Date/Time of Define-XML document generation: 2020-12-11T20:15:05Z

Define-XML version: 2.0.0

Stylesheet version: 2018-11-21

Standard: SDTM-IG 3.2
Study Name: COVID-19
Study Description: A Phase 2a, Randomized, Observer-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older
Protocol Name: mRNA-1273-P201
Metadata Name: Study COVID-19 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	ts.xpt
TV	Trial Visits	TRIAL DESIGN	One record per planned visit per arm	Tabulation	STUDYID, VISITNUM, ARMCD	tv.xpt
CO	Comments	SPECIAL PURPOSE	One record per comment per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, COSEQ	co.xpt
DM	Demographics	SPECIAL PURPOSE	One record per subject	Tabulation	STUDYID, USUBJID	dm.xpt
SE	Subject Elements	SPECIAL PURPOSE	One record per actual element per subject	Tabulation	USUBJID, SUBJID, TAETORD	se.xpt
SV	Subject Visits	SPECIAL PURPOSE	One record per actual visit per subject	Tabulation	STUDYID, USUBJID, SUBJID, VISITNUM	sv.xpt
XM	Multiple Participations	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, ECTRT, ECSTDTC	ec.xpt
EX	Exposure	INTERVENTIONS	One record per constant dosing interval per subject	Tabulation	STUDYID, DOMAIN, USUBJID, EXTRT, EXSTDTC	ex.xpt
PR	Procedures	INTERVENTIONS	One record per recorded procedure per occurrence per subject	Tabulation	STUDYID, USUBJID, PRTRT, PRSTDTC	pr.xpt
AE	Adverse Events	EVENTS	One record per adverse event per subject	Tabulation	STUDYID, USUBJID, SUBJID, AEDECOD, AESTDTC, AETERM	ae.xpt
CE	Clinical Events	EVENTS	One record per event per subject	Tabulation	STUDYID, USUBJID, CECAT, CESCAT, CETERM, CEDTC, CELNKGRP	ce.xpt
DS	Disposition	EVENTS	One record per disposition status or protocol milestone per subject	Tabulation	STUDYID, USUBJID, SUBJID, DSSTDTC, DSDECOD, DSCAT, DSSCAT	ds.xpt
DV	Protocol Deviations	EVENTS	One record per protocol deviation per subject	Tabulation	STUDYID, USUBJID, SUBJID, DVTERM, DVSTDTC	dv.xpt
ER	Environmental and Social Factors	EVENTS	One record per event per subject	Tabulation	STUDYID, USUBJID, ERCAT, ERTERM	er.xpt
HO	Healthcare Encounter	EVENTS	One record per healthcare encounter per subject	Tabulation	STUDYID, USUBJID, HOSTDTC, HOENDTC	ho.xpt
MH	Medical History	EVENTS	One record per medical history event per subject	Tabulation	STUDYID, USUBJID, SUBJID, MHDECOD, MHTERM, MHSTDTC, MHENDTC	mh.xpt
VE	Visit Events	EVENTS	One record per event per subject	Tabulation	STUDYID, USUBJID, VISITNUM, VESTDTC, VETERM	ve.xpt
IE	Inclusion/Exclusion Criteria Not Met	FINDINGS	One record per inclusion/exclusion criterion not met per subject	Tabulation	STUDYID, USUBJID, SUBJID, IETESTCD	ie.xpt
IS	Immunogenicity Specimen Assessments	FINDINGS	One record per test per visit per subject	Tabulation	STUDYID, USUBJID, ISCAT, ISTESTCD, VISITNUM, ISDTC	is.xpt
LB	Laboratory Test 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	lb.xpt
MB	Microbiology Specimen	FINDINGS	One record per microbiology specimen finding per time point per visit per subject	Tabulation	STUDYID, USUBJID, MBTESTCD, MBSPEC, MBDTC, MBCAT, MBSCAT	mb.xpt
RP	Reproductive System Findings	FINDINGS	One record per Reproductive System Finding per time point per visit per subject	Tabulation	STUDYID, USUBJID, RPTESTCD	rp.xpt
SS	Subject Status	FINDINGS	One record per finding per visit per subject	Tabulation	STUDYID, USUBJID, SSTESTCD, VISITNUM	ss.xpt
VS	Vital Signs	FINDINGS	One record per vital sign measurement per time point per visit per subject	Tabulation	STUDYID, USUBJID, VSTESTCD, VISITNUM, VSCAT, VSDTC, EPOCH, VSTPTNUM, VSTPTREF	vs.xpt
FAAE	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, SUBJID, FACAT, FATESTCD, FAOBJ, FALNKGRP, FADTC, FATPTNUM	faae.xpt
FACE	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, SUBJID, FACAT, FATESTCD, FAOBJ, FALNKGRP, FADTC, FATPTNUM	face.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, SUBJID, FACAT, FATESTCD, FAOBJ, VISITNUM, FADTC	faot.xpt
RELREC	Related Records	RELATIONSHIP	One record per related record, group of records or datasets	Tabulation	STUDYID, USUBJID, RELID	relrec.xpt
SUPPAE	Supplemental Qualifiers 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 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 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 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 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 DV (Protocol Deviations)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppdv.xpt
