Date/Time of Define-XML document generation: 2021-07-19T16:08:33Z

Define-XML version: 2.0.0

Stylesheet version: 2018-11-21

Standard: SDTM-IG 3.2
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

Datasets

Datasets
Dataset	Description	Class	Structure	Purpose	Keys	Location
TA	Trial Arms	TRIAL DESIGN	One record per planned element per arm	Tabulation	STUDYID, ARMCD, TAETORD	ta.xpt
TE	Trial Elements	TRIAL DESIGN	One record per planned element	Tabulation	STUDYID, ETCD	te.xpt
TI	Trial Inclusion/Exclusion Criteria	TRIAL DESIGN	One record per I/E criterion	Tabulation	STUDYID, IETESTCD	ti.xpt
TS	Trial Summary	TRIAL DESIGN	One record per trial summary parameter value	Tabulation	STUDYID, TSPARMCD, TSSEQ, TSVAL	ts.xpt
TV	Trial Visits	TRIAL DESIGN	One record per planned visit per arm	Tabulation	STUDYID, VISITNUM, ARMCD	tv.xpt
DM	Demographics	SPECIAL PURPOSE	One record per subject	Tabulation	STUDYID, USUBJID	dm.xpt
RELREC	Related Records	SPECIAL PURPOSE	One record per related record, group of records or dataset	Tabulation	STUDYID, USUBJID, RELID, RDOMAIN, IDVAR, IDVARVAL, RELTYPE	relrec.xpt
SE	Subject Elements	SPECIAL PURPOSE	One record per actual element per subject	Tabulation	STUDYID, USUBJID, SUBJID, TAETORD, SESTDTC	se.xpt
SV	Subject Visits	SPECIAL PURPOSE	One record per actual visit per subject	Tabulation	STUDYID, USUBJID, SUBJID, VISITNUM, VISIT	sv.xpt
XM	Multiple Participation	SPECIAL PURPOSE	One record per subject	Tabulation	STUDYID, USUBJID	xm.xpt
CM	Concomitant Medications	INTERVENTIONS	One record per recorded medication occurrence or constant-dosing interval per subject	Tabulation	STUDYID, USUBJID, CMTRT, CMSTDTC	cm.xpt
EC	Exposure as Collected	INTERVENTIONS	One record per protocol-specified study treatment, collected-dosing interval, per subject, per mood	Tabulation	STUDYID, USUBJID, SUBJID, ECTRT, ECSTDTC	ec.xpt
EX	Exposure	INTERVENTIONS	One record per constant dosing interval per subject	Tabulation	STUDYID, USUBJID, EXTRT, EXSTDTC	ex.xpt
PR	Procedures	INTERVENTIONS	One record per recorded procedure per occurrence per subject	Tabulation	STUDYID, USUBJID, PRCAT, PRSCAT, PRTRT, PRSTDTC, PRSPID	pr.xpt
AE	Adverse Events	EVENTS	One record per adverse event per subject	Tabulation	STUDYID, USUBJID, SUBJID, AEDECOD, AETERM, AESTDTC, AEGRPID, AEREFID	ae.xpt
CE	Clinical Events	EVENTS	One record per event per subject, per collected term, per vaccine, per date time of each vaccine	Tabulation	STUDYID, USUBJID, CETERM, CETPTREF, CERFTDTC, CESTDTC	ce.xpt
DS	Disposition	EVENTS	One record per disposition status or protocol milestone per subject	Tabulation	STUDYID, USUBJID, SUBJID, DSDECOD, DSTERM, DSSTDTC, DSCAT, DSSCAT, DSREFID	ds.xpt
DV	Protocol Deviations	EVENTS	One record per protocol deviation per subject	Tabulation	STUDYID, USUBJID, DVTERM, DVCAT, DVSTDTC	dv.xpt
HO	Healthcare Encounters	EVENTS	One record per healthcare encounter per subject	Tabulation	STUDYID, USUBJID, HOTERM, HOSTDTC	ho.xpt
MH	Medical History	EVENTS	One record per medical history event per subject	Tabulation	STUDYID, USUBJID, SUBJID, MHCAT, MHTERM, MHDECOD, MHSTDTC, MHSPID, MHDTC, MHOCCUR	mh.xpt
DD	Death Details	FINDINGS	One record per finding per subject	Tabulation	STUDYID, USUBJID, DDTESTCD	dd.xpt
IE	Inclusion/Exclusion Criteria Not Met	FINDINGS	One record per inclusion/exclusion criterion not met per subject	Tabulation	STUDYID, USUBJID, IETESTCD	ie.xpt
IS	Immunogenicity Specimen Assessment	FINDINGS	One record per test per visit per subject	Tabulation	STUDYID, USUBJID, SUBJID, ISCAT, ISTESTCD, VISITNUM, ISDTC, ISORRES, ISREFID, ISREASND	is.xpt
LB	Laboratory Tests Results	FINDINGS	One record per analyte per planned time point number per time point reference per visit per subject	Tabulation	STUDYID, USUBJID, SUBJID, LBCAT, LBTESTCD, LBSPEC, VISITNUM, LBDTC, LBORRES, LBSTAT	lb.xpt
MB	Microbiology Specimen	FINDINGS	One record per microbiology specimen finding per time point per visit per subject	Tabulation	STUDYID, USUBJID, SUBJID, MBCAT, MBSCAT, MBTESTCD, MBSPEC, MBREFID, MBDTC, VISITNUM, MBORRES	mb.xpt
RP	Reproductive System Findings	FINDINGS	One record per Reproductive System Finding per time point per visit per subject	Tabulation	STUDYID, USUBJID, RPTESTCD, VISITNUM, RPDTC	rp.xpt
SC	Subject Characteristics	FINDINGS	One record per characteristic per subject	Tabulation	STUDYID, USUBJID, SCTESTCD, SCSTRESC, SCORRES	sc.xpt
VS	Vital Signs	FINDINGS	One record per vital sign measurement per time point per visit per subject	Tabulation	STUDYID, USUBJID, VSCAT, VSSCAT, VSTESTCD, VSSPID, VISITNUM, VSTPTNUM, VSDTC, VSORRES	vs.xpt
XQ	Virus Sequencing	FINDINGS	One record per lineage per example reference per subject	Tabulation	STUDYID, USUBJID, XQREFID	xq.xpt
FAAE	Findings About Adverse Events (FA)	FINDINGS ABOUT	One record per finding per object per time point per time point reference per visit per subject	Tabulation	STUDYID, USUBJID, FAEVAL, FATESTCD, FATEST, FAOBJ, FASPID, FADTC	faae.xpt
FACE	Findings About Clinical Events (FA)	FINDINGS ABOUT	One record per finding per object per time point per time point reference per visit per subject	Tabulation	STUDYID, USUBJID, FAEVAL, FATESTCD, FATEST, FAOBJ, FASPID, FADTC	face.xpt
FAEF	Findings About Efficacy Events (FA)	FINDINGS ABOUT	One record per finding per object per time point per time point reference per visit per subject	Tabulation	STUDYID, USUBJID, FATESTCD, FATEST, FAOBJ, FASPID, FADTC	faef.xpt
FAOT	Findings About Events or Interventions (FA)	FINDINGS ABOUT	One record per finding per object per time point per time point reference per visit per subject	Tabulation	STUDYID, USUBJID, FACAT, FATESTCD, FAOBJ, VISITNUM, FADTC, FAORRES	faot.xpt
SUPPAE	Supplemental Qualifiers for AE (Adverse Events)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppae.xpt
SUPPCE	Supplemental Qualifiers for CE (Clinical Events)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppce.xpt
SUPPCM	Supplemental Qualifiers for CM (Concomitant Medications)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppcm.xpt
SUPPDM	Supplemental Qualifiers for DM (Demographics)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppdm.xpt
SUPPDS	Supplemental Qualifiers for DS (Disposition)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppds.xpt
SUPPDV	Supplemental Qualifiers for DV (Protocol Deviations)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppdv.xpt
SUPPEC	Supplemental Qualifiers for EC (Exposure as Collected)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppec.xpt
SUPPFAAE	Supplemental Qualifiers for FAAE (SUPPFA)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppfaae.xpt
SUPPFACE	Supplemental Qualifiers for FACE (SUPPFA)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppface.xpt
SUPPFAEF	Supplemental Qualifiers for FAEF (SUPPFA)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppfaef.xpt
SUPPFAOT	Supplemental Qualifiers for FAOT (SUPPFA)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppfaot.xpt
SUPPHO	Supplemental Qualifiers for HO (Healthcare Encounters)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppho.xpt
SUPPIE	Supplemental Qualifiers for IE (Inclusion/Exclusion Criteria Not Met)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppie.xpt
SUPPIS	Supplemental Qualifiers for IE (Immunogenicity Specimen Assessment)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppis.xpt
SUPPMB	Supplemental Qualifiers for MB (Microbiology Specimen)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppmb.xpt
SUPPMH	Supplemental Qualifiers for MH (Medical History)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppmh.xpt
SUPPRP	Supplemental Qualifiers for RP (Reproductive System Findings)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	supprp.xpt
SUPPSC	Supplemental Qualifiers for SC (Subject Characteristics)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppsc.xpt
SUPPSV	Supplemental Qualifiers for SV (Subject Visits)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppsv.xpt
SUPPVS	Supplemental Qualifiers for VS (Vital Signs)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppvs.xpt
SUPPXQ	Supplemental Qualifiers for XQ (Virus Sequencing)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppxq.xpt

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Trial Arms (TA)

TA (Trial Arms) - TRIAL DESIGN Location: ta.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
ARMCD	Planned Arm Code	text	Topic	8	Planned Arm Code • "A" = "mRNA-1273" • "PLA" = "Placebo" • "PLAA" = "Placebo-mRNA-1273"	Assigned
ARM	Description of Planned Arm	text	Synonym Qualifier	12	Description of Planned Arm • "Placebo" • "mRNA-1273" • "Placebo-mRNA-1273"	Protocol
TAETORD	Planned Order of Element within Arm	integer	Timing	8		Protocol
ETCD	Element Code	text	Record Qualifier	6	Element Code [6 Terms]	Assigned
ELEMENT	Description of Element	text	Synonym Qualifier	9	Description of Element [6 Terms]	Protocol
TABRANCH	Branch	text	Rule	31		Protocol
TATRANS	Transition Rule	text	Rule	1		Protocol Missing value for all records
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Protocol

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Trial Elements (TE)

TE (Trial Elements) - TRIAL DESIGN Location: te.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
ETCD	Element Code	text	Topic	6	Element Code [6 Terms]	Assigned
ELEMENT	Description of Element	text	Synonym Qualifier	9	Description of Element [6 Terms]	Protocol
TESTRL	Rule for Start of Element	text	Rule	35		Protocol
TEENRL	Rule for End of Element	text	Rule	31		Protocol
TEDUR	Planned Duration of Element	durationDatetime	Timing		ISO 8601	Protocol

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Trial Inclusion/Exclusion Criteria (TI)

TI (Trial Inclusion/Exclusion Criteria) - TRIAL DESIGN Location: ti.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
IETESTCD	Inclusion/Exclusion Criterion Short Name	text	Topic	6	Inclusion/Exclusion Test Code [27 Terms]	Assigned
IETEST	Inclusion/Exclusion Criterion	text	Synonym Qualifier	199		Assigned
IECAT	Inclusion/Exclusion Category	text	Grouping Qualifier	9	Category for Inclusion/Exclusion • "EXCLUSION" • "INCLUSION"	Assigned
TIVERS	Protocol Criteria Versions	text	Record Qualifier	1	Protocol Criteria Versions [7 Terms]	Protocol

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Trial Summary (TS)

TS (Trial Summary) - TRIAL DESIGN Location: ts.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
TSSEQ	Sequence Number	integer	Identifier	8		Assigned
TSPARMCD	Trial Summary Parameter Short Name	text	Topic	8	Trial Summary Parameter Test Code [45 Terms]	Assigned
TSPARM	Trial Summary Parameter	text	Synonym Qualifier	40	Trial Summary Parameter Test Name [45 Terms]	Assigned
TSVAL	Parameter Value	text	Result Qualifier	198		Assigned
TSVAL1	Parameter Value 1	text	Result Qualifier	38		Assigned
TSVAL2	Parameter Value 2	text	Result Qualifier	1		Assigned Missing value for all records
TSVALNF	Parameter Null Flavor	text	Result Qualifier	4		Assigned
TSVALCD	Parameter Value Code	text	Result Qualifier	11		Assigned
TSVCDREF	Name of the Reference Terminology	text	Result Qualifier	18		Assigned
TSVCDVER	Version of the Reference Terminology	date	Result Qualifier		ISO 8601	Assigned

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Trial Visits (TV)

TV (Trial Visits) - TRIAL DESIGN Location: tv.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	20	Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2	Assigned
VISITNUM	Visit Number	integer	Topic	8	Assigned
VISIT	Visit Name	text	Synonym Qualifier	100	Protocol
VISITDY	Planned Study Day of Visit	integer	Timing	8	Protocol
ARMCD	Planned Arm Code	text	Record Qualifier	8	Assigned
TVSTRL	Visit Start Rule	text	Rule	47	Protocol
TVENRL	Visit End Rule	text	Rule	22	Protocol

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Demographics (DM)

DM (Demographics) - SPECIAL PURPOSE Location: dm.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPDM (Supplemental Qualifiers for DM)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text	Topic	9		CRF Annotated Case Report Form [8 ]
RFSTDTC	Subject Reference Start Date/Time	datetime	Record Qualifier		ISO 8601	Derived First Dose date from EX domain
RFENDTC	Subject Reference End Date/Time	datetime	Record Qualifier		ISO 8601	Derived Last Dose date from EX domain
RFXSTDTC	Date/Time of First Study Treatment	datetime	Record Qualifier		ISO 8601	Derived Equals RFSTDTC
RFXENDTC	Date/Time of Last Study Treatment	datetime	Record Qualifier		ISO 8601	Derived Equals RFENDTC
RFICDTC	Date/Time of Informed Consent	date	Record Qualifier		ISO 8601	CRF Annotated Case Report Form [8 ]
RFPENDTC	Date/Time of End of Participation	datetime	Record Qualifier		ISO 8601	Derived Last known date in study data
DTHDTC	Date/Time of Death	date	Record Qualifier		ISO 8601	CRF Annotated Case Report Form [33 ] Note: Selecting earlier of the dates from page 25 and 33
DTHFL	Subject Death Flag	text	Record Qualifier	1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [33 ] Note: Check both data from page 25 and 33
SITEID	Study Site Identifier	text	Record Qualifier	5		Assigned
BRTHDTC	Date/Time of Birth	partialDate	Record Qualifier		ISO 8601	CRF Annotated Case Report Form [7 ]
AGE	Age	integer	Record Qualifier	8		CRF Annotated Case Report Form [7 ]
AGEU	Age Units	text	Variable Qualifier	5	Age Unit • "YEARS"	Assigned
SEX	Sex	text	Record Qualifier	1	Sex • "F" • "M"	CRF Annotated Case Report Form [7 ]
RACE	Race	text	Record Qualifier	41	Race [9 Terms]	CRF Annotated Case Report Form [7 ]
ETHNIC	Ethnicity	text	Record Qualifier	22	Ethnic Group • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	CRF Annotated Case Report Form [7 ]
ARMCD	Planned Arm Code	text	Record Qualifier	8	Planned Arm Code • "A" = "mRNA-1273" • "PLA" = "Placebo" • "PLAA" = "Placebo-mRNA-1273"	Assigned
ARM	Description of Planned Arm	text	Synonym Qualifier	12	Description of Planned Arm • "Placebo" • "mRNA-1273" • "Placebo-mRNA-1273"	Assigned
ACTARMCD	Actual Arm Code	text	Record Qualifier	3	Actual Arm Code • "A" = "mRNA-1273" • "PLA" = "Placebo" • "PLAA" = "Placebo-mRNA-1273"	Assigned
ACTARM	Description of Actual Arm	text	Synonym Qualifier	9	Description of Actual Arm • "Placebo" • "mRNA-1273" • "Placebo-mRNA-1273"	Assigned
COUNTRY	Country	text	Record Qualifier	3	Country • "USA"	Assigned

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Related Records (RELREC)

RELREC (Related Records) - SPECIAL PURPOSE Location: relrec.xpt
Variable	Label / Description	Type	Length or Display Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	20	Protocol
RDOMAIN	Related Domain Abbreviation	text	6	Assigned
USUBJID	Unique Subject Identifier	text	50	Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	200	Assigned
IDVARVAL	Identifying Variable Value	text	200	Assigned
RELTYPE	Relationship Type	text	10	Assigned
RELID	Relationship Identifier	text	10	Assigned

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Subject Elements (SE)

SE (Subject Elements) - SPECIAL PURPOSE Location: se.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [8 ]
SESEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
ETCD	Element Code	text	Topic	6	Element Code [6 Terms]	Assigned
ELEMENT	Description of Element	text	Synonym Qualifier	9	Description of Element [6 Terms]	Protocol
TAETORD	Planned Order of Element within Arm	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	50	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXENDTC<RFSTDTC or both RFXSTDTC and --ENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<= --STDTC and --ENDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= --STDTC and --ENDTC <= RFPENDTC
SESTDTC	Start Date/Time of Element	datetime	Timing		ISO 8601	Derived For Screening element (SCREEN), start date is Informed Consent date; For first dose element (V, PBO, VOL) start date is first dose date; and for Follow-up element (FUA, FUB), start date is visit date 28 days after last vaccination.
SEENDTC	End Date/Time of Element	datetime	Timing		ISO 8601	Derived For Screening element (SCREEN), end date is first dose date if non missing -1, or end of participation date if subject never dosed; For element (V, PBO, VOL), end date is last dose date if non missing + 28 or the end of participation date which ever come to first
SESTDY	Study Day of Start of Observation	integer	Timing	8		Derived --STDTC - DM.RFSTDTC if --STDTC < DM.RFSTDTC, --STDTC - DM.RFSTDTC + 1 if --STDTC >= DM.RFSTDTC
SEENDY	Study Day of End of Observation	integer	Timing	8		Derived --ENDTC - DM.RFSTDTC if --ENDTC < RFSTDTC, --ENDTC - DM.RFSTDTC + 1 if --ENDTC >= RFSTDTC

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Subject Visits (SV)

SV (Subject Visits) - SPECIAL PURPOSE Location: sv.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPSV (Supplemental Qualifiers for SV)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [8 ]
SVSEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
VISITNUM	Visit Number	float	Topic	8		Assigned
VISIT	Visit Name	text	Synonym Qualifier	100		CRF Annotated Case Report Form [51 ]
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	40	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXENDTC<RFSTDTC or both RFXSTDTC and --ENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<= --STDTC and --ENDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= --STDTC and --ENDTC <= RFPENDTC
SVSTDTC	Start Date/Time of Visit	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [6 23 37 51 52 ]
SVENDTC	End Date/Time of Visit	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [6 23 37 51 52 ]
SVSTDY	Study Day of Start of Visit	integer	Timing	8		Derived --STDTC - DM.RFSTDTC if --STDTC < DM.RFSTDTC, --STDTC - DM.RFSTDTC + 1 if --STDTC >= DM.RFSTDTC
SVENDY	Study Day of End of Visit	integer	Timing	8		Derived --ENDTC - DM.RFSTDTC if --ENDTC < RFSTDTC, --ENDTC - DM.RFSTDTC + 1 if --ENDTC >= RFSTDTC
SVUPDES	Description of Unplanned Visit	text	Synonym Qualifier	200		Assigned
SVPRESP	Subject Visits Pre-specified	text		1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [23 ]
SVOCCUR	Subject Visits Occurrence	text		1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [23 ]
SVTERM	Subject Visits Term	text		159		CRF Annotated Case Report Form [23 52 ]
SVEPCHGI	Epi/Pandemic Related Change Indicator	text		4		CRF Annotated Case Report Form [37 ]
SVCNTMOD	Contact Mode	text		17		CRF Annotated Case Report Form [3 23 37 ]
SVREASOC	Reason for Occur Value	text		200		CRF Annotated Case Report Form [23 52 ]

