTGR1N>=8 where ADARP7D.PARAMCD='ERYTHDIA' and ATOXGRN>0 3. ADARSUM.PARAMCD is 'SWELLDUR', for the same subject and same vaccination (ATPTREF), the smallest ADARP7D.ATPTGR1N>=8 where ADARP7D.PARAMCD='SWELLDIA' and ATOXGRN>0
ANL02FL Computation
Set to 'Y' if PARAMCD in (PAINDUR, ERYTHDUR, SWELLDUR, HEADADUR, LYMPHDUR, FATIGDUR, MYALGDUR, ARTHRDUR, NAUSEDUR, CHILLDUR, FEVERDUR, ANYDUR, LOCDUR, SYSDUR) and no corresponded symptom last beyond day 7 (no any record is found from ADARP7D by ATPTREF)
ATOXGR Computation
Set to the highest ATOXGR by subject, ADAR.PARAMCD, and vaccination (ATPTREF)
ATOXGRANY Computation
Set to the highest ATOXGR by subject, and vaccination (ATPTREF)
ATOXGRG Computation
Set to the highest ATOXGR by subject, ADAR.PARCAT1, and vaccination (ATPTREF)
ATPTREF Computation
Set to ADAR.ATPTREF if data from ADAR For source data from FAAE: Set to ‘Vaccination 1’ if FAAE.FATPTREF contains ‘DOSE 1’, or Set to ‘Vaccination 2’ if FAAE.FATPTREF contains ‘DOSE 2’ For source data from VS, Set to ‘Vaccination 1’ if VS.VSTPTREF contains ‘DOSE 1’, or Set to ‘Vaccination 2’ if VS.VSTPTREF contains ‘DOSE 2’
AVAL Computation
1. Get number of days from ADAR: Count total number of records with ATOXGRN>0 per subject, per symptom (ADAR.PARAMCD) and per vaccination (ATPTREF). If there are more than one record within same day (ADAR.ATPTGR1), then count it once only 2. Get number of days from ADARP7D: Count total number of records with ATOXGRN>0 and ADAR.P7D.ATPTGR1N>=8 per subject, per symptom (ADARP7D.PARAMCD) and per vaccination (ATPTREF). If there are more than one record within same day (ADARP7D.ATPTGR1), then count it once only 3. Calculate the sum of the number of records from steps 1 and 2 per subject per, per symptom (PARAMCD) and per vaccination (ATPTREF)
AVAL Any Computation
1. Get number of days from ADAR: Count total number of records with ATOXGRN>0 per subject and per vaccination (ATPTREF). If there are more than one record within same day (ADAR.ATPTGR1), then count it once only 2. Get number of days from ADARP7D: Count total number of records with ATOXGRN>0 and ADARP7D.ATPTGR1N>=8 per subject and per vaccination (ATPTREF). If there are more than one record within same day (ADARP7D.ATPTGR1), then count it once only 3. Calculate the sum of the number of records from steps 1 and 2 per subject per and per vaccination (ATPTREF)
AVALC Computation
Derived worse case of each AR symptom occurred within 7 days per vaccination (ATPTREF) where PARAMCD in (WLYMPH, WPAIN, WERYTH, WSWELL, WHEAD, WFATIGUE, WMYALGIA, WARTHR, WNAUSEA, WCHILLS, WFEVER): Set to ADAR.AVALC where ADAR.ATOXGR is the worse case per AR symptom within 7 Days per vaccination (ATPTREF) Note: The higher number of ADAR.ATOXGRN, the worse symptom grade
AVALG Computation
1. Get number of days from ADAR: Count total number of records with ATOXGRN>0 per subject, per symptom category (ADAR.PARCAT1) and per vaccination (ATPTREF). If there are more than one record within same day (ADAR.ATPTGR1), then count it once only 2. Get number of days from ADARP7D: Count total number of records with ATOXGRN>0 and ADARP7D.ATPTGR1N>=8 per subject, per symptom category (ADARP7D.PARCAT1) and per vaccination (ATPTREF). If there are more than one record within same day (ADARP7D.ATPTGR1), then count it once only 3. Calculate the sum of the number of records from steps 1 and 2 per subject per, per symptom (PACAT1) and per vaccination (ATPTREF)
PARAM Computation
Create one PARAM per subject per PARCAT1 per ATPTREF by following Solicited AR Summary Analysis Dataset Parameter Code
PARCAT1 Computation
Set to 'LOCAL' if PARAMCD in (LYMPHDUR, PAINDUR, ERYTHDUR, SWELLDUR, WLYMPH, WPAIN, WERYTH, WSWELL, WSLAR) Set to 'SYSTEMIC' if PARAMCD in (HEADADUR, FATIGDUR, MYALGDUR ARTHRDUR, NAUSEDUR, CHILLDUR, FEVERDUR, WHEAD, WFATIGUE, WMYALGIA, WARTHR, WNAUSEA, WCHILLS,WFEVER, WSSAR)
PARAMCD EQ CHILLS Computation
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC= ‘NO INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘SOME INTERFERENCE WITH ACTIVITY NOT REQUIRING MEDICAL ATTENTION’ or contains 'GRADE 2' Set to 'Grade 3' if FASTRESC= ‘PREVENTS DAILY ACTIVITY AND REQUIRES MEDICAL ATTENTION’ or contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
ERYTHDIA and SWELLDIA Computation
Set to 'Grade 0' if .<AVAL < 25 mm or FASTRESC contains 'GRADE 0' Set to 'Grade 1' if AVAL = 25 - 50 mm or FASTRESC contains 'GRADE 1' Set to 'Grade 2' if AVAL = 51 - 100 mm or FASTRESC contains 'GRADE 2' Set to 'Grade 3' if AVAL > 100 mm or FASTRESC contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
PARAMCD EQ FEVER Computation
Grade 0 if .<AVAL < 38.0°C or FASTRESC contains 'GRADE 0' Grade 1 if 38.0<=AVAL<=38.4°C or FASTRESC contains 'GRADE 1' Grade 2 if 38.4<AVAL<=38.9°C or FASTRESC contains 'GRADE 2' Grade 3 if 38.9<AVAL<=40.0°C or FASTRESC contains 'GRADE 3' Grade 4 if AVAL > 40.0°C or FASTRESC contains 'GRADE 4'
FATIGUE, MYALGIA, ARTHRALG) Computation
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC= 'NO INTERFERENCE WITH ACTIVITY' or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘SOME INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 2' Set to 'Grade 3' if FASTRESC= ‘SIGNIFICANT; PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3' Grade 4 if FASTRESC contains 'GRADE 4'
PARAMCD EQ HEADACHE Computation
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC=’NO INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR SOME INTERFERENCE WITH ACTIVITY’ or contains 'GRADE 2'; Set to 'Grade 3' if FASTRESC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
PARAMCD EQ LYMPH Computation
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC=’DOES NOT INTERFERE WITH ACTIVITY’ or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH SOME ACTIVITY’ or contains 'GRADE 2' Set to 'Grade 3' if FASTRESC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'; Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
NAUSEA Computation
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC= ‘NO INTERFERENCE WITH ACTIVITY OR 1-2 EPISODES/24 HOURS’ or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘SOME INTERFERENCE WITH ACTIVITY OR >2 EPISODES/24 HOURS’ or contains 'GRADE 2' Set to 'Grade 3' if FASTRESC= ‘PREVENTS DAILY ACTIVITY, REQUIRES OUTPATIENT IV HYDRATION’ or contains 'GRADE 3' Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
PARAM EQ PAIN Computation
Set to 'Grade 0' if FASTRESC=’NONE’ or contains 'GRADE 0' Set to 'Grade 1' if FASTRESC=’DOES NOT INTERFERE WITH ACTIVITY’ or contains 'GRADE 1' Set to 'Grade 2' if FASTRESC= ‘REPEATED USE OF OVER-THE-COUNTER PAIN RELIEVER > 24 HOURS OR INTERFERES WITH ACTIVITY’ or contains 'GRADE 2' Grade 3 if FASTRESC= ‘ANY USE OF PRESCRIPTION PAIN RELIEVER OR PREVENTS DAILY ACTIVITY’ or contains 'GRADE 3'; Set to 'Grade 4' if FASTRESC contains 'GRADE 4'
AENDT Computation
Converted date part of CM.CMENDTC to numeric if day, month, and year are all present If day and month are both missing, AENDT is whichever is earliest of the following: 31DECYYYY, EOSDT, or DTHDT If only day is missing, AENDT is whichiever is earliest of the following: EOSDT, DTHDT, or xxMMMYYYY where xx is the last day of the month
AENDTF Computation
Set to 'D' if only the day is imputed, or Set to 'M' if the day and the month are imputed
AENDY Computation
Set to AENDT - TR01SDT + 1 if AENDT >= TR01SDT, or Set to AENDT - TR01SDT if AENDT < TR01SDT
ASTDT Computation
Convert date part of CM.CMSTDTC to numeric if day, month, and year are all present See ADCM.ASTDT from Additional ADaM Variable Definition Doc for partial date imputation rules