SUPPER	Supplemental Qualifiers ER (Environmental and Social Factors)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	supper.xpt
SUPPFAAE	Supplemental Qualifiers (SUPPFA)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppfaae.xpt
SUPPFACE	Supplemental Qualifiers (SUPPFA)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppface.xpt
SUPPFAOT	Supplemental Qualifiers (SUPPFA)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppfaot.xpt
SUPPHO	Supplemental Qualifiers HO (Healthcare Encounter)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppho.xpt
SUPPIS	Supplemental Qualifiers IS (Immunogenicity Specimen Assessments)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppis.xpt
SUPPLB	Supplemental Qualifiers LB (Laboratory Test Results)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	supplb.xpt
SUPPMB	Supplemental Qualifiers 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 MH (Medical History)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppmh.xpt
SUPPPR	Supplemental Qualifiers PR (Procedures)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	supppr.xpt
SUPPRP	Supplemental Qualifiers RP (Reproductive System Findings)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	supprp.xpt
SUPPVE	Supplemental Qualifiers VE (Visit Events)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppve.xpt
SUPPVS	Supplemental Qualifiers - VS (Vital Signs)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppvs.xpt
SUPPXM	Supplemental Qualifiers XM (Multiple Participations)	RELATIONSHIP	One record per IDVAR, IDVARVAL and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppxm.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	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
ARMCD	Planned Arm Code	text	Topic	4	Planned Arm Code • "A100" = "mRNA-1273 100 ug" • "A50" = "mRNA-1273 50 ug" • "PLA" = "Placebo"	Assigned
ARM	Description of Planned Arm	text	Synonym Qualifier	16	Description of Planned Arm • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Protocol
TAETORD	Planned Order of Element within Arm	integer	Timing	8		Protocol
ETCD	Element Code	text	Record Qualifier	7	Element Code [6 Terms]	Assigned
ELEMENT	Description of Element	text	Synonym Qualifier	43	Description of Element • "Screening" • "Placebo" • "mRNA-1273 50 ug" • "mRNA-1273 100 ug" • "Follow up"	Protocol
TABRANCH	Branch	text	Rule	38		Protocol
TATRANS	Transition Rule	text	Rule	1		Protocol
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	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	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
ETCD	Element Code	text	Topic	7	Element Code [6 Terms]	Assigned
ELEMENT	Description of Element	text	Synonym Qualifier	43	Description of Element • "Screening" • "Placebo" • "mRNA-1273 50 ug" • "mRNA-1273 100 ug" • "Follow up"	Protocol
TESTRL	Rule for Start of Element	text	Rule	43		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	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
IETESTCD	Inclusion/Exclusion Criterion Short Name	text		8		Assigned
IETEST	Inclusion/Exclusion Criterion	text	Synonym Qualifier	200		Assigned
IECAT	Inclusion/Exclusion Category	text	Grouping Qualifier	9	Category for Inclusion/Exclusion • "EXCLUSION" • "INCLUSION"	Assigned
TIVERS	Protocol Criteria Versions	text	Record Qualifier	11		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	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
TSSEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
TSGRPID	Group ID	text		20		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	199		Assigned
TSVAL1	Parameter Value 1	text	Result Qualifier	135		Assigned
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	14	Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2	Assigned
VISITNUM	Visit Number	integer	Topic	8	Assigned
VISIT	Visit Name	text	Synonym Qualifier	28	Protocol
VISITDY	Planned Study Day of Visit	integer	Timing	8	Protocol
ARMCD	Planned Arm Code	text	Record Qualifier	4	Assigned
TVSTRL	Visit Start Rule	text	Rule	47	Protocol
TVENRL	Visit End Rule	text	Rule	22	Protocol