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Multiple Participation (XM)

XM (Multiple Participation) - SPECIAL PURPOSE Location: xm.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	20		Protocol
DOMAIN	Domain Abbreviation	text	2		Assigned
USUBJID	Unique Subject Identifier	text	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text	9		CRF Annotated Case Report Form [8 ]
RFSTDTC	Subject Reference Start Date/Time	datetime		ISO 8601	Derived First Dose date from EX domain
RFENDTC	Subject Reference End Date/Time	datetime		ISO 8601	Derived Last Dose date from EX domain
RFXSTDTC	Date/Time of First Study Treatment	datetime		ISO 8601	Derived Equals RFSTDTC
RFXENDTC	Date/Time of Last Study Treatment	datetime		ISO 8601	Derived Equals RFENDTC
RFICDTC	Date/Time of Informed Consent	date		ISO 8601	CRF Annotated Case Report Form [8 ]
RFPENDTC	Date/Time of End of Participation	date		ISO 8601	Derived Last known date in study data
DTHDTC	Date/Time of Death	datetime		ISO 8601	Assigned Missing value for all records
DTHFL	Subject Death Flag	text	1		Assigned Missing value for all records
SITEID	Study Site Identifier	text	5		Assigned
INVNAM	Investigator Name	text	69		Assigned
BRTHDTC	Date/Time of Birth	partialDate		ISO 8601	CRF Annotated Case Report Form [7 ]
AGE	Age	integer	8		CRF Annotated Case Report Form [7 ]
AGEU	Age Units	text	5	Age Unit • "YEARS"	Assigned
SEX	Sex	text	1	Sex • "F" • "M"	CRF Annotated Case Report Form [7 ]
RACE	Race	text	41	Race [9 Terms]	CRF Annotated Case Report Form [7 ]
ETHNIC	Ethnicity	text	22	Ethnic Group • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	CRF Annotated Case Report Form [7 ]
ARMCD	Planned Arm Code	text	8		Assigned Missing value for all records
ARM	Description of Planned Arm	text	12		Assigned Missing value for all records
ACTARMCD	Actual Arm Code	text	3		Assigned Missing value for all records
ACTARM	Description of Actual Arm	text	9		Assigned Missing value for all records
COUNTRY	Country	text	3	Country • "USA"	Assigned

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Concomitant Medications (CM)

CM (Concomitant Medications) - INTERVENTIONS Location: cm.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPCM (Supplemental Qualifiers for CM)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [8 ]
CMSEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
CMSPID	Sponsor-Defined Identifier	text	Identifier	3		Assigned Row ID Number in the format of '0xx'
CMTRT	Reported Name of Drug, Med, or Therapy	text	Topic	200		CRF Annotated Case Report Form [28 ]
CMDECOD	Standardized Medication Name	text	Synonym Qualifier	200	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
CMCAT	Category for Medication	text	Grouping Qualifier	23	Category for Medication • "CONCOMITANT MEDICATIONS" • "PRIOR MEDICATIONS" • "VACCINATION"	Assigned
CMINDC	Indication	text	Record Qualifier	181		CRF Annotated Case Report Form [28 ]
CMCLAS	Medication Class	text	Variable Qualifier	64	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
CMCLASCD	Medication Class Code	text	Variable Qualifier	3	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
CMDOSE	Dose per Administration	float	Record Qualifier	11		CRF Annotated Case Report Form [28 ]
CMDOSTXT	Dose Description	text	Record Qualifier	25		CRF Annotated Case Report Form [28 ] A copy of CMDOSE in text format. It may include additional information for dose collected as a range
CMDOSU	Dose Units	text	Variable Qualifier	7	Dose Units in Concomitant Medications [9 Terms]	CRF Annotated Case Report Form [28 ]
CMDOSFRQ	Dosing Frequency per Interval	text	Variable Qualifier	7	Dosing Frequency in Concomitant Medications [12 Terms]	CRF Annotated Case Report Form [28 ]
CMROUTE	Route of Administration	text	Variable Qualifier	24	Route of Administration in Concomitant Medications [16 Terms]	CRF Annotated Case Report Form [28 29 ]
EPOCH	Epoch	text	Timing	20	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXENDTC<RFSTDTC or both RFXSTDTC and --ENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<= --STDTC and --ENDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= --STDTC and --ENDTC <= RFPENDTC
CMSTDTC	Start Date/Time of Medication	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [29 ]
CMENDTC	End Date/Time of Medication	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [29 ]
CMSTDY	Study Day of Start of Medication	integer	Timing	8		Derived --STDTC - DM.RFSTDTC if --STDTC < DM.RFSTDTC, --STDTC - DM.RFSTDTC + 1 if --STDTC >= DM.RFSTDTC
CMENDY	Study Day of End of Medication	integer	Timing	8		Derived --ENDTC - DM.RFSTDTC if --ENDTC < RFSTDTC, --ENDTC - DM.RFSTDTC + 1 if --ENDTC >= RFSTDTC
CMENRTPT	End Relative to Reference Time Point	text	Timing	7	Relation to Reference Period (ENRTPT) • "ONGOING"	CRF Annotated Case Report Form [29 ]
CMENTPT	End Reference Time Point	text	Timing	10		Derived if CMENRTPT is not missing, then set to DM.RFPENDTC

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Exposure as Collected (EC)

EC (Exposure as Collected) - INTERVENTIONS Location: ec.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPEC (Supplemental Qualifiers for EC)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [8 ]
ECSEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
ECREFID	Reference ID	text	Identifier	6		Assigned
ECLNKID	Link ID	text	Identifier	7		Assigned
ECTRT	Name of Treatment	text	Topic	9		eDT
ECPRESP	Pre-Specified	text	Record Qualifier	1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [19 ]
ECOCCUR	Occurrence	text	Record Qualifier	1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [19 ]
ECDOSE	Dose	float	Record Qualifier	8		Protocol
ECDOSU	Dose Units	text	Variable Qualifier	2	Dose Units in Exposure as Collected • "mL"	Protocol
ECDOSFRM	Dose Form	text	Variable Qualifier	9	Dose Form in Exposure as Collected • "INJECTION"	Protocol
ECDOSFRQ	Dosing Frequency per Interval	text	Variable Qualifier	4	Dosing Frequency in Exposure as Collected • "ONCE"	CRF Annotated Case Report Form [19 ]
ECROUTE	Route of Administration	text	Variable Qualifier	13	Route of Administration in Exposure as Collected • "INTRAMUSCULAR"	CRF Annotated Case Report Form [19 ]
ECLOC	Location of Dose Administration	text	Record Qualifier	3	Location of Dose Administration for Exposure as Collected • "ARM"	CRF Annotated Case Report Form [19 ]
ECLAT	Laterality	text	Record Qualifier	5	Laterality in Exposure as Collected • "LEFT" • "RIGHT"	CRF Annotated Case Report Form [19 ]
VISITNUM	Visit Number	integer	Timing	8		Assigned
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
VISIT	Visit Name	text	Timing	100		Derived Calculated based on SV info
ECSTDTC	Start Date/Time of Treatment	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [19 ]
ECENDTC	End Date/Time of Treatment	datetime	Timing		ISO 8601	Derived Same as --STDTC
ECSTDY	Study Day of Start of Treatment	integer	Timing	8		Derived --STDTC - DM.RFSTDTC if --STDTC < DM.RFSTDTC, --STDTC - DM.RFSTDTC + 1 if --STDTC >= DM.RFSTDTC
ECENDY	Study Day of End of Treatment	integer	Timing	8		Derived --ENDTC - DM.RFSTDTC if --ENDTC < RFSTDTC, --ENDTC - DM.RFSTDTC + 1 if --ENDTC >= RFSTDTC
EPOCH	Epoch	text	Timing	20	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXENDTC<RFSTDTC or both RFXSTDTC and --ENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<= --STDTC and --ENDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= --STDTC and --ENDTC <= RFPENDTC

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Exposure (EX)

EX (Exposure) - INTERVENTIONS Location: ex.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
EXSEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
EXLNKID	Link ID	text	Identifier	7		Assigned
EXTRT	Name of Treatment	text	Topic	9	Name of Treatment • "PLACEBO" • "mRNA-1273"	eDT
EXDOSE	Dose	integer	Record Qualifier	8		Protocol
EXDOSU	Dose Units	text	Variable Qualifier	2	Dose Units in Exposure • "ug"	Protocol
EXDOSFRM	Dose Form	text	Variable Qualifier	9	Dose Form in Exposure • "INJECTION"	Protocol
EXDOSFRQ	Dosing Frequency per Interval	text	Variable Qualifier	4	Dosing Frequency in Exposure • "ONCE"	CRF Annotated Case Report Form [19 ]
EXROUTE	Route of Administration	text	Variable Qualifier	13	Route of Administration in Exposure • "INTRAMUSCULAR"	CRF Annotated Case Report Form [19 ]
EXLOC	Location of Dose Administration	text	Record Qualifier	3	Location of Dose Administration for Exposure • "ARM"	CRF Annotated Case Report Form [19 ]
EXLAT	Laterality	text	Variable Qualifier	5	Laterality in Exposure • "LEFT" • "RIGHT"	CRF Annotated Case Report Form [19 ]
VISITNUM	Visit Number	integer	Timing	8		Assigned
VISIT	Visit Name	text	Timing	100		Derived Calculated based on SV info
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	40	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXENDTC<RFSTDTC or both RFXSTDTC and --ENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<= --STDTC and --ENDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= --STDTC and --ENDTC <= RFPENDTC
EXSTDTC	Start Date/Time of Treatment	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [19 ]
EXENDTC	End Date/Time of Treatment	datetime	Timing		ISO 8601	Derived Same as --STDTC
EXSTDY	Study Day of Start of Treatment	integer	Timing	8		Derived --STDTC - DM.RFSTDTC if --STDTC < DM.RFSTDTC, --STDTC - DM.RFSTDTC + 1 if --STDTC >= DM.RFSTDTC
EXENDY	Study Day of End of Treatment	integer	Timing	8		Derived --ENDTC - DM.RFSTDTC if --ENDTC < RFSTDTC, --ENDTC - DM.RFSTDTC + 1 if --ENDTC >= RFSTDTC

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Procedures (PR)

PR (Procedures) - INTERVENTIONS Location: pr.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [8 ]
PRSEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
PRGRPID	Group ID	text	Identifier	10		CRF Annotated Case Report Form [48 ]
PRSPID	Sponsor-Defined Identifier	text	Identifier	3		Assigned
PRLNKID	Link ID	text	Identifier	9		Assigned
PRTRT	Reported Name of Procedure	text	Topic	126		CRF Annotated Case Report Form [31 48 ]
PRCAT	Category	text	Grouping Qualifier	22	Category for Procedures • "CONCOMITANT PROCEDURES" • "EFFICACY"	Assigned
PRSCAT	Subcategory	text	Grouping Qualifier	17	Subcategory for Procedures • "COVID-19 SEVERITY"	Assigned
PRPRESP	Pre-specified	text	Record Qualifier	1	No Yes Response (Yes only) • "Y"	Assigned Set to 'Y' for EFFICACY
PROCCUR	Occurrence	text	Record Qualifier	1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [48 ]
PRSTAT	Completion Status	text	Record Qualifier	8	Not Done • "NOT DONE"	eDT
PRINDC	Indication	text	Record Qualifier	140		CRF Annotated Case Report Form [31 ]
EPOCH	Epoch	text	Timing	40	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXENDTC<RFSTDTC or both RFXSTDTC and --ENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<= --STDTC and --ENDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= --STDTC and --ENDTC <= RFPENDTC
PRSTDTC	Start Date/Time of Procedure	date	Timing		ISO 8601	CRF Annotated Case Report Form [31 48 ]
PRENDTC	End Date/Time of Procedure	date	Timing		ISO 8601	CRF Annotated Case Report Form [48 ]
PRSTDY	Study Day of Start of Procedure	integer	Timing	8		Derived --STDTC - DM.RFSTDTC if --STDTC < DM.RFSTDTC, --STDTC - DM.RFSTDTC + 1 if --STDTC >= DM.RFSTDTC
PRENDY	Study Day of End of Procedure	integer	Timing	8		Derived --ENDTC - DM.RFSTDTC if --ENDTC < RFSTDTC, --ENDTC - DM.RFSTDTC + 1 if --ENDTC >= RFSTDTC

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Adverse Events (AE)

AE (Adverse Events) - EVENTS Location: ae.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPAE (Supplemental Qualifiers for AE)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [8 ]
AESEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
AEGRPID	Group ID	text	Identifier	3		Assigned Record position on CRF in z3 format
AEREFID	Reference ID	text	Identifier	25		Assigned Based on Dose, concatenate "DOSE 1" or "DOSE 2" with Dosing date
AESPID	Sponsor-Defined Identifier	text	Identifier	6		CRF Annotated Case Report Form [25 ]
AELNKGRP	Link Group ID	text	Identifier	4		Assigned Based on Dose, concatenate '1' or '2' to LNKGRP as per CRF
AETERM	Reported Term for the Adverse Event	text	Topic	189		CRF Annotated Case Report Form [25 ]
AELLT	Lowest Level Term	text	Variable Qualifier	54	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
AELLTCD	Lowest Level Term Code	integer	Variable Qualifier	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
AEDECOD	Dictionary-Derived Term	text	Synonym Qualifier	50	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
AEPTCD	Preferred Term Code	integer	Variable Qualifier	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
AEHLT	High Level Term	text	Variable Qualifier	75	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
AEHLTCD	High Level Term Code	integer	Variable Qualifier	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
AEHLGT	High Level Group Term	text	Variable Qualifier	86	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
AEHLGTCD	High Level Group Term Code	integer	Variable Qualifier	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
AECAT	Category for Adverse Event	text	Grouping Qualifier	14	Category for Adverse Event • "ADVERSE EVENT" • "REACTOGENICITY"	Assigned
AESCAT	Subcategory for Adverse Event	text	Grouping Qualifier	5	Subcategory for Adverse Event • "PIMMC"	Assigned
AEBODSYS	Body System or Organ Class	text	Record Qualifier	67	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
AEBDSYCD	Body System or Organ Class Code	integer	Variable Qualifier	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
AESOC	Primary System Organ Class	text	Variable Qualifier	67	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
AESOCCD	Primary System Organ Class Code	integer	Variable Qualifier	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
AESEV	Severity/Intensity	text	Record Qualifier	8	Severity/Intensity Scale for Adverse Events • "MILD" • "MODERATE" • "SEVERE"	CRF Annotated Case Report Form [25 ]
AESER	Serious Event	text	Record Qualifier	1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [25 ]
AEACN	Action Taken with Study Treatment	text	Record Qualifier	16	Action Taken with Study Treatment • "DOSE DELAYED" • "DOSE NOT CHANGED" • "DRUG WITHDRAWN" • "NOT APPLICABLE"	CRF Annotated Case Report Form [26 ]
AEACNOTH	Other Action Taken	text	Record Qualifier	45		CRF Annotated Case Report Form [26 ]
AEREL	Causality	text	Record Qualifier	14	Causality • "NOT APPLICABLE" • "NOT RELATED" • "RELATED"	CRF Annotated Case Report Form [26 ]
AERELNST	Relationship to Non-Study Treatment	text	Record Qualifier	14	Relationship to Non-Study Treatment • "NOT APPLICABLE" • "NOT RELATED" • "RELATED"	CRF Annotated Case Report Form [26 ]
AEOUT	Outcome of Adverse Event	text	Record Qualifier	32	Outcome of Event in Adverse Events [6 Terms]	CRF Annotated Case Report Form [26 ]
AESCONG	Congenital Anomaly or Birth Defect	text		1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [26 ]
AESDISAB	Persist or Signif Disability/Incapacity	text	Record Qualifier	1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [25 ]
AESDTH	Results in Death	text	Record Qualifier	1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [25 ]
AESHOSP	Requires or Prolongs Hospitalization	text	Record Qualifier	1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [25 ]
AESLIFE	Is Life Threatening	text	Record Qualifier	1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [25 ]
AESMIE	Other Medically Important Serious Event	text	Record Qualifier	1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [26 ]
AETOXGR	Standard Toxicity Grade	text	Record Qualifier	1	Standard Toxicity Grade in Adverse Events • "1" • "2" • "3" • "4"	CRF Annotated Case Report Form [25 ]
EPOCH	Epoch	text	Timing	20	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXENDTC<RFSTDTC or both RFXSTDTC and --ENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<= --STDTC and --ENDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= --STDTC and --ENDTC <= RFPENDTC
AESTDTC	Start Date/Time of Adverse Event	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [25 ]
AEENDTC	End Date/Time of Adverse Event	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [25 ]
AESTDY	Study Day of Start of Adverse Event	integer	Timing	8		Derived --STDTC - DM.RFSTDTC if --STDTC < DM.RFSTDTC, --STDTC - DM.RFSTDTC + 1 if --STDTC >= DM.RFSTDTC
AEENDY	Study Day of End of Adverse Event	integer	Timing	8		Derived --ENDTC - DM.RFSTDTC if --ENDTC < RFSTDTC, --ENDTC - DM.RFSTDTC + 1 if --ENDTC >= RFSTDTC
AEENRF	End Relative to Reference Period	text	Timing	7	Relation to Reference Period • "ONGOING"	CRF Annotated Case Report Form [25 ]
AEDUR	Duration of Adverse Event	durationDatetime	Timing		ISO 8601	Derived AEENDTC - Reference Vaccine Date - 6 where AECAT="REACTOGENICITY" (See Reviewers Guide for details) Study Data Reviewer’s Guide

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Clinical Events (CE)

CE (Clinical Events) - EVENTS Location: ce.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPCE (Supplemental Qualifiers for CE)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
CESEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
CEGRPID	Group ID	text	Identifier	21	CE Group ID • "EVIDENCE OF SHOCK" • "EVIDENCE OF PNEUMONIA"	Assigned Assgined as per CRF for EFFICACY records only, otherwise blank.
CESPID	Sponsor-Defined Identifier	text	Identifier	10		Assigned concatenate INSTANCEID \|\|"-"\|\|RECORDPOSITION; For Adjudication, assigned from CLINICAL_ID
CELNKGRP	Link Group ID	text	Identifier	10		CRF Annotated Case Report Form [53 54 55 ]
CETERM	Reported Term for the Clinical Event	text	Topic	83		CRF Annotated Case Report Form [25 39 40 41 48 49 53 54 55 ]
CECAT	Category for Clinical Event	text	Grouping Qualifier	14	Category for Clinical Event • "ADJUDICATION" • "EFFICACY" • "REACTOGENICITY"	Assigned
CESCAT	Subcategory for Clinical Event	text	Grouping Qualifier	19	Subcategory for Clinical Event • "ADMINISTRATION SITE" • "COVID-19" • "COVID-19 SEVERITY" • "SEVERE COVID-19" • "SYSTEMIC"	Assigned
CEPRESP	Clinical Event Pre-Specified	text	Variable Qualifier	1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [38 39 40 41 47 48 49 53 54 55 ]
CEOCCUR	Clinical Event Occurrence	text	Record Qualifier	1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [25 39 40 41 47 48 49 53 54 55 ]
CESTAT	Completion Status	text	Record Qualifier	8	Not Done • "NOT DONE"	CRF Annotated Case Report Form [39 40 41 ]
CESEV	Severity/Intensity	text	Record Qualifier	8	Severity/Intensity Scale for Clinical Events [6 Terms]	CRF Annotated Case Report Form [25 39 40 41 ]
CETOXGR	Toxicity Grade	text	Record Qualifier	1	Toxicity Grade in Clinical Events • "0" • "1" • "2" • "3" • "4"	CRF Annotated Case Report Form [25 ]
EPOCH	Epoch	text	Timing	20	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXENDTC<RFSTDTC or both RFXSTDTC and --ENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<= --STDTC and --ENDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= --STDTC and --ENDTC <= RFPENDTC
CEDTC	Date/Time of Event Collection	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [39 47 48 49 53 54 55 ]
CESTDTC	Start Date/Time of Clinical Event	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [25 47 48 49 ]
CEENDTC	End Date/Time of Clinical Event	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [25 47 48 ]
CESER	Serious Event	text		1	No Yes Response (Yes only) • "Y"	Derived For CECAT = REACTOGENICITY: Set to Y if AESPIDX corresponds to a record where AESER = Y
CEDY	Study Day of Event Collection	integer	Timing	8		Derived --DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC
CESTDY	Study Day of Start of Observation	integer	Timing	8		Derived --STDTC - DM.RFSTDTC if --STDTC < DM.RFSTDTC, --STDTC - DM.RFSTDTC + 1 if --STDTC >= DM.RFSTDTC
CEENDY	Study Day of End of Observation	integer	Timing	8		Derived --ENDTC - DM.RFSTDTC if --ENDTC < RFSTDTC, --ENDTC - DM.RFSTDTC + 1 if --ENDTC >= RFSTDTC
CEDUR	Duration	durationDatetime	Timing		ISO 8601	Derived Calculated as duration days between --ENDY and --STDY date in format "PdD". If calculated value is negative, then blank
CETPT	Planned Time Point Name	text	Timing	53		Protocol
CETPTNUM	Planned Time Point Number	float	Timing	8		Assigned
CETPTREF	Time Point Reference	text	Timing	6		Assigned
CERFTDTC	Date/Time of Reference Time Point	datetime	Timing		ISO 8601	Derived Set to EXSTDTC based on CETPTREF
CESHOSP	Requires or Prolongs Hospitalization	text	Record Qualifier	1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [49 ]