Additional ADaM Variable Definition

ASTDTF Computation
Set to 'D' if only the day is imputed, or Set to 'M' if the day and the month are imputed
ASTDY Computation
Set to ASTDT - TR01SDT + 1 if ASTDT >= TR01SDT, or Set to ASTDT - TR01SDT if ASTDT < TR01SDT
ATCLEV1T Computation
Set to SUPPCM.QVAL where QNAM='ATCLEV1T'
ATCLEV2T Computation
Set to CM.CMCLAS
ATCLEV3T Computation
Set to SUPPCM.QVAL where QNAM='ATCLEV3T'
ATCLEV4T Computation
Set to SUPPCM.QVAL where QNAM='ATCLEV4T'
CMDECOD1 Computation
Set to SUPPCM.QVAL where QNAM='CMDECOD1'
CMDECOD2 Computation
Set to SUPPCM.QVAL where QNAM='CMDECOD2'
CMDECOD3 Computation
Set to SUPPCM.QVAL where QNAM='CMDECOD3'
CMFOTHSP Computation
Set to SUPPCM.QVAL where QNAM='CMFOTHSP'
CMMOI1FL Computation
Y' if SUPPCM.QVAL='Y' where  QNAM='CMPLX'
CMMOI2FL Computation
Set to 'Y' if the first 8 digits of SUPPCM.QVAL (where SUPPCM.QNAM="CMPROTCD") is in the first 8 digits of import.pain_drugcode.DRUGCODE
CMMOI3FL Computation
Y' if ATCLEV4T='INFLUENZA VACCINES'
CMPROTCD Computation
Set to SUPPCM.QVAL where QNAM='CMPROTCD'
CMROTHSP Computation
Set to SUPPCM.QVAL where QNAM='CMROTHSP'
CMSOLFL Computation
Set to SUPPCM.QVAL when QNAM='CMSOL'
CMTRTO1 Computation
Set to SUPPCM.QVAL where QNAM='CMTRTO1'
CMUOTHSP Computation
Set to SUPPCM.QVAL where QNAM='CMUOTHSP'
FUPFL Computation
Set to 'Y' if APERIOD=1 and (AENDT > TR01EDT + 27 days or AENDT is missing); or if APERIOD=2 and (AENDT > TR02EDT + 27 days or AENDT is missing); missing otherwise
MDOSREF Computation
Set to 'Vaccination 1' if 1. missing < ADSL.TR01SDT <= ASTDT < ADSL.DOSE2DT or 2. missing < ADSL.TR01SDT <= ASTDT and ADSL.DOS2DT is missing and (ADSL.TR02SDT is missing or missing < ASTDT < ADSL.TR02SDT), Set to 'Vaccination 2' if 1. missing < ADSL.DOS2DT <= ASTDT < ADSL.TR02SDT or 2. missing < ADSL.DOS2DT <= ASTDT and ADSL.TR02SDT is missing, Set to 'OL Vaccination 1' if 1. missing < ADSL.TR02SDT <= ASTDT<ADSL.OLDOS2DT or 2. missing < ADSL.TR02SDT <= ASTDT and ADSL.OLDOS2DT is missing, Set to 'OL Vaccination 2' if missing < ADSL.OLDOS2DT <= ASTDT
MRDSTDY Computation
Set to ASTDT – TR01SDT + 1 if MDOSREF='Vaccination 1', Set to ASTDT – DOS2DT + 1 if MDOSREF='Vaccination 2', Set to ASTDT – TR02SDT + 1 if MDOSREF='OL Vaccination 1', Set to ASTDT – OLDOS2DT + 1 if MDOSREF='OL Vaccination 2'
ONTRTFL Computation
Set to 'Y' if APERIOD=1 and (ASTDT <= TR01EDT + 27 days) and (AENDT >= TR01SDT or AENDT is missing); or if ASTDT is missing and (AENDT >= TR01SDT or AENDT is missing); or if APERIOD=2 and (ASTDT <= TR02EDT + 27 days) and (AENDT >= TR02SDT or AENDT is missing); or if ASTDT is missing and (AENDT >= TR02SDT or AENDT is missing); or missing otherwise
PREFL Computation
"Y" if ASTDT < TR01SDT or ASTDT is missing; missing otherwise
APERIOD Computation
Set to 2 if non-missing AP02SSDT<=DVSTDTC, Otherwise, Set to 1
DVSIG Computation
Set to SUPPDV.QVAL where SUPPDV.QNAM='DVSIG'
DVTERM1 Computation
Set to SUPPDV.QVAL where SUPPDV.QNAM='DVTERM1'
BOD Computation
Set to the first ADEFF.ADT where PARAMCD = 'COVIDA' and APERIOD = 1 and . < ADT <= EFFCODT per USUBJID, Set to missing, otherwise
BOI Computation
Set to the first ADEFF.ADT where PARAMCD='COVIDA' and APERIOD = 1 and . < ADT <= EFFCODT, Set to ADEFF.ADT where PARAMCD = 'ASYMPINF' and APERIOD = 1 and . < ADT <= EFFCODT if ADEFF.ADT where PARAMCD='COVIDA' per USUBJID is missing, Set to missing, otherwise
ANL01FL Computation
Set to 'Y' to the record with maximum of AVAL where paramcd = BOD28D per USUBJID
ANL01FL Computation
Set to 'Y' to the record with maximum of AVAL where paramcd = BOI28D per USUBJID
BOD Computation
For PARAMCD = “BOD7D”: Set to 0 if EVENTMO > AWRANGEN or ADT=missing Set to 3 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' and not missing (ADSL.DTHDT) and (DTHDT - ADT + 1) <= 7. Set to 2 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' and USUBJID is in HO and 1 <= (any non-missing numeric HO.HOSTDTC – ADT + 1) <= 7 Set to 1 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' For PARAMCD = “BOD28D”: Set to 0 if EVENTMO > AWRANGEN or ADT=missing Set to 3 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' and not missing (ADSL.DTHDT) and (DTHDT - ADT + 1) <= 28. Set to 2 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' and USUBJID is in HO and 1 <= (any non-missing numeric HO.HOSTDTC – ADT + 1) <= 28 Set to 1 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA'
BOI Computation
For PARAMCD = “BOI7D”: Set to 0 if EVENTMO > AWRANGEN or ADT=missing Set to 3 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' and not missing (ADSL.DTHDT) and (DTHDT-ADT+1) <= 7. Set to 2 if ADEFF.AVALC = 'Y' where PARAMCD='COVIDA' and USUBJID is in HO and 1<=(any non-missing numeric HO.HOSTDTC - ADT + 1) <= 7 Set to 1 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' Set to 0.5 if ADEFF.AVALC = 'Y' where PARAMCD = 'ASYMPINF' For PARAMCD = “BOI28D”: Set to 0 if EVENTMO > AWRANGEN or ADT=missing Set to 3 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' and not missing (ADSL.DTHDT) and (DTHDT-ADT+1) <= 28 Set to 2 if ADEFF.AVALC = 'Y' where PARAMCD='COVIDA' and USUBJID is in HO and 1<=(any non-missing numeric HO.HOSTDTC - ADT + 1) <= 28 Set to 1 if ADEFF.AVALC = 'Y' where PARAMCD = 'COVIDA' Set to 0.5 if ADEFF.AVALC = 'Y' where PARAMCD = 'ASYMPINF'
BOD Computation
Set EVENTMO = ADT - RANDDT+1)/30.4375 and create # of records per USUBJID per PARAMCD based on EVENTMO: Create 4 records if EVENTMO >= 18: AWRANGE = 'Randomization through 6 Months', ' After 6 Months through 12 Months', ' After 12 Months through 18 Months', ' After 18 Months through Completion' Create 3 records if EVENTMO >= 12: AWRANGE = 'Randomization through 6 Months', ' After 6 Months through 12 Months', ' After 12 Months through 18 Months' Create 2 records if EVENTMO >= 6: AWRANGE = 'Randomization through 6 Months', ' After 6 Months through 12 Months' Create 1 records, otherwise: AWRANGE = 'Randomization through 6 Months'
BOI Computation
Set EVENTMO = ADT - RANDDT+1)/30.4375 and create # of records per USUBJID per PARAMCD based on EVENTMO: Create 5 records If EVENTMO >=13 or ADT is missing: AWRANGE= 'Baseline through Month 1', 'After Month 1 through Month 2', 'After Month 2 through Month 7', 'After Month 7 through Month 13', and 'After Month 13 through Month 25' Create 4 records if EVENTMO >=7: AWRANGE= 'Baseline through Month 1', 'After Month 1 through Month 2', 'After Month 2 through Month 7', and 'After Month 7 through Month 13' Create 3 records if EVENTMO >=2: AWRANGE='Baseline through Month 1', 'After Month 1 through Month 2', and 'After Month 2 through Month 7' Create 2 records if EVENTMO >=1: AWRANGE = 'Baseline through Month 1' and 'After Month 1 through Month 2'. Create 1 record, otherwise: AWRANGE = 'Baseline through Month 1'
BOD Computation
Set to 1 if AWRANGE='Randomization through 6 Months'; Set to 2 if AWRANGE='After 6 Months through 12 Months'; Set to 3 if AWRANGE='After 12 Months through 18 Months'; Set to 4 if AWRANGE='After 18 Months through Completion';
BOI Computation
Set to 1 if AWRANGE='Baseline through Month 1'; Set to 2 if AWRANGE='After Month 1 through Month 2'; Set to 3 if AWRANGE='After Month 2 through Month 7'; Set to 4 if AWRANGE='After Month 7 through Month 13'; Set to 5 if AWRANGE='After Month 13 through Month 25';
ADT Computation
Step 1: Convert date part of FADTC to numeric if source data are from FAEF Convert date part of VSDTC to numeric if source data are from VS Step 2: Keep all records that occurred on or after COVID-19 (ADT from step 1 >= COVIDADT)
AGAPFL Computation
1) Sort the data by subject (SUBJID) and ADT 2) Set to 'Y' if ADT - last ADT > 28 and set 'Y' to all records on or after the ADT per subject
ANL01FL Computation
Set to 'Y' if HOSPFL ne 'Y' and ARELTG2N = 1 and AGAPFL ne 'Y'
ARELTPG1 Computation
Set to '<= 14 Days after COVID-19 Onset Date' if 1 <= ARELTPTN <= 15 Set to '> 14 Days after COVID-19 Onset Date' if ARELTPTN > 15
ARELTPG2 Computation
Set to '<= 28 Days after COVID-19 Onset Date' if 1 <= ARELTPTN <= 29 Set to '> 28 Days after COVID-19 Onset Date' if ARELTPTN > 29
ARELTPT Computation
Set to 'Day ' || ARELTPTN
ARELTPTN Computation
Set to ADT - COVIDADT + 1
AVAL.VS Computation
Set to VS.VSSTRESN
AVAL.FA Computation
Set to 0 if AVALC = 'NONE' 1 if AVALC = 'MILD' 2 if AVALC = 'MODERATE' 3 if AVALC = 'SEVERE'
AVALC.VS Computation
Set to Null
AVALC.FA Computation
Set to FAEF.FASTRESC
COVIDADT Computation
Set to first ADEFF.ADT where PARAMCD='COVIDA' and APERIOD = 1 and . < ADT <= EFFCODT per subject
FASYMPFL Computation
Set to 'Y' to the first ADT where PARAMCD ne (TEMP or OXYSAT) and AVAL > 0
HOSPFL Computation
Set to 'Y' per subject (USUBJID) if HO.HOOCCUR = 'Y' and .z < COVIDADT <= HOSTDTC where HOTERM = 'HOSPITAL' or 'ADMITTED TO ICU'
PARAM Computation
Set to VS.VSTEST || ' ( ||VSSTRESU|| ')' if source data from VS. Please add space between VSTEST and VSSTRESU Set to FAEF.FAOBJ if source data from FAEF. If FAOBJ='Myalgia', re-code it as 'Muscle Aches (Myalgia)' and if FAOBJ='Rhinorrhea', re-code it as 'Runny Nose (Rhinorrhea)'
PARCAT1 Computation
Set to 'Oxygen Saturation or Temperature' if PARAMCD = 'TEMP' or 'OXYSAT' Set to 'Non Oxygen Saturation and Temperature'
SRCDOM Computation
Set to 'FAEF' if source data are from FAEF Set to 'VS' if source data are from VS
SRCSEQ Computation
FAEF.FASEQ if source data are from FAEF VS.VSSEQ if source data are from VS
SRCVAR Computation
Set to 'FASTRESC' if source data are from FAEF Set to 'VSSTRESN' if source data are from VS
ASYMPINA Computation
Set to earlier date of: 1. Date of positive PCR test (MB.MBDTC) meets derivation of PARAM = 'Asymptomatic SARS-CoV-2 Infection per Adjudication' 2. Date of seroconversion due to infection (ADIS.ADT) where CRIT5FL = 'Y' and VISIT doesn't contain 'UNSCH' or 'ILLNESS' or 'CONVALESCENCE'
ASYMPINF Computation
Set to earlier date of: 1. Date of positive PCR test, ie, MB.MBDTC that meets derivation of PARAM = "Asymptomatic SARS-CoV-2 Infection"; 2. Date of seroconversion due to infection, ie, ADIS.ADT where CRIT5FL = "Y" and VISIT doesn't contain 'UNSCH' or 'ILLNESS' or 'CONVALESCENCE' in upper case.
COVID Computation
Set to the later date of the following two dates: 1. Date of positive PCR test (MB.MBDTC) meets derivation of PARAM = 'COVID-19' 2. Earliest date from following symptom date: Systemic symptoms: earliest ADSYMP.ADT of the 2nd eligible systemic symptom that occurred within +/-14 days window of positive PCR date Respiratory symptom: earliest ADSYMP.ADT (use ADSYMP.ASTDT for PARAMCD in ('CEPNEU', 'REPNEU') and use ADSYMP.ADT when ADSYMP.ASTDT is missing) of the 1st eligible respiratory symptom that occurred within +/-14 days window of positive PCR date
COVIDA Computation
Set to CE.CESDTC where CECAT='ADJUDICATION' and (CESCAT in ('COVID-19', 'SEVERE COVID-19'))
COVIDS Computation
Set to the later date of the following two dates: 1. Date of positive PCR test, ie, MB.MBDTC that meets derivation of PARAM = 'COVID-19 (Considering Scheduled RT-PCR)' 2. Earliest date from following symptom date: Systemic symptoms: earliest ADSYMP.ADT of the 2nd eligible systemic symptom that occurred within +/-14 days window of positive PCR date Respiratory symptom: earliest ADSYMP.ADT (use ADSYMP.ASTDT for PARAMCD 'CEPNEU' and 'REPNEU' and use ADSYMP.ADT when ADSYMP.ASTDT is missing) of the 1st eligible respiratory symptom that occurred within +/-14 days window of positive PCR date
COVIDSD Computation
Set to the later date of the following two dates: 1. Date of positive PCR test (MB.MBDTC) that meets derivation of PARAM = 'COVID-19 (Secondary Definition)' 2. Date of eligible symptom(s), defined as earliest ADSYMP.ADT of the 1st eligible symptom that occurred within +/-14 days window of positive PCR date
COVIDSDS Computation
Set to the later date of the following two dates: 1. Date of positive PCR test (MB.MBDTC) that meets derivation of PARAM = 'COVID-19 (Secondary Definition and Considering Scheduled RT-PCR)' 2. Date of eligible symptom(s), defined as earliest ADSYMP.ADT of the 1st eligible symptom that occurred within +/-14 days window of positive PCR date
COVIDSEV Computation
Set to the later date of the following dates: 1. ADT where PARAMCD = 'COVID' 2. Earliest date of first eligible severe symptom, defined as below: a. ADSYMP.ASTDT where ADSYMP.PARAMCD in ('RR30', 'HR125', 'OXYGEN93', 'PAO2F300', 'RF', 'ARDS', 'S90D60', 'VASOPRES', 'ARDYSF', 'HEPDYSF', 'NEURDYSF', 'ICU') with -14/+28 days window of positive PCR date. If ADSYMP.ASTDT is missing or < PCRDT-14 and ADSYMP.AENDT is within the window, use PCRDT-14 as the start date. Use ADSYMP.ADT when ADSYMP.ASTDT and ADSYMP.AENDT are missing b. ADSYMP.ADT where ADSYMP.PARAMCD = 'O2SAT93' with -14/+28 days window of positive PCR date c. ADSL.DTHDT if subject exists in AE with AE.AESDTH = 'Y' and SUPPAE.QNAM = 'AECVDIAG' and QVAL = 'Y' and ADSL.DTHDT within -14/+28 days window of positive PCR date