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Comments (CO)

CO (Comments) - SPECIAL PURPOSE Location: co.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
RDOMAIN	Related Domain Abbreviation	text	Record Qualifier	2	Related Domain Abbreviation in Comments • "FA" • "LB" • "MB"	Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
COSEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
IDVAR	Identifying Variable	text	Record Qualifier	8	Identifying Variable in Comments • "FASEQ" • "LBSEQ" • "MBSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	6		Assigned
COREF	Comment Reference	text	Record Qualifier	23		CRF Annotated Case Report Form [31 32 ]
COVAL	Comment	text	Topic	199		CRF Annotated Case Report Form [31 32 ]

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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 DM)
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
SUBJID	Subject Identifier for the Study	text	Topic	9		Assigned Subject identified assigned during screening
RFSTDTC	Subject Reference Start Date/Time	datetime	Record Qualifier		ISO 8601	Derived Set to the first non-missing study drug exposure date/time
RFENDTC	Subject Reference End Date/Time	datetime	Record Qualifier		ISO 8601	Derived Set to the last non-missing study drug exposure date/time
RFXSTDTC	Date/Time of First Study Treatment	datetime	Record Qualifier		ISO 8601	Derived Set to the first non-missing study drug exposure date/time
RFXENDTC	Date/Time of Last Study Treatment	datetime	Record Qualifier		ISO 8601	Derived Set to the last non-missing study drug exposure date/time
RFICDTC	Date/Time of Informed Consent	date	Record Qualifier		ISO 8601	CRF Annotated Case Report Form [6 ]
RFPENDTC	Date/Time of End of Participation	date	Record Qualifier		ISO 8601	Derived Set to date of completed, or discontinued from study, or last assessment date if subject is still ongoing
DTHDTC	Date/Time of Death	text	Record Qualifier	1		CRF Annotated Case Report Form [43 ]
DTHFL	Subject Death Flag	text	Record Qualifier	1		Derived Set to 'Y' if reason of discontinue treatment, and /or end of study is death or outcome of an AE is fatal, otherwise, set to missing
SITEID	Study Site Identifier	text	Record Qualifier	5		Assigned
INVNAM	Investigator Name	text	Synonym Qualifier	45		Assigned
BRTHDTC	Date/Time of Birth	partialDate	Record Qualifier		ISO 8601	CRF Annotated Case Report Form [5 ]
AGE	Age	integer	Record Qualifier	8		CRF Annotated Case Report Form [5 ]
AGEU	Age Units	text	Variable Qualifier	5	Age Unit • "YEARS"	CRF Annotated Case Report Form [5 ]
SEX	Sex	text	Record Qualifier	1	Sex • "F" • "M"	CRF Annotated Case Report Form [5 ]
RACE	Race	text	Record Qualifier	41	Race [8 Terms]	CRF Annotated Case Report Form [5 ]
ETHNIC	Ethnicity	text	Record Qualifier	22	Ethnic Group • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	CRF Annotated Case Report Form [5 ]
ARMCD	Planned Arm Code	text	Record Qualifier	4	Planned Arm Code • "A100" = "mRNA-1273 100 ug" • "A50" = "mRNA-1273 50 ug" • "PLA" = "Placebo"	Assigned based on randomization number
ARM	Description of Planned Arm	text	Synonym Qualifier	16	Description of Planned Arm • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Assigned from TA.ARM based on ARMCD
ACTARMCD	Actual Arm Code	text	Record Qualifier	4	Actual Arm Code • "A100" = "mRNA-1273 100 ug" • "A50" = "mRNA-1273 50 ug" • "PLA" = "Placebo"	Assigned Actual treatment code is from actual treatment lookup table
ACTARM	Description of Actual Arm	text	Synonym Qualifier	16	Description of Actual Arm • "Placebo" • "mRNA-1273 100 ug" • "mRNA-1273 50 ug"	Assigned from TA.ARM based on ACTARMCD
COUNTRY	Country	text	Record Qualifier	3	Country • "USA"	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	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
SUBJID	Subject Identifier for the Study	text		9		Assigned Subject identified assigned during screening
SESEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
ETCD	Element Code	text	Topic	7	Element Code [6 Terms]	Assigned
ELEMENT	Description of Element	text	Synonym Qualifier	43	Description of Element • "Screening" • "Placebo" • "mRNA-1273 50 ug" • "mRNA-1273 100 ug" • "Follow up"	Protocol
TAETORD	Planned Order of Element within Arm	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Assigned Assigned from TA
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-50, V-100, PBO) start date is first dose date; and for Follow-up element (FU), 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-50, V-100, PBO), 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
SEUPDES	Description of Unplanned Element	text		30		eDT Get detailed dosing error information for the injection where dosing error occurred