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Disposition (DS)

DS (Disposition) - EVENTS Location: ds.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPDS (Supplemental Qualifiers for DS)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [8 ]
DSSEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
DSREFID	Reference ID	text	Identifier	6		CRF Annotated Case Report Form [4 ]
DSSPID	Sponsor-Defined Identifier	text	Identifier	6		CRF Annotated Case Report Form [32 ]
DSTERM	Reported Term for the Disposition Event	text	Topic	200		CRF Annotated Case Report Form [4 8 32 33 ]
DSDECOD	Standardized Disposition Term	text	Synonym Qualifier	39	Standardized Disposition Term [16 Terms]	Assigned
DSCAT	Category for Disposition Event	text	Grouping Qualifier	18	Category for Disposition Event • "DISPOSITION EVENT" • "PROTOCOL MILESTONE"	Assigned
DSSCAT	Subcategory for Disposition Event	text	Grouping Qualifier	15	Subcategory for Disposition Event • "SCREEN FAILURE" • "STUDY TREATMENT" • "OPEN LABEL" • "END OF STUDY"	Assigned
EPOCH	Epoch	text	Timing	20	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXENDTC<RFSTDTC or both RFXSTDTC and --ENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<= --STDTC and --ENDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= --STDTC and --ENDTC <= RFPENDTC
DSSTDTC	Start Date/Time of Disposition Event	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [4 5 32 33 ]
DSSTDY	Study Day of Start of Disposition Event	integer	Timing	8		Derived --STDTC - DM.RFSTDTC if --STDTC < DM.RFSTDTC, --STDTC - DM.RFSTDTC + 1 if --STDTC >= DM.RFSTDTC

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Protocol Deviations (DV)

DV (Protocol Deviations) - EVENTS Location: dv.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPDV (Supplemental Qualifiers for DV)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [7 ]
DVSEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
DVSPID	Sponsor-Defined Identifier	text	Identifier	9		Assigned
DVTERM	Protocol Deviation Term	text	Topic	198		eDT
DVCAT	Category for Protocol Deviation	text	Grouping Qualifier	18	Category for Protocol Deviation • "ICH/GCP Deviation" • "Protocol Deviation"	Assigned
DVSCAT	Subcategory for Protocol Deviation	text	Grouping Qualifier	30	Subcategory for Protocol Deviation [25 Terms]	Assigned
EPOCH	Epoch	text	Timing	40	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXENDTC<RFSTDTC or both RFXSTDTC and --ENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<= --STDTC and --ENDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= --STDTC and --ENDTC <= RFPENDTC
DVSTDTC	Start Date/Time of Deviation	date	Timing		ISO 8601	eDT
DVSTDY	Study Day of Start of Deviation	integer	Timing	8		Derived --STDTC - DM.RFSTDTC if --STDTC < DM.RFSTDTC, --STDTC - DM.RFSTDTC + 1 if --STDTC >= DM.RFSTDTC

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Healthcare Encounters (HO)

HO (Healthcare Encounters) - EVENTS Location: ho.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPHO (Supplemental Qualifiers for HO)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
HOSEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
HOREFID	Reference ID	text	Identifier	35		Assigned
HOSPID	Sponsor-Defined Identifier	text	Identifier	65		CRF Annotated Case Report Form [25 ]
HOTERM	Reported Term for Healthcare Encounter	text	Topic	18		CRF Annotated Case Report Form [25 49 55 ]
HODECOD	Dictionary-Derived Term	text	Synonym Qualifier	8	Dictionary-Derived Term in Healthcare Encounters • "HOSPITAL" • "ICU" • "MAAE"	Assigned
HOCAT	Category for Healthcare Encounter	text	Grouping Qualifier	14	Category for Healthcare Encounters • "ADVERSE EVENTS" • "E-DIARY" • "EFFICACY"	Assigned
HOSCAT	Subcategory for Healthcare Encounter	text	Grouping Qualifier	17	Subcategory for Healthcare Encounters • "COVID-19 SEVERITY"	Assigned
HOPRESP	Pre-Specified Healthcare Encounter	text	Record Qualifier	1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [49 55 ]
HOOCCUR	Healthcare Encounter Occurrence	text	Record Qualifier	1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [49 55 56 ]
EPOCH	Epoch	text	Timing	20	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXENDTC<RFSTDTC or both RFXSTDTC and --ENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<= --STDTC and --ENDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= --STDTC and --ENDTC <= RFPENDTC
HODTC	Date/Time of Event Collection	date	Timing		ISO 8601	CRF Annotated Case Report Form [49 ]
HOSTDTC	Start Date/Time of Healthcare Encounter	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [25 49 56 67 ]
HOENDTC	End Date/Time of Healthcare Encounter	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [25 49 56 67 ]
HODY	Study Day of Event Collection	integer		8		Derived HODTC - DM.RFSTDTC + 1 if HODTC>=DM.RFSTDTC
HOSTDY	Study Day of Start of Observation	integer	Timing	8		Derived --STDTC - DM.RFSTDTC if --STDTC < DM.RFSTDTC, --STDTC - DM.RFSTDTC + 1 if --STDTC >= DM.RFSTDTC
HOENDY	Study Day of End of Healthcare Encounter	integer	Timing	8		Derived --ENDTC - DM.RFSTDTC if --ENDTC < RFSTDTC, --ENDTC - DM.RFSTDTC + 1 if --ENDTC >= RFSTDTC
HODUR	Duration of Healthcare Encounter	durationDatetime	Timing		ISO 8601	CRF Annotated Case Report Form [25 ]

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Medical History (MH)

MH (Medical History) - EVENTS Location: mh.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPMH (Supplemental Qualifiers for MH)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [8 ]
MHSEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
MHSPID	Sponsor-Defined Identifier	text	Identifier	3		Assigned
MHTERM	Reported Term for the Medical History	text	Topic	195		CRF Annotated Case Report Form [4 12 ]
MHDECOD	Dictionary-Derived Term	text	Synonym Qualifier	61	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
MHPTCD	Preferred Term Code	integer	Variable Qualifier	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
MHLLT	Lowest Level Term	text	Variable Qualifier	84	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
MHLLTCD	Lowest Level Term Code	integer	Variable Qualifier	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
MHHLT	High Level Term	text	Variable Qualifier	82	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
MHHLTCD	High Level Term Code	integer	Variable Qualifier	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
MHHLGT	High Level Group Term	text	Variable Qualifier	86	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
MHHLGTCD	High Level Group Term Code	integer	Variable Qualifier	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
MHCAT	Category for Medical History	text	Grouping Qualifier	24	Category for Medical History • "GENERAL" • "COSMETIC OR MEDICAL INDICATIONS" • "RISK FACTOR FOR COVID-19"	Assigned
MHPRESP	Medical History Event Pre-Specified	text	Variable Qualifier	1	No Yes Response (Yes only) • "Y"	Assigned
MHOCCUR	Medical History Occurrence	text	Record Qualifier	1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [4 ]
MHBODSYS	Body System or Organ Class	text	Record Qualifier	67	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
MHSOCCD	Primary System Organ Class Code	integer	Variable Qualifier	8	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
EPOCH	Epoch	text	Timing	20	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXENDTC<RFSTDTC or both RFXSTDTC and --ENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<= --STDTC and --ENDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= --STDTC and --ENDTC <= RFPENDTC
MHDTC	Date/Time of History Collection	date	Timing		ISO 8601	CRF Annotated Case Report Form [4 ]
MHSTDTC	Start Date/Time of Medical History Event	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [12 ]
MHENDTC	End Date/Time of Medical History Event	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [12 ]
MHDY	Study Day of History Collection	integer	Timing	8		Derived --DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC
MHSTDY	Study Day of Start of Observation	integer	Timing	8		Derived --STDTC - DM.RFSTDTC if --STDTC < DM.RFSTDTC, --STDTC - DM.RFSTDTC + 1 if --STDTC >= DM.RFSTDTC
MHENDY	Study Day of End of Observation	integer	Timing	8		Derived --ENDTC - DM.RFSTDTC if --ENDTC < RFSTDTC, --ENDTC - DM.RFSTDTC + 1 if --ENDTC >= RFSTDTC
MHENRTPT	End Relative to Reference Time Point	text	Timing	7	Relation to Reference Period (ENRTPT) • "ONGOING"	Assigned
MHENTPT	End Reference Time Point	date	Timing		ISO 8601	Derived =DM.RFICDTC

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Death Details (DD)

DD (Death Details) - FINDINGS Location: dd.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [8 ]
DDSEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
DDTESTCD	Death Detail Assessment Short Name	text	Topic	8	Death Detail Assessment Short Name • "AUTOPERF" = "Autopsy Performed" • "DTHCAUS" = "Main Cause of Death"	Assigned
DDTEST	Death Detail Assessment Name	text	Synonym Qualifier	19	Death Detail Assessment Name • "Autopsy Performed" • "Main Cause of Death"	Assigned
DDORRES	Result or Finding as Collected	text	Result Qualifier	13		CRF Annotated Case Report Form [33 ]
DDSTRESC	Character Result/Finding in Std Format	text	Result Qualifier	13		Derived --ORRES value converted to standard unit if applicable; otherwise a copy of --ORRES
EPOCH	Epoch	text	Timing	20	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXDTC<RFSTDTC or both RFSDTC and RFENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= XXDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= XXDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= XXDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= XXDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<=XXDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= XXDTC <= RFPENDTC
DDDTC	Date/Time of Collection	date	Timing		ISO 8601	CRF Annotated Case Report Form [33 ]
DDDY	Study Day of Collection	integer	Timing	8		Derived --DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC

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Inclusion/Exclusion Criteria Not Met (IE)

IE (Inclusion/Exclusion Criteria Not Met) - FINDINGS Location: ie.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPIE (Supplemental Qualifiers for IE)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [8 ]
IESEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
IETESTCD	Inclusion/Exclusion Criterion Short Name	text	Topic	6	Inclusion/Exclusion Test Code [27 Terms]	Assigned
IETEST	Inclusion/Exclusion Criterion	text	Synonym Qualifier	199		Assigned
IECAT	Inclusion/Exclusion Category	text	Grouping Qualifier	9	Category for Inclusion/Exclusion • "EXCLUSION" • "INCLUSION"	CRF Annotated Case Report Form [10 ]
IEORRES	I/E Criterion Original Result	text	Result Qualifier	1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [10 ]
IESTRESC	I/E Criterion Result in Std Format	text	Result Qualifier	1	No Yes Response • "Y" • "N"	Derived --ORRES value converted to standard unit if applicable; otherwise a copy of --ORRES
VISITNUM	Visit Number	integer	Timing	8		Assigned
VISIT	Visit Name	text	Timing	100		Derived Calculated based on SV info
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	20	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXDTC<RFSTDTC or both RFSDTC and RFENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= XXDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= XXDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= XXDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= XXDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<=XXDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= XXDTC <= RFPENDTC
IEDTC	Date/Time of Collection	date	Timing		ISO 8601	CRF Annotated Case Report Form [8 ]
IEDY	Study Day of Collection	integer	Timing	8		Derived --DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC

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Immunogenicity Specimen Assessment (IS)

IS (Immunogenicity Specimen Assessment) - FINDINGS Location: is.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPIS (Supplemental Qualifiers for IE)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [8 ]
ISSEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
ISREFID	Reference ID	text	Identifier	11		Assigned
ISTESTCD	Immunogenicity Test/Exam Short Name	text	Topic	8	Immunogenicity Test/Exam Short Name [10 Terms]	Assigned
ISTEST	Immunogenicity Test or Examination Name	text	Synonym Qualifier	31	Immunogenicity Test or Examination Name [10 Terms]	Assigned
ISCAT	Category for Immunogenicity Test	text	Grouping Qualifier	35	Category for Immunogenicity Specimen Assessments • "IMMUNOGENICITY ASSESSMENT" • "Serum SARS-CoV-2 Binding Antibodies" • "Serum SARS-CoV-2 Neutralizing Antibodies"	Assigned
ISORRES	Results or Findings in Original Units	text	Result Qualifier	8		eDT
ISORRESU	Original Units	text	Variable Qualifier	5	Original Units for Immunogenicity Specimen Assessments • "AU/mL"	eDT
ISORNRLO	Reference Range Lower Limit-Std Units	text	Variable Qualifier	1		eDT Missing value for all records
ISORNRHI	Reference Range Upper Limit-Std Units	text	Variable Qualifier	1		eDT Missing value for all records
ISSTRESC	Result or Finding in Standard Format	text	Result Qualifier	8		Derived --ORRES value converted to standard unit if applicable; otherwise a copy of --ORRES
ISSTRESN	Numeric Results/Findings in Std. Units	float	Result Qualifier	8		Derived A copy of --STRESC in Numeric format, if applicable
ISSTRESU	Standard Units	text	Variable Qualifier	5	Standard Units for Immunogenicity Specimen Assessments • "AU/mL"	Assigned
ISSTAT	Completion Status	text	Record Qualifier	8	Not Done • "NOT DONE"	CRF Annotated Case Report Form [20 46 ]
ISREASND	Reason Not Done	text	Record Qualifier	85		CRF Annotated Case Report Form [46 ]
ISNAM	Vendor Name	text	Record Qualifier	11	Vendor Name for Immunogenicity Specimen Assessment • "DUKE" • "PPD Vaccine" • "VRC"	eDT
ISSPEC	Specimen Type	text	Record Qualifier	5	Specimen Type in Immunogenicity Specimen Assessment • "SERUM" • "BLOOD"	eDT
ISMETHOD	Method of Test or Examination	text		60		eDT
ISLLOQ	Lower Limit of Quantitation	float		20		eDT
VISITNUM	Visit Number	float	Timing	8		Assigned
VISIT	Visit Name	text	Timing	100		Derived Calculated based on SV info
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	20	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXDTC<RFSTDTC or both RFSDTC and RFENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= XXDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= XXDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= XXDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= XXDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<=XXDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= XXDTC <= RFPENDTC
ISDTC	Date/Time of Collection	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [20 46 ]
ISDY	Study Day of Visit/Collection/Exam	integer	Timing	8		Derived --DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC

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Laboratory Tests Results (LB)

LB (Laboratory Tests Results) - FINDINGS Location: lb.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
LBSEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
LBTESTCD	Lab Test or Examination Short Name	text	Topic	3	Laboratory Test Code • "FSH" = "Follicle Stimulating Hormone" • "HCG" = "Choriogonadotropin Beta"	Assigned
LBTEST	Lab Test or Examination Name	text	Synonym Qualifier	28	Laboratory Test Name • "Choriogonadotropin Beta" • "Follicle Stimulating Hormone"	Assigned
LBCAT	Category for Lab Test	text	Grouping Qualifier	14	Category for Lab Test • "CHEMISTRY" • "PREGNANCY TEST"	Assigned
LBORRES	Result or Finding in Original Units	text	Result Qualifier	8		CRF Annotated Case Report Form [18 ]
LBORRESU	Original Units	text	Variable Qualifier	1		CRF Annotated Case Report Form [18 ] Missing value for all records
LBORNRLO	Reference Range Lower Limit in Orig Unit	text	Variable Qualifier	1		CRF Annotated Case Report Form [18 ] Missing value for all records
LBORNRHI	Reference Range Upper Limit in Orig Unit	text	Variable Qualifier	1		CRF Annotated Case Report Form [18 ] Missing value for all records
LBSTRESC	Character Result/Finding in Std Format	text	Result Qualifier	8		Derived --ORRES value converted to standard unit if applicable; otherwise a copy of --ORRES
LBSTRESN	Numeric Result/Finding in Standard Units	float	Result Qualifier	8		Derived A copy of --STRESC in Numeric format, if applicable
LBSTRESU	Standard Units	text	Variable Qualifier	1		Assigned Missing value for all records
LBSTNRLO	Reference Range Lower Limit-Std Units	float	Variable Qualifier	8		Derived --ORNRLO value converted to standard unit if applicable; otherwise a copy of --ORNRLO
LBSTNRHI	Reference Range Upper Limit-Std Units	float	Variable Qualifier	8		Derived --ORNRHI value converted to standard unit if applicable; otherwise a copy of --ORNRHI
LBNRIND	Reference Range Indicator	text	Variable Qualifier	1		eDT Missing value for all records
LBSTAT	Completion Status	text	Record Qualifier	8	Not Done • "NOT DONE"	CRF Annotated Case Report Form [18 ]
LBSPEC	Specimen Type	text	Record Qualifier	5	Specimen Type in Laboratory Tests Results • "SERUM" • "URINE"	CRF Annotated Case Report Form [18 ]
LBBLFL	Baseline Flag	text	Record Qualifier	1	No Yes Response (Yes only) • "Y"	Derived Set to "Y", for the last record of per USUBJID/LBCAT/LBTESTCD, for non-missing LBORRES and LBSTAT not "NOT DONE" and LBDTC <= RFSTDTC
VISITNUM	Visit Number	float	Timing	8		Assigned
VISIT	Visit Name	text	Timing	100		Derived Calculated based on SV info
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	20	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXDTC<RFSTDTC or both RFSDTC and RFENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= XXDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= XXDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= XXDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= XXDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<=XXDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= XXDTC <= RFPENDTC
LBDTC	Date/Time of Specimen Collection	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [18 ]
LBDY	Study Day of Specimen Collection	integer	Timing	8		Derived --DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [8 ]

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Microbiology Specimen (MB)