COVIDSVS Computation
Set to the later date of the following dates: 1. ADT where PARAMCD = 'COVIDS' 2. Earliest date of first eligible severe symptom, defined as below: a. ADSYMP.ASTDT where ADSYMP.PARAMCD in ('RR30', 'HR125', 'OXYGEN93', 'PAO2F300', 'RF', 'ARDS', 'S90D60', 'VASOPRES', 'ARDYSF', 'HEPDYSF', 'NEURDYSF', 'ICU') with -14/+28 days window of positive PCR date. If ADSYMP.ASTDT is missing or < PCRDT-14 and ADSYMP.AENDT is within the window, use PCRDT-14 as the start date. Use ADSYMP.ADT when ADSYMP.ASTDT and ADSYMP.AENDT are missing b. ADSYMP.ADT where ADSYMP.PARAMCD = 'O2SAT93' with -14/+28 days window of positive PCR date c. ADSL.DTHDT if subject exists in AE with AE.AESDTH = 'Y' and SUPPAE.QNAM = 'AECVDIAG' and QVAL = 'Y' and ADSL.DTHDT within -14/+28 days window of positive PCR date
DEATHCVD Computation
Set to ADSL.DTHDT due to COVID-19
INFECT Computation
Set to earlier date of: 1. Date of positive PCR test, ie, MB.MBDTC that meets derivation of PARAM = "SARS-CoV-2 Infection Regardless of Symptomatology or Severity". 2. Date of seroconversion due to infection, ie, ADIS.ADT where CRIT5FL = "Y".
ADY Computation
Set to ADT - ADSL.TR01SDT + 1 if ADT is on or after ADSL.TR01SDT Set to ADT - ADSL.TR01SDT if ADT is before ADSL.TR01SDT
ANL01FL Computation
Set to 'Y' for the record with AVALC = 'Y' and earliest ADT per PARAMCD
ASYMPINA Computation
Create a record for PARAM = 'Asymptomatic SARS-CoV-2 Infection per Adjudication' and AVALC = 'Y' if no prior COVID-19 symptoms (no record created with PARAMCD='COVIDA' or 'COVIDSDS' and AVALC = 'Y' and ADT on/before the earlier date of 1 and 2) and at least one of the following criteria is met: 1. has positive RT-PCR test at Day 29 or participant decision visit (MB.MBTESTCD='SARSCOV2' and MB.MBSTRESC is in ('DETECTED', ‘POSITIVE') and VISIT = 'Visit 2 Day 29' or 'Participant Decision Visit / OL-D1') 2. has seroconversion due to infection (ADIS.CRIT5FL = 'Y' and VISIT doesn't contain 'UNSCH' or 'ILLNESS' or 'CONVALESCENCE')
ASYMPINF Computation
Create a record for PARAM = 'Asymptomatic SARS-CoV-2 Infection' and AVALC = 'Y' if no prior COVID-19 symptoms (no record created with PARAMCD='COVIDS' or 'COVIDSDS' and AVALC = 'Y' and ADT on/before the earlier date of 1 and 2) and at least one of the following criteria is met: 1. has positive RT-PCR test at Day 29 or participant decision visit (ie, MB.MBTESTCD='SARSCOV2', MB.MBSTRESC is in ('DETECTED', 'POSITIVE') and VISIT in ('Visit 2 Day 29', 'Participant Decision Visit / OL-D1') 2. has seroconversion due to infection (ADIS.CRIT5FL = 'Y' and VISIT doesn't contain 'UNSCH' or 'ILLNESS' or 'CONVALESCENCE')
AVALC Computation
Set to 'Y'
AVISIT Computation
Only apply for PARAMCD in ('ASYMPINF, 'ASYMPINA'): 1. Use MB.VISIT of the RT-PCR result in below derivation if the case is derived based on positive RT-PCR only 2. Use ADIS.AVISIT of the seroconversion if the case is derived based on seroconversion only 3. Use MB.VISIT in below derivation if the case is derived based on both positive RT-PCR and seroconversion If ADY>1, Set to 'Day xx' part of VISIT for VISITNUM=6, 10, 15, 21, 32, Set to VISIT for VISIT = 'Participant Decision Visit / OL-D1', Set to 'Open Label Day 29' if VISIT = 'OL-D29', Set to 'Open Label Day 57' if VISIT = 'OL-D57', Set to null if other PARAMCD,
COVID Computation
Create a record for PARAM = 'COVID-19' for each positive RT-PCR if following conditions are met: 1. RT-PCR is positive (MB.MBTESTCD='SARSCOV2' and MB.MBSTRESC is in ('DETECTED' or ‘POSITIVE’) after first dose (MB.MBDTC > ADSL.TR01SDT (non-missing)) and VISIT is not in ('Visit 2 Day 29', 'Participant Decision Visit / OL-D1') ) 2. if symptom(s) occurred within +/-14 days window of positive PCR date (symptom event found from ADSYMP where ADSYMP.AVALC=Y and MB.MBDTC-14 <= ADSYMP.ADT <= MB.MBDTC+14): (a) at least two systemic symptom events found from ADSYMP where PARAMCD in ('FEVER', 'CHILLS', 'MYALGIA'/'BODYACHE', 'HEADACHE', 'STHROAT', 'NLSMELL'/'NLTASTE') where 'NLSMELL' and/or 'NLTASTE' are considered as one symptom, 'MYALGIA' and/or 'BODYACHE' are considered as one symptom, or (b) at least one respiratory symptom event found from ADSYMP where PARAMCD in ('COUGH', 'SHBREATH', 'DIBREATH', 'CEPNEU', 'REPNEU'). For 'CEPNEU' and 'REPNEU', use ADSYMP.ASTDT in place of ADSYMP.ADT and use ADSYMP.ADT when ADSYMP.ASTDT is missing
COVIDA Computation
Create a record for PARAM = 'COVID-19 per Adjudication' if subject has SUPPCE.QVAL containing 'EVENT MEETS THE CHARTER DEFINITION OF COVID-19' where QNAM='CEREASOC'
COVIDS Computation
Create a record for PARAM = 'COVID-19 (Considering Scheduled RT-PCR)' if following conditions are met: 1. RT-PCR is positive (MB.MBTESTCD='SARSCOV2', MB.MBSTRESC is in ('DETECTED', ‘POSITIVE) after first dose (MB.MBDTC > ADSL.TR01SDT (non-missing))) 2. if symptom(s) occurred within +/-14 days window of positive PCR date (symptom event found from ADSYMP where ADSYMP.AVALC=Y and MB.MBDTC-14 <= ADSYMP.ADT <= MB.MBDTC+14): (a) at least two systemic symptom events found from ADSYMP where PARAMCD in ('FEVER', 'CHILLS', 'MYALGIA'/'BODYACHE', 'HEADACHE', 'STHROAT', 'NLSMELL'/'NLTASTE') where 'NLSMELL' and/or 'NLTASTE' are considered as one symptom, 'MYALGIA' and/or 'BODYACHE' are considered as one symptom, or (b) at least one respiratory symptom event found from ADSYMP where PARAMCD in ('COUGH', 'SHBREATH', 'DIBREATH', 'CEPNEU', 'REPNEU'). For 'CEPNEU' and 'REPNEU', use ADSYMP.ASTDT in place of ADSYMP.ADT and use ADSYMP.ADT when ADSYMP.ASTDT is missing
COVIDSD Computation
Create record for PARAM = 'COVID-19' for each RT-PCR is Positive (Secondary Definition)' if following conditions are met: 1. Select all subjects where RT-PCR is Positive (MB.MBSTRESC=DETECTED or POSITIVE due to prompt symptom) after First Dose (MBDTC>ADSL.TR01SDTC) and VISIT is not 'VISIT 2 Day 29' or 'Participant Decision Visit / OL-D1' 2. If a systemic symptom occurred within +/-14 days window of date with detected /positive as test result (a) any systemic symptom event found from ADSYMP where PARAMCD in ('FEVER', 'CHILLS', 'COUGH', 'SHBREATH', 'DIBREATH', 'FATIGUE', 'MYALGIA', 'BODYACHE', 'HEADACHE', 'NLTASTE', 'NLSMELL', 'STHROAT', 'NASALCON', 'RUNNOSE', 'NAUSEA', 'VOMIT', 'DIARRHEA')
COVIDSDS Computation
Create a record for PARAM = 'COVID-19 (Secondary Definition and Considering Scheduled RT-PCR)' for each positive RT-PCR test after first dose if at least one systemic symptom occurred within +/-14 days window of positive PCR date: ADSYMP.PARAMCD in ('FEVER', 'CHILLS', 'COUGH', 'SHBREATH', 'DIBREATH', 'FATIGUE', 'MYALGIA', 'BODYACHE', 'HEADACHE', 'NLTASTE', 'NLSMELL', 'STHROAT', 'NASALCON', 'RUNNOSE', 'NAUSEA', 'VOMIT', 'DIARRHEA') and ADSYMP.AVALC=Y and MB.MBDTC-14 <= ADSYMP.ADT <= MB.MBDTC+14
COVIDSEV Computation
Create record for PARAM='Severe COVID-19' if following conditions are met: 1. Subject with PARAMCD='COVID', 2. At least one severe symptom (a) or (b) occurred within -14/+28 days window of positive PCR date (a) ADSYMP.PARAMCD in ('RR30', 'HR125', 'OXYGEN93', 'O2SAT93', 'PAO2F300', 'RF', 'ARDS', 'S90D60', 'VASOPRES', 'ARDYSF', 'HEPDYSF', 'NEURDYSF', 'ICU') and ADSYMP.AVALC='Y' and ((PCRDT-14 <= (ADT, ASTDT, or AENDT) <= PCRDT+28) or (ASTDT < PCRDT-14 and AENDT > PCRDT+28)), (b) AE.AESDTH = 'Y' and SUPPAE.QNAM = 'AECVDIAG' and QVAL = 'Y' and PCRDT-14 <= ADSL.DTHDT <= PCRDT+28
COVIDSVA Computation
Create a record for PARAM = 'Severe COVID-19 per Adjudication' if subject has SUPPCE.QVAL containing 'EVENT MEETS THE CHARTER DEFINITION OF SEVERE COVID-19' where QNAM='CEREASOC'
COVIDSVS Computation
Create record for PARAM='Severe COVID-19 (Considering Scheduled RT-PCR)' if following conditions are met: 1. Subject with PARAMCD='COVIDS' and AVALC = 'Y' 2. At least one severe symptom occurred within -14/+28 days window of positive PCR date (a) ADSYMP.PARAMCD in ('RR30', 'HR125', 'OXYGEN93', 'PAO2F300', 'RF', 'ARDS', 'S90D60', 'VASOPRES', 'ARDYSF', 'HEPDYSF', 'NEURDYSF', 'ICU') and ADSYMP.AVALC='Y' and (PCRDT-14 <= ADSYMP.ASTDT<= PCRDT+28, or PCRDT-14 <= ADSYMP.AENDT<= PCRDT+28, or (ADSYMP.ASTDT < PCRDT-14 and ADSYMP.AENDT > PCRDT+28), use PCRDT-14 <= ADSYMP.ADT<= PCRDT+28 when ADSYMP.ASTDT and ADSYMP.AENDT are missing) (b) ADSYMP.PARAMCD = 'O2SAT93' and ADSYMP.AVALC='Y' and PCRDT-14 <= ADSYMP.ADT<= PCRDT+28 (c) AE.AESDTH = 'Y' and SUPPAE.QNAM = 'AECVDIAG' and QVAL = 'Y' and PCRDT-14 <= ADSL.DTHDT <= PCRDT+28
DEATHCVD Computation
Create a record for PARAM = 'Death Caused by COVID-19' if subject has AE.AESDTH = 'Y' and SUPPAE.QNAM = 'AECVDIAG' and QVAL = 'Y' and ADSL.DTHDT is non-missing
EVIDINF Computation
For PARAMCD = 'INFECT', 'ASYMPINF', or 'ASYMPINA' Set to 'Virology' if the case is derived based on positive RT-PCR only, Set to 'Serology' if the case is derived based on seroconversion only, Set to 'Virology and Serology' if the case is derived based on both positive RT-PCR and seroconversion
INFECT Computation
Create a record for PARAM = 'SARS-CoV-2 Infection Regardless of Symptomatology or Severity' if at least one of the following criteria is met: 1. has seroconversion due to infection (ADIS.CRIT5FL = 'Y') 2. has positive RT-PCR test after first dose (MB.MBTESTCD='SARSCOV2', MB.MBSTRESC is in ('DETECTED', 'POSITIVE’) and MB.MBDTC > ADSL.TR01SDT (non-missing)
PARCAT1 Computation
Set to 'DERIVED PER ADJUDICATION' if PARAMCD in ('COVIDA', 'COVIDSVA', 'ASYMPINA'), otherwise, Set to 'DERIVED PER SAP'
PCRD29FL Computation
Set to 'Y' if the case is derived using positive RT-PCR at Day 29 ( MB.MBTESTCD = 'SARSCOV2', MB.MBSTRESC is in ('DETECTED' or 'POSITIVE' ), MB.VISIT = 'Visit 2 Day 29', and MB.MBDTC=PCRDT (non-missing)
PCRDT Computation
See derivation of PARAM. For PARAMCD = "COVID", "COVIDSD", "COVIDS", "COVIDSDS", set to the date of positive PCR test that meets derivation of corresponding PARAM; For PARAMCD = "COVIDSEV", set to the date of positive PCR test where PARAMCD = "COVID"; For PARAMCD = "COVIDSVS", set to the date of positive PCR test where PARAMCD = "COVIDS"; For PARAMCD = "INFECT", "ASYMPINF", or "ASYMPINA", set to null if PARAM is created based on seroconversion only (not based on positive RT-PCR), else set to the date of PCR test that meets derivation of corresponding PARAM; For PARAMCD = "DEATHCVD", set to the date of most recent post-baseline positive PCR if available (MB.MBDTC where MB.MBTESTCD="SARSCOV2", MB.MBSTRESC is "DETECTED" or "POSITIVE" in upper case, and MBDTC > ADSL.TR01SDT (non-missing)). Otherwise, null.
AENDT Computation
Converted date part of EX.EXENDTC to numeric
ASEQ Computation
Sort by USUBJID, VISIT, EX.EXSEQ, EX.ECSEQ and start from 1, increase by 1 for records within each subject
ASTDT Computation
Convert date part of EX.EXSTDTC to numeric
ASTDTM Computation
Convert EXSTDTC to numeric
DOSEYNFL Computation
Set to 'Y' if EXSTDTC is not missing. Set to 'N' if EXSTDTC is missing and EC.ECOCCUR='N'
NDOSERS Computation
Set to EC.ECREASOC
NDOSRSP Computation
Set to SUPPEC.QVAL where QNAM='EXREASSP'
NDOSRSP1 Computation
Set to SUPPEC.QVAL where QNAM='EXREASP1'
NDOSRSP2 Computation
Set to SUPPEC.QVAL where QNAM='EXREASP2'
SRCDOM Computation
Set to EX.DOMAIN if source data are from EX or Set to EC.DOMAIN if source data are from EC
SRCSEQ Computation
Set to EX.EXSEQ if source data are from EX or Set to EC.ECSEQ if source data are from EC
ABLFL Computation
Set to 'Y' for the latest (ADT) non-missing AVAL on or before ADSL.TR01SDT for each SUBJID, PARCAT1 and PARAMCD. Use ADT and TR01SDT if time is not available
ADT Computation
Convert date part of IS.ISDTC to numeric
ADTM Computation
Convert IS.ISDTC to numeric
ADY Computation
Set to ADT - ADSL.TR01SDT if ADT is before ADSL.TR01SDT, otherwise, Set to ADT - ADSL.TR01SDT + 1 if ADT is on or after ADSL.TR01SDT
ANL01FL Computation
If ABLFL='Y', then set to 'Y' For post-baseline assessments where AVISITN is non-missing and result (AVAL) is non-missing, per subject per parameter and per AVISIT: Within an AVISIT, set to ‘Y’ for the assessment at scheduled visit (i.e., VISIT doesn't contain "Unsched"). If there are 2 or more assessments at scheduled visit, set ‘Y’ to the latest assessment. If there are 2 or more assessments with non-missing AVAL on the latest assessment date, use the smaller AVAL, If there is no scheduled visit, set to 'Y' for the assessment closest to the target study day (record with minimum AWTDIFF) in the visit window. If there are 2 or more assessments equal distance to the target study day (AWTDIFFs are same), set to the latest assessment. If there are 2 or more assessments with non-missing AVAL on the latest assessment date, use the smaller AVAL
APERIOD Computation
Set to 2 if ADT>=AP02SDT>Missing, Otherwise, Set to 1
ATM Computation
Convert time part of IS.ISDTC to numeric
ATPT Computation
Set to 'Day x' If AVISIT='Illness Visit Day x' or 'Illness Visit y Day x' (See ADIS.AVISIT from Additional ADaM Variable Definition Doc). Otherwise, set to null