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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
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
SUBJID	Subject Identifier for the Study	text		9		Assigned Subject identified assigned during screening
SVSEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
VISITNUM	Visit Number	float	Topic	8		Assigned Set to TV.VISITNUM based on VISIT
VISIT	Visit Name	text	Synonym Qualifier	28		Assigned
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --STDTC is greater or equal to SESTDTC and Less than or equal to SEENDTC
SVSTDTC	Start Date/Time of Visit	date	Timing		ISO 8601	Derived Set to visit date taking the first one recorded
SVENDTC	End Date/Time of Visit	date	Timing		ISO 8601	Derived Set to visit date taking the last one recorded
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	104		Assigned

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Multiple Participations (XM)

XM (Multiple Participations) - SPECIAL PURPOSE Location: xm.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPXM (Supplemental Qualifiers XM)
STUDYID	Study Identifier	text	14		Protocol
DOMAIN	Domain Abbreviation	text	2		Assigned
USUBJID	Unique Subject Identifier	text	25		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 3.4.1
SUBJID	Subject Identifier for the Study	text	9		Assigned Subject identified assigned during screening
RFSTDTC	Subject Reference Start Date/Time	text	16		Assigned
RFENDTC	Subject Reference End Date/Time	text	16		Assigned
RFICDTC	Date/Time of Informed Consent	date		ISO 8601	CRF Annotated Case Report Form [6 ]
RFPENDTC	Date/Time of End of Participation	date		ISO 8601	Assigned
DTHDTC	Date/Time of Death	text	1		Assigned A missing value
DTHFL	Subject Death Flag	text	1		Assigned A missing value
SITEID	Study Site Identifier	text	5		Assigned
INVNAM	Investigator Name	text	45		Assigned
BRTHDTC	Date/Time of Birth	partialDate		ISO 8601	CRF Annotated Case Report Form [5 ]
AGE	Age	integer	8		CRF Annotated Case Report Form [5 ]
AGEU	Age Units	text	5	Age Unit • "YEARS"	CRF Annotated Case Report Form [5 ]
SEX	Sex	text	1	Sex • "F" • "M"	CRF Annotated Case Report Form [5 ]
RACE	Race	text	41	Race [8 Terms]	CRF Annotated Case Report Form [5 ]
ETHNIC	Ethnicity	text	22	Ethnic Group • "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" • "NOT REPORTED" • "UNKNOWN"	CRF Annotated Case Report Form [5 ]
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 CM)
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
CMSEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
CMSPID	Sponsor-Defined Identifier	text	Identifier	3		Assigned
CMTRT	Reported Name of Drug, Med, or Therapy	text	Topic	137		CRF Annotated Case Report Form [35 ]
CMDECOD	Standardized Medication Name	text	Synonym Qualifier	189	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
CMCAT	Category for Medication	text	Grouping Qualifier	44	Category for Medication • "Prior/Concomitant Medication and Vaccination"	Assigned
CMINDC	Indication	text	Record Qualifier	83		CRF Annotated Case Report Form [35 ]
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	8		CRF Annotated Case Report Form [35 ]
CMDOSTXT	Dose Description	text	Record Qualifier	16		CRF Annotated Case Report Form [35 ]
CMDOSU	Dose Units	text	Variable Qualifier	7	Dose Units in Concomitant Medications [9 Terms]	CRF Annotated Case Report Form [35 ]
CMDOSFRQ	Dosing Frequency per Interval	text	Variable Qualifier	10	Dosing Frequency in Concomitant Medications [11 Terms]	CRF Annotated Case Report Form [35 ]
CMROUTE	Route of Administration	text	Variable Qualifier	13	Route of Administration in Concomitant Medications [12 Terms]	CRF Annotated Case Report Form [35 36 ]
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --STDTC is greater or equal to SESTDTC and Less than or equal to SEENDTC
CMSTDTC	Start Date/Time of Medication	text	Timing	10		CRF Annotated Case Report Form [36 ]
CMENDTC	End Date/Time of Medication	text	Timing	10		CRF Annotated Case Report Form [36 ]
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		Derived Set to ONGOING if Ongoing checked
CMENTPT	End Reference Time Point	text		20		Derived Set to DM.RFPENDTC if CMENRTPT is non-missing