MB (Microbiology Specimen) - FINDINGS Location: mb.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPMB (Supplemental Qualifiers for MB)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [8 ]
MBSEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
MBGRPID	Group ID	text		8		Derived Set to '001' if MBCAT=SARS-CoV-2 Set to '002' if BIOFIRE Set to '003' if local labs (Localfl=Y)
MBREFID	Reference ID	text	Identifier	11		Assigned
MBTESTCD	Microbiology Test or Finding Short Name	text	Topic	8	Microbiology Specimen Test Code [22 Terms]	Assigned
MBTEST	Microbiology Test or Finding Name	text	Synonym Qualifier	40	Microbiology Specimen Test Name [22 Terms]	Assigned
MBCAT	Category for Microbiology Finding	text	Grouping Qualifier	10	Category for Microbiology Finding • "BIOFIRE" • "SARS-CoV-2"	Assigned
MBSCAT	Subcategory for Microbiology Finding	text	Grouping Qualifier	21	Subcategory for Microbiology Finding [7 Terms]	Assigned
MBORRES	Result or Finding in Original Units	text	Result Qualifier	12		CRF Annotated Case Report Form [42 ]
MBSTRESC	Character Result/Finding in Std Format	text	Result Qualifier	12		Derived --ORRES value converted to standard unit if applicable; otherwise a copy of --ORRES
MBRESCAT	Result Category	text	Variable Qualifier	8	Result Category for Microbiology Finding • "ABNORMAL" • "NORMAL"	Derived Coded MBSTRESC result as "Not Detected" -> "NORMAL", "Detected" -> "ABNORMAL"
MBSTAT	Completion Status	text	Record Qualifier	8	Not Done • "NOT DONE"	CRF Annotated Case Report Form [22 42 43 44 45 ]
MBREASND	Reason Microbiology Not Performed	text	Record Qualifier	17		CRF Annotated Case Report Form [43 44 45 ]
MBNAM	Vendor Name	text	Record Qualifier	85		CRF Annotated Case Report Form [42 ]
MBSPEC	Specimen Type	text	Record Qualifier	16	Specimen Type in Microbiology Specimen • "SALIVA" • "SWABBED MATERIAL"	CRF Annotated Case Report Form [42 43 44 45 ]
MBMETHOD	Method of Test or Examination	text	Record Qualifier	25	Method of Test or Examination in Microbiology Specimen • "MULTIPLEX" • "REVERSE TRANSCRIPTASE PCR"	CRF Annotated Case Report Form [42 ]
VISITNUM	Visit Number	float	Timing	8		Assigned
VISIT	Visit Name	text	Timing	100		Derived Calculated based on SV info
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	20	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXDTC<RFSTDTC or both RFSDTC and RFENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= XXDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= XXDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= XXDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= XXDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<=XXDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= XXDTC <= RFPENDTC
MBDTC	Date/Time of Specimen Collection	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [21 42 43 44 45 ]
MBDY	Study Day of MB Specimen Collection	integer	Timing	8		Derived --DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC
MBTPT	Planned Time Point Name	text	Timing	11		CRF Annotated Case Report Form [43 44 45 ]
MBTPTNUM	Planned Time Point Number	integer	Timing	8		Assigned

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Reproductive System Findings (RP)

RP (Reproductive System Findings) - FINDINGS Location: rp.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPRP (Supplemental Qualifiers for RP)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [8 ]
RPSEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
RPTESTCD	Repro System Findings Test Short Name	text	Topic	8	Repro System Findings Test Short Name • "CHILDPOT" = "Childbearing Potential"	Assigned
RPTEST	Reproductive System Findings Test Name	text	Synonym Qualifier	22	Reproductive System Findings Test Name • "Childbearing Potential"	Assigned
RPORRES	Result or Finding in Original Units	text	Result Qualifier	1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [17 ]
RPORRESU	Original Units	text		20		Assigned
RPSTRESC	Character Result/Finding in Std. Format	text	Result Qualifier	20	No Yes Response • "Y" • "N"	Derived --ORRES value converted to standard unit if applicable; otherwise a copy of --ORRES
RPSTRESN	Numeric Result/Finding in Standard Units	integer		8		Assigned
RPSTRESU	Standard Units	text		20		Assigned
VISITNUM	Visit Number	integer	Timing	8		Assigned
VISIT	Visit Name	text	Timing	100		Derived Calculated based on SV info
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	40	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXDTC<RFSTDTC or both RFSDTC and RFENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= XXDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= XXDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= XXDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= XXDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<=XXDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= XXDTC <= RFPENDTC
RPDTC	Date/Time of Measurements	date	Timing		ISO 8601	CRF Annotated Case Report Form [17 ]
RPDY	Study Day of Repro System Findings	integer	Timing	8		Derived --DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC

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Subject Characteristics (SC)

SC (Subject Characteristics) - FINDINGS Location: sc.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPSC (Supplemental Qualifiers for SC)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [8 ]
SCSEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
SCTESTCD	Subject Characteristic Short Name	text	Topic	8	Subject Characteristic Test Code [18 Terms]	Assigned
SCTEST	Subject Characteristic	text	Synonym Qualifier	40	Subject Characteristics Test Name [18 Terms]	Assigned
SCCAT	Category for Subject Characteristic	text	Grouping Qualifier	17	Category for Subject Characteristic • "COVID-19 EXPOSURE"	Assigned
SCSCAT	Subcategory for Subject Characteristic	text	Grouping Qualifier	38	Subcategory for Subject Characteristic • "LOCATION AND LIVING CIRCUMSTANCES RISK" • "OCCUPATIONAL RISK"	Assigned
SCORRES	Result or Finding in Original Units	text	Result Qualifier	200		CRF Annotated Case Report Form [35 36 ]
SCSTRESC	Character Result/Finding in Std Format	text	Result Qualifier	1		Derived --ORRES value converted to standard unit if applicable; otherwise a copy of --ORRES

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Vital Signs (VS)

VS (Vital Signs) - FINDINGS Location: vs.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPVS (Supplemental Qualifiers for VS)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
SUBJID	Subject Identifier for the Study	text		9		CRF Annotated Case Report Form [8 ]
VSSEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
VSSPID	Sponsor-Defined Identifier	text	Identifier	10		Assigned
VSLNKGRP	Link Group ID	text	Identifier	9		CRF Annotated Case Report Form [53 ]
VSTESTCD	Vital Signs Test Short Name	text	Topic	8	Vital Signs Test Code [12 Terms]	Assigned
VSTEST	Vital Signs Test Name	text	Synonym Qualifier	35	Vital Signs Test Name [12 Terms]	Assigned
VSCAT	Category for Vital Signs	text	Grouping Qualifier	14	Category for Vital Signs • "EFFICACY" • "REACTOGENICITY"	Assigned
VSSCAT	Subcategory for Vital Signs	text	Grouping Qualifier	17	Subcategory for Vital Signs • "COVID-19" • "COVID-19 SEVERITY" • "SYSTEMIC"	Assigned
VSORRES	Result or Finding in Original Units	text	Result Qualifier	9		CRF Annotated Case Report Form [39 ]
VSORRESU	Original Units	text	Variable Qualifier	11	Original Units for Vital Signs [11 Terms]	CRF Annotated Case Report Form [39 47 ]
VSSTRESC	Character Result/Finding in Std Format	text	Result Qualifier	12		Derived --ORRES value converted to standard unit if applicable; otherwise a copy of --ORRES
VSSTRESN	Numeric Result/Finding in Standard Units	float	Result Qualifier	8		Derived A copy of --STRESC in Numeric format, if applicable
VSSTRESU	Standard Units	text	Variable Qualifier	11	Standard Units for Vital Signs [8 Terms]	Assigned
VSSTAT	Completion Status	text	Record Qualifier	8	Not Done • "NOT DONE"	CRF Annotated Case Report Form [13 14 53 ]
VSLOC	Location of Vital Signs Measurement	text	Record Qualifier	8	Location of Vital Sign Measurement • "AXILLARY" • "ORAL CAVITY" • "OTHER"	CRF Annotated Case Report Form [13 14 15 ]
VSTOXGR	Standard Toxicity Grade	text	Variable Qualifier	1	Toxicity Grade in Vital Signs • "0" • "1" • "2" • "3" • "4"	CRF Annotated Case Report Form [53 ]
VSSEV	Severity	text	Record Qualifier	8	Severity in Vital Signs [7 Terms]	CRF Annotated Case Report Form [53 ]
VSBLFL	Baseline Flag	text	Record Qualifier	1	No Yes Response (Yes only) • "Y"	Derived Set to "Y" for the last record per USUBJID,VSTESTCD where VSORRES is not missing and VSSTAT not "NOT DONE" and VSDTC <= RFSTDTC
VISITNUM	Visit Number	float	Timing	8		Assigned
VISIT	Visit Name	text	Timing	100		Assigned
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	40	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXDTC<RFSTDTC or both RFSDTC and RFENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= XXDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= XXDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= XXDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= XXDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<=XXDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= XXDTC <= RFPENDTC
VSDTC	Date/Time of Measurements	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [13 14 39 47 53 ]
VSDY	Study Day of Vital Signs	integer	Timing	8		Derived --DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC
VSTPT	Planned Time Point Name	text	Timing	53		CRF Annotated Case Report Form [14 53 ]
VSTPTNUM	Planned Time Point Number	float	Timing	8		Assigned
VSTPTREF	Time Point Reference	text	Timing	6		Assigned

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Virus Sequencing (XQ)

XQ (Virus Sequencing) - FINDINGS Location: xq.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPXQ (Supplemental Qualifiers for XQ)
STUDYID	Study Identifier	text	14		Protocol
DOMAIN	Domain Abbreviation	text	2		Assigned
USUBJID	Unique Subject Identifier	text	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
XQSEQ	Sequence Number	integer	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
XQGRPID	Group ID	text	10		eDT
XQREFID	Specimen ID	text	10		eDT
XQTESTCD	Test Code	text	8	Virus Sequencing Test Code • "LINEAGE" = "Lineage Based on Mutations in S"	eDT
XQTEST	Test Description	text	40		eDT
XQCAT	Category for Lab Test	text	20		eDT
XQSTRESC	Character Result/Finding in Std Format	text	10		eDT
XQNAM	Vendor Name	text	20		eDT
XQMETHOD	Method Code	text	8	Virus Sequence Method Code • "Sequence"	eDT
XQDTC	Date/Time of Collection	text	20		eDT
XQDY	Study Day of Visit/Collection/Exam	integer	8		Derived --DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC

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Findings About Adverse Events (FAAE)

FAAE (Findings About Adverse Events, FA) - FINDINGS ABOUT Location: faae.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPFAAE (Supplemental Qualifiers for FAAE)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
FASEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
FAGRPID	Group ID	text	Identifier	7		Assigned
FASPID	Sponsor-Defined Identifier	text	Identifier	10		Assigned
FALNKGRP	Link Group ID	text	Identifier	10		CRF Annotated Case Report Form [25 57 58 59 60 61 62 63 64 65 68 ]
FATESTCD	Findings About Test Short Name	text	Topic	8	Findings About Adverse Events Test Code • "LDIAM" = "Longest Diameter" • "OCCUR" = "Occurrence" • "SEV" = "Severity/Intensity"	Assigned
FATEST	Findings About Test Name	text	Synonym Qualifier	27	Findings About Adverse Events Test Name • "Longest Diameter" • "Occurrence Indicator" • "Severity/Intensity"	Assigned
FAOBJ	Object of the Observation	text	Record Qualifier	69		CRF Annotated Case Report Form [25 57 58 59 60 61 62 63 64 65 68 ]
FACAT	Category for Findings About	text	Grouping Qualifier	20	Category for Findings About Adverse Events • "REACTOGENICITY"	CRF Annotated Case Report Form [25 57 58 59 60 61 62 63 64 65 68 ]
FASCAT	Subcategory for Findings About	text	Grouping Qualifier	19	Subcategory for Findings About Adverse Events • "ADMINISTRATION SITE" • "SYSTEMIC"	CRF Annotated Case Report Form [25 57 58 59 60 61 62 63 64 65 68 ]
FAORRES	Result or Finding in Original Units	text	Result Qualifier	94		CRF Annotated Case Report Form [25 57 58 59 60 61 62 63 64 65 68 ]
FAORRESU	Original Units	text	Variable Qualifier	2	Original Units for Findings About Adverse Events • "mm"	CRF Annotated Case Report Form [58 59 ]
FASTRESC	Character Result/Finding in Std Format	text	Result Qualifier	94		Derived --ORRES value converted to standard unit if applicable; otherwise a copy of --ORRES
FASTRESN	Numeric Result/Finding in Standard Units	integer	Result Qualifier	8		Derived A copy of --STRESC in Numeric format, if applicable
FASTRESU	Standard Units	text	Variable Qualifier	2	Standard Units for Findings About Adverse Events • "mm"	Assigned
FASTAT	Completion Status	text	Record Qualifier	8	Not Done • "NOT DONE"	Assigned
FAEVAL	Evaluator	text	Record Qualifier	13	Evaluator for Findings About Adverse Events • "INVESTIGATOR" • "STUDY SUBJECT"	Assigned
EPOCH	Epoch	text	Timing	40	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXDTC<RFSTDTC or both RFSDTC and RFENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= XXDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= XXDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= XXDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= XXDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<=XXDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= XXDTC <= RFPENDTC
FADTC	Date/Time of Collection	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [25 57 58 59 60 61 62 63 64 65 68 ]
FADY	Study Day of Collection	integer	Timing	8		Derived --DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC
FATPT	Planned Time Point Name	text	Timing	53		CRF Annotated Case Report Form [57 58 59 60 61 62 63 64 65 68 ]
FATPTNUM	Planned Time Point Number	integer	Timing	8		Assigned
FATPTREF	Time Point Reference	text	Timing	6		Assigned Dose # (Vaccine 1 or Vaccine 2)
FARFTDTC	Date/Time of Reference Time Point	datetime	Timing		ISO 8601	Derived FARFTDTC is derived by merging EX and e-Diary data (CRF Page 52 – 53, 55 – 66) with Dose # as merging key to get Dose Date and Time Date Time of Dose #
FAEVLINT	Evaluation Interval	text	Timing	4		Assigned

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Findings About Clinical Events (FACE)

FACE (Findings About Clinical Events, FA) - FINDINGS ABOUT Location: face.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPFACE (Supplemental Qualifiers for FACE)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
FASEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
FAGRPID	Group ID	text	Identifier	7		Assigned
FASPID	Sponsor-Defined Identifier	text	Identifier	10		Assigned
FALNKGRP	Link Group ID	text	Identifier	10		CRF Annotated Case Report Form [25 54 55 ]
FATESTCD	Findings About Test Short Name	text	Topic	8	Findings About Clinical Events Test Code • "LDIAM" = "Longest Diameter" • "OCCUR" = "Occurrence" • "SEV" = "Severity/Intensity"	Assigned
FATEST	Findings About Test Name	text	Synonym Qualifier	27	Findings About Clinical Events Test Name • "Longest Diameter" • "Occurrence Indicator" • "Severity/Intensity"	Assigned
FAOBJ	Object of the Observation	text	Record Qualifier	69		CRF Annotated Case Report Form [25 54 55 ]
FACAT	Category for Findings About	text	Grouping Qualifier	20	Category for Findings About Clinical Events • "REACTOGENICITY"	CRF Annotated Case Report Form [25 54 55 ]
FASCAT	Subcategory for Findings About	text	Grouping Qualifier	19	Subcategory for Findings About Clinical Events • "ADMINISTRATION SITE" • "SYSTEMIC"	CRF Annotated Case Report Form [25 54 55 ]
FAORRES	Result or Finding in Original Units	text	Result Qualifier	94		CRF Annotated Case Report Form [25 54 55 ]
FAORRESU	Original Units	text	Variable Qualifier	2	Original Units for Findings About Clinical Events • "mm"	CRF Annotated Case Report Form [25 54 55 ]
FASTRESC	Character Result/Finding in Std Format	text	Result Qualifier	94		Derived --ORRES value converted to standard unit if applicable; otherwise a copy of --ORRES
FASTRESN	Numeric Result/Finding in Standard Units	integer	Result Qualifier	8		Derived A copy of --STRESC in Numeric format, if applicable
FASTRESU	Standard Units	text	Variable Qualifier	2	Standard Units for Findings About Clinical Events • "mm"	Assigned
FASTAT	Completion Status	text	Record Qualifier	8	Not Done • "NOT DONE"	CRF Annotated Case Report Form [54 55 ]
FAEVAL	Evaluator	text	Record Qualifier	13	Evaluator for Findings About Clinical Events • "INVESTIGATOR" • "STUDY SUBJECT"	Assigned
EPOCH	Epoch	text	Timing	40	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXDTC<RFSTDTC or both RFSDTC and RFENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= XXDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= XXDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= XXDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= XXDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<=XXDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= XXDTC <= RFPENDTC
FADTC	Date/Time of Collection	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [25 56 ]
FADY	Study Day of Collection	integer	Timing	8		Derived --DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC
FATPT	Planned Time Point Name	text	Timing	53		CRF Annotated Case Report Form [54 55 ]
FATPTNUM	Planned Time Point Number	float	Timing	8		Assigned
FATPTREF	Time Point Reference	text	Timing	6		Assigned Dose # (Vaccine 1 or Vaccine 2)
FARFTDTC	Date/Time of Reference Time Point	datetime	Timing		ISO 8601	Derived FARFTDTC is derived by merging EX and e-Diary data (CRF Page 52 – 53, 55 – 66) with Dose # as merging key to get Dose Date and Time Date Time of Dose #
FAEVLINT	Evaluation Interval	text	Timing	4		Assigned
FAEVINTX	Evaluation Interval Text	text	Timing	17		Assigned

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Findings About Efficacy Events (FAEF)

FAEF (Findings About Efficacy Events, FA) - FINDINGS ABOUT Location: faef.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPFAEF (Supplemental Qualifiers for FAEF)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
FASEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
FASPID	Sponsor-Defined Identifier	text	Identifier	10		Assigned
FALNKGRP	Link Group ID	text	Identifier	10		Assigned
FATESTCD	Findings About Test Short Name	text	Topic	8	Findings About Efficacy Events Test Code • "OCCUR" = "Occurrence" • "SEV" = "Severity/Intensity"	Assigned
FATEST	Findings About Test Name	text	Synonym Qualifier	27	Findings About Efficacy Events Test Name • "Occurrence Indicator" • "Severity/Intensity"	Assigned
FAOBJ	Object of the Observation	text	Record Qualifier	69		CRF Annotated Case Report Form [39 40 41 47 48 49 ]
FACAT	Category for Findings About	text	Grouping Qualifier	20	Category for Findings About Efficacy Events • "EFFICACY"	CRF Annotated Case Report Form [39 40 41 47 48 49 ]
FASCAT	Subcategory for Findings About	text	Grouping Qualifier	19	Subcategory for Findings About Efficacy Events • "COVID-19" • "COVID-19 SEVERITY"	CRF Annotated Case Report Form [39 40 41 47 48 49 ]
FAORRES	Result or Finding in Original Units	text	Result Qualifier	94		CRF Annotated Case Report Form [39 40 41 47 48 49 ]
FASTRESC	Character Result/Finding in Std Format	text	Result Qualifier	94		Derived --ORRES value converted to standard unit if applicable; otherwise a copy of --ORRES
FASTAT	Completion Status	text	Record Qualifier	8	Not Done • "NOT DONE"	CRF Annotated Case Report Form [39 40 41 ]
EPOCH	Epoch	text	Timing	40	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXDTC<RFSTDTC or both RFSDTC and RFENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= XXDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= XXDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= XXDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= XXDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<=XXDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= XXDTC <= RFPENDTC
FADTC	Date/Time of Collection	date	Timing		ISO 8601	CRF Annotated Case Report Form [39 47 48 49 ]
FAENDTC	End Date/Time of Observation	date	Timing		ISO 8601	CRF Annotated Case Report Form [47 48 ]
FADY	Study Day of Collection	integer	Timing	8		Derived --DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC
FAENDY	Study Day of End of Observation	integer	Timing	8		Derived --ENDTC - DM.RFSTDTC if --ENDTC < RFSTDTC, --ENDTC - DM.RFSTDTC + 1 if --ENDTC >= RFSTDTC
FATPT	Planned Time Point Name	text	Timing	53		CRF Annotated Case Report Form [38 39 ]
FATPTNUM	Planned Time Point Number	integer	Timing	8		Assigned

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Findings About Events or Interventions (FAOT)