Additional ADaM Variable Definition

AVAL Computation
Set to LOG10(0.5* times ISLLOQ) if ISSTRESC contains '<' or 'BQL' or ISSTRESN<ISLLOQ, Set to LOG10(ISULOQ) if ISSTRESC contains '>', Set to LOG10(IS.ISSTRESN), Otherwise
AVALC Computation
Set to IS.ISSTRESC if PARAMCD='SARSCOV2'
AVALO Computation
Set to 0.5 times ISLLOQ if ISSTRESC contains '<' or 'BQL' or ISSTRESN<ISLLOQ, Set to ISULQ if ISSTRSC contains ">", Set to IS.ISSTRESN, Otherwise
AVALS Computation
Set to null
AVISIT Computation
See ADIS.AVISIT from Additional ADaM Variable Definition Doc.

Additional ADaM Variable Definition

AWTDIFF Computation
Set to absolute value of (ADY - AWTARGET)
BASE Computation
Set to AVAL where ABLFL = 'Y' for each SUBJID, PARCAT1 and PARAMCD
CHG Computation
Set to AVAL - BASE for post-baseline records
CRIT1 Computation
Set to '>=2-fold Increase from Baseline' if CRIT1FL='Y'
CRIT1FL Computation
Set to 'Y' if baseline result contains ('<', 'BQL') or ISSTRESN<ISLLOQ, and post-baseline >= 2 x ISLLOQ (AVAL>=2 * ISLLOQ) or baseline result does not contains ('<' , 'BQL') and not <ISLLOQ and post-baseline increase 2 times from the baseline value (R2BASE>=2)
CRIT2 Computation
Set to '>=3-fold Increase from Baseline' if CRIT2FL='Y'
CRIT2FL Computation
Set to 'Y' if baseline result contains ('<', 'BQL') or ISSTRESN<ISLLOQ, and post-baseline >= 2 x ISLLOQ (AVAL>=3 * ISLLOQ) or baseline result does not contain ('<' , 'BQL') and not <ISLLOQ and post-baseline increase 3 times from the baseline value (R2BASE>=3)
CRIT3 Computation
Set to '>=4-fold Increase from Baseline' if CRIT3FL='Y'
CRIT3FL Computation
Set to 'Y' if baseline result contains '<xxx' or ISSTRESN<ISLOD or ISSTRESN<ISLLOQ, and post-baseline >= 4 x ISLLOQ (AVAL>=4 * ISLLOQ) or baseline result does not contain '<' and not <ISLOD and not <ISLLOQ and post-baseline increase 4 times from the baseline value (R2BASE>=4)
CRIT4 Computation
Set to 'Seroconversion Due to Vaccination' if CRIT4FL='Y'
CRIT4FL Computation
Set to 'Y' if baseline result ISSTRESC contains ('<', 'BQL') or ISSTRESN<ISLLOQ and post-baseline >= ISLLOQ, or baseline result does not contain ('<' , 'BQL') and not < ISLLOQ and post-baseline increase 4 times from the baseline value (R2BASE>=4)
CRIT5 Computation
Set to 'Seroconversion Due to Infection if CRIT5FL='Y'
CRIT5FL Computation
For ADSL.ELECSBL= 'Negative': Set to 'Y' if PARAMCD='SARSCOV2' and post-baseline ISSTRESC='Positive' For ADSL.ELECSBL = 'Positive': Set to 'Y' if PARAMCD='V66IGGEN' and post-baseline result increased 4 times from the baseline (R2BASE>=4)
CRIT6 Computation
Set to 'Seroconversion' if CRIT6FL='Y'
CRIT6FL Computation
Set to 'Y' if baseline result contains ('<', 'BQL') or ISSTRESN<ISLLOQ and post-baseline >= ISLLOQ (AVAL>=ISLLOQ) or baseline result does not contain ('<', 'BQL') and >= ISLLOQ and post-baseline increase x times from the baseline value (R2BASE>=x) where x=3.3 for PARAMCD='PSVNT50', x=2.3 for PARAMCD='PSVNT80', x=4.6 for PARAMCD='V65IGGS', x=1.9 for PARAMCD='S2PIGG', and x=4 for other PARAMCD
DTYPE Computation
Set to 'HALFLLOQ' if ISSTRESN<LLOQ or ISSTRESC contains '<' or 'BQL' Set to 'ULOQ' if ISSTRESC contains '>'
EUAVACFL Computation
Set to 'Y' if .< ADSL.EUAVACDT < ADT
ISLLOQ Computation
SUPPIS.QVAL where QNAM is 'ISLLOQ'
ISLOD Computation
Set to SUPPIS.QVAL where QNAM is 'ISLOD'
ISULOQ Computation
Set to SUPPIS.QVAL where QNAM is 'ISULOQ'
PARAM Computation
For PARCAT1='Serum SARS-CoV-2 Neutralizing Antibodies', Set to ISTEST For PARCAT1='Serum SARS-CoV-2 Binding Antibodies': Set to ISTEST " (" ||ISSTRESU|| ")" if PARAMCD does not contain 'L10' and ISSTRESU is non-missing, or ISTEST if ISSTRESU is not available for the test If PARAMCD contains 'L10' then assign PARAM based on PARAMCD: Set to 'LOG10(PsVNT50)' if PARAMCD='L10PVN50' Set to 'LOG10(PsVNT80)' if PARAMCD='L10PVN80' Set to 'LOG10(MN50)' if PARAMCD='L10MN50' Set to 'LOG10(VAC65 Spike IgG Antibody)' if PARAMCD='LV65IGGS' Set to 'LOG10(VAC66 Nucleocapsid IgG Antibody)' if PARAMCD='LV66IGGN' Set to 'LOG10(SARSCOV2S2P IgG Antibody)' if PARAMCD='LS2PIGG' Set to 'LOG10(SARSCOV2RBD IgG Antibody)' if PARAMCD='LRBDIGG' Set to 'LOG10(SARSCOV2NP IgG Antibody)' if PARAMCD='LNPIGG'.
PARAMCD Computation
Set to ISTESTCD and create follow PARAMCDs if AVAL is not missing and PARAM ne 'Elecsys SARS Cov-2 assay': L10PVN50, L10PVN80, L10MN50, LV65IGGS, LV66IGGN, LS2PIGG, LRBDIGG, LNPIGG
PARAMTYP Computation
Set to 'DERIVED' if PARAMCD contains 'L10' or 'LV58' or 'LV65' or 'LV66'
PARCAT1 Computation
Set to IS.ISCAT
PARCAT2 Computation
Set to 'Keep Actual Values Beyond ULOQ' if PARAMCD ne 'SARSCOV2'
R2BASE Computation
Set to AVAL/BASE if both are available and BASE is not 0 for post-baseline records and baseline result does not contain '<' or 'BQL' or ISSTRESN<ISLLOQ
RANGE Computation
Set to SUPPIS.QVAL where QNAM is 'RANGE'
TRTA Computation
If ADTM>TR01SDTM>. and (ADTM<=DOS2DTM or TR01SDTM is the last dose date time): Set to 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 1', Set to 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'Day 1' If ADTM> ADSL.DOS2DTM>. and (ADTM<ADSL.TR02SDTM or ADSL.DOS2DTM is the last dose date time): Set to 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'Day 29', Set to 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'Day 29' If ADTM >ADSL.TR02SDTM>. and (ADTM<ADSL.OLDO2DTM or TR02SDTM is the last dose date time): Set to 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'OL-D1', Set to 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'OL-D1' If .<ADSL.OLDO2DTM<=ADTM: Set to 'Placebo' if EX.EXTRT='PLACEBO' where EX.VISIT contains 'OL-D29', Set to 'mRNA-1273' if EX.EXTRT='mRNA-1273' where EX.VISIT contains 'OL-D29' Note: If time part of ADTM, TR01SDTM, DOS2DTM, TR02SDTM, or OLDO2DTM is missing, use ADT, TR01SDT, DOSE2DT, TR02SDT, and OLDOS2DT to replace ADTM, TR01SDTM, DOS2DTM, TR02SDTM, and OLDO2DTM, respectively
ABLFL Computation
Set to 'Y' for last ADT on or before ADSL.TR01SDT with AVALC = 'Negative'/'Positive' for each SUBJID, PARCAT1 and PARAMCD. If there are multiple tests on the same date, select AVALC in the order of Positive > Negative
ADT Computation
Convert date part of MB.MBDTC to numeric
ADTM Computation
Convert MB.MBDTC to numeric
ADY Computation
Set to ADT - ADSL.TR01SDT if ADT is before ADSL.TR01SDT Set to ADT - ADSL.TR01SDT + 1 if ADT is on or after ADSL.TR01SDT
ANL01FL Computation
See ADMB.ANL01FL from Additional ADaM Variable Difinition Doc