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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
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
ECSEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
ECREFID	Reference ID	text	Identifier	6		Derived Set to "DOSE 1" if VISIT="VISIT 1 DAY 1" or "DOSE 2" if VISIT="VISIT 4 DAY 29"
ECTRT	Name of Treatment	text	Topic	9	Name of Treatment • "PLACEBO" • "mRNA-1273"	Derived Set to Placebo or mRNA-1273 after merging by randomization ID from randomization file
ECPRESP	Pre-Specified	text	Record Qualifier	1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [26 ]
ECOCCUR	Occurrence	text	Record Qualifier	1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [26 ]
ECDOSE	Dose	float	Record Qualifier	8		Assigned Set to 0.5
ECDOSU	Dose Units	text	Variable Qualifier	2	Dose Units in Exposure as Collected • "mL"	Assigned Set to "mL"
ECDOSFRM	Dose Form	text	Variable Qualifier	9	Dose Form in Exposure as Collected • "INJECTION"	Assigned Set to Set to "INJECTION" if Treatment given
ECDOSFRQ	Dosing Frequency per Interval	text	Variable Qualifier	4	Dosing Frequency in Exposure as Collected • "ONCE"	CRF Annotated Case Report Form [26 ]
ECROUTE	Route of Administration	text	Variable Qualifier	13	Route of Administration in Exposure as Collected • "INTRAMUSCULAR"	CRF Annotated Case Report Form [26 ]
ECLOC	Location of Dose Administration	text	Record Qualifier	3	Location of Dose Administration for Exposure as Collected • "ARM"	CRF Annotated Case Report Form [26 ]
ECLAT	Laterality	text	Record Qualifier	5	Laterality in Exposure as Collected • "LEFT" • "RIGHT"	CRF Annotated Case Report Form [26 ]
VISITNUM	Visit Number	integer	Timing	8		Assigned Set to TV.VISITNUM based on VISIT
VISIT	Visit Name	text	Timing	28		Assigned
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --STDTC is greater or equal to SESTDTC and Less than or equal to SEENDTC
ECSTDTC	Start Date/Time of Treatment	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [26 ]
ECENDTC	End Date/Time of Treatment	datetime	Timing		ISO 8601	Assigned
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
ECREASOC	Reason for Occur Value	text	Record Qualifier	200		CRF Annotated Case Report Form [26 ]