FAOT (Findings About Events or Interventions, FA) - FINDINGS ABOUT Location: faot.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPFAOT (Supplemental Qualifiers for FAOT)
STUDYID	Study Identifier	text	Identifier	20		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
FASEQ	Sequence Number	integer	Identifier	8		Derived For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
FATESTCD	Findings About Test Short Name	text	Topic	8	Findings About Events or Interventions Test Code [6 Terms]	Assigned
FATEST	Findings About Test Name	text	Synonym Qualifier	27	Findings About Events or Interventions Test Name [6 Terms]	Assigned
FAOBJ	Object of the Observation	text	Record Qualifier	69		Assigned
FACAT	Category for Findings About	text	Grouping Qualifier	20	Category for Findings About Events or Interventions • "PHYSICAL EXAMINATION" • "SAFETY"	Assigned
FASCAT	Subcategory for Findings About	text	Grouping Qualifier	19	Subcategory for Findings About Events or Interventions • "SAFETY DIARY"	Assigned
FAORRES	Result or Finding in Original Units	text	Result Qualifier	94		eDT Data is from follow-up e-Diary
FASTRESC	Character Result/Finding in Std Format	text	Result Qualifier	94		Derived --ORRES value converted to standard unit if applicable; otherwise a copy of --ORRES
FASTRESN	Numeric Result/Finding in Standard Units	float	Result Qualifier	8		Assigned Missing value for all records
VISITNUM	Visit Number	float	Timing	8		Assigned
VISIT	Visit Name	text	Timing	100		Derived Calculated based on SV info
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	40	Epoch • "SCREENING" • "BLINDED TREATMENT" • "FOLLOW-UP BLINDED PHASE" • "OPEN LABEL TREATMENT" • "FOLLOW-UP OPEN LABEL PHASE"	Derived Set to 'SCREENING' If XXDTC<RFSTDTC or both RFSDTC and RFENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= XXDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= XXDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= XXDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= XXDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<=XXDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= XXDTC <= RFPENDTC
FADTC	Date/Time of Collection	date	Timing		ISO 8601	eDT Data is from follow-up e-Diary
FADY	Study Day of Collection	integer	Timing	8		Derived --DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC
FATPT	Planned Time Point Name	text	Timing	53		CRF Annotated Case Report Form [69 ]
FATPTNUM	Planned Time Point Number	text	Timing	6		Assigned

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Supplemental Qualifiers for AE (SUPPAE)

SUPPAE (Supplemental Qualifiers for AE, Adverse Events) - RELATIONSHIP Location: suppae.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: AE (Adverse Events)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for AE • "AESEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for AE [15 Terms]	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "AECVDIAG"	confirmed diagnosis Symptom Covid-19	text		3	confirmed diagnosis Symptom Covid-19 • "No" • "Yes"	CRF Annotated Case Report Form [25 ]
➤ QNAM = "AEDICNM"	Coder Dictionary Name	text		6	Coder Dictionary Name • "MedDRA"	Assigned
➤ QNAM = "AEDICVR"	Coder Dictionary Version	float		4	Coder Dictionary Version • 23.0	Assigned
➤ QNAM = "MAAEFL"	Medically-attended AE Flag	text		1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [25 ]
➤ QNAM = "AESEVSTD"	Severity Coded Value	text		16	Severity Coded Value • "Grade 1/Mild" • "Grade 2/Moderate" • "Grade 3/Severe" • "Grade 4"	Assigned
➤ QNAM = "AESOFL"	Solicited Adverse Reaction?	text		1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [25 ]
➤ QNAM = "AESPID1"	AE ID coded value	text		35		Assigned
➤ QNAM = "AEHOSPEN"	AE Hosp End Date	date			ISO 8601	CRF Annotated Case Report Form [25 ]
➤ QNAM = "AEHOSPST"	AE Hosp Start Date	date			ISO 8601	CRF Annotated Case Report Form [25 ]
➤ QNAM = "HOSPIDX"	HO Sponsor-Defined Identifier	text		75		Assigned Set up link between SDTM.HO and SDTM.AE, SDTM.FACE/FAAE
➤ QNAM = "AEICUSTD"	Admitted to ICU? Coded Value	text		10		CRF Annotated Case Report Form [25 ]
➤ QNAM = "DSSPIDX"	DS Sponsor-Defined Identifier	text		20		Assigned Set up link between SDTM.DS and SDTM.AE or SDTM.DS and SDTM.FACE/FAAE if data was captured in Adverse Event
➤ QNAM = "AEOUTSP"	Recovered/Resolved with Sequelae, specif	text		200		CRF Annotated Case Report Form [26 ]
➤ QNAM = "REMOVEFL"	AR Remove Flag	text		1	No Yes Response (Yes only) • "Y"	Derived Set to 'Y' when (AECAT='REACTOGENICITY' and AESER ne 'Y') and AEENDTC is within the 7-day window of Dose 1 Reference date. For Dose 2, compare the 7 day window with Dose 2 Reference and AE End date if AE Start is after Dose 2date. AEENDTC is imputed with "T11:59" if time part is missing; But if AE end date is same as Dose date then imputed with "T23:59". If AESTDTC is incomplete and on same date as Dose date, then impute "T23:59"
➤ QNAM = "RECON"	Reconstructed Data	text		1	No Yes Response (Yes only) • "Y"	Derived Set to 'Y' if data is captured from Adverse Event Form
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for CE (SUPPCE)

SUPPCE (Supplemental Qualifiers for CE, Clinical Events) - RELATIONSHIP Location: suppce.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: CE (Clinical Events)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for CE • "CESEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for CE [9 Terms]	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "CEREASOC"	Reason Clinical Event Outcome	text		90		eDT
➤ QNAM = "MAAEFL"	Medically-attended AE Flag	text		1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [25, 55 ]
➤ QNAM = "AEFLAG"	Medically-attended Flag from AE	text		1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [25 ]
➤ QNAM = "HOSPIDX"	HO Sponsor-Defined Identifier	text		29		Assigned Set up link between SDTM.HO and SDTM.AE, SDTM.FACE/FAAE
➤ QNAM = "AESEVX"	AE Severity/Intensity	text		16	AE Severity/Intensity • "GRADE 1/MILD" • "GRADE 2/MODERATE" • "GRADE 3/SEVERE" • "GRADE 4"	Derived Both Toxicity Grade and Severity
➤ QNAM = "AESPIDX"	AE Sponsor-Defined Identifier	text		22		Assigned Set to a link between SDTM.AE and SDTM.DS, SDTM.FACE/FAAE
➤ QNAM = "DSSPIDX"	DS Sponsor-Defined Identifier	text		20		Assigned Set up link between SDTM.DS and SDTM.AE or SDTM.DS and SDTM.FACE/FAAE if data was captured in Adverse Event
➤ QNAM = "SAEDTC"	SAE Date	text		20		Derived Set to SDTM.AESTDTC where AESER=Y and AEDECOD is one of pre-define solicited Adverse reaction symptom
➤ QNAM = "SAEDY"	SAE Day	text		8		Derived Set to SDTM.AESDY where AESER=Y and AEDECOD is one of pre-define solicited Adverse reaction symptom
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for CM (SUPPCM)

SUPPCM (Supplemental Qualifiers for CM, Concomitant Medications) - RELATIONSHIP Location: suppcm.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: CM (Concomitant Medications)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for CM • "CMSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for CM [25 Terms]	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "ATCLEV1C"	Name of MedicationATC_CODE	text		1	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "ATCLEV1T"	Name of MedicationATC	text		63	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "ATCLEV3C"	Name of MedicationATC3_CODE	text		4	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "ATCLEV3T"	Name of MedicationATC3	text		71	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "ATCLEV4C"	Name of MedicationATC4_CODE	text		5	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "ATCLEV4T"	Name of MedicationATC4	text		96	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMDICNM"	Name of Medication_CoderDictName	text		17	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMDICVR"	Name of Medication_CoderDictVersion	integer		6	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMONGOYN"	Ongoing	text		1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [29 ]
➤ QNAM = "CMPLX"	Prophylaxis	text		3	Prophylaxis • "No" • "Yes"	CRF Annotated Case Report Form [28 ]
➤ QNAM = "CMPROTCD"	Name of MedicationPRODUCT_CODE	text		13	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMSOL"	Was medication taken for solicited event	text		1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [29 ]
➤ QNAM = "CMSTUNKC"	Start date completely unknown	integer		1	Start date completely unknown • 0 • 1	CRF Annotated Case Report Form [29 ]
➤ QNAM = "CMTRADCD"	Trade Name of Med code	text		13	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMTRADE"	Trade Name of Medication	text		185	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMTRTTN"	Name of MedicationSYNONYM	text		200	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMUOTHSP"	Dose Unit Other, Specify	text		196		CRF Annotated Case Report Form [28 ]
➤ QNAM = "CMFOTHSP"	Frequency Other, specify	text		200		CRF Annotated Case Report Form [28 ]
➤ QNAM = "CMROTHSP"	If Route of Administration is Other, spe	text		90		CRF Annotated Case Report Form [29 ]
➤ QNAM = "CMDECOD1"	Standardized Medication Name1	text		200	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMDECOD2"	Standardized Medication Name2	text		200	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMDECOD3"	Standardized Medication Name3	text		200	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMTRTO1"	Name of Medication	text		200		CRF Annotated Case Report Form [28 ] 2nd 200 chars of CMTRT
➤ QNAM = "CMTRTTN1"	Name of Medication Synonym1	text		200	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMTRTTN2"	Name of MedicationSYNONYM2	text		200	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for DM (SUPPDM)

SUPPDM (Supplemental Qualifiers for DM, Demographics) - RELATIONSHIP Location: suppdm.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: DM (Demographics)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5		Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for DM [16 Terms]	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "AGE_DER"	Age (Derived)	integer		2		eDT
➤ QNAM = "COHORT"	Cohort	text		34	Cohort • ">=18 and <65 years and at risk" • ">=18 and <65 years and not at risk" • ">=65 years"	CRF Annotated Case Report Form [4 ]
➤ QNAM = "PREVSCR"	Was this participant screen previously	text		1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [8 ]
➤ QNAM = "PROTVER"	Protocol Version	text		15	Protocol Version Coded Value • "AMENDMENT 1" • "AMENDMENT 2" • "AMENDMENT 3" • "AMENDMENT 4" • "AMENDMENT 5"	Protocol
➤ QNAM = "RACE1"	White	text		5	White • "WHITE"	CRF Annotated Case Report Form [7 ]
➤ QNAM = "RACE4"	American Indian or Alaska Native	text		32	American Indian or Alaska Native • "AMERICAN INDIAN OR ALASKA NATIVE"	CRF Annotated Case Report Form [7 ]
➤ QNAM = "RACE2"	Black	text		25	Black • "BLACK OR AFRICAN AMERICAN"	CRF Annotated Case Report Form [7 ]
➤ QNAM = "RACEOTH"	If race is Other, specify	text		47		CRF Annotated Case Report Form [7 ]
➤ QNAM = "RACE3"	Asian	text		5	Asian • "ASIAN"	CRF Annotated Case Report Form [7 ]
➤ QNAM = "RACE6"	Other	text		5	Other • "OTHER"	CRF Annotated Case Report Form [7 ]
➤ QNAM = "SUBJID1"	Previous subject number	text		9		CRF Annotated Case Report Form [8 ]
➤ QNAM = "RACE5"	Native Hawaiian or other Pacific Island	text		41	Native Hawaiian or other Pacific Island • "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER"	CRF Annotated Case Report Form [7 ]
➤ QNAM = "UNBLNA"	NA - Unblinded Amendment 5 Discontinued	text		10	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [5 ]
➤ QNAM = "UNBLNDYN"	Was the participant unblinded	text		1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [5 ]
➤ QNAM = "UNBLMRNA"	Was the participant receive mRNA-1273	text		1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [5 ]
➤ QNAM = "UNBLPROT"	Unblinded Protocol Version Coded Value	text		40		CRF Annotated Case Report Form [5 ]
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for DS (SUPPDS)

SUPPDS (Supplemental Qualifiers for DS, Disposition) - RELATIONSHIP Location: suppds.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: DS (Disposition)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for DS • "DSSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for DS [8 Terms]	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "ENROLYN"	Was participant enrolled in the study YN	text		1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [8 ]
➤ QNAM = "AESPIDX"	AE Sponsor-Defined Identifier	text		50		Assigned Set to a link between SDTM.AE and SDTM.DS, SDTM.FACE/FAAE
➤ QNAM = "DSEOTDT"	Date of Disposition at EOT	date			ISO 8601	CRF Annotated Case Report Form [32 ]
➤ QNAM = "DSTERMOX"	Discontinuation reason, specify	text		200		CRF Annotated Case Report Form [32 ]
➤ QNAM = "DSTERMP1"	Reason for Discont Other, specify1	text		200		CRF Annotated Case Report Form [32 ]
➤ QNAM = "DSTERMSX"	Primary reason for treatment discont. St	text		200		CRF Annotated Case Report Form [32 ]
➤ QNAM = "DSTERMX"	Primary reason for treatment discontinua	text		200		CRF Annotated Case Report Form [32 ]
➤ QNAM = "IRTVISDT"	IRT Date of Unblinding	text		20		eDT
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for DV (SUPPDV)

SUPPDV (Supplemental Qualifiers for DV, Protocol Deviations) - RELATIONSHIP Location: suppdv.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: DV (Protocol Deviations)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for DV • "DVSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for DV [7 Terms]	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "DVSIG"	Significant	text		15	Significant • "NOT SIGNIFICANT" • "SIGNIFICANT"	eDT
➤ QNAM = "SEVDES"	Severity Code and Description	text		85	Severity Code and Description [8 Terms]	eDT
➤ QNAM = "DECSRTNL"	Decision Made and Rationale	text		200		eDT
➤ QNAM = "DECSRTN1"	Decision Made and Rationale 1	text		200		eDT
➤ QNAM = "DECSRTN2"	Decision Made and Rationale 2	text		200		eDT
➤ QNAM = "DVTERM1"	Description2	text		77		eDT
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for EC (SUPPEC)

SUPPEC (Supplemental Qualifiers for EC, Exposure as Collected) - RELATIONSHIP Location: suppec.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: EC (Exposure as Collected)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for EC • "ECSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for EC • "EXREASSP" = "Reason not given, specify" • "EXREASTD" = "Reason not given Coded Value" • "ECREASOC" = "Reason for Occur value"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "ECREASOC"	Reason for Occur value	text		200		CRF Annotated Case Report Form [19 ]
➤ QNAM = "EXREASTD"	Reason not given Coded Value	text		21	Reason not given Coded Value [11 Terms]	Assigned
➤ QNAM = "EXREASSP"	Reason not given, specify	text		99		CRF Annotated Case Report Form [19 ]
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for FAAE (SUPPFAAE)

SUPPFAAE (Supplemental Qualifiers for FAAE, SUPPFA) - RELATIONSHIP Location: suppfaae.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: FAAE (Findings About Adverse Events)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for FAAE • "FASEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for FAAE • "AESPIDX" = "AE Sponsor-Defined Identifier" • "HOSPIDX" = "HO Sponsor-Defined Identifier" • "MAAEFL" = "Medically-attended AE Flag" • "DSSPIDX" = "DS Sponsor-Defined Identifier" • "RECON" = "Reconstructed Data"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "AESPIDX"	AE Sponsor-Defined Identifier	text		14		Assigned Set to a link between SDTM.AE and SDTM.DS, SDTM.FACE/FAAE
➤ QNAM = "DSSPIDX"	DS Sponsor-Defined Identifier	text		16		Assigned Set up link between SDTM.DS and SDTM.AE or SDTM.DS and SDTM.FACE/FAAE if data was captured in Adverse Event
➤ QNAM = "HOSPIDX"	HO Sponsor-Defined Identifier	text		16		Assigned Set up link between SDTM.HO and SDTM.AE, SDTM.FACE/FAAE
➤ QNAM = "MAAEFL"	Medically-attended AE Flag	text		1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [25 67 ]
➤ QNAM = "RECON"	Reconstructed Data	text		1		Assigned
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for FACE (SUPPFACE)

SUPPFACE (Supplemental Qualifiers for FACE, SUPPFA) - RELATIONSHIP Location: suppface.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: FACE (Findings About Clinical Events)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for FACE • "FASEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for FACE • "AESPIDX" = "AE Sponsor-Defined Identifier" • "HOSPIDX" = "HO Sponsor-Defined Identifier" • "MAAEFL" = "Medically-attended AE Flag" • "DSSPIDX" = "DS Sponsor-Defined Identifier" • "RECON" = "Reconstructed Data"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "AESPIDX"	AE Sponsor-Defined Identifier	text		14		Assigned Set to a link between SDTM.AE and SDTM.DS, SDTM.FACE/FAAE
➤ QNAM = "DSSPIDX"	DS Sponsor-Defined Identifier	text		16		Assigned Set up link between SDTM.DS and SDTM.AE or SDTM.DS and SDTM.FACE/FAAE if data was captured in Adverse Event
➤ QNAM = "HOSPIDX"	HO Sponsor-Defined Identifier	text		16		Assigned Set up link between SDTM.HO and SDTM.AE, SDTM.FACE/FAAE
➤ QNAM = "MAAEFL"	Medically-attended AE Flag	text		1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [25 55 ]
➤ QNAM = "RECON"	Reconstructed Data	text		1		Derived Set to 'Y' if data is captured from Adverse Event Form
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for FAEF (SUPPFAEF)

SUPPFAEF (Supplemental Qualifiers for FAEF, SUPPFA) - RELATIONSHIP Location: suppfaef.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: FAEF (Findings About Efficacy Events)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for FAEF • "FASEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for FAEF • "FAEVDTC" = "Start Date/Time of Collection" • "FAEVDY" = "Study Day of Start of Observation" • "HOSPIDX" = "HO Sponsor-Defined Identifier"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "FAEVDTC"	Start Date/Time of Collection	date			ISO 8601	CRF Annotated Case Report Form [47 ]
➤ QNAM = "FAEVDY"	Study Day of Start of Observation	integer		8		Derived Set to FAEVDTC - RFXSDTC + 1
➤ QNAM = "HOSPIDX"	HO Sponsor-Defined Identifier	text		12		Assigned
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for FAOT (SUPPFAOT)

SUPPFAOT (Supplemental Qualifiers for FAOT, SUPPFA) - RELATIONSHIP Location: suppfaot.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: FAOT (Findings About Events or Interventions)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for FAOT • "FASEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for FAOT • "CLIN2" = "Contact your Study Clinic-confirm" • "CLIN2J" = "Contact your Study Clinic New Symp-confi" • "CLIN4A" = "Contact Healthcare Provider -confirm"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "CLIN2J"	Contact your Study Clinic New Symp-confi	text		77		eDT Data is from follow-up e-Diary
➤ QNAM = "CLIN4A"	Contact Healthcare Provider -confirm	text		77		eDT Data is from follow-up e-Diary
➤ QNAM = "CLIN2"	Contact your Study Clinic-confirm	text		77		eDT Data is from follow-up e-Diary
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for HO (SUPPHO)

SUPPHO (Supplemental Qualifiers for HO, Healthcare Encounters) - RELATIONSHIP Location: suppho.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: HO (Healthcare Encounters)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for HO • "HOSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for HO • "HOEVAL" = "HO Evaluator"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "HOEVAL"	HO Evaluator	text		20		Assigned Set to 'INVESTIGATOR' for data collected via CRF Set to 'STUDY SUBJECT' for data collected via e-Diary
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for IE (SUPPIE)

SUPPIE (Supplemental Qualifiers for IE, Inclusion/Exclusion Criteria Not Met) - RELATIONSHIP Location: suppie.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: IE (Inclusion/Exclusion Criteria Not Met)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for IE • "IESEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for IE • "PROTVER" = "Protocol Version Coded Value"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "PROTVER"	Protocol Version Coded Value	text		11	Protocol Version Coded Value • "Amendment 1" • "Amendment 2" • "Amendment 3" • "Amendment 4" • "Amendment 5"	CRF Annotated Case Report Form [8 ]
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for IE (SUPPIS)