Additional ADaM Variable Definition

ATM Computation
Convert time part of MB.MBDTC to numeric
ATPT Computation
Set to MB.MBTPT if MB.MBTPT is not missing or Set ATPT='Day x' if original AVISIT='Illness Visit Day x' or 'Illness Visit y Day x'
AVALC Computation
Set to 'Negative' if upcase(MBSTRESC) is 'NOT DETECTED' or 'NEGATIVE' or Set to 'Positive' if upcase(MBSTRESC) is 'DETECTED' or 'POSITIVE' Set to MBSTRESC, Otherwise
AVISIT Computation
See ADMB.AVISIT from Additional ADaM Variable Difinition Doc.

Additional ADaM Variable Definition

AWRANGE Computation
See ADMB.AWRANGE from Additional ADaM Variable Difinition Doc.

Additional ADaM Variable Definition

AWTARGET Computation
See ADMB.AWTARGET from Additional ADaM Variable Difinition Doc.

Additional ADaM Variable Definition

AWTDIFF Computation
Set to absolute value of (ADY - AWTARGET)
BASEC Computation
Set to AVALC where ABLFL = 'Y' for each SUBJID, PARCAT1 and PARAMCD
LDTCLIA Computation
Set to SUPPMB.QVAL where QNAM is 'LDTCLIA'
LOCALFL Computation
Set to SUPPMB.QVAL where QNAM is 'LOCALFL'
PARAM Computation
Set to MB.MBTEST
PARAMCD Computation
Set to MB.MBTESTCD
PARCAT1 Computation
Set to MB.MBCAT
CQ01FL Computation
Set to 'Y' if CQ01NAM is not missing
CQ01NAM Computation
Set to 'Autoimmune' if MHDECOD is in import.CMQ where CMQNAME='AUTOIMMUNE'
CQ02FL Computation
Set to 'Y' if CQ02NAM is not missing
CQ02NAM Computation
Set to 'Dermal Filler Reaction Post Vaccination' if MHDECOD is in import.CMQ where CMQNAME='DERMAL FILLER REACTION POST VACCINATION'
SMQ01FL Computation
Set to 'Y' if SMQ01NAM is not missing
SMQ01NAM Computation
Set to 'Anaphylactic Reaction' if AEDECOD is in import.SMQ where SMQNAME='ANAPHYLACTIC REACTION'
SMQ01SC Computation
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='ANAPHYLACTIC REACTION'
SMQ02FL Computation
Set to 'Y' if SMQ02NAM is not missing and SMQ02SC is 'Narrow'
SMQ02NAM Computation
Set to 'Angioedema' if MHDECOD is in import.SMQ where SMQNAME='ANGIOEDEMA'
SMQ02SC Computation
Set to SMQ.SCOPE if MHDECOD is in import.SMQ where SMQNAME='ANGIOEDEMA'
SMQ06FL Computation
Set to 'Y' if SMQ06NAM is not missing and SMQ06SC is 'Narrow'
SMQ06NAM Computation
Set to 'Hypersensitivity' if AEDECOD is in import.SMQ where SMQNAME='HYPERSENSITIVITY'
SMQ06SC Computation
Set to SMQ.SCOPE if AEDECOD is in import.SMQ where SMQNAME='HYPERSENSITIVITY'
AVALC Computation
For PARAMCD='OTHERLOC' or 'OTHEROCC', set to 'N' if SC.SCSTRESC='N', else set to 'Y' if SCSTRESC is not missing. For other PARAMCD, set to SC.SCSTRESC.
OTHSPY Computation
If PARAMCD='OTHEROCC' or 'OTHERLOC', set to SCSTRESC. Otherwise, set to null.
PARAM Computation
Set to mixed case of SC.SCTEST if SC.SCTEST not in ('Other', 'High density housing', 'Low density, multi-family setting', 'Multi-family dwelling', 'Nursing Home or Assisted Living Facility', 'Single family home') or Set to 'Resides in High Density Housing' if SC.SCTEST='High density housing' or Set to 'Resides in Low Density, Multi-Family Setting' if SC.SCTEST='Low density, multi-family setting' or Set to 'Resides in Multi-Family Dwelling'if SC.SCTEST='Multi-family dwelling' or Set to 'Resides in Nursing Home or Assisted Living Facility' if SC.SCTEST='Nursing Home or Assisted Living Facility' or Set to 'Resides in a Single Family Home' if SC.SCTEST='Single family home' or Set to 'Other Occupational Risk' if SC.SCTEST='Other' and PARCAT1='OCCUPATIONAL RISK' or Set to 'Other Location And Living Circumstances Risk' if SC.SCTEST='Other' and PARCAT1='LOCATION AND LIVING CIRCUMSTANCES RISK'
PARCAT1 Computation
Set to SC.SCSCAT
AGEGR1 Computation
Set to '>=18 and <65 Years' if 18<=AGE<65 Set to '>=65 Years' if AGE >=65
AGEGR1 Computation
Based on AGEGR1: Set to 1 if AGEGR1 is '>=18 and <65 Years' Set to 2 if AGEGR1 is '>=65 Years'
AGEGR2 Computation
Set to '>=18 and <65 Years' if 18 <= AGE < 65 Set to '>=65 and <75 Years' if 65 <= AGE < 75 Set to '>=75 if AGE >= 75 Years'
AGEGR2N Computation
Base on AGEGR2: Set to 1 if AGEGR2 is '>=18 and <65 Years' Set to 2 if AGEGR2 is '>=65 and <75 Years' Set to 3 if AGEGR2 is '>=75 Years'
AGEGR3 Computation
Set to '>=18 and <65 Years' if non-missing AGE<65, Set to '>=65 and <75 Years' if 65 <= AGE < 75, Set to '>=75 and <85 Years' if 75 <= AGE < 85, Set to '>=85 Years' if AGE >= 85
AGEGR3N Computation
Set to 1 if AGEGR2 is '>=18 and <65 Years', Set to 2 if AGEGR2 is '>=65 and <75 Years', Set to 3 if AGEGR2 is '>=75 and <85 Years', Set to 4 if AGEGR2 is '>=85 Years'
AGEGR4 Computation
Set to '>=18 and <=25 Years' if 18 <=AGE<=25, Set to '>=26 and <=50 Years' if 26 <= AGE <= 50
AGEGR4N Computation
Set to 1 if AGEGR4 is '>=18 and <=25 Years', Set to 2 if AGEGR4 is '>=26 and <=50 Years'
AP01EDT Computation
Set to AP02SDT-1 if AP02SDT is not missing, Set to the earlier date of EOSDT and DTHDT
AP01SDT Computation
Set to RANDDT
AP01SEDT Computation
Set to AP02SSDT-1 if AP02SSDT is not missing, Set to the earlier date of EOSDT and DTHDT
AP01SSDT Computation
Set to RANDDT
AP02EDT Computation
Set to the earlier date of EOSDT and DTHDT if AP02SDT is not missing
AP02SDT Computation
Set to PDVDT, UBLDDT, or IRTVISDT, whichever is the earliest date after TR01EDT. If AP02SDT is after EOSDT or DTHDT then set AP02SDT as missing.
AP02SEDT Computation
Set to the earlier date of EOSDT and DTHDT if AP02SSDT is not missing
AP02SSDT Computation
Set to TR02SDT if not missing, Set to PDVDT, UBLDDT, or IRTVISDT, whichever is earlier
BMIBL Computation
Set to WEIGHTBL/(HEIGHTBL in meters)^2
CBNRS Computation
Set to SUPPRP.QVAL where QNAM='CBRSN' and VISIT='Screening'
CCIASFL Computation
Set to 'Y' if RANDFL='Y' and subject is in the ccIAS Cohort sampling list. Set to 'N', otherwise Note: Use latest ccias_unblinded dataset. Subject eligibilities for sampling are specified in Immune sampling plan
CHILDBP Computation
Set to RP.RPORRES where RPTESTCD is CHILDPOT and VISIT='Screening'
COMPLFL Computation
Set to 'Y' if USUBJID exists in DS where DSCAT = 'DISPOSITION EVENT' and DS.DSSCAT = 'END OF STUDY' and DSDECOD = 'COMPLETED' Set to 'N' if USUBJID exists in DS where DSCAT = 'DISPOSITION EVENT' and DS.DSSCAT = 'END OF STUDY' and DSDECOD <> 'COMPLETED'
COVIDAFL Computation
Set to 'Y' where SUPPCE.QNAM='CEREASOC' and SUPPCE.QVAL containing 'EVENT MEETS THE CHARTER DEFINITION OF COVID-19' and CE.CESTDTC<=EFFCODT, Set to 'N', otherwise
CUTOFFDT Computation
Set to TS.TSVAL where TS.TSPARMCD='DCUTDTC'
CVDSVAFL Computation
Set to 'Y' where SUPPCE.QNAM='CEREASOC' and SUPPCE.QVAL containing 'EVENT MEETS THE CHARTER DEFINITION OF SEVERE COVID-19' and CE.CESTDTC<=EFFCODT, Set to 'N', otherwise
DCSREAS Computation
Set to DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' AND DSDECOD not in ('COMPLETED', 'ADVERSE EVENT', 'SAE', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT', 'PROTOCOL DEVIATION', 'OTHER', 'DEATH') Set to 'Adverse Event' if DS.DSDECOD is 'ADVERSE EVENT' Set to 'Serious Adverse Event' if DS.DSDECOD is 'SAE' Set to 'Protocol Deviation' if DS.DSDECOD is 'PROTOCOL DEVIATION' Set to 'Other' if DS.DSDECOD is 'OTHER' Set to 'Physician Decision' if DS.DSDECOD is 'PHYSICIAN DESICION' Set to 'Withdrawal of Consent by Participant' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT' Set to 'Death' if DS.DSDECOD='DEATH'
DCSREASP Computation
Set to DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' AND DSDECOD in ('ADVERSE EVENT', 'SAE', 'PHYSICIAN DESICION', 'WITHDRAWAL BY SUBJECT', 'PROTOCOL DEVIATION', 'OTHER') and DSTERM^=DSDECOD
DCT01RS Computation
Set to DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' and EPOCH='BLINDED TREATMENT' AND DSDECOD not in ('COMPLETED', 'ADVERSE EVENT', 'SERIOUS ADVERSE EVENT', 'PHYSICIAN DECISION', 'WITHDRAWAL BY SUBJECT', 'PROTOCOL DEVIATION', 'OTHER', 'DEATH', 'COVID'), Set to 'Adverse Event' if DS.DSDECOD is 'ADVERSE EVENT', Set to 'Serious Adverse Event' if DS.DSDECOD is 'SERIOUS ADVERSE EVENT', Set to 'Protocol Deviation' if DS.DSDECOD is 'PROTOCOL DEVIATION', Set to 'Other' if DS.DSDECOD is 'OTHER', Set to 'Physician Decision' if DS.DSDECOD is 'PHYSICIAN DECISION', Set to 'Withdrawal of Consent by Participant' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT', Set ot 'Death' if DS.DSDECOD='DEATH', Set to 'Due to SARS-CoV-2' if DS.DSDECOD='COVID', Set to 'Death' if DS.DSDECOD='DEATH' Set to 'Discontinuation from Study' if EOT01STT='DISCONTINUED' and COMPLFL='N' and no above mentioned record in DS
DCT01RSP Computation
Set to DS.DSTERM where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' and EPOCH='BLINDED TREATMENT' AND DSDECOD in ('ADVERSE EVENT', 'SERIOUS ADVERSE EVENT', 'PHYSICIAN DECISION', 'WITHDRAWAL BY SUBJECT', 'PROTOCOL DEVIATION', 'OTHER')
DCT02RS Computation
Set to DS.DSTERM where DS.DSCAT='DISPOSITION EVENT' and DS.DSSCAT='STUDY TREATMENT' and DS.EPOCH='OPEN LABEL TREATMENT' and DS.DSDECOD not in ('COMPLETED', 'ADVERSE EVENT', 'SERIOUS ADVERSE EVENT', 'PHYSICIAN DECISION', 'WITHDRAWAL BY SUBJECT', 'PROTOCOL DEVIATION', 'OTHER', 'DEATH', 'COVID'), Set to 'Adverse Event' if DS.DSDECOD is 'ADVERSE EVENT', Set to 'Serious Adverse Event' if DS.DSDECOD is 'SERIOUS ADVERSE EVENT', Set to 'Protocol Deviation' if DS.DSDECOD is 'PROTOCOL DEVIATION', Set to 'Other' if DS.DSDECOD is 'OTHER', Set to 'Physician Decision' if DS.DSDECOD is 'PHYSICIAN DESICION', Set to 'Withdrawal of Consent by Participant' if DS.DSDECOD is 'WITHDRAWAL BY SUBJECT', Set to 'Death' if DS.DSDECOD='DEATH', Set to 'Due to SARS-CoV-2' if DS.DSDECOD='COVID', Set to 'Discontinuation from Study' if EOT02STT='DISCONTINUED' and COMPLFL='N' and no above mentioned record in DS
DCT02RSP Computation
Set to DS.DSTERM where DS.DSCAT='DISPOSITION EVENT' and DS.DSSCAT='STUDY TREATMENT' and DS.EPOCH='OPEN LABEL TREATMENT' AND DS.DSDECOD in ('ADVERSE EVENT', 'SERIOUS ADVERSE EVENT', 'PHYSICIAN DECISION', 'WITHDRAWAL BY SUBJECT', 'PROTOCOL DEVIATION', 'OTHER')
DOS2DTM Computation
Convert EX.EXSTDTC to numeric where EX.VISIT contains 'Day 29' and EX.EXSTDTC is non-missing
DOSE1FL Computation
Set to 'Y' if USUBJID exists in EX with non-missing EXSTDTC where EX.VISIT contains 'Day 1' Set to 'N', otherwise
DOSE2DT Computation
Convert date part of EX.EXSTDTC to numeric where EX.VISIT contains 'Day 29' and EX.EXSTDTC is non-missing
DOSE2FL Computation
Set 'Y' if USUBJID exists in EX with non-missing EXSTDTC where EX.VISIT contains 'Day 29' Set to 'N' otherwise
DSDTHSP Computation
Set to SUPPDD.QVAL where SUPPDD.QNAM='DSDTHSP'
DTHAUTOP Computation
Set to DD.DDORRES where DDTESTCD='AUTOPERF'
DTHCAUS Computation
Set to DD.DDORRES where DDTESTCD='DTHCAUS'
DTHDT Computation
Convert DD.DDDTC to numeric or Convert AEENDTC where AE.AESDTH='Y' to numeric if DD.DDDTC is missing
EFFCODT Computation
Set to CUTOFFDT or EUAVACDT, whichever is the earliest date after TR01EDT.
ELECSBL Computation
Set to 'Positive' if USUBJID exists in IS with ISTESTCD='SARSCOV2', ISORRES='Positive' and non-missing ISDTC<=TR01SDT Set to 'Negative' if USUBJID exists with ISTESTCD='SARSCOV2', ISORRES='Negative' and non-missing ISDTC<=TR01SDT, Otherwise, Set to null. Note: Use last (only consider date part) non-missing results on/before TR01SDT for derivation
EOSDT Computation
Convert DS.DSSTDTC where DSCAT='DISPOSITION EVENT' and DSSCAT='END OF STUDY' to numeric
EOSDY Computation
Set to EOSDT-TR01SDT+1 if SAFFL='Y' and EOSDT>=TR01SDT Set to EOSDT-RANDDT+1 if RANDFL='Y' and EOSDT>=RANDDT Set to missing, otherwise
EOSSTT Computation
If RANDFL='Y': Set to 'COMPLETED' if COMPLFL='Y' Set to 'DISCONTINUED' if COMPLFL='N' Set to 'ONGOING' If RANDFL='N' then Set to null
EOT01DT Computation
Convert DS.DSSTDTC where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' and EPOCH='BLINDED TREATMENT' to numeric, set to DOSE2DT if EOT01STT is 'COMPLETED'
EOT01DY Computation
Set to EOT01DT-TR01SDT+1 if EOT01DT>=TR01SDT
EOT01STT Computation
Set to 'COMPLETED' if DOSE2FL='Y', Set to 'DISCONTINUED' if USUBJID exists in DS where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' and DSDECOD^='COMPLETED' and EPOCH='BLINDED TREATMENT'
EOT02DT Computation
Covert DS.DSSTDTC where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' and EPOCH='OPEN LABEL TREATMENT' or 'FOLLOW-UP OPEN LABEL PHASE' to numeric Set to OLDOS2DT if EOT02STT is 'COMPLETED' and (OLDOS2FL='Y' and TRT01AN^=2), or set to TR02EDT if (OLDOS1FL='Y' and TRT01AN=2)
EOT02DY Computation
EOT02DT-TR02SDT+1 if EOT02DT>=TR02SDT
EOT02STT Computation
Set to 'COMPLETED' if (OLDOS2FL='Y' and TRT01AN^=2) or (OLDOS1FL='Y' and TRT01AN=2), Set to 'DISCONTINUED' if USUBJID exists in DS where DSCAT='DISPOSITION EVENT' and DSSCAT='STUDY TREATMENT' AND DSDECOD^='COMPLETED' and EPOCH='OPEN LABEL TREATMENT ', Set to 'ONGOING' if (TRT02PN=2 and OLDOS1FL^='Y' and OLDOS2FL^='Y') or (TRT01AN^=2 and TRT02PN=2 and OLDOS2FL^='Y')
EUAVACDT Computation
See ADSL.EUAVACDT from ADaM-Variable-Definition.pdf