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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	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
EXSEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
EXTRT	Name of Treatment	text	Topic	9	Name of Treatment • "PLACEBO" • "mRNA-1273"	Derived Set to Placebo or mRNA-1273 after merging by randomization ID from randomization file
EXDOSE	Dose	integer	Record Qualifier	8		Derived Set to 0 if EXTRT = "PLACEBO" or set to Actual dose from IRT
EXDOSTXT	Dose Description	text		20		eDT Get detailed dosing error information for the injection where dosing error occurred
EXDOSU	Dose Units	text	Variable Qualifier	2	Dose Units in Exposure • "ug"	Assigned
EXDOSFRM	Dose Form	text	Variable Qualifier	9	Dose Form in Exposure • "INJECTION"	Assigned
EXDOSFRQ	Dosing Frequency per Interval	text	Variable Qualifier	4	Dosing Frequency in Exposure • "ONCE"	CRF Annotated Case Report Form [26 ]
EXROUTE	Route of Administration	text	Variable Qualifier	13	Route of Administration in Exposure • "INTRAMUSCULAR"	CRF Annotated Case Report Form [26 ]
EXLOC	Location of Dose Administration	text	Record Qualifier	3	Location of Dose Administration for Exposure • "ARM"	CRF Annotated Case Report Form [26 ]
EXLAT	Laterality	text	Variable Qualifier	5	Laterality in Exposure • "LEFT" • "RIGHT"	CRF Annotated Case Report Form [26 ]
VISITNUM	Visit Number	integer	Timing	8		Assigned Set to TV.VISITNUM based on VISIT
VISIT	Visit Name	text	Timing	28		Assigned
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --STDTC is greater or equal to SESTDTC and Less than or equal to SEENDTC
EXSTDTC	Start Date/Time of Treatment	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [26 ]
EXENDTC	End Date/Time of Treatment	datetime	Timing		ISO 8601	Assigned
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
Related Supplemental Qualifiers Dataset: SUPPPR (Supplemental Qualifiers PR)
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
PRSEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
PRSPID	Sponsor-Defined Identifier	text	Identifier	3		Assigned
PRTRT	Reported Name of Procedure	text	Topic	27		CRF Annotated Case Report Form [38 ]
PRINDC	Indication	text	Record Qualifier	15	Procedure Indication • "ADVERSE EVENT" • "DIAGNOSTIC" • "MEDICAL HISTORY" • "OTHER"	CRF Annotated Case Report Form [38 ]
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --STDTC is greater or equal to SESTDTC and Less than or equal to SEENDTC
PRSTDTC	Start Date/Time of Procedure	date	Timing		ISO 8601	CRF Annotated Case Report Form [38 ]
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

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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 AE)
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
SUBJID	Subject Identifier for the Study	text		9		Assigned Subject identified assigned during screening
AESEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
AEREFID	Reference ID	text	Identifier	25		Derived Set to "DOSE 1" concatenate date time of Dose 1 if AE Onset date time is before dose 2 date time or dose 2 date time is missing, otherwise set to "DOSE 2" concatenate date time of Dose 2
AESPID	Sponsor-Defined Identifier	text	Identifier	3		Derived set to "AE-" + AE log number by subject identifier
AELNKGRP	Link Group ID	text	Identifier	4		Derived Assigned values from 1010 to 1150 for each event term with Dose 1 and assigned values from 2010 to 2150 for each event term with Dose 2
AETERM	Reported Term for the Adverse Event	text	Topic	70		CRF Annotated Case Report Form [40 ]
AELLT	Lowest Level Term	text	Variable Qualifier	31	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	33	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	57	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	55	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 [41 ]
AESER	Serious Event	text	Record Qualifier	1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [40 ]
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 [40 ]
AEACNOTH	Other Action Taken	text	Record Qualifier	45		CRF Annotated Case Report Form [40 ]
AEREL	Causality	text	Record Qualifier	14	Causality • "NOT APPLICABLE" • "NOT RELATED" • "RELATED"	CRF Annotated Case Report Form [40 ]
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 [40 ]
AEOUT	Outcome of Adverse Event	text	Record Qualifier	26	Outcome of Event in Adverse Events • "NOT RECOVERED/NOT RESOLVED" • "RECOVERED/RESOLVED" • "RECOVERING/RESOLVING" • "UNKNOWN"	CRF Annotated Case Report Form [40 ]
AESCONG	Congenital Anomaly or Birth Defect	text	Record Qualifier	1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [40 ]
AESDISAB	Persist or Signif Disability/Incapacity	text	Record Qualifier	1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [40 ]
AESDTH	Results in Death	text	Record Qualifier	1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [40 ]
AESHOSP	Requires or Prolongs Hospitalization	text	Record Qualifier	1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [40 ]
AESLIFE	Is Life Threatening	text	Record Qualifier	1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [40 ]
AESMIE	Other Medically Important Serious Event	text	Record Qualifier	1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [40 ]
AETOXGR	Standard Toxicity Grade	text	Record Qualifier	8	Standard Toxicity Grade in Adverse Events • "1" • "2" • "3" • "4"	CRF Annotated Case Report Form [41 ]
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --STDTC is greater or equal to SESTDTC and Less than or equal to SEENDTC
AESTDTC	Start Date/Time of Adverse Event	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [40 ]
AEENDTC	End Date/Time of Adverse Event	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [40 ]
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
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
AEENRF	End Relative to Reference Period	text	Timing	7	Relation to Reference Period • "ONGOING"	CRF Annotated Case Report Form [40 ]