SUPPIS (Supplemental Qualifiers for IE, Immunogenicity Specimen Assessment) - RELATIONSHIP Location: suppis.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: IS (Immunogenicity Specimen Assessment)
STUDYID	Study Identifier	text	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	2		Assigned
USUBJID	Unique Subject Identifier	text	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	5	Identifying Variable in Supplemental Qualifiers for IS • "ISSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	4		Assigned
QNAM	Qualifier Variable Name	text	8	Qualifier Variable Name for Supplemental Qualifiers for IS [8 Terms]	Assigned
QLABEL	Qualifier Variable Label	text	40		Assigned
QVALVLM	Data Value	text	200
➤ QNAM = "DILFAC"	Dilution Factor	integer	8		eDT
➤ QNAM = "INITDIL"	Initial Dilution	integer	8		eDT
➤ QNAM = "ISLOD"	Limit of Detection	float	10		eDT
➤ QNAM = "ISULOQ"	Upper Limit of Quantitation	float	12		eDT
➤ QNAM = "SAMPNOTE"	Toxicity notes-Duke	text	45		eDT
➤ QNAM = "TESTDT"	Date of Test-Duke	text	10		eDT
➤ QNAM = "TESTGDT"	Date of Test-VRC	text	10		eDT
➤ QNAM = "TSTCOM"	Test Comment-Vaccine	text	200		eDT
QORIG	Origin	text	8		Assigned
QEVAL	Evaluator	text	1		Assigned Missing value for all records

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Supplemental Qualifiers for MB (SUPPMB)

SUPPMB (Supplemental Qualifiers for MB, Microbiology Specimen) - RELATIONSHIP Location: suppmb.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: MB (Microbiology Specimen)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for MB • "MBSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for MB [7 Terms]	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "RPTDTM"	Reported Date	datetime			ISO 8601	eDT
➤ QNAM = "LDTCLIA"	CLIA Certified	text		3	CLIA Certified • "No" • "Yes"	CRF Annotated Case Report Form [42 ]
➤ QNAM = "LDTVISDT"	Covid Test Visit Date	date			ISO 8601	eDT
➤ QNAM = "LOCALFL"	From Covid Diag Test	text		1	No Yes Response (Yes only) • "Y"	eDT
➤ QNAM = "LBPANEL3"	Lab Test	text		21	Lab Test • "Nasopharyngeal Swab 1" • "Nasopharyngeal Swab 2"	eDT
➤ QNAM = "TSTCOM"	Test Level Comments	text		200		eDT
➤ QNAM = "LDTTESTO"	Other, Specify	text		187		CRF Annotated Case Report Form [42 ]
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for MH (SUPPMH)

SUPPMH (Supplemental Qualifiers for MH, Medical History) - RELATIONSHIP Location: suppmh.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: MH (Medical History)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for MH • "MHSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for MH • "MHDICNM" = "Condition_CoderDictName" • "MHDICVR" = "Condition_CoderDictVersion" • "MHENUNKC" = "Stop date completely unknown" • "MHSTUNKC" = "Start date completely unknown"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "MHDICNM"	Condition_CoderDictName	text		6	Condition_CoderDictName • "MedDRA"	Assigned
➤ QNAM = "MHDICVR"	Condition_CoderDictVersion	float		4	Condition_CoderDictVersion • 23.0	Assigned
➤ QNAM = "MHENUNKC"	Stop date completely unknown	text		1	Stop date completely unknown • "N" • "Y"	CRF Annotated Case Report Form [12 ]
➤ QNAM = "MHSTUNKC"	Start date completely unknown	text		1	Start date completely unknown • "N" • "Y"	CRF Annotated Case Report Form [12 ]
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for RP (SUPPRP)

SUPPRP (Supplemental Qualifiers for RP, Reproductive System Findings) - RELATIONSHIP Location: supprp.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: RP (Reproductive System Findings)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for RP • "RPSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for RP [6 Terms]	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "CBRSN"	If No, what is the reason	text		25	If No, what is the reason • "Other" • "Partner medically sterile" • "Post-menopausal" • "Surgically sterile"	CRF Annotated Case Report Form [17 ]
➤ QNAM = "CBSP"	If Partner medically sterile or Other, s	text		179		CRF Annotated Case Report Form [17 ]
➤ QNAM = "CBSDAUNK"	Date of surgery unknown	text		1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [17 ]
➤ QNAM = "CBSDTC"	If Surgically sterile, date of surgery-I	text		10		CRF Annotated Case Report Form [17 ]
➤ QNAM = "CBENDTC"	If Post-menopausal, date of last menstru	text		10		CRF Annotated Case Report Form [17 ]
➤ QNAM = "CBENDUNK"	Date of last menstruation unknown	text		1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [17 ]
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for SC (SUPPSC)

SUPPSC (Supplemental Qualifiers for SC, Subject Characteristics) - RELATIONSHIP Location: suppsc.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: SC (Subject Characteristics)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for SC • "SCSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for SC • "SCORRS1" = "Result or Finding 1"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "SCORRS1"	Result or Finding 1	text		2		CRF Annotated Case Report Form [35 ]
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for SV (SUPPSV)

SUPPSV (Supplemental Qualifiers for SV, Subject Visits) - RELATIONSHIP Location: suppsv.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: SV (Subject Visits)
STUDYID	Study Identifier	text	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	2		Assigned
USUBJID	Unique Subject Identifier	text	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	5	Identifying Variable in Supplemental Qualifiers for SV • "SVSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	4		Assigned
QNAM	Qualifier Variable Name	text	8	Qualifier Variable Name for Supplemental Qualifiers for SV • "SVTERM1" = "Subject Visits Term" • "SVUPDES1" = "Description of Unplanned Visit 1" • "SVUPDES2" = "Description of Unplanned Visit 2"	Assigned
QLABEL	Qualifier Variable Label	text	40		Assigned
QVALVLM	Data Value	text	200
➤ QNAM = "SVTERM1"	Subject Visits Term	text	200		CRF Annotated Case Report Form [23 52 ]
➤ QNAM = "SVUPDES1"	Description of Unplanned Visit 1	text	200		CRF Annotated Case Report Form [6 51 ]
➤ QNAM = "SVUPDES2"	Description of Unplanned Visit 2	text	200		CRF Annotated Case Report Form [6 51 ]
QORIG	Origin	text	8		CRF Annotated Case Report Form [6 51 ]
QEVAL	Evaluator	text	1		Assigned Missing value for all records

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Supplemental Qualifiers for VS (SUPPVS)

SUPPVS (Supplemental Qualifiers for VS, Vital Signs) - RELATIONSHIP Location: suppvs.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: VS (Vital Signs)
STUDYID	Study Identifier	text	Identifier	20		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	50		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers for VS • "VSSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	4		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers for VS • "MEDTAK" = "Medication taken today for pain or fever" • "MEDTAKP" = "Prevent pain or fever" • "MEDTAKT" = "Treat Pain or Fever" • "VSLOCSP" = "Other Route of Measurement, specify"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "MEDTAK"	Medication taken today for pain or fever	text		1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [53 ]
➤ QNAM = "MEDTAKP"	Prevent pain or fever	text		1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [53 ]
➤ QNAM = "MEDTAKT"	Treat Pain or Fever	text		1	No Yes Response • "Y" • "N"	CRF Annotated Case Report Form [53 ]
➤ QNAM = "VSLOCSP"	Other Route of Measurement, specify	text		43		CRF Annotated Case Report Form [13 14 15 ]
QORIG	Origin	text	Result Qualifier	8		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned Missing value for all records

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Supplemental Qualifiers for XQ (SUPPXQ)

SUPPXQ (Supplemental Qualifiers for XQ, Virus Sequencing) - RELATIONSHIP Location: suppxq.xpt
Variable	Label / Description	Type	Length or Display Format	Origin / Source / Method / Comment
Related Parent Dataset: XQ (Virus Sequencing)
STUDYID	Study Identifier	text	20	Protocol
RDOMAIN	Related Domain Abbreviation	text	2	Assigned
USUBJID	Unique Subject Identifier	text	50	Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-' For the same subject with multiple screening number, USUBJID will be based on primary enrollment screen number. See RG 3.4.26
IDVAR	Identifying Variable	text	5	Assigned
IDVARVAL	Identifying Variable Value	text	4	Assigned
QNAM	Qualifier Variable Name	text	8	Assigned
QLABEL	Qualifier Variable Label	text	40	Assigned
QVALVLM	Data Value	text	200
➤ QNAM = "HAPLOTTY"	Virus Haplotype	text	90	eDT
QORIG	Origin	text	8	Assigned
QEVAL	Evaluator	text	1	Assigned Missing value for all records

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Description of Actual Arm

Permitted Value (Code)
Placebo
mRNA-1273
Placebo-mRNA-1273

Actual Arm Code

Permitted Value (Code)	Display Value (Decode)
A	mRNA-1273
PLA	Placebo
PLAA	Placebo-mRNA-1273

Action Taken with Study Treatment [C66767]

Permitted Value (Code)
DOSE DELAYED [*]
DOSE NOT CHANGED [C49504]
DRUG WITHDRAWN [C49502]
NOT APPLICABLE [C48660]

* Extended Value

Category for Adverse Event

Permitted Value (Code)
ADVERSE EVENT
REACTOGENICITY

Outcome of Event in Adverse Events [C66768]

Permitted Value (Code)
FATAL [C48275]
NOT RECOVERED/NOT RESOLVED [C49494]
RECOVERED/RESOLVED [C49498]
RECOVERED/RESOLVED WITH SEQUELAE [C49495]
RECOVERING/RESOLVING [C49496]
UNKNOWN [C17998]

Causality

Permitted Value (Code)
NOT APPLICABLE
NOT RELATED
RELATED

Relationship to Non-Study Treatment

Permitted Value (Code)
NOT APPLICABLE
NOT RELATED
RELATED

Subcategory for Adverse Event

Permitted Value (Code)
PIMMC

Severity/Intensity Scale for Adverse Events [C66769]

Permitted Value (Code)
MILD [C41338]
MODERATE [C41339]
SEVERE [C41340]

Standard Toxicity Grade in Adverse Events

Permitted Value (Code)
1
2
3
4

Age Unit [C66781]

Permitted Value (Code)
YEARS [C29848]

Description of Planned Arm

Permitted Value (Code)
Placebo
mRNA-1273
Placebo-mRNA-1273

Planned Arm Code

Permitted Value (Code)	Display Value (Decode)
A	mRNA-1273
PLA	Placebo
PLAA	Placebo-mRNA-1273

Category for Clinical Event

Permitted Value (Code)
ADJUDICATION
EFFICACY
REACTOGENICITY

CE Group ID

Permitted Value (Code)
EVIDENCE OF SHOCK
EVIDENCE OF PNEUMONIA

Subcategory for Clinical Event

Permitted Value (Code)
ADMINISTRATION SITE
COVID-19
COVID-19 SEVERITY
SEVERE COVID-19
SYSTEMIC

Severity/Intensity Scale for Clinical Events

Permitted Value (Code)
ABNORMAL
MILD
MODERATE
NONE
NORMAL
SEVERE

Toxicity Grade in Clinical Events

Permitted Value (Code)
0
1
2
3
4

Category for Medication

Permitted Value (Code)
CONCOMITANT MEDICATIONS
PRIOR MEDICATIONS
VACCINATION

Dosing Frequency in Concomitant Medications [C71113]

Permitted Value (Code)
BID [C64496]
EVERY WEEK [C67069]
ONCE [C64576]
OTHER [*]
PRN [C64499]
QD [C25473]
QID [C64530]
QM [C64498]
QOD [C64525]
QS [*]
TID [C64527]
UNKNOWN [C17998]

* Extended Value

Dose Units in Concomitant Medications [C71620]

Permitted Value (Code)
CAPSULE [C48480]
IU [C48579]
Other [*]
PUFF [C65060]
TABLET [C48542]
g [C48155]
mL [C28254]
mg [C28253]
ug [C48152]

* Extended Value

Route of Administration in Concomitant Medications [C66729]

Permitted Value (Code)
INTRALESIONAL [C38250]
INTRAMUSCULAR [C28161]
INTRAOCULAR [C38255]
INTRAPERITEONEAL [*]
INTRAVENOUS [C38276]
INTRAVENOUS BOLUS [C38274]
INTRAVENOUS DRIP [C38279]
NASAL [C38284]
ORAL [C38288]
OTHER [*]
RECTAL [C38295]
RESPIRATORY (INHALATION) [C38216]
SUBCUTANEOUS [C38299]
TOPICAL [C38304]
TRANSDERMAL [C38305]
VAGINAL [C38313]

* Extended Value

Country

Permitted Value (Code)
USA

Death Detail Assessment Name

Permitted Value (Code)
Autopsy Performed
Main Cause of Death

Death Detail Assessment Short Name

Permitted Value (Code)	Display Value (Decode)
AUTOPERF	Autopsy Performed
DTHCAUS	Main Cause of Death

Category for Disposition Event [C74558]

Permitted Value (Code)
DISPOSITION EVENT [C74590]
PROTOCOL MILESTONE [C74588]

Standardized Disposition Term

Permitted Value (Code)
ADVERSE EVENT
COMPLETED
COVID
DEATH
INFORMED CONSENT OBTAINED
LOST TO FOLLOW-UP
MET ELIGIBILITY CRITERIA BUT NOT NEEDED
PHYSICIAN DECISION
PREGNANCY
PROTOCOL DEVIATION
RANDOMIZED
SCREEN FAILURE
SERIOUS ADVERSE EVENT
TREATMENT UNBLINDED
WITHDRAWAL BY SUBJECT
OTHER

Subcategory for Disposition Event [C170443]

Permitted Value (Code)
SCREEN FAILURE [*]
STUDY TREATMENT [C170570]
OPEN LABEL [*]
END OF STUDY [*]

* Extended Value

Category for Protocol Deviation

Permitted Value (Code)
ICH/GCP Deviation
Protocol Deviation

Subcategory for Protocol Deviation

Permitted Value (Code)
Accidental Unblinding
Concomitant Medication
Data Privacy
Exclusion Criteria
ICF Process/Timing
Inclusion Criteria
Informed Consent
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
Missing Endpoint Assessments
Study Procedures/Assessments
Study Treatment Admin/Dispense
Study Treatment Randomization
Visit Scheduling
Withdrawal/Term Criteria

Dose Form in Exposure as Collected [C66726]

Permitted Value (Code)
INJECTION [C42946]

Dosing Frequency in Exposure as Collected [C71113]

Permitted Value (Code)
ONCE [C64576]

Dose Units in Exposure as Collected [C71620]

Permitted Value (Code)
mL [C28254]

Laterality in Exposure as Collected [C99073]

Permitted Value (Code)
LEFT [C25229]
RIGHT [C25228]

Location of Dose Administration for Exposure as Collected [C74456]

Permitted Value (Code)
ARM [C32141]

Route of Administration in Exposure as Collected [C66729]

Permitted Value (Code)
INTRAMUSCULAR [C28161]

Description of Element

Permitted Value (Code)
Screening
Placebo in blinded phase
mRNA-1273 in blinded phase
Follow up in blinded phase
mRNA-1273 in open-label phase
Follow up in open-label phase

Relation to Reference Period (ENRTPT) [C66728]

Permitted Value (Code)
ONGOING [C53279]

Epoch [C99079]

Permitted Value (Code)
SCREENING [C48262]
BLINDED TREATMENT [C102255]
FOLLOW-UP BLINDED PHASE [*]
OPEN LABEL TREATMENT [C102256]
FOLLOW-UP OPEN LABEL PHASE [*]

* Extended Value

Element Code

Permitted Value (Code)	Display Value (Decode)
SCREEN	Screening
PBO	Placebo in blinded phase
V	mRNA-1273 in blinded phase
FUA	Follow up in blinded phase
VOL	mRNA-1273 in open-label phase
FUB	Follow up in open-label phase

Ethnic Group [C66790]

Permitted Value (Code)
HISPANIC OR LATINO [C17459]
NOT HISPANIC OR LATINO [C41222]
NOT REPORTED [C43234]
UNKNOWN [C17998]

Dose Form in Exposure [C66726]

Permitted Value (Code)
INJECTION [C42946]

Dosing Frequency in Exposure [C71113]

Permitted Value (Code)
ONCE [C64576]

Dose Units in Exposure [C71620]

Permitted Value (Code)
ug [C48152]

Laterality in Exposure [C99073]

Permitted Value (Code)
LEFT [C25229]
RIGHT [C25228]

Location of Dose Administration for Exposure [C74456]

Permitted Value (Code)
ARM [C32141]

Route of Administration in Exposure [C66729]

Permitted Value (Code)
INTRAMUSCULAR [C28161]

Name of Treatment

Permitted Value (Code)
PLACEBO
mRNA-1273

Category for Findings About Adverse Events

Permitted Value (Code)
REACTOGENICITY

Evaluator for Findings About Adverse Events [C78735]

Permitted Value (Code)
INVESTIGATOR [*]
STUDY SUBJECT [*]

* Extended Value

Original Units for Findings About Adverse Events [C71620]

Permitted Value (Code)
mm [*]

* Extended Value

Subcategory for Findings About Adverse Events

Permitted Value (Code)
ADMINISTRATION SITE
SYSTEMIC

Standard Units for Findings About Adverse Events [C71620]

Permitted Value (Code)
mm [*]

* Extended Value

Findings About Adverse Events Test Name

Permitted Value (Code)
Longest Diameter
Occurrence Indicator
Severity/Intensity

Findings About Adverse Events Test Code

Permitted Value (Code)	Display Value (Decode)
LDIAM	Longest Diameter
OCCUR	Occurrence
SEV	Severity/Intensity

Category for Findings About Clinical Events

Permitted Value (Code)
REACTOGENICITY

Evaluator for Findings About Clinical Events [C78735]

Permitted Value (Code)
INVESTIGATOR [*]
STUDY SUBJECT [*]

* Extended Value

Original Units for Findings About Clinical Events [C71620]

Permitted Value (Code)
mm [*]

* Extended Value

Subcategory for Findings About Clinical Events

Permitted Value (Code)
ADMINISTRATION SITE
SYSTEMIC

Standard Units for Findings About Clinical Events [C71620]

Permitted Value (Code)
mm [*]

* Extended Value

Findings About Clinical Events Test Name

Permitted Value (Code)
Longest Diameter
Occurrence Indicator
Severity/Intensity

Findings About Clinical Events Test Code

Permitted Value (Code)	Display Value (Decode)
LDIAM	Longest Diameter
OCCUR	Occurrence
SEV	Severity/Intensity

Category for Findings About Efficacy Events

Permitted Value (Code)
EFFICACY

Subcategory for Findings About Efficacy Events

Permitted Value (Code)
COVID-19
COVID-19 SEVERITY

Findings About Efficacy Events Test Name

Permitted Value (Code)
Occurrence Indicator
Severity/Intensity

Findings About Efficacy Events Test Code

Permitted Value (Code)	Display Value (Decode)
OCCUR	Occurrence
SEV	Severity/Intensity

Category for Findings About Events or Interventions

Permitted Value (Code)
PHYSICAL EXAMINATION
SAFETY

Subcategory for Findings About Events or Interventions

Permitted Value (Code)
SAFETY DIARY

Findings About Events or Interventions Test Name

Permitted Value (Code)
Assessment
COVID-19 Exposure
Changes in Health
Healthcare Provider Contact
New COVID Symptoms
Occurrence Indicator

Findings About Events or Interventions Test Code

Permitted Value (Code)	Display Value (Decode)
ASSESS	Assessment
CHGHLTH	Changes in Health
COVIDEXP	COVID-19 Exposure
HLTHPCT	Healthcare Provider Contact
NEWSYMP	New COVID Symptoms
OCCUR	Occurrence