Additional ADaM Variable Definition

FASEREAS Computation
Only for subjects with RANDFL='Y' 1. Set to 'Did not receive any vaccination' if there is no record exists in EX with non-missing EXSTDTC 2. Set to 'Had major protocol deviations' if there is at least one record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis' or '2 - Exclude from all efficacy analysis (full analysis set and per-protocol analysis set)' or '8 - Exclude from all analysis sets except for randomization and DVSTDTC <= AP01EDT (condition of DVSTDTC <= AP01EDT applies only when AP01EDT is not missing), After above steps, if a subject satisfies more than one of 1-2, then concatenate reason with ',' Set to null, otherwise
FASFL Computation
Set to 'Y' if all criteria met: 1. RANDFL='Y', 2. USUBJID exists in EX with non-missing EXSTDTC, 3. There is no record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis sets', or '2 - Exclude from all efficacy analysis (full analysis set and per-protocol analysis set)' or '8 - Exclude from all analysis sets except for randomization set' and (DVSTDTC <= EFFCODT and DVSTDTC <= AP01EDT and AP01EDT is not missing or DVSTDTC <= EFFCODT if AP01ENDT is missing) Set to 'N', otherwise
HEIGHTBL Computation
Set to the last non-missing VS.VSSTRESN where VSTESTCD = “HEIGHT” and (VSDTC is before the first vaccination (DM.RFXSTDTC) or on the first vaccination date with VSTPT contains 'PRE-DOSE'), if missing use non-missing VS.VSSTRESN where VSTESTCD='HEIGHT' and or VISIT='Screening' with VSTPT^='POST-DOSE'
IRTVISDT Computation
Convert date part of SUPPDS.QVAL where QNAM = 'IRTVISDT' to numeric
MINORITY Computation
Only for subjects with (RACE is not missing or not equal to ‘NOT REPORTED’ or ‘UNKNOWN’ ) or (ETHNIC is not missing or not equal to ‘NOT REPORTED’ or ‘UNKNOWN’ ): Set to 'Minority' if ADSL.RACE is equal to ''AMERICAN INDIAN OR ALASKA NATIVE', 'BLACK OR AFRICAN AMERICAN', 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER', or ADSL.ETHNIC= ‘HISPANIC OR LATINO’, Set to 'Non-minority', otherwise
MITTERS Computation
Only for subjects with RANDFL='Y'. 1. Set to 'Did not receive any vaccination' if there is no record exists in EX with non-missing EXSTDTC, 2. Set to 'Had major protocol deviations' If there is at least one record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis' or '2 - Exclude from all efficacy analysis (full analysis set and per-protocol analysis set)' or '8 - Exclude from all analysis sets except for randomization set' and DVSTDTC <= EFFCODT and DVSTDTC <= AP01EDT (condition of DVSTDTC <= AP01EDT applies only when AP01EDT is not missing), 3. Set to 'PCR and/or serology positive at baseline' if SCOV2BL='Positive', 4. Set to 'PCR and/or serology missing at baseline' if SCOV2BL='', After above steps, if a subject satisfies more than one of 1-4, then concatenate reason with ',' Set to null, otherwise
MITTFL Computation
Set to 'Y' if FASFL='Y' and SCOV2BL = 'Negative' Set to 'N', otherwise
OLDO2DTM Computation
Convert non-missing EX.EXSTDTC where EX.VISIT='OL-D29' to numeric.
OLDOS1FL Computation
Set to 'Y' if USUBJID exists in EX with non-missing EXSTDTC where EX.VISIT contains 'OL-D1', Set to 'N', otherwise
OLDOS2DT Computation
Convert date part of non-missing EX.EXSTDTC where EX.VISIT='OL-D29' to numeric
OLDOS2FL Computation
Set to 'Y' if USUBJID exists in EX with non-missing EXSTDTC where EX.VISIT contains 'OL-D29', Set to 'N', otherwise
PDVDT Computation
Convert date part of SV.SVSTDTC where VISIT='Participant Decision Visit / OL-D1'
PPEREAS Computation
Only for subjects with RANDFL='Y' 1. Set to 'Excluded from mITT population' if MITTFL='N', 2. Set to 'Did not receive Vaccination #2 per schedule' if DOSE2FL='N' 3. Set to 'Had major protocol deviations' if there is at least one record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis sets' or '2 - Exclude from all efficacy analysis (full analysis set and per-protocol analysis set)' or '3 - Exclude from per-protocol analysis set only' or '8 - Exclude from all analysis sets except for randomization set' and DVSTDTC <= EFFCODT and DVSTDTC <= AP01EDT (condition of DVSTDTC <= AP01EDT applies only when AP01EDT is not missing) 4. Set to 'Received incorrect vaccination' if there is any record in EX where EXTRT (non-missing) ne TRT01P in any case, 5. Set to 'Received Vaccination #2 out of window' if DOSE2FL='Y' and (non-missing DOSE2DT - TR01SDT < 21 or > 42), After above steps, if a subject satisfies more than one of 1-5, then concatenate reason with ',' Set to null otherwise
PPROTFL Computation
Set 'Y' if all criteria met: 1. MITTFL='Y', 2. DOSE2FL='Y' and 21 <= DOSE2DT - TR01SDT <= 42, 3. There is no record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis sets' or '2 - Exclude from all efficacy analysis (full analysis set and per-protocol analysis set)' or '3 - Exclude from per-protocol analysis set only' or '8 - Exclude from all analysis sets except for randomization set' and (DVSTDTC <= EFFCODT and DVSTDTC <= AP01EDT if AP01EDT is not missing or DVSTDTC <= EFFCODT if AP01EDT is missing), 4. There is no record in EX where EXTRT (non-missing) ne TRT01P in any case Set to 'N', otherwise
PPSIEREA Computation
Only for subjects with RANDFL='Y': 1. Set to 'Not in random subcohort for immunogenicity' if RANDIGFL='N', 2. Set to 'Did not receive Vaccination #2 per schedule' if DOSE2FL='N', 3. Set to 'Had major protocol deviations' if there is at least one record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis sets' or '2 - Exclude from all efficacy analysis (full analysis set and per-protocol analysis set)' or '3 - Exclude from per-protocol analysis set only' or '8 - Exclude from all analysis sets except for randomization set' and DVSTDTC <= EFFCODT and DVSTDTC <= AP01EDT (condition of DVSTDTC <= AP01EDT applies only when AP01EDT is not missing), 4. Set to 'Received incorrect vaccination in blinded phase' if there is any dosing error in blinded phase - can find record where iEXTRT (non-missing) ne TRT01P and VISIT in ('Visit 1 Day 1' 'Visit 2 Day 29') and in any case, 5. Set to 'Received Vaccination #2 out of window' if DOSE2FL='Y' and (non-missing DOSE2DT - TR01SDT < 21 or > 42), 6. Set to 'Human Immunodeficiency Virus Infection' if RSKF6 is not missing, Concatenate reason with ',' if a subject satisfies more than one of 1-6
PPSIFL Computation
Set to 'Y' if all criteria met: 1. RANDIGFL='Y', 2. DOSE2FL='Y' and 21 <= DOSE2DT - TR01SDT <= 42, 3. There is no record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis sets' or '2 - Exclude from all efficacy analysis (full analysis set and per-protocol analysis set)' or '3 - Exclude from per-protocol analysis set only' or '8 - Exclude from all analysis sets except for randomization set' and (DVSTDTC <= EFFCODT and DVSTDTC <= AP01EDT if AP01EDT is not missing or DVSTDTC <= EFFCODT if AP01EDT is missing), 4. There is no records found in EX where EXTRT not missing and EXTRT ne TRT01P in any case, 5. RSKF6 is missing Set to 'N', otherwise
PREVSCR Computation
Set to SUPPDM.QVAL where QNAM='PREVSCR' per USUBJID
PROTVER Computation
Set to SUPPDM.QVAL where QNAM is PROTVER
RACEGR1 Computation
Set to 'Caucasian' if RACE='WHITE' Set to 'Non-caucasian' if RACE is not missing or not equal to ‘NOT REPORTED’ or ‘UNKNOWN’
RACEGR1N Computation
Based on RACEGR1: Set to 1 if RACEGR1='Caucasian' Set to 2 if RACEGR1 is 'Non-caucasian'
RACESPY Computation
Set to SUPPDM.QVAL where QNAM is RACEOTH if RACE='OTHER', Concatenate SUPPDM.QVAL with ', ' where QNAM is among RACE1 - RACE6 if RACE='MULTIPLE'
RANDDT Computation
Set to DS.DSSTDTC where DSTERM='RANDOMIZED' and DSCAT='PROTOCOL MILESTONE'
RANDFL Computation
Set to 'Y' if both criteria met: 1. USUBJID exists in DS where DSDECOD='RANDOMIZED' and DSSTDTC not missing and DSREFID not missing 2. there is no record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis sets' and DVSTDTC <= AP02SDT (condition of DVSTDTC <= AP02SDT applies only when AP02SDT is not missing) Set to 'N', otherwise
RANDIGFL Computation
Set to 'Y' if subject is randomized to the ccIAS cohort sampling list (RANDSFL='Y' in ccias_unblinded dataset), Set to 'N', otherwise Note: Use latest ccias_unblinded dataset. Subject eligibilities for sampling are specified in Immune sampling plan
RANDNUM Computation
Set to DS.DSREFID
RETHGR1 Computation
Only for subjects with (non-missing RACE not equal to ‘NOT REPORTED’ or ‘UNKNOWN’) or (non-missing ETHNIC not equal to ‘NOT REPORTED’ or ‘UNKNOWN’): Set to 'White' if RACE='WHITE' and ETHNIC ne 'HISPANIC OR LATINO' Set to 'Community of Colors', otherwise
RETHGR1N Computation
Based on RETHGR1 Set to 1 if RETHGR1='White' Set to 2 if RETHGR1='Communities of Color'
RFICDT Computation
Set to date part of DM.RFICDTC in numeric format
RISKGR1 Computation
Only derived for subjects where RANDFL='Y': Set to 'At Risk' if at least one of RSKF1-RSK6 in not missing, otherwise Set to 'Not At Risk'
RISKGR1N Computation
Based on RISKGR1: Set to 1 if RISKGR1='At Risk' Set to 2 if RISKGR1='Not At Risk'
RSKF1 Computation
Set to 'Chronic Lung Disease' if exist record in MH where MHTERM='LUNG DISEASE' and MHOCCUR='Y' and MHCAT='RISK FACTOR FOR COVID-19'
RSKF2 Computation
Set to 'Significant Cardiac Disease' if exist record in MH where MHTERM='CARDIAC DISEASE' and MHOCCUR='Y' and MHCAT='RISK FACTOR FOR COVID-19'
RSKF3 Computation
Set to 'Severe Obesity' if exist record in MH where MHTERM='SEVERE OBESITY' and MHOCCUR='Y' and MHCAT='RISK FACTOR FOR COVID-19'
RSKF4 Computation
Set to 'Diabetes' if exist record in MH where MHTERM='DIABETES' and MHOCCUR='Y' and MHCAT='RISK FACTOR FOR COVID-19'
RSKF5 Computation
Set to 'Liver Disease' if exist record in MH where MHTERM='LIVER DISEASE' and MHOCCUR='Y' and MHCAT='RISK FACTOR FOR COVID-19'
RSKF6 Computation
Set to 'Human Immunodeficiency Virus Infection' if exist record in MH where MHTERM='HIV' and MHOCCUR='Y' and MHCAT='RISK FACTOR FOR COVID-19'
RTPCRBL Computation
Set to 'Positive' if USUBJID exists in MB with MBTESTCD='SARSCOV2' and SUPPMB.QVAL is not 'Y' where QNAM is 'LOCALFL' and MBSTRESC='Detected' and date part of non-missing MBDTC<=TR01SDT, otherwise Set to 'Negative' if USUBJID exists MB with MBTESTCD='SARSCOV2' and SUPPMB.QVAL is not 'Y' where QNAM is 'LOCALFL' and MBSTRESC='Not Detected' and date part of non-missing MBDTC<=TR01SDT Note: Use last (only consider date part) non-missing results on/before TR01SDT for derivation
SAFEREAS Computation
Only for subjects with RANDFL='Y' 1. Set to 'Did not receive any vaccination' if there is no record exists in EX with non-missing EXSTDTC, 2. Set to 'Had major protocol deviations' if there is at least one record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis' or '8 - Exclude from all analysis sets except for randomization set' and DVSTDTC <= AP01EDT (condition of DVSTDTC <= AP01EDT applies only when AP01EDT is not missing), After above steps, if a subject satisfies more than one of 1-2, then concatenate reason with ',' Set to Null, otherwise
SAFFL Computation
Set to 'Y' if all criteria met: 1. RANDFL='Y', 2. USUBJID exists in EX with non-missing EXSTDTC, 3. There is no record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis sets', or '8 - Exclude from all analysis sets except for randomization set' and (DVSTDTC <= EFFCODT and DVSTDTC <= AP01EDT and AP01EDT is not missing or DVSTDTC <= EFFCODT if AP01ENDT is missing) Set to 'N', otherwise
SAR1ERS Computation
Only for subjects with RANDFL='Y' 1. Set to 'Did not receive Vaccination' if there is no record exists in EX with non-missing EXSTDTC, 2. Set to 'Had major protocol deviations' If there is at least one record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis' or '8 - Exclude from all analysis sets except for randomization set' and DVSTDTC <= AP01EDT (condition of DVSTDTC <= AP01EDT applies only when AP01EDT is not missing), 3. Set to 'Did not contribute any solicited AR data for Vaccination #1' if SAFFL='Y' and SAR1FL='N', After above steps, if a subject satisfies more than one of 1-3, then concatenate reason with ',' Set to null, otherwise
SAR1FL Computation
Set to 'Y' if both criteria met: 1. SAFFL='Y' 2. Have at least one non-missing FAORRES where FATPTREF = 'DOSE 1' in FACE OR have at least one non-missing VSORRES where VSTPTREF = 'DOSE 1' and VSTEST contains "Temperature" where VSCAT contains "REACTOGENICITY" in VS Set to 'N', otherwise
SAR2ERS Computation
Only for subjects with RANDFL='Y' 1. Set to 'Did not receive Vaccination' if there is no record exists in EX with non-missing EXSTDTC, 2. Set to 'Had major protocol deviations' if there is at least one record where SUPPDV.QNAM ='SEVDES' and SUPPDV.QVAL is '1 - Exclude from all analysis' or '8 - Exclude from all analysis sets except for randomization set' and DVSTDTC <= AP01EDT (condition of DVSTDTC <= AP01EDT applies only when AP01EDT is not missing), 3. Set to 'Did not receive Vaccination' if SAFFL='Y' and DOSE2FL='N', 4. Set to 'Did not contribute any solicited AR data for Vaccination #2' if SAFFL='Y' and DOSE2FL='Y' and SAR2FL='N', After above steps, if a subject satisfies more than one of 1-4, then concatenate reason with ',' Set to Null, otherwise
SAR2FL Computation
Set to 'Y' if all criteria met: 1. SAFFL='Y' 2. Have at least one non-missing FAORRES where FATPTREF = 'DOSE 2' in FACE OR have at least one non-missing VSORRES where VSTPTREF = 'DOSE 2' and VSTEST contains 'Temperature' where VSCAT contains 'REACTOGENICITY' in VS 3. DOSE2FL='Y' Set to 'N', otherwise
SARAFL Computation
Set to 'Y' if SAR1FL='Y' or SAR2FL='Y' Set to 'N', otherwise
SCOV2BL Computation
Set to 'Positive' if RTPCRBL='Positive' or ELECSBL='Positive' Set to 'Negative' if RTPCRBL='Negative' and ELECSBL='Negative'
CBNRS Computation
Set to SUPPRP.QVAL where QNAM='CBRSN' and VISIT='Screening'
CHILDBP Computation
Set to RP.RPORRES where RPTESTCD is CHILDPOTand VISIT=Screening
PREVSCR Computation
Set to SUPPDM.QVAL where QNAM='PREVSCR' per USUBJID
PROTVER Computation
Set to SUPPDM.QVAL where QNAM is PROTVER and VISIT = Screening
RACESPY Computation
If RACE='OTHER' then set to SUPPDM.QVAL where QNAM is RACEOTH, If RACE='MULTIPLE' then concatenate mixed case of QVAL with ', ' where QNAM is among RACE1 - RACE6
RFICDT Computation
Convert date part of DM.RFICDTC
SCFREAS Computation
Mixed case of DS.DSTERM where DSCAT = 'DISPOSITION EVENT' and DSSCAT='SCREEN FAILURE' and DS.DSDECOD ^= 'OTHER'. Set to 'Other' if DS.DSDECOD = 'OTHER' where DSCAT = 'DISPOSITION EVENT' and DSSCAT = 'SCREEN FAILURE'
SCFREASP Computation
Set to DS.DSTERM where SCFREAS='Other'
STRATAR Computation
Set to SUPPDM.QVAL where QNAM='COHORT'
STRATARN Computation
Based on 'STRATAR': Set to 1 if '>=18 and <65 Years and Not at Risk' Set to 2 if '>=18 and <65 Years and at Risk' Set to 3 if '>=65 Years'
STRATAV Computation
Set to '>=18 and <65 Years and Not at Risk' if AGEGR1N=1 and all of RSKF1--RSKF6 are missing Set to '>=18 and <65 Years and at Risk' if AGEGR1N=1 and at least one of RSKF1--RSKF6 is not missing Set to '>=65 Years' if AGEGR1N=2
STRATAVN Computation
Based on 'STRATAV': Set to 1 if '>=18 and <65 Years and Not at Risk' Set to 2 if '>=18 and <65 Years and at Risk' Set to 3 if '>=65 Years'
STUDDUR1 Computation
Derived for subjects with SAFFL='Y': Set to EOSDT-RANDDT+1 if EOSDT not missing Set to CUTOFFDT-RANDDT+1 if EOSDT missing and EOSSTT='ONGOING'
STUDDUR2 Computation
Derived for subjects with SAFFL='Y': Set to EOSDT-TR01SDT+1 if EOSDT not missing set to CUTOFFDT-TR01SDT+1 if EOSDT missing and EOSSTT='ONGOING'
STUDDUR3 Computation
Derived for subjects with SAFFL='Y': Set to EOSDT-DOSE2DT+1 if DOSE2FL='Y' and EOSDT not missing Set to CUTOFFDT-DOSE2DT+1 if DOSE2FL='Y' and EOSDT missing and EOSSTT='ONGOING' Set to 0 if DOSE2FL='N'
STUDDUR4 Computation
DOSE2DT - TR01SDT
STUDDUR5 Computation
AP02SDT - RANDDT + 1, Note: Use EOSDT if AP02SDT is missing, Use CUTOFFDT if EOSDT is also missing
STUDDUR6 Computation
Derive for subjects with AP02SDT not missing: EOSDT - AP02SDT + 1, Note: Use CUTOFFDT if EOSDT is missing
TR01EDT Computation
Convert date part of the latest non-missing EX.EXENDTC where VISIT in ('Visit 1 Day 1', 'Visit 2 Day 29') to numeric
TR01EDTM Computation
Convert the latest non-missing EX.EXENDTC where VISIT in ('Visit 1 Day 1', 'Visit 2 Day 29') to numeric
TR01SDT Computation
Convert date part of DM.RFXSTDTC to numeric
TR01SDTM Computation
Convert DM.RFXSTDTC to numeric
TR02EDT Computation
Convert date part of latest non-missing EX.EXENDTC where VISIT in ('Participant Decision Visit / OL-D1', 'OL-D29') to numeric
TR02EDTM Computation
Convert latest non-missing EX.EXENDTC where VISIT in ('Participant Decision Visit / OL-D1', 'OL-D29') to numeric
TR02SDT Computation
Convert date part of non-missing EXSTDTC where EX.VISIT='Participant Decision Visit / OL-D1') to numeric
TR02SDTM Computation
Convert non-missing EX.EXSTDTC where VISIT='Participant Decision Visit / OL-D1' to numeric
TRT01A Computation
Set to 'mRNA-1273' if at least one EX.EXTRT='mRNA-1273' where VISIT in ('Visit 1 Day 1' 'Visit 2 Day 29') and EX.EXSTDTC is not missing, Set to 'Placebo' if EX.EXTRT='PLACEBO' where VISIT in ('Visit 1 Day 1' 'Visit 2 Day 29') and EX.EXSTDTC is not missing
TRT01P Computation
Set to 'mRNA-1273' if ARM starts with 'mRNA-1273', Set to 'Placebo' if ARM starts with 'Placebo'
TRT02A Computation
Set to 'mRNA-1273' if at least one EX.EXTRT='mRNA-1273' where VISIT in ('Participant Decision Visit / OL-D1', 'OL-D29') and EX.EXSTDTC is not missing, Set to 'Placebo' if EX.EXTRT='PLACEBO' where VISIT in ('Participant Decision Visit / OL-D1', 'OL-D29')) and EX.EXSTDTC is not missing
TRT02P Computation
Set to 'mRNA-1273' where SUPPDM.QVAL='Y' and SUPPDM.QNAM='UNBLMRNA'
TRTEDT Computation
Convert date part of DM.RFXENDTC to numeric
TRTSDT Computation
Convert date part of DM.RFXSTDTC to numeric
TRTSEQA Computation
Based on TRT01AN and TRT02AN: Set to 'Placebo' if TRT01AN=1 and TRT02AN <> 2, Set to 'Placebo-mRNA-1273' if TRT01AN=1 and TRT02AN=2, Set to 'mRNA-1273' if TRT01AN=2
TRTSEQP Computation
Based on TRT01PN and TRT02PN: Set to 'Placebo' if TRT01PN=1 and TRT02PN <> 2, Set to 'Placebo-mRNA-1273' if TRT01PN=1 and TRT02PN=2, Set to 'mRNA-1273' if TRT01PN=2
TTDTH1 Computation
DTHDT - TR01SDT
TTDTH2 Computation
DTHDT - AP02SDT if AP02SDT is not missing
UBLDDT Computation
Set to date part DS.DSSTDTC where DSDECOD = 'TREATMENT UNBLINDED'
UICDT Computation
Covert date part DS.DSSTDTC where DSSCAT='Open Label' and DSDECOD = 'INFORMED CONSENT OBTAINED' to numeric
WEIGHTBL Computation
Set to the last non-missing VS.VSSTRESN where VSTESTCD = “WEIGHT” and (VSDTC is before the first vaccination (DM.RFXSTDTC) or on the first vaccination date with VSTPT contains 'PRE-DOSE'), if missing use non-missing VS.VSSTRESN where VSTESTCD='WEIGHT' and or VISIT='Screening' with VSTPT^='POST-DOSE'
ADT Computation
Convert date part of --DTC to numeric
ADY Computation
Set to ADT - ADSL.TR01SDT + 1 if ADT is on or after ADSL.TR01SDT, Set to ADT - ADSL.TR01SDT if ADT is before ADSL.TR01SDT
AENDT Computation
Convert date part of FAENDTC to numeric if source data are from FAEF, Convert date part of PR.PRENDTC to numeric if source data are from PR, Convert date part of HO.HOENDTC to numeric if For source data are from HO
AENDY Computation
Set to AENDT - ADSL.TR01SDT + 1 if AENDT is on or after ADSL.TR01SDT, Set to AENDT - ADSL.TR01SDT if AENDT is before ADSL.TR01SDT
ASTDT Computation
For source data are from FAEF: Convert date part of SUPPFAEF.QVAL where SUPPFAEF.QNAM='FAEVDTC' to numeric For source data are from PR: Convert date part of PR.PRSTDTC to numeric For source data are from HO: Convert date part of HO.HOSTDTC to numeric
ASTDY Computation
Set to ASTDT - ADSL.TR01SDT + 1 if ASTDT is on or after ADSL.TR01SDT, Set to ASTDT - ADSL.TR01SDT if ASTDT is before ADSL.TR01SDT
ATPT Computation
Set to FAEF.FATPT if source data are from FAEF, Set to VS.VSTPT if source data are from VS, Set to null, Otherwise
AVALC Computation
Set to PR.PROCCUR if source data are from PR Set to HO.HOOCCUR if source data are from HO For SDTM.FAEF as source data: Set to 'Y' if FAEF.FASCAT='COVID-19' and FAEF.FASTRESC in ('MILD', 'MODERATE', 'SEVERE') Set to 'N' if FAEF.FASCAT='COVID-19' and FAEF.FASTRESC = 'NONE' Set to FAEF.FASTRESC if FAEF.FASCAT='COVID-19 SEVERITY' For SDTM.VS as source data: Set to 'Y' if VSTESTCD='OXYSAT' and non-missing VSSTRESN<=93 Set to 'Y' if VSTESTCD='TEMP' and non-missing VSSTRESN>=38 and VSSTRESU='C'
AVISIT Computation
Set to 'Illness Visit'. For subject with multiple Illness Visit Day 1 (FA.FATPT='Day 1') on different dates, if ADT is on/after the 2nd Illness Visit Day 1 and prior to the 3rd Illness Visit Day 1 (if available), then set to 'Illness Visit 2', and so on
LNKID Computation
Set to PRLNKID if source data are from PR, or Set to --SPID in individual source data
PARAM Computation
Set to PR.PRTRT if source data are from PR Set to HO.HOTERM if source data are from HO and re-code 'ADMITTED TO ICU' to 'Admission to an intensive care unit due to SARS-CoV-2' For SDTM.FAEF as source data: Set to FAEF.FAOBJ and recode follwing symptom terms - Recode to 'Vasopressors Required' if FAEF.FAOBJ='Evidence of Shock Requires Vasopressors' Recode to 'Muscle Aches (Myalgia)' if FAEF.FAOBJ='Myalgia' Recode to 'Runny Nose (Rhinorrhea)' if FAEF.FAOBJ='Rhinorrhea' For SDTM.VS as source data: Set to 'O2 Saturation <=93%' if VSSCAT='COVID-19' and VSTESTCD='OXYSAT' and VSSTRESN is not missing and VSSTRESN<=93 Set to 'Fever' if VSSCAT='COVID-19' and VSTESTCD='TEMP' and VSSTRESN is not missing and VSSTRESN>=38
PARCAT1 Computation
Set to 'COVID-19 SEVERITY' if source data are from HO, else set to --SCAT in individual source data Re-code 'COVID-19' to 'COVID-19 SYMPTOM'
SEV Computation
For SDTM.FAEF as source data: Set to FAEF.FASTRESC if FAEF.FASCAT = 'COVID-19' and FASTRESC in ('MILD', 'MODERATE', 'SEVERE') Set to null, Otherwise
SRCDOM Computation
Set to FAEF.DOMAIN if source data are from FAEF Set to VS.DOMAIN if source data are from VS Set to PR.DOMAIN if source data are from PR Set to HO.DOMAIN if source data are from HO
SRCSEQ Computation
Set to FAEF.FASEQ if source data are from FAEF Set to VS.CESEQ if source data are from VS Set to PR.PRSEQ if source data are from PR Set to HO.HOSEQ if source data are from HO
SRCVAR Computation
Set to 'FASTRESC' if source data are from FAEF Set to 'VSSTRESN' if source data are from VS Set to 'PROCCUR' if source data are from PR Set to 'HOOCCUR' if source data are from HO
TCVDSVC Computation
See ADTTEA.ADT where PARAMCD in ('TCVDSVC1', 'TCVDSVC2', 'TCVDSVC3', 'TCVDSVC4', 'TCVDSVC5', 'TCVDSVC6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TCVDSVC9 Computation
See ADTTEA.ADT where PARAMCD = 'TCVDSVC9' from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTCVDC Computation
See ADTTEA.ADT where in ('TTCVDC1', 'TTCVDC2', 'TTCVDC3', 'TTCVDC4', 'TTCVDC5', 'TTCVDC6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTCVDC9 Computation
See ADTTEA.ADT where PARAMCD = 'TTCVDC9' from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