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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 CE)
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
CESEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
CELNKGRP	Link Group ID	text	Identifier	4		CRF Annotated Case Report Form [31 32 47 48 49 50 ]
CETERM	Reported Term for the Clinical Event	text	Topic	37	Clinical Events [14 Terms]	CRF Annotated Case Report Form [31 32 47 48 49 50 ]
CECAT	Category for Clinical Event	text	Grouping Qualifier	14	Category for Clinical Event • "REACTOGENICITY"	Assigned Set to "REACTOGENICITY"
CESCAT	Subcategory for Clinical Event	text	Grouping Qualifier	19	Subcategory for Clinical Event • "ADMINISTRATION SITE" • "SYSTEMIC"	Assigned Set to "ADMINISTRATION SITE" for Pain, Redness,Swelling Underarm Gland and Injection site pages. and "SYSTEMIC" for Headache, Fatigue, Muscle ache, Joints ache, Nausea, Chills, Rash, and Temperature pages
CEPRESP	Clinical Event Pre-Specified	text	Variable Qualifier	1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [31 32 47 48 49 50 ]
CEOCCUR	Clinical Event Occurrence	text	Record Qualifier	1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [31 32 47 48 49 50 ]
CESTAT	Completion Status	text	Record Qualifier	8		CRF Annotated Case Report Form [31 32 ] Set to "NOT DONE" if no event data is collected within 7 days of each vaccine
CETOXGR	Toxicity Grade	text		8	Standard Toxicity Grade in Clinical Events • "0" • "1" • "2" • "3" • "4"	CRF Annotated Case Report Form [41 ]
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --DTC is greater or equal to SESTDTC and Less than or equal to SEENDTC.
CEDTC	Date/Time of Event Collection	datetime	Timing		ISO 8601	Derived Last symptom event assessment date time based on CETPTREF within observed period (7 days)
CESTDTC	Start Date/Time of Clinical Event	datetime	Timing		ISO 8601	Derived First symptom event occured date time based on CETPTREF within observed period (7 days)
CEENDTC	End Date/Time of Clinical Event	datetime	Timing		ISO 8601	Derived Date of last occurrence of event of each vaccine
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 Number of days with symptom event occurred within observed period (7 Days) based on CETPTREF
CETPT	Planned Time Point Name	text	Timing	49		Protocol
CETPTNUM	Planned Time Point Number	float	Timing	8		Assigned
CETPTREF	Time Point Reference	text	Timing	6		CRF Annotated Case Report Form [31 32 ]
CEEVINTX	Evaluation Interval Text	text	Timing	17	Evaluation Interval • "SINCE VACCINATION"	Assigned
CERFTDTC	Date/Time of Reference Time Point	datetime	Timing		ISO 8601	Assigned Set to EXSTDTC based on CETPTREF

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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 DS)
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
SUBJID	Subject Identifier for the Study	text		9		Assigned Subject identified assigned during screening
DSSEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
DSREFID	Reference ID	text	Identifier	4		CRF Annotated Case Report Form [25 ]
DSSPID	Sponsor-Defined Identifier	text		10		CRF Annotated Case Report Form [42 43 ]
DSTERM	Reported Term for the Disposition Event	text	Topic	179		CRF Annotated Case Report Form [6 25 42 43 ]
DSDECOD	Standardized Disposition Term	text	Synonym Qualifier	25	Standardized Disposition Term [12 Terms]	Assigned
DSCAT	Category for Disposition Event	text	Grouping Qualifier	18	Category for Disposition Event • "PROTOCOL MILESTONE" • "DISPOSITION EVENT"	Assigned
DSSCAT	Subcategory for Disposition Event	text	Grouping Qualifier	15	Subcategory for Disposition Event • "SCREEN FAILURE" • "STUDY TREATMENT" • "END OF STUDY"	Assigned
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --STDTC is greater or equal to SESTDTC and Less than or equal to SEENDTC
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
DSSTDTC	Start Date/Time of Disposition Event	date	Timing		ISO 8601	CRF Annotated Case Report Form [25 42 43 ]