Category for Healthcare Encounters

Permitted Value (Code)
ADVERSE EVENTS
E-DIARY
EFFICACY

Dictionary-Derived Term in Healthcare Encounters [C171444]

Permitted Value (Code)
HOSPITAL [*]
ICU [*]
MAAE [*]

* Extended Value

Subcategory for Healthcare Encounters

Permitted Value (Code)
COVID-19 SEVERITY

Category for Inclusion/Exclusion [C66797]

Permitted Value (Code)
EXCLUSION [C25370]
INCLUSION [C25532]

Category for Immunogenicity Specimen Assessments

Permitted Value (Code)
IMMUNOGENICITY ASSESSMENT
Serum SARS-CoV-2 Binding Antibodies
Serum SARS-CoV-2 Neutralizing Antibodies

Vendor Name for Immunogenicity Specimen Assessment

Permitted Value (Code)
DUKE
PPD Vaccine
VRC

Original Units for Immunogenicity Specimen Assessments [C71620]

Permitted Value (Code)
AU/mL [C70504]

Specimen Type in Immunogenicity Specimen Assessment [C78734]

Permitted Value (Code)
SERUM [C13325]
BLOOD [C12434]

Standard Units for Immunogenicity Specimen Assessments [C71620]

Permitted Value (Code)
AU/mL [C70504]

Immunogenicity Test or Examination Name [C120526]

Permitted Value (Code)
Blood [*]
All Immunogenicity [*]
SARSCOV2NP IgG Antibody [*]
PsVNT50 [*]
PsVNT80 [*]
SARSCOV2RBD IgG Antibody [*]
SARSCOV2S2P IgG Antibody [*]
Severe Acute Resp Syndrome Coronavirus 2 [*]
VAC65 Spike IgG Antibody [*]
VAC66 Nucleocapsid IgG Antibody [*]

* Extended Value

Immunogenicity Test/Exam Short Name [C120525]

Permitted Value (Code)	Display Value (Decode)
BLD [*]	Blood
ISALL [*]	All Immunogenicity
NPIGG [*]	SARSCOV2NP IgG Antibody
PSVNT50 [*]	PsVNT50
PSVNT80 [*]	PsVNT80
RBDIGG [*]	SARSCOV2RBD IgG Antibody
S2PIGG [*]	SARSCOV2S2P IgG Antibody
SARSCOV2 [*]	Severe Acute Resp Syndrome Coronavirus 2
V65IGGS [*]	VAC65 Spike IgG Antibody
V66IGGN [*]	VAC66 Nucleocapsid IgG Antibody

* Extended Value

Category for Lab Test

Permitted Value (Code)
CHEMISTRY
PREGNANCY TEST

Specimen Type in Laboratory Tests Results [C78734]

Permitted Value (Code)
SERUM [C13325]
URINE [C13283]

Laboratory Test Name [C67154]

Permitted Value (Code)
Choriogonadotropin Beta [C64851]
Follicle Stimulating Hormone [C74783]

Laboratory Test Code [C65047]

Permitted Value (Code)	Display Value (Decode)
FSH [C74783]	Follicle Stimulating Hormone
HCG [C64851]	Choriogonadotropin Beta

Category for Microbiology Finding

Permitted Value (Code)
BIOFIRE
SARS-CoV-2

Method of Test or Examination in Microbiology Specimen [C85492]

Permitted Value (Code)
MULTIPLEX [*]
REVERSE TRANSCRIPTASE PCR [C18136]

* Extended Value

Result Category for Microbiology Finding

Permitted Value (Code)
ABNORMAL
NORMAL

Subcategory for Microbiology Finding

Permitted Value (Code)
Nasal Swab
Nasopharyngeal Swab
Nasopharyngeal Swab 1
Nasopharyngeal Swab 2
Other
Saliva
Swab

Specimen Type in Microbiology Specimen [C78734]

Permitted Value (Code)
SALIVA [C13275]
SWABBED MATERIAL [C150895]

Microbiology Specimen Test Name [C120528]

Permitted Value (Code)
Adenovirus [*]
All Microbiology Specimen [*]
Bordetella pertussis [*]
Chlamydophila pneumoniae [*]
Coronavirus 229E [*]
Coronavirus HKU1 [*]
Coronavirus NL63 [*]
Coronavirus OC43 [*]
Human Rhinovirus/Enterovirus [*]
Human metapneumovirus [*]
Influenza A [*]
Influenza A subtype H1 [*]
Influenza A subtype H1/2009 [*]
Influenza A subtype H3 [*]
Influenza B [*]
Mycoplasma pneumoniae [C156543]
Parainfluenza Virus 1 [*]
Parainfluenza Virus 2 [*]
Parainfluenza Virus 3 [*]
Parainfluenza Virus 4 [*]
Respiratory Syncytial Virus [C171526]
Severe Acute Resp Syndrome Coronavirus 2 [C171532]

* Extended Value

Microbiology Specimen Test Code [C120527]

Permitted Value (Code)	Display Value (Decode)
B41080 [*]	Coronavirus 229E
B41081 [*]	Parainfluenza Virus 1
B41082 [*]	Parainfluenza Virus 2
B41083 [*]	Chlamydophila 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
MBALL [*]	All Microbiology Specimen
MPN [C156543]	Mycoplasma pneumoniae
SARSCOV2 [C171532]	Severe Acute Resp Syndrome Coronavirus 2
RSV [C171526]	Respiratory Syncytial Virus

* Extended Value

Category for Medical History

Permitted Value (Code)
GENERAL
COSMETIC OR MEDICAL INDICATIONS
RISK FACTOR FOR COVID-19

Not Done [C66789]

Permitted Value (Code)
NOT DONE [C49484]

No Yes Response [C66742]

Permitted Value (Code)
Y [C49488]
N [C49487]

Category for Procedures

Permitted Value (Code)
CONCOMITANT PROCEDURES
EFFICACY

Subcategory for Procedures

Permitted Value (Code)
COVID-19 SEVERITY

confirmed diagnosis Symptom Covid-19

Permitted Value (Code)
No
Yes

Coder Dictionary Name

Permitted Value (Code)
MedDRA

Coder Dictionary Version

Permitted Value (Code)
23.0

Severity Coded Value

Permitted Value (Code)
Grade 1/Mild
Grade 2/Moderate
Grade 3/Severe
Grade 4

AE Severity/Intensity

Permitted Value (Code)
GRADE 1/MILD
GRADE 2/MODERATE
GRADE 3/SEVERE
GRADE 4

Prophylaxis

Permitted Value (Code)
No
Yes

Start date completely unknown

Permitted Value (Code)
0
1

Cohort

Permitted Value (Code)
>=18 and <65 years and at risk
>=18 and <65 years and not at risk
>=65 years

Protocol Version Coded Value

Permitted Value (Code)
AMENDMENT 1
AMENDMENT 2
AMENDMENT 3
AMENDMENT 4
AMENDMENT 5

White

Permitted Value (Code)
WHITE

Black

Permitted Value (Code)
BLACK OR AFRICAN AMERICAN

Asian

Permitted Value (Code)
ASIAN

American Indian or Alaska Native

Permitted Value (Code)
AMERICAN INDIAN OR ALASKA NATIVE

Native Hawaiian or other Pacific Island

Permitted Value (Code)
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER

Other

Permitted Value (Code)
OTHER

Significant

Permitted Value (Code)
NOT SIGNIFICANT
SIGNIFICANT

Severity Code and Description

Permitted Value (Code)
1 - Exclude from all analysis sets
3 - Exclude from per-protocol analysis set only
8 - Exclude from all analysis sets except for randomization set
9 - Will be handled by statistical analysis; Pfizer EUA
10 - Will be handled by statistical analysis; Moderna EUA
12 - Will be handled by statistical analysis; Astra Zeneca Investigational Vaccine
13 - Will be handled by statistical analysis; Unknown EUA Vaccine
99 - Include in all analyses (minor PD)

Reason not given Coded Value

Permitted Value (Code)
ADVERSE EVENT
COVID
DEATH
LOST TO FOLLOW-UP
OTHER
PHYSICIAN AE
PHYSICIAN DECISION
PREGNANCY
PROTOCOL DEVIATION
TERMINATED BY SPONSOR
WITHDRAWAL OF CONSENT

Protocol Version Coded Value

Permitted Value (Code)
Amendment 1
Amendment 2
Amendment 3
Amendment 4
Amendment 5

Lab Test

Permitted Value (Code)
Nasopharyngeal Swab 1
Nasopharyngeal Swab 2

CLIA Certified

Permitted Value (Code)
No
Yes

Condition_CoderDictName

Permitted Value (Code)
MedDRA

Condition_CoderDictVersion

Permitted Value (Code)
23.0

Stop date completely unknown

Permitted Value (Code)
N
Y

Start date completely unknown

Permitted Value (Code)
N
Y

If No, what is the reason

Permitted Value (Code)
Other
Partner medically sterile
Post-menopausal
Surgically sterile

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]
NOT REPORTED [C43234]
OTHER [*]
UNKNOWN [C17998]
WHITE [C41261]

* Extended Value

Reproductive System Findings Test Name [C106478]

Permitted Value (Code)
Childbearing Potential [C106508]

Repro System Findings Test Short Name [C106479]

Permitted Value (Code)	Display Value (Decode)
CHILDPOT [C106508]	Childbearing Potential

Category for Subject Characteristic

Permitted Value (Code)
COVID-19 EXPOSURE

Subcategory for Subject Characteristic

Permitted Value (Code)
LOCATION AND LIVING CIRCUMSTANCES RISK
OCCUPATIONAL RISK

Subject Characteristics Test Name [C103330]

Permitted Value (Code)
Border Protection and Military Personnel [*]
Educators and Students [*]
Emergency Response [*]
Healthcare workers [*]
High density housing [*]
Hospitality and Tourism Workers [*]
Low density, multi-family setting [*]
Manufacturing and Production Operations [*]
Multi-family dwelling [*]
No Risk Identified [*]
Nursing Home or Assisted Living Facility [*]
Other [*]
Pastoral, Social, Public Health Workers [*]
Personal Care and in-home services [*]
Retail or Restaurant Operations [*]
Single family home [*]
Transportation and delivery services [*]
Warehouse shipping, fulfillment centers [*]

* Extended Value

Subject Characteristic Test Code [C74559]

Permitted Value (Code)	Display Value (Decode)
ALF [*]	Nursing Home or Assisted Living Facility
BRDRPROT [*]	Border Protection and Military Personnel
EDUSTU [*]	Educators and Students
EMERGNCY [*]	Emergency Response
HIDENSTY [*]	High density housing
HLTHCARE [*]	Healthcare workers
HOSPTOUR [*]	Hospitality and Tourism Workers
LODENSTY [*]	Low density, multi-family setting
MANPROD [*]	Manufacturing and Production Operations
MULTFAM [*]	Multi-family dwelling
NORISK [*]	No Risk Identified
OTHER [*]	Other
PERSCARE [*]	Personal Care and in-home services
PSPHLTH [*]	Pastoral, Social, Public Health Workers
RETLOPS [*]	Retail or Restaurant Operations
SFH [*]	Single family home
TRANSDEL [*]	Transportation and delivery services
WARESHP [*]	Warehouse shipping, fulfillment centers

* Extended Value

Sex [C66731]

Permitted Value (Code)
F [C16576]
M [C20197]

Relation to Reference Period [C66728]

Permitted Value (Code)
ONGOING [C53279]

Identifying Variable in Supplemental Qualifiers for AE

Permitted Value (Code)
AESEQ

Qualifier Variable Name for Supplemental Qualifiers for AE

Permitted Value (Code)	Display Value (Decode)
AECVDIAG	confirmed diagnosis Symptom Covid-19
AEDICNM	Coder Dictionary Name
AEDICVR	Coder Dictionary Version
AEHOSPEN	AE Hosp End Date
AEHOSPST	AE Hosp Start Date
AEICUSTD	Admitted to ICU? Coded Value
AEOUTSP	Recovered/Resolved with Sequelae, specif
AESEVSTD	Severity Coded Value
AESOFL	Solicited Adverse Reaction?
AESPID1	AE ID coded value
DSSPIDX	DS Sponsor-Defined Identifier
HOSPIDX	HO Sponsor-Defined Identifier
AETRTEM	Treatment Emergent Flag
REMOVEFL	AR Remove Flag
MAAEFL	Medically-attended AE Flag

Identifying Variable in Supplemental Qualifiers for CE

Permitted Value (Code)
CESEQ

Qualifier Variable Name for Supplemental Qualifiers for CE

Permitted Value (Code)	Display Value (Decode)
AEFLAG	Medically-attended Flag from AE
AESEVX	AE Severity/Intensity
AESPIDX	AE Sponsor-Defined Identifier
CEREASOC	Reason Clinical Event Outcome
DSSPIDX	DS Sponsor-Defined Identifier
HOSPIDX	HO Sponsor-Defined Identifier
MAAEFL	Medically-attended AE Flag
SAEDTC	SAE Date
SAEDY	SAE Day

Identifying Variable in Supplemental Qualifiers for CM

Permitted Value (Code)
CMSEQ

Qualifier Variable Name for Supplemental Qualifiers for CM

Permitted Value (Code)	Display Value (Decode)
ATCLEV1C	Name of MedicationATC_CODE
ATCLEV1T	Name of MedicationATC
ATCLEV3C	Name of MedicationATC3_CODE
ATCLEV3T	Name of MedicationATC3
ATCLEV4C	Name of MedicationATC4_CODE
ATCLEV4T	Name of MedicationATC4
CMDECOD1	Standardized Medication Name1
CMDECOD2	Standardized Medication Name2
CMDECOD3	Standardized Medication Name3
CMDICNM	Name of Medication_CoderDictName
CMDICVR	Name of Medication_CoderDictVersion
CMFOTHSP	Frequency Other, specify
CMONGOYN	Ongoing
CMPLX	Prophylaxis
CMPROTCD	Name of MedicationPRODUCT_CODE
CMROTHSP	If Route of Administration is Other, spe
CMSOL	Was medication taken for solicited event
CMSTUNKC	Start date completely unknown
CMTRADCD	Trade Name of Med code
CMTRADE	Trade Name of Medication
CMTRTTN	Name of Medication Synonym
CMTRTTN1	Name of Medication Synonym1
CMTRTTN2	Name of MedicationSYNONYM2
CMTRTO1	Name of Medication
CMUOTHSP	Dose Unit Other, Specify

Qualifier Variable Name for Supplemental Qualifiers for DM

Permitted Value (Code)	Display Value (Decode)
AGE_DER	Age (Derived)
COHORT	Cohort
PREVSCR	Was this participant screen previously
PROTVER	Protocol Version
RACE1	White
RACE2	Black
RACE3	Asian
RACE4	American Indian or Alaska Native
RACE5	Native Hawaiian or other Pacific Island
RACE6	Other
RACEOTH	If race is Other, specify
SUBJID1	Previous subject number
UNBLMRNA	Will participant receive mRNA-1273
UNBLNA	NA - Unblinded Amendment 5 Discontinued
UNBLNDYN	Was the participant unblinded
UNBLPROT	Unblinded Protocol Version Coded Value

Identifying Variable in Supplemental Qualifiers for DS

Permitted Value (Code)
DSSEQ

Qualifier Variable Name for Supplemental Qualifiers for DS

Permitted Value (Code)	Display Value (Decode)
AESPIDX	AE Sponsor-Defined Identifier
ENROLLYN	Was participant enrolled in the study YN
DSEOTDT	Date of Disposition at EOT
DSTERMOX	Discontinuation reason, specify
DSTERMP1	Reason for Discont Other, specify1
DSTERMSX	Primary reason for treatment discont. St
DSTERMX	Primary reason for treatment discontinua
IRTVISDT	IRT Date of Unblinding

Identifying Variable in Supplemental Qualifiers for DV

Permitted Value (Code)
DVSEQ

Qualifier Variable Name for Supplemental Qualifiers for DV

Permitted Value (Code)	Display Value (Decode)
DECSRTNL	Decision Made and Rationale
DECSRTN1	Decision Made and Rationale 1
DECSRTN2	Decision Made and Rationale 2
DECSRTN3	Decision Made and Rationale 3
DVSIG	Significant
DVTERM1	Description2
SEVDES	Severity Code and Description

Identifying Variable in Supplemental Qualifiers for EC

Permitted Value (Code)
ECSEQ

Qualifier Variable Name for Supplemental Qualifiers for EC

Permitted Value (Code)	Display Value (Decode)
EXREASSP	Reason not given, specify
EXREASTD	Reason not given Coded Value
ECREASOC	Reason for Occur value

Identifying Variable in Supplemental Qualifiers for FAAE

Permitted Value (Code)
FASEQ

Qualifier Variable Name for Supplemental Qualifiers for FAAE

Permitted Value (Code)	Display Value (Decode)
AESPIDX	AE Sponsor-Defined Identifier
HOSPIDX	HO Sponsor-Defined Identifier
MAAEFL	Medically-attended AE Flag
DSSPIDX	DS Sponsor-Defined Identifier
RECON	Reconstructed Data

Identifying Variable in Supplemental Qualifiers for FACE

Permitted Value (Code)
FASEQ

Qualifier Variable Name for Supplemental Qualifiers for FACE

Permitted Value (Code)	Display Value (Decode)
AESPIDX	AE Sponsor-Defined Identifier
HOSPIDX	HO Sponsor-Defined Identifier
MAAEFL	Medically-attended AE Flag
DSSPIDX	DS Sponsor-Defined Identifier
RECON	Reconstructed Data

Identifying Variable in Supplemental Qualifiers for FAEF

Permitted Value (Code)
FASEQ

Qualifier Variable Name for Supplemental Qualifiers for FAEF

Permitted Value (Code)	Display Value (Decode)
FAEVDTC	Start Date/Time of Collection
FAEVDY	Study Day of Start of Observation
HOSPIDX	HO Sponsor-Defined Identifier

Identifying Variable in Supplemental Qualifiers for FAOT

Permitted Value (Code)
FASEQ

Qualifier Variable Name for Supplemental Qualifiers for FAOT

Permitted Value (Code)	Display Value (Decode)
CLIN2	Contact your Study Clinic-confirm
CLIN2J	Contact your Study Clinic New Symp-confi
CLIN4A	Contact Healthcare Provider -confirm

Identifying Variable in Supplemental Qualifiers for HO

Permitted Value (Code)
HOSEQ

Qualifier Variable Name for Supplemental Qualifiers for HO

Permitted Value (Code)	Display Value (Decode)
HOEVAL	HO Evaluator

Identifying Variable in Supplemental Qualifiers for IE

Permitted Value (Code)
IESEQ

Qualifier Variable Name for Supplemental Qualifiers for IE

Permitted Value (Code)	Display Value (Decode)
PROTVER	Protocol Version Coded Value

Identifying Variable in Supplemental Qualifiers for IS

Permitted Value (Code)
ISSEQ

Qualifier Variable Name for Supplemental Qualifiers for IS

Permitted Value (Code)	Display Value (Decode)
DILFAC	Dilution Factor
INITDIL	Initial Dilution
ISLOD	Limit of Detection
ISULOQ	Upper Limit of Quantitation
SAMPNOTE	Toxicity notes-Duke
TESTDT	Date of Test-Duke
TESTGDT	Date of Test-VRC
TSTCOM	Test Comment-Vaccine

Identifying Variable in Supplemental Qualifiers for MB

Permitted Value (Code)
MBSEQ

Qualifier Variable Name for Supplemental Qualifiers for MB

Permitted Value (Code)	Display Value (Decode)
LBPANEL3	Lab Test
LDTCLIA	CLIA Certified
LDTTESTO	Other, Specify
LDTVISDT	Covid Test Visit Date
LOCALFL	From Covid Diag Test
RPTDTM	Reported Date
TSTCOM	Test Level Comments

Identifying Variable in Supplemental Qualifiers for MH

Permitted Value (Code)
MHSEQ

Qualifier Variable Name for Supplemental Qualifiers for MH

Permitted Value (Code)	Display Value (Decode)
MHDICNM	Condition_CoderDictName
MHDICVR	Condition_CoderDictVersion
MHENUNKC	Stop date completely unknown
MHSTUNKC	Start date completely unknown

Identifying Variable in Supplemental Qualifiers for RP

Permitted Value (Code)
RPSEQ

Qualifier Variable Name for Supplemental Qualifiers for RP

Permitted Value (Code)	Display Value (Decode)
CBENDTC	If Post-menopausal, date of last menstru
CBENDUNK	Date of last menstruation unknown
CBRSN	If No, what is the reason
CBSDAUNK	Date of surgery unknown
CBSDTC	If Surgically sterile, date of surgery-I
CBSP	If Partner medically sterile or Other, s

Identifying Variable in Supplemental Qualifiers for SC

Permitted Value (Code)
SCSEQ

Qualifier Variable Name for Supplemental Qualifiers for SC

Permitted Value (Code)	Display Value (Decode)
SCORRS1	Result or Finding 1

Identifying Variable in Supplemental Qualifiers for SV

Permitted Value (Code)
SVSEQ

Qualifier Variable Name for Supplemental Qualifiers for SV

Permitted Value (Code)	Display Value (Decode)
SVTERM1	Subject Visits Term
SVUPDES1	Description of Unplanned Visit 1
SVUPDES2	Description of Unplanned Visit 2

Identifying Variable in Supplemental Qualifiers for VS

Permitted Value (Code)
VSSEQ

Qualifier Variable Name for Supplemental Qualifiers for VS

Permitted Value (Code)	Display Value (Decode)
MEDTAK	Medication taken today for pain or fever
MEDTAKP	Prevent pain or fever
MEDTAKT	Treat Pain or Fever
VSLOCSP	Other Route of Measurement, specify

Inclusion/Exclusion Test Code

Permitted Value (Code)	Display Value (Decode)
EXC01	Participants who are acutely ill or febrile 72 hours prior to or at Screening may be rescheduled. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
EXC02	Is pregnant or breastfeeding.
EXC03	Known history of SARS-CoV-2 infection.
EXC04	Prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19.
EXC05	Demonstrated inability to comply with the study procedures.
EXC06	An immediate family member or household member of this study's personnel.
EXC07	History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
EXC07A	Known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients.
EXC08	Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
EXC09	Has received or plans to receive a vaccine within 28 days prior to the first dose or plans to receive a non-study vaccine within 28 days prior to or after any dose of IP.
EXC09A	Has received or plans to receive a non-study vaccine within 28 days before/after any dose of IP (except for seasonal influenza vaccine which not permitted within 14 days before/after any dose of IP).
EXC10	Has participated in an interventional clinical study within 28 days prior to the day of enrollment.
EXC11	Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition.
EXC11A	Immunosuppressive or immunodeficient state, including HIV infection, asplenia, recurrent severe infections.
EXC11B	Immunosuppressive or immunodeficient state, asplenia, recurrent severe infections (HIVpositive participants on stable antiretroviral therapy are not excluded).
EXC11C	Immunosuppressive or immunodeficient state, asplenia, recurrent severe infections (HIVpositive participants with CD4 count =350 cells/mm3 and an undetectable HIV viral load within the past year).
EXC12	Has received systemic immunosuppressants/immune-modifying drugs for >14 days in total within 6 months prior to Screening. Topical tacrolimus is allowed if not used within 14 days prior to Screening.
EXC12A	Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids = 20 mg/day of prednisone equivalent).
EXC13	Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening.
EXC14	Has donated >= 450 mL of blood products within 28 days prior to Screening.
INC01	Adults, >= 18 years of age at time of consent, who are at high risk of SARS-CoV-2 infection.
INC02	Understands and agrees to comply with the study procedures and provides written informed consent.
INC03	Able to comply with study procedures based on the assessment of the Investigator.
INC04	Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile or postmenopausal.
INC05	Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the criteria listed in the protocol.
INC06	Male participants that could result in pregnancy of sexual partners must agree to practice adequate contraception and refrain from sperm donation from the 1st dose to 3 months after the second dose.
INC07	Healthy adults or adults with pre-existing medical conditions who are in stable condition.

Protocol Criteria Versions

Permitted Value (Code)
Original
Amendment 1
Amendment 2
Amendment 3
Amendment 4
Amendment 5
Amendment 6

Trial Summary Parameter Test Name [C67152]

Permitted Value (Code)
Actual Number of Subjects [C98703]
Adaptive Design [C146995]
Added on to Existing Treatments [C49703]
Clinical Study Sponsor [C70793]
Control Type [C49647]
Data Cutoff Date [C98717]
Data Cutoff Description [C98718]
Diagnosis Group [C49650]
Extension Trial Indicator [C139274]
Healthy Subject Indicator [C98737]
Intervention Model [C98746]
Intervention Type [C98747]
Investigational Therapy or Treatment [C41161]
Number of Groups/Cohorts [C126063]
Pediatric Investigation Plan Indicator [C126069]
Pediatric Postmarket Study Indicator [C123631]
Pediatric Study Indicator [C123632]
Pharmacologic Class [C98768]
Planned Country of Investigational Sites [C98770]
Planned Maximum Age of Subjects [C49694]
Planned Minimum Age of Subjects [C49693]
Planned Number of Arms [C98771]
Planned Number of Subjects [C49692]
Primary Outcome Measure [C98772]
Rare Disease Indicator [C126070]
Registry Identifier [C98714]
SDTM IG Version [C156604]
SDTM Version [C156605]
Secondary Outcome Measure [C98781]
Sex of Participants [C49696]
Study End Date [C90462]
Study Start Date [C69208]
Study Stop Rules [C49698]
Study Type [C142175]
Therapeutic Area [C101302]
Trial Blinding Schema [C49658]
Trial Disease/Condition Indication [C112038]
Trial Intent Type [C49652]
Trial Length [C49697]
Trial Phase Classification [C48281]
Trial Primary Objective [C85826]
Trial Secondary Objective [C85827]
Trial Title [C49802]
Trial Type [C49660]
Trial is Randomized [C25196]

Trial Summary Parameter Test Code [C66738]

Permitted Value (Code)	Display Value (Decode)
ACTSUB [C98703]	Actual Number of Subjects
ADAPT [C146995]	Adaptive Design
ADDON [C49703]	Added on to Existing Treatments
AGEMAX [C49694]	Planned Maximum Age of Subjects
AGEMIN [C49693]	Planned Minimum Age of Subjects
DCUTDESC [C98718]	Data Cutoff Description
DCUTDTC [C98717]	Data Cutoff Date
EXTTIND [C139274]	Extension Trial Indicator
FCNTRY [C98770]	Planned Country of Investigational Sites
HLTSUBJI [C98737]	Healthy Subject Indicator
INDIC [C112038]	Trial Disease/Condition Indication
INTMODEL [C98746]	Intervention Model
INTTYPE [C98747]	Intervention Type
LENGTH [C49697]	Trial Length
NARMS [C98771]	Planned Number of Arms
NCOHORT [C126063]	Number of Groups/Cohorts
OBJPRIM [C85826]	Trial Primary Objective
OBJSEC [C85827]	Trial Secondary Objective
OUTMSPRI [C98772]	Primary Outcome Measure
OUTMSSEC [C98781]	Secondary Outcome Measure
PCLAS [C98768]	Pharmacologic Class
PDPSTIND [C123631]	Pediatric Postmarket Study Indicator
PDSTIND [C123632]	Pediatric Study Indicator
PIPIND [C126069]	Pediatric Investigation Plan Indicator
PLANSUB [C49692]	Planned Number of Subjects
RANDOM [C25196]	Trial is Randomized
RDIND [C126070]	Rare Disease Indicator
REGID [C98714]	Registry Identifier
SDTIGVER [C156604]	SDTM IG Version
SDTMVER [C156605]	SDTM Version
SENDTC [C90462]	Study End Date
SEXPOP [C49696]	Sex of Participants
SPONSOR [C70793]	Clinical Study Sponsor
SSTDTC [C69208]	Study Start Date
STOPRULE [C49698]	Study Stop Rules
STYPE [C142175]	Study Type
TBLIND [C49658]	Trial Blinding Schema
TCNTRL [C49647]	Control Type
TDIGRP [C49650]	Diagnosis Group
THERAREA [C101302]	Therapeutic Area
TINDTP [C49652]	Trial Intent Type
TITLE [C49802]	Trial Title
TPHASE [C48281]	Trial Phase Classification
TRT [C41161]	Investigational Therapy or Treatment
TTYPE [C49660]	Trial Type

Category for Vital Signs

Permitted Value (Code)
EFFICACY
REACTOGENICITY

Location of Vital Sign Measurement [C74456]

Permitted Value (Code)
AXILLARY [*]
ORAL CAVITY [C12421]
OTHER [*]

* Extended Value

Original Units for Vital Signs [C66770]

Permitted Value (Code)
% [C25613]
C [C42559]
F [C44277]
LB [C48531]
beats/min [C49673]
breaths/min [C49674]
cm [C49668]
in [C48500]
kg [C28252]
kg/m2 [C49671]
mmHg [C49670]

Subcategory for Vital Signs

Permitted Value (Code)
COVID-19
COVID-19 SEVERITY
SYSTEMIC

Severity in Vital Signs

Permitted Value (Code)
ABNORMAL
GRADE 0
GRADE 1
GRADE 2
GRADE 3
GRADE 4
NORMAL

Standard Units for Vital Signs [C66770]

Permitted Value (Code)
% [C25613]
C [C42559]
beats/min [C49673]
breaths/min [C49674]
cm [C49668]
kg [C28252]
kg/m2 [C49671]
mmHg [C49670]

Vital Signs Test Name [C67153]

Permitted Value (Code)
Vital Signs Collection [*]
Body Mass Index [C16358]
Diastolic Blood Pressure [C25299]
Heart Rate [C49677]
Height [C25347]
Oxygen Saturation [C60832]
PP Arterial O2/Fraction Inspired O2 [*]
Pulse Rate [C49676]
Respiratory Rate [C49678]
Systolic Blood Pressure [C25298]
Temperature [*]
Weight [C25208]

* Extended Value

Vital Signs Test Code [C66741]

Permitted Value (Code)	Display Value (Decode)
BMI [C16358]	Body Mass Index
DIABP [C25299]	Diastolic Blood Pressure
HEIGHT [C25347]	Height
HR [C49677]	Heart Rate
OXYSAT [C60832]	Oxygen Saturation
PO2FIO2 [*]	PP Arterial O2/Fraction Inspired O2
PULSE [C49676]	Pulse Rate
RESP [C49678]	Respiratory Rate
SYSBP [C25298]	Systolic Blood Pressure
TEMP [C174446]	Temperature
VSALL [*]	Vital Signs Collection
WEIGHT [C25208]	Weight

* Extended Value

Toxicity Grade in Vital Signs

Permitted Value (Code)
0
1
2
3
4

Virus Sequence Method Code

Permitted Value (Code)
Sequence

Virus Sequencing Test Code

Permitted Value (Code)	Display Value (Decode)
LINEAGE	Lineage Based on Mutations in S

No Yes Response (Yes only) [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
National Drug File - Reference Terminology	NDF-RT	2020-09-08
Systematized Nomenclature of Medicine	SNOMED	2020-09-01
Unique Ingredient Identifier	UNII	2020-08-18
Medications Dictionary	WHODD	GLOBALB3Mar20

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Methods

Methods
Method	Type	Description
AEDUR	Computation	AEENDTC - Reference Vaccine Date - 6 where AECAT="REACTOGENICITY" (See Reviewers Guide for details) Study Data Reviewer’s Guide
AESEVX	Computation	Both Toxicity Grade and Severity
CERFTDTC	Computation	Set to EXSTDTC based on CETPTREF
SAEDTC	Computation	Set to SDTM.AESTDTC where AESER=Y and AEDECOD is one of pre-define solicited Adverse reaction symptom
SAEDY	Computation	Set to SDTM.AESDY where AESER=Y and AEDECOD is one of pre-define solicited Adverse reaction symptom
CESER	Computation	For CECAT = REACTOGENICITY: Set to Y if AESPIDX corresponds to a record where AESER = Y
CMENTPT	Computation	if CMENRTPT is not missing, then set to DM.RFPENDTC
EPOCH based on --DTC	Computation	Set to 'SCREENING' If XXDTC<RFSTDTC or both RFSDTC and RFENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= XXDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= XXDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= XXDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= XXDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= XXDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<=XXDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= XXDTC <= RFPENDTC
DUR	Computation	Calculated as duration days between --ENDY and --STDY date in format "PdD". If calculated value is negative, then blank
DY	Computation	--DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC
ENDTC	Computation	Same as --STDTC
ENDY	Computation	--ENDTC - DM.RFSTDTC if --ENDTC < RFSTDTC, --ENDTC - DM.RFSTDTC + 1 if --ENDTC >= RFSTDTC
FAEVDY	Computation	Set to FAEVDTC - RFXSDTC + 1
FARFDTC	Computation	FARFTDTC is derived by merging EX and e-Diary data (CRF Page 52 – 53, 55 – 66) with Dose # as merging key to get Dose Date and Time
HODY	Computation	HODTC - DM.RFSTDTC + 1 if HODTC>=DM.RFSTDTC
LBBLFL	Computation	Set to "Y", for the last record of per USUBJID/LBCAT/LBTESTCD, for non-missing LBORRES and LBSTAT not "NOT DONE" and LBDTC <= RFSTDTC
MBGRPID	Computation	Set to '001' if MBCAT=SARS-CoV-2 Set to '002' if BIOFIRE Set to '003' if local labs (Localfl=Y)
MBRESCAT	Computation	Coded MBSTRESC result as "Not Detected" -> "NORMAL", "Detected" -> "ABNORMAL"
MHENTPT	Computation	=DM.RFICDTC
RECON	Computation	Set to 'Y' if data is captured from Adverse Event Form
REMOVEFL	Computation	Set to 'Y' when (AECAT='REACTOGENICITY' and AESER ne 'Y') and AEENDTC is within the 7-day window of Dose 1 Reference date. For Dose 2, compare the 7 day window with Dose 2 Reference and AE End date if AE Start is after Dose 2date. AEENDTC is imputed with "T11:59" if time part is missing; But if AE end date is same as Dose date then imputed with "T23:59". If AESTDTC is incomplete and on same date as Dose date, then impute "T23:59"
RFENDTC	Computation	Last Dose date from EX domain
RFPENDTC	Computation	Last known date in study data
RFSTDTC	Computation	First Dose date from EX domain
RFXENDTC	Computation	Equals RFENDTC
RFXSTDTC	Computation	Equals RFSTDTC
SEENDTC	Computation	For Screening element (SCREEN), end date is first dose date if non missing -1, or end of participation date if subject never dosed; For element (V, PBO, VOL), end date is last dose date if non missing + 28 or the end of participation date which ever come to first
SEQ	Computation	For each USUBJID starting with 1 and incremented by 1, sorted by dataset key variables.
SESTDTC	Computation	For Screening element (SCREEN), start date is Informed Consent date; For first dose element (V, PBO, VOL) start date is first dose date; and for Follow-up element (FUA, FUB), start date is visit date 28 days after last vaccination.
EPOCH based on --STDTC	Computation	Set to 'SCREENING' If XXENDTC<RFSTDTC or both RFXSTDTC and --ENDTC are missing Set to 'BLINDED TREATMENT': •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 2 if the date is not missing + 28, DM.RFPENDTC) •RFXSTDTC <= --STDTC and --ENDTC <= min (Date of Dose 1 if there is no dose 2 date + 28, DM.RFPENDTC) Set to 'FOLLOW-UP BLINDED PHASE': •min (Date of Dose 2 if Dose2 Date is not missing + 28, DM.RFPENDTC) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing •min (Date of Dose1 if Dose2 Date is missing + 28, DM.RFPENDT) <= --STDTC and --ENDTC <= Date of OL1 if OL1 Date is not missing or RFPENDT if OL1 Date is missing Set to 'OPEN-LABEL TREATMENT': •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC ) •Date of OL1 <= --STDTC and --ENDTC <= min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) Set to 'FOLLOW-UP OPEN-LABEL PHASE': •min (Date of OL2 Date if OL2 Date is not missing + 28, RFPENDTC )<= --STDTC and --ENDTC <= RFPENDTC •min (Date of OL1 Date if OL2 Date is missing + 28, RFPENDTC ) <= --STDTC and --ENDTC <= RFPENDTC
STDY	Computation	--STDTC - DM.RFSTDTC if --STDTC < DM.RFSTDTC, --STDTC - DM.RFSTDTC + 1 if --STDTC >= DM.RFSTDTC
STNRHI	Computation	--ORNRHI value converted to standard unit if applicable; otherwise a copy of --ORNRHI
STNRLO	Computation	--ORNRLO value converted to standard unit if applicable; otherwise a copy of --ORNRLO
STRESC	Computation	--ORRES value converted to standard unit if applicable; otherwise a copy of --ORRES
STRESN	Computation	A copy of --STRESC in Numeric format, if applicable
USUBJID	Computation	The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
VISIT	Computation	Calculated based on SV info
VSBLFL	Computation	Set to "Y" for the last record per USUBJID,VSTESTCD where VSORRES is not missing and VSSTAT not "NOT DONE" and VSDTC <= RFSTDTC

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Datasets

Trial Arms (TA)

Trial Elements (TE)

Trial Inclusion/Exclusion Criteria (TI)

Trial Summary (TS)

Trial Visits (TV)

Demographics (DM)

Related Records (RELREC)

Subject Elements (SE)

Subject Visits (SV)

Multiple Participation (XM)

Concomitant Medications (CM)

Exposure as Collected (EC)

Exposure (EX)

Procedures (PR)

Adverse Events (AE)

Clinical Events (CE)

Disposition (DS)

Protocol Deviations (DV)

Healthcare Encounters (HO)

Medical History (MH)

Death Details (DD)

Inclusion/Exclusion Criteria Not Met (IE)

Immunogenicity Specimen Assessment (IS)

Laboratory Tests Results (LB)

Microbiology Specimen (MB)

Reproductive System Findings (RP)

Subject Characteristics (SC)

Vital Signs (VS)

Virus Sequencing (XQ)

Findings About Adverse Events (FAAE)

Findings About Clinical Events (FACE)

Findings About Efficacy Events (FAEF)

Findings About Events or Interventions (FAOT)

Supplemental Qualifiers for AE (SUPPAE)

Supplemental Qualifiers for CE (SUPPCE)

Supplemental Qualifiers for CM (SUPPCM)

Supplemental Qualifiers for DM (SUPPDM)

Supplemental Qualifiers for DS (SUPPDS)

Supplemental Qualifiers for DV (SUPPDV)

Supplemental Qualifiers for EC (SUPPEC)

Supplemental Qualifiers for FAAE (SUPPFAAE)

Supplemental Qualifiers for FACE (SUPPFACE)

Supplemental Qualifiers for FAEF (SUPPFAEF)

Supplemental Qualifiers for FAOT (SUPPFAOT)

Supplemental Qualifiers for HO (SUPPHO)

Supplemental Qualifiers for IE (SUPPIE)

Supplemental Qualifiers for IE (SUPPIS)

Supplemental Qualifiers for MB (SUPPMB)

Supplemental Qualifiers for MH (SUPPMH)

Supplemental Qualifiers for RP (SUPPRP)

Supplemental Qualifiers for SC (SUPPSC)

Supplemental Qualifiers for SV (SUPPSV)

Supplemental Qualifiers for VS (SUPPVS)

Supplemental Qualifiers for XQ (SUPPXQ)

CodeLists

External Dictionaries

Methods