CDCCD Computation
Set to SDTM.XQ.XQCAT
TCVDSVC Computation
See ADTTEA.ENVTDESC where PARAMCD in ('TCVDSVC1', 'TCVDSVC2', 'TCVDSVC3', 'TCVDSVC4', 'TCVDSVC5', 'TCVDSVC') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TCVDSVC9 Computation
See ADTTE.CNSR where PARAMCD = 'TCVDSVC9' from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTCVDC Computation
See ADTTEA.CNSR where in ('TTCVDC1', 'TTCVDC2', 'TTCVDC3', 'TTCVDC4', 'TTCVDC5', 'TTCVDC6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTCVDC9 Computation
See ADTTE.CNSR where PARAMCD = 'TTCVDC9' from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TCVDSVC Computation
See ADTTEA.EVNTDESC where PARAMCD in ('TCVDSVC1', 'TCVDSVC2', 'TCVDSVC3', 'TCVDSVC4', 'TCVDSVC5', 'TCVDSVC6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TCVDSVC9 Computation
See ADTTE.EVNTDESC where PARAMCD=TCVDSVC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTCVDC Computation
See ADTTEA.ENVTDESC where in ('TTCVDC1', 'TTCVDC2', 'TTCVDC3', 'TTCVDC4', 'TTCVDC5', 'TTCVDC6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTCVDC9 Computation
See ADTTEA.ENVTDESC where PARAMCD = 'TCVDSVC9' from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

ASYMPINF Computation
See ADTTE.ADT where PARAMCD in 'TTASYMP1', 'TTASYMP2', 'TTASYMP3', 'TTASYMP4', 'TTASYMP5', 'TTASYMP6', 'TTASYCR1', 'TTASYCR2', 'TTASYCR3', 'TTASYCR4', 'TTASYCR5', 'TTASYCR6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

COVIDS Computation
See ADTTE.ADT where PARAMCD in 'TTCVDC1', 'TTCVDC2', 'TTCVDC3', 'TTCVDC4', 'TTCVDC5', 'TTCVDC6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

COVIDSDS Computation
See ADTTE.ADT where PARAMCD in ('TCVDSDC1', 'TCVDSDC2', 'TCVDSDC3','TCVDSDC4', 'TCVDSDC5', 'TCVDSDC6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

COVIDSVS Computation
See ADTTE.ADT where PARAMCD in (('TCVDSVC1', 'TCVDSVC2', 'TCVDSVC3', 'TCVDSVC4', 'TCVDSVC5', 'TCVDSVC6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

DEATHCVD Computation
See ADTTE.ADT where PARAMCD in ('TTDTHCV1', 'TTDTHCV2', 'TTDTHCV3', 'TTDTHCV4', 'TTDTHCV5', 'TTDTHCV6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTDEATH Computation
See ADTTE.ADT where PARAMCD = 'TTDEATH' from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

INFECT Computation
See ADTTE.ADT where PARAMCD in ('TTINF1', 'TTINF2', 'TTINF3','TTINF4','TTINF5','TTINF6') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TCVDSDC9 Computation
See ADTTE.ADT where PARAMCD=TCVDSDC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TCVDSVC9 Computation
See ADTTE.ADT where PARAMCD=TCVDSVC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTASYMP9 Computation
See ADTTE.ADT where PARAMCD=TTASYMP9 or PARAMCD = TTASYCR9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTCVDC9 Computation
See ADTTE.ADT where PARAMCD=TTCVDC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTDEATH9 Computation
See ADTTE.ADT where PARAMCD=TTDEATH9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTDTHCV9 Computation
See ADTTE.ADT where PARAMCD=TTDTHCV9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTINF9 Computation
See ADTTE.ADT where PARAMCD=TTINF9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

LGROUP Computation
Set to SDTM.XQ.XQGRPID
LINEAGES Computation
Set to SDTM.XQ.XQSTRESC if XQSTRESC ne "Empty"
PARCAT1 Computation
Set to ADEFF.PARCAT1
STARTDT Computation
Set to ADSL.RANDDT if PARAMCD not in (TTCVDC9, TCVDSVC9), Otherwise, Set to ADSL.AP02SDT
AVAL Computation
Set to Event date or censor date (ADT) - STARTDT+1
TASYCRB Computation
See ADTTEB.ADT where PARAMCD in 'TASYCRB1', 'TASYCRB2', 'TASYCRB3', 'TASYCRB4', 'TASYCRB5') rom Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTINFB Computation
See ADTTEB.ADT where PARAMCD in 'TTINFB1', 'TTINFB2', 'TTINFB3', 'TTINFB4', 'TTINFB5') rom Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TASYCRB Computation
See ADTTE.CNSR where PARAMCD in 'TASYCRB1', 'TASYCRB2', 'TASYCRB3', 'TASYCRB4', 'TASYCRB5') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTINF Computation
See ADTTE.CNSR where PARAMCD in 'TTINFB1', 'TTINFB2', 'TTINFB3', 'TTINFB4', 'TTINFB5') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TASYCRB Computation
See ADTTE.EVNTDESC where PARAMCD in 'TASYCRB1', 'TASYCRB2', 'TASYCRB3', 'TASYCRB4', 'TASYCRB5') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTINF Computation
See ADTTE.EVNTDESC where PARAMCD in 'TTINFB1', 'TTINFB2', 'TTINFB3', 'TTINFB4', 'TTINFB5') from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

STARTDT Computation
Set to ADSL.RANDDT
ASYMPINF Computation
See ADTTE.CNSR where PARAMCD in (TTASYMP1, TTASYMP2, TTASYMP3, TTASYMP4, TTASYMP5, TTASYMP6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

COVIDS Computation
See ADTTE.CNSR where PARAMCD in (TTCVDC1, TTCVDC2, TTCVDC3, TTCVDC4, TTCVDC5, TTCVDC6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

COVIDSDS Computation
See ADTTE.CNSR where PARAMCD in (TCVDSDC1, TCVDSDC2, TCVDSDC3,TCVDSDC4, TCVDSDC5, TCVDSDC6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

COVIDSVS Computation
See ADTTE.CNSR where PARAMCD in (TCVDSVC1, TCVDSVC2, TCVDSVC3, TCVDSVC4, TCVDSVC5, TCVDSVC6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

DEATHCVD Computation
See ADTTE.CNSR where PARAMCD in (TTDTHCV1, TTDTHCV2, TTDTHCV3, TTDTHCV4, TTDTHCV5, TTDTHCV6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTDEATH Computation
See ADTTE.CNSR where PARAMCD = TTDEATH from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

INFECT Computation
See ADTTE.CNSR where PARAMCD in (TTINF1, TTINF2, TTINF3, TTINF4, TTINF5, TTINF6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TCVDSDC9 Computation
See ADTTE.CNSR where PARAMCD = TCVDSDC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TCVDSVC9 Computation
See ADTTE.CNSR where PARAMCD = TCVDSVC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTASYCR Computation
See ADTTE.CNSR where PARAMCD in (TTASYCR1, TTASYCR2, TTASYCR3, TTASYCR4, TTASYCR5, TTASYCR6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTASYCR9 Computation
See ADTTE.CNSR where PARAMCD=TTASYCR9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTASYMP9 Computation
See ADTTE.CNSR where PARAMCD=TTASYMP9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTCVDC9 Computation
See ADTTE.CNSR where PARAMCD=TTCVDC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTDEATH9 Computation
See ADTTE.CNSR where PARAMCD=TTDEATH9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTDTHCV9 Computation
See ADTTE.CNSR where PARAMCD=TTDTHCV9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTINF9 Computation
See ADTTE.CNSR where PARAMCD=TTINF9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

ASYMPINF Computation
See ADTTE.EVNTDESC where PARAMCD in (TTASYMP1, TTASYMP2, TTASYMP3, TTASYMP4, TTASYMP5, TTASYMP6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

COVIDS Computation
See ADTTE.EVNTDESC where PARAMCD in (TTCVDC1, TTCVDC2, TTCVDC3, TTCVDC4, TTCVDC5, TTCVDC6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

COVIDSDS Computation
See ADTTE.EVNTDESC where PARAMCD in (TCVDSDC1, TCVDSDC2, TCVDSDC3,TCVDSDC4, TCVDSDC5, TCVDSDC6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

COVIDSVS Computation
See ADTTE.EVNTDESC where PARAMCD in (TCVDSVC1, TCVDSVC2, TCVDSVC3, TCVDSVC4, TCVDSVC5, TCVDSVC6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

DEATHCVD Computation
See ADTTE.EVNTDESC where PARAMCD in (TTDTHCV1, TTDTHCV2, TTDTHCV3, TTDTHCV4, TTDTHCV5, TTDTHCV6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTDEATH Computation
Set to 'All-Cause Death' if ADSL.DTHDT is not missing and ADSL.AP02SDT is not missing, Set to 'No All-Cause Death'

Additional ADaM Variable Definition

INFECT Computation
See ADTTE.EVNTDESC where PARAMCD in (TTINF1, TTINF2, TTINF3, TTINF4, TTINF5, TTINF6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TCVDSDC9 Computation
See ADTTE.EVNTDESC where PARAMCD=TCVDSDC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TCVDSVC9 Computation
See ADTTE.EVNTDESC where PARAMCD=TCVDSVC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTASYCR Computation
See ADTTE.EVNTDESC where PARAMCD in (TTASYCR1, TTASYCR2, TTASYCR3, TTASYCR4, TTASYCR5, TTASYCR6) from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTASYCR9 Computation
See ADTTE.EVNTDESC where PARAMCD=TTASYCR9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTASYMP9 Computation
See ADTTE.EVNTDESC where PARAMCD=TTASYMP9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTCVDC9 Computation
See ADTTE.EVNTDESC where PARAMCD=TTCVDC9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTDEATH9 Computation
See ADTTE.EVNTDESC where PARAMCD=TTDEATH9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTDTHCV9 Computation
See ADTTE.EVNTDESC where PARAMCD=TTDTHCV9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

TTINF9 Computation
See ADTTE.EVNTDESC where PARAMCD=TTINF9 from Additional ADaM Variable Definition Doc