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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 DV)
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
SUBJID	Subject Identifier for the Study	text		9		Assigned Subject identified assigned during screening
DVSEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
DVTERM	Protocol Deviation Term	text	Topic	199		eDT
DVCAT	Category for Protocol Deviation	text	Grouping Qualifier	18	Category for Protocol Deviation • "ICH/GCP Deviation" • "Protocol Deviation"	eDT
DVSCAT	Subcategory for Protocol Deviation	text	Grouping Qualifier	28	Subcategory for Protocol Deviation [11 Terms]	eDT
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --STDTC is greater or equal to SESTDTC and Less than or equal to SEENDTC
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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Environmental and Social Factors (ER)

ER (Environmental and Social Factors) - EVENTS Location: er.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPER (Supplemental Qualifiers ER)
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
ERSEQ	Sequence Number	integer		8		Assigned Order within each USUBJID and generated the key sequence of the domain
ERTERM	Reported Term	text		94	How was the Participant Exposed? [7 Terms]	CRF Annotated Case Report Form [29 ]
ERCAT	Category	text		17	Category for Environmental and Social Factors • "COVID-19 EXPOSURE"	CRF Annotated Case Report Form [29 ]
ERPRESP	Pre-specified	text		1	No Yes Response (Yes only) • "Y"	Assigned
EROCCUR	Occurrence	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [29 ]
VISITNUM	Visit Number	float	Timing	8		Assigned Set to TV.VISITNUM based on VISIT
VISIT	Visit Name	text	Timing	28		Assigned
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --STDTC is greater or equal to SESTDTC and Less than or equal to SEENDTC
ERDTC	Date/Time of Collection	date			ISO 8601	Assigned
ERSTDTC	Start Date/Time of Observation	date			ISO 8601	CRF Annotated Case Report Form [29 ]
ERDY	Study Day of Visit/Collection/Exam	integer		8		Derived --DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC
ERSTDY	Study Day of Start of Observation	integer		8		Derived --STDTC - DM.RFSTDTC if --STDTC < DM.RFSTDTC, --STDTC - DM.RFSTDTC + 1 if --STDTC >= DM.RFSTDTC
ERDUR	Duration	durationDatetime			ISO 8601	CRF Annotated Case Report Form [29 ]

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Healthcare Encounter (HO)

HO (Healthcare Encounter) - EVENTS Location: ho.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPHO (Supplemental Qualifiers HO)
STUDYID	Study Identifier	text	14		Protocol
DOMAIN	Domain Abbreviation	text	2		Assigned
USUBJID	Unique Subject Identifier	text	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
SUBJID	Subject Identifier for the Study	text	9		Assigned Subject identified assigned during screening
HOSPID	Sponsor-Defined Identifier	text	10		Assigned
HOSEQ	Sequence Number	integer	8		Assigned
HOREFID	Reference ID	text	25		Derived If data source is from adverse event, then Set to "DOSE 1" concatenate date time of Dose 1 if AE Onset date time is before dose 2 date time or dose 2 date time is missing, otherwise set to "DOSE 2" concatenate date time of Dose 2; If data source is from e-Diary, then Set "DOSE 1" data time of Dose 1 if Medical Attended event occurred before dose 2 date time or dose 2 date time is missing, otherwise, set to "DOSE 2" concatenate date time of Dose 2
HOTERM	Reported Term for Healthcare Encounter	text	16		Derived Set to "HOSPITAL" if an event captured in AE form indicates this event requires hospitalization, set to "ADMITTED TO ICU" if an event captured in AE form indicates this event requires ICU, set to "MEDICAL ATTENDED" if an AR symptom indicates this AR symptom requires MEDICAL ATTENDED
HODECOD	Dictionary-Derived Term	text	8		Assigned
HOOCCUR	Healthcare Encounter Occurrence	text	1		Derived Set to "Y" if HO.HOTERM="MEDICAL ATTENDED", set to "Y" if HOTERM="ADMITTED TO ICU" and HODUR>0, set to null if HO.HOTERM="HOSPITAL", otherwise, set to "N"
HOPRESP