Additional ADaM Variable Definition

PARAM Computation
See controlled terms. Create one PARAM per subject for all full analysis subjects (FASFL = 'Y')
STARTDT Computation
Set to ADSL.RANDDT if PARAMCD not in (TTCVDC9, TCVDSVC9, TCVDSDC9, TTASYMP9, TTASYCR9, TTINF9, TTDTHCV9, TTDEATH9), Otherwise, Set to ADSL.AP02SDT
AVAL Computation
Derive based on the temporary variable SUM (see derivation of EVENTSEQ) and date of first symtom occure per subject (ADEFF3.ADT where FASYMPFL = 'Y') If SUM = 0 where EVENTSEQ = 1, set to the earliest date of (ADSL.DTHDT, ADSL.EOSDT, ADSL.CUTOFFDT) - TR01SDT. if 0 < SUM <= Q1 where EVENTSEQ = 1, set to the ADT - TR01SDT. if Q1 <= SUM < Median , then do: 1) if EVENTSEQ = 1, set to the ADT - TR01SDT. 2) if EVENTSEQ = 2, set to the ADT - TR01SDT + (1e-10). if Median <= SUM < Q3, then do: 1) if EVENTSEQ = 1, set to the ADT - TR01SDT. 2) if EVENTSEQ = 2, set to the ADT - TR01SDT + (1e-10). 3) if EVENTSEQ = 3, set to the ADT - TR01SDT + (2e-10). if Q3 <= SUM, then do: 1) if EVENTSEQ = 1, set to the ADT - TR01SDT. 2) if EVENTSEQ = 2, set to the ADT - TR01SDT + (1e-10). 3) if EVENTSEQ = 3, set to the ADT - TR01SDT + (2e-10). 4) if EVENTSEQ = 4, set to the ADT - TR01SDT + (3e-10).
CNSR Computation
If EVENTSEQ = 1, then do: 1) Set to 1 If temporary variable SUM (see derivation of EVENTSEQ) = 0, 2) Set to 0 If temporary variable SUM (see derivation of EVENTSEQ) > 0, if EVENTSEQ = 2 or 3 or 4, then set to 0 Note: (1 for censor; 0 for event)
EVENTSEQ Computation
Derive based on the records with ADEFF3.ANL01FL='Y' and PARCAT1N = 1 and PPROTFL = ’Y’. Step 1. Calculate temporary variable SUM = sum of AVAL per subject (SUBJID). Step 2. Calcalate min, max, Q1 and Q3 of SUM. Step 3. Assgin EVENTSEQ as follows: If SUM = 0 or 0 < SUM < Q1, assign one record/row with EVENTSEQ = 1; if Q1 <= SUM < Median, assign one record/row with EVENTSEQ = 1 and one record/row with EVENTSEQ = 2; if Median <= SUM < Q3, assign one record/row with EVENTSEQ = 1 and one record/row with EVENTSEQ = 2 and one record/row with EVENTSEQ = 3; if Q3 <= SUM, assign one record/row with EVENTSEQ = 1 and one record/row with EVENTSEQ = 2 and one record/row with EVENTSEQ = 3 and one record/row with EVENTSEQ = 4;
EVNTDESC Computation
For each USUBJID, Set to ‘No symptom’ if temporary variable SUM (see derivation of EVENTSEQ) = 0, Set to ‘0 < Total COVID-19 Symptoms Score < Q1’ if 0 < temporary variable SUM (see derivation of EVENTSEQ) < Q1, Set to ‘Q1 <= Total COVID-19 Symptoms Score < Median’ if Q1 <= temporary variable SUM (see derivation of EVENTSEQ) < Median, Set to ‘Median <= Total COVID-19 Symptoms Score < Q3’ if Median <= temporary variable SUM (see derivation of EVENTSEQ) < Q3, Set to ‘Q3 <= Total COVID-19 Symptoms Score’ if Q3 <= temporary variable SUM (see derivation of EVENTSEQ).
STARTVAL Computation
Derive based on the date of first symtom occure per subject (ADEFF3.ADT where FASYMPFL = 'Y') If EVENTSEQ = 1, set to 0. if EVENTSEQ = 2, set to the (ADT - ADSL.TR01SDT). if EVENTSEQ = 3, set to the (ADT - ADSL.TR01SDT) + (1e-10). if EVENTSEQ = 4, set to the (ADT - ADSL.TR01SDT) + (2e-10).
AVALD Computation
If where ADEFF2.PARAMCD contains 'BOD' : If ADEFF2.AVAL=0: Set to the earliest date of (ADSL.DTHDT, ADSL.EOSDT, ADSL.EFFCODT, ADSL.AP01EDT) - ADSL.RANDDT if and EVENTSEQ=1, Else: Set to the ADEFF2.ADT- ADSL.RANDDT where EVENTSEQ=1, Set to the ADEFF2.ADT- ADSL.RANDDT+(1e-10) where EVENTSEQ=2 Set to the ADEFF2.ADT- ADSL.RANDDT +(2e-10) where EVENTSEQ=3
AVALI Computation
Set to the earliest date of (ADSL.DTHDT, ADSL.EOSDT, ADSL.EFFCODT, ADSL.AP01EDT) - TR01SDT if ADEFF2.AVAL=0 and EVENTSEQ=1, Set to the ADEFF2.ADT- TR01SDT if EVENTSEQ=1, Set to the ADEFF2.ADT- TR01SDT +(1e-10) if EVENTSEQ=2, Set to the ADEFF2.ADT- TR01SDT +(2e-10) if EVENTSEQ=3, Set to the ADEFF2.ADT- TR01SDT +(3e-10) if EVENTSEQ=4, Set to the ADEFF2.ADT- TR01SDT +(4e-10) if EVENTSEQ=5, Set to the ADEFF2.ADT- TR01SDT +(5e-10) if EVENTSEQ=6
CNSRD Computation
If EVENTSEQ=1, then do: 1)Set to 1 If ADEFF2.AVAL=0 where PARAMCD contains 'BOD', 2)Set to 0 If ADEFF2.AVAL>=1 where PARAMCD contains 'BOD', If EVENTSEQ=2 or 3, then set to 0 Note: (1 for censor; 0 for event)
CNSRI Computation
If EVENTSEQ=1, then do: 1)Set to 1 If ADEFF2.AVAL=0 where PARAMCD contains 'BOI', 2)Set to 0 If ADEFF2.AVAL>=0.5 where PARAMCD contains 'BOI', If EVENTSEQ>=2, then set to 0 Note: (1 for censor; 0 for event)
EVENTSEQD Computation
Derive based on the records with ADEFF2.ANL01FL='Y': If ADEFF2.AVAL=0 or 1 where PARAMCD contains 'BOD', assign one record/row with EVENTSEQ=1, If ADEFF2.AVAL=2 where PARAMCD contains 'BOD', assign one record/row with EVENTSEQ=1 and one record/row with EVENTSEQ=2, If ADEFF2.AVAL=3 where PARAMCD contains 'BOD', assign one record/row with EVENTSEQ=1 and one record/row with EVENTSEQ=2 and one record/row with EVENTSEQ=3
EVENTSEQI Computation
Derive based on the records with ADEFF2.ANL01FL='Y': If ADEFF2.AVAL=0 or 0.5 where PARAMCD contains 'BOI', assign one record/row with EVENTSEQ=1, If ADEFF2.AVAL=1 where PARAMCD contains 'BOI', assign one record/row with EVENTSEQ=1 and one record/row with EVENTSEQ=2, If ADEFF2.AVAL=2 where PARAMCD contains 'BOI', assign one record/row with EVENTSEQ=1 and one record/row with EVENTSEQ=2 and one record/row with EVENTSEQ=3 and one record/row with EVENTSEQ=4, If ADEFF2.AVAL=3 where PARAMCD contains 'BOI', assign one record/row with EVENTSEQ=1 and one record/row with EVENTSEQ=2 and one record/row with EVENTSEQ=3 and one record/row with EVENTSEQ=4 and one record/row with EVENTSEQ=5 and one record/row with EVENTSEQ=6
EVNTDESCD Computation
For each USUBJID, Set to 'Without COVID-19' if ADEFF2.AVAL=0 where PARAMCD contains 'BOD', Set to 'COVID-19 without hospitalization' if ADEFF2.AVAL= 1 where PARAMCD contains 'BOD', Set to 'COVID-19 with hospitalization' if ADEFF2.AVAL=2 where PARAMCD contains 'BOD', Set to 'Death' if ADEFF2.AVAL=3 where PARAMCD contains 'BOD'
EVNTDESCI Computation
For each USUBJID, Set to 'No infection’ if ADEFF2.AVAL=0 where PARAMCD contains 'BOI', Set to 'Asymptomatic infection' if ADEFF2.AVAL=0.5 where PARAMCD contains 'BOI', Set to 'COVID-19 without hospitalization' if ADEFF2.AVAL=1 where PARAMCD contains 'BOI', Set to 'COVID-19 with hospitalization' if ADEFF2.AVAL=2 where PARAMCD contains 'BOI', Set to 'Death' if ADEFF2.AVAL=3 where PARAMCD contains 'BOI'
PARAM Computation
Create # of records based on ADEFF2.PARAMCD and ADEFF2.AVAL: Set to "Burden of Disease Score" if data is derived from ADEFF2.PARAMCD in (BOD7D, BOD28D) Set to 'Burden of Infection Score' if data is derived from ADEFF2.PARAMCD in (BOI7D, BOI28D)
STARTVALD Computation
Set to 0 if EVENTSEQ=1, Set to the (ADEFF2.ADT- ADSL.RANDDT) if EVENTSEQ=2, Set to the (ADEFF2.ADT- ADSL.RANDDT)+(1e-10) if EVENTSEQ=3
STARTVALI Computation
Set to 0 if EVENTSEQ=1, set to the (ADEFF2.ADT-ADSL.TR01SDT) if EVENTSEQ=2, Set to the (ADEFF2.ADT-ADSL.TR01SDT) +(1e-10) if EVENTSEQ=3, Set to the (ADEFF2.ADT-ADSL.TR01SDT) +(2e-10) if EVENTSEQ=4, Set to the (ADEFF2.ADT-ADSL.TR01SDT) +(3e-10) if EVENTSEQ=5, Set to the (ADEFF2.ADT-ADSL.TR01SDT) +(4e-10) if EVENTSEQ=6
ABLFL Computation
Set to 'Y' for the latest (consider both ADT and ATM) non-missing assessment (AVAL>. or non-missing AVALC) on or before TR01SDTM (TR01SDT if time part of TR01SDTM is missing) for each SUBJID and PARAMCD Note: exclude records where ADT is the same as TR01SDT and VSTPT^='PRE-DOSE'
ADT Computation
Convert date part of VS.VSDTC to numeric
ADTM Computation
Convert VS.VSDTC to numeric
ADY Computation
Set to ADT - ADSL.TR01SDT + 1 if ADT is on or after ADSL.TR01SDT, or Set to ADT - ADSL.TR01SDT if ADT is before ADSL.TR01SDT
ANL01FL Computation
If ABLFL='Y', then set to 'Y'; for post-baseline assessments where AVISITN is non-missing and result (AVAL) is non-missing, per subject per parameter and per AVISIT per ATPT, Within an AVISIT and ATPT, set to ‘Y’ for the assessment at scheduled visit (i.e., VISIT doesn't contain "UNSCHED"). If there are 2 or more assessments at same visit, set to the last assessment. If there is no scheduled visit, set to 'Y' for the assessment closest to the target study day (record with minimum AWTDIFF) in the visit window. If there are 2 or more assessments equal distance to the target study day (AWTDIFFs are same), set to the last assessment.
ANL02FL Computation
For post baseline records where PARAMCD in ('PULSE', 'SYSBP'), per subject per parameter per AVISIT per ATPT where AVISIT NE 'Baseline': Set to 'Y' for the worst toxicity grade (ATOXGRL) where ATOXDSCL is not missing using the following order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0. If there are more than one worst toxicity grades, then set to the first record
ANL03FL Computation
For post baseline records, per subject per parameter per AVISIT where AVISIT NE 'Baseline' Set to 'Y' for the worst toxicity grade (ATOXGRH) where ATOXDSCH is not missing using the following order: Grade 4> Grade 3>Grade 2>Grade 1>Grade 0.If there are more than one worst toxicity grades, then set to the first record
APERIOD Computation
Set to 2 if non-missing AP02SSDT<=ADT, Otherwise, Set to 1
ASTAGE Computation
Only derive for post baseline records where DOSE1FL='Y': For APERIOD=1: If DOSE2FL='Y' then set TEMP to date of VISIT 3 (i.e. SV.SVSTDTC where SV.VISIT = 'Visit 3 Day 57') else if DOSE2FL ne 'Y' then set TEMP to date of VISIT 2 (i.e. SV.SVSTDTC where SV.VISIT = 'Visit 2 Day 29') Then do following: set to ‘Vaccination stage’ If .< ADSL.TR01SDTM <=ADTM and ADT<=earliest date of (TEMP, ADSL.EOSDT, ADSL.DTHDT) Set to 'Follow-Up Analysis Period' if ADT > non-missing TEMP. If TEMP, ADSL.EOSDT, and ADSL.DTHDT are all unavailable, set to ‘Vaccination stage’ For APERIOD=2: If OLDOS2FL ='Y' then set TEMP to date of OL-Day57 (i.e. SV.SVSTDTC where SV.VISIT = 'OL-Day 57') else if OLDOS2FL ne 'Y' then set TEMP to date of OL-Day29 (i.e. SV.SVSTDTC where SV.VISIT = 'OL-Day 29') Then do following: set to ‘Vaccination stage’ If .< ADSL.TR02SDTM <=ADTM and ADT<=earliest date of (TEMP, ADSL.EOSDT, ADSL.DTHDT) Set to 'Follow-Up Analysis Period' if ADT > non-missing TEMP. If TEMP, ADSL.EOSDT, and ADSL.DTHDT are all unavailable, set to ‘Vaccination stage’ Else Set to missing
ATOXDSCH Computation
Set to: 'Fever' if PARAMCD = 'TEMP' 'Tachycardia' if PARAMCD = 'PULSE' 'Systolic Hypertension' if PARAMCD = 'SYSBP' 'Diastolic Hypertension' if PARAMCD = 'DIABP' 'Respiratory Rate Increased' if PARAMCD = 'RESP'
ATOXDSCL Computation
Set to 'Bradycardia' if PARAMCD = 'PULSE' Hypotension' if PARAMCD = 'SYSBP'
ATOXGRH Computation
Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 91 – 95 Set to 'Grade 2' if 96 – 100 Set to 'Grade 3' if >100 Grade 4 is based on medical input Otherwise, set to 'Grade 0'
ATOXGRH Computation
Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 101 – 115 Set to 'Grade 2' if 116 – 130 Set to 'Grade 3' if >130 Grade 4 is based on medical input Otherwise, set to 'Grade 0'
ATOXGRH Computation
Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 17 – 20 Set to 'Grade 2' if 21 – 25 Set to 'Grade 3' if >25 Grade 4 is based on medical input Otherwise, set to 'Grade 0'
ATOXGRH Computation
Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 141 – 150 Set to 'Grade 2' if 151 – 155 Set to 'Grade 3' if >155 Grade 4 is based on medical input Otherwise, set to 'Grade 0'
ATOXGRH Computation
Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 38.0 – 38.4 Set to 'Grade 2' if >38.4 – 38.9 Set to 'Grade 3' if >38.9 – 40.0 Set to 'Grade 4' if >40.0 Otherwise, set to 'Grade 0'
ATOXGRL Computation
Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 50 – 54 Set to 'Grade 2' if 45 – 49 Set to 'Grade 3' if <45 Grade 4 is based on medical input Otherwise, set to 'Grade 0'
ATOXGRL Computation
Assign AVAL toxicity grading as follows If AVAL is not missing: Set to 'Grade 1' if 85 – 89 Set to 'Grade 2' if 80 – 84 Set to 'Grade 3' if <80 Grade 4 is based on medical input Otherwise, set to Grade '0'
ATPT Computation
Set to ‘Day x’ if AVISIT='Illness Visit Day x' or 'Illness Visit y Day x' (see derivation of AVISIT)
AVAL Computation
Set to VS.VSSTRESN
AVISIT Computation
See ADVS.AVISIT from Additional ADaM Variable Definition Doc.

Additional ADaM Variable Definition

AWRANGE Computation
Set to '<=1 Pre-dose' for 'Baseline' 'Day 1 Post-dose' for 'Day 1' 'Day 2 - Day 43' for 'Day 29' 'Day 44 - Day 133' for 'Day 57' 'Day 134 – Day 301' for 'Day 209' 'Day 302 – Day 576' for 'Day 394' 'Day 577 - Day 773' for 'Day 759' 'Participant Decision Visit / OL-D1' for 'Participant Decision Visit / OL-D1' 'Day 2 – Day 43 Relative to Participant Decision Visit / OL-D1' for 'Open Label Day 29' 'Day 44 – Day 71 Relative to Participant Decision Visit / OL-D1' for 'Open Label Day 57' 'Illness Visit Day 1' for 'Illness Visit” and ATPT='Day 1' 'Illness Visit y Day 1' for 'Illness Visit y' and ATPT='Day 1' 'Illness Visit Day 2 - Illness Visit Day 35' for 'Illness Visit' and ATPT='Day 28' 'Illness Visit y Day 2 - Illness Visit y Day 35' for 'Illness Visit y' and ATPT='Day 28'
AWTARGET Computation
Set to 1 if AVISIT = 'Baseline' Set to 1 if AVISIT = 'Day 1' Set to 29 if AVISIT = 'Day 29' Set to 57 if AVISIT = 'Day 57' Set to 209 if AVISIT = 'Day 209' Set to 394 if AVISIT = 'Day 394' Set to 759 if AVISIT = 'Day 759' Set to ADY where AVISIT='Participant Decision Visit / OL-D1' for 'Participant Decision Visit / OL-D1' Set to ADY + 28 where AVISIT='Participant Decision Visit / OL-D1' for 'Open Label Day 29' Set to ADY + 56 where AVISIT='Participant Decision Visit / OL-D1' for 'Open Label Day 57' Set to ADY where AVISIT='Illness Visit' for 'Illness Visit' and ATPT='Day 1' Set to ADY where AVISIT='Illness Visit y' for 'Illness Visit y' and ATPT='Day 1' Set to ADY + 27 where AVISIT='Illness Visit' for 'Illness Visit' and ATPT='Day 28' Set to ADY + 27 where AVISIT='Illness Visit y' for 'Illness Visit y' and ATPT='Day 28'
AWTDIFF Computation
Set to absolute value of ( ADY - AWTARGET )
BASE Computation
Merge value of nonmissing AVAL where ABLFL = 'Y' by USUBJID and PARAMCD, then Set to AVAL where ABLFL = 'Y'
BTOXGRH Computation
Merge value of nonmissing ATOXGRH where ABLFL = 'Y' by USUBJID and PARAMCD
BTOXGRL Computation
Merge value of nonmissing ATOXGRL where ABLFL = 'Y' by USUBJID and PARAMCD
CHG Computation
For post baseline records only, if AVAL and BASE are both non-missing, set to AVAL - BASE Note: post-baseline records are defined as any result where ADTM > TR01SDTM or (ADTM=TR01SDTM and VSTPT^='PRE-DOSE') if time is available, if time is not available use (ADY=1 and VSTPT^='PRE-DOSE') or ADY > 1)
MDOSREF Computation
Set to 'Vaccination 1' if ( . < ADSL.TR01SDTM <= ADTM < ADSL.DOS2DTM ) or ( .< ADSL.TR01SDTM <= ADTM and ADSL.DOS2DTM is missing and (TR02SDTM is missing or .<ASTDTM<ADSL.TR02SDTM)), Set to 'Vaccination 2' if ( .< ADSL.DOS2DTM <= ADTM < ADSL.TR02SDTM ) or ( .< ADSL.DOS2DTM <= ADTM and ADSL.TR02SDTM is missing), Set to 'OL Vaccination 1' if (.<ADSL.TR02SDTM<=ADTM<ADSL.OLDO2DTM) or (.<ADSL.TR02SDTM<=ADTM and ADSL.OLDO2DTM is missing), Set to 'OL Vaccination 2' if .<ADSL.OLDO2DTM<=ADTM Note: using date variables for comparison when time part is not available
MRDDY Computation
Set to ADT – ADSL.TR01SDT+ 1 If MDOSREF='Vaccination 1', Set to ADT – ADSL.DOSE2DT+ 1 If MDOSREF='Vaccination 2', Set to ADT – ADSL.TR02SDT+ 1 If MDOSREF='OL Vaccination 1', Set to ADT – ADSL.OLDO2SDT+ 1 If MDOSREF='OL Vaccination 2'
PARAM Computation
VS.VSTEST ' (' ||VSSTRESU|| ')' if VSSTRESU is non-missing, if VSSTRESU is missing, use the non-missing VSSTRESU from the same VSTEST
PCHG Computation
Set to (CHG/BASE)*100 if BASE ne 0
SHIFT1 Computation
Only populate for post-baseline records where PARAMCD in ('PULSE', 'SYSBP') Set to BTOXGRL || ' to ' ||ATOXGRL if both of BTOXGRL and ATOXGRL are not missing If either BTOXGRL or ATOXGRL is missing: Set the missing BTOXGRL or ATOXGRL to 'UNK', then Set to BTOXGRL || ' to ' || ATOXGRL
SHIFT2 Computation
Only populate for post-baseline records Set to BTOXGRH || ' to '|| ATOXGRH if both of BTOXGRH and ATOXGRH are not missing If either BTOXGRH or ATOXGRH is missing: Set the missing BTOXGRH and ATOXGRH to 'UNK' Set to BTOXGRH || ' to ' || ATOXGRH
VSLOCSP Computation
Set to SUPPCM.QVAL where QNAM='VSLOCSP'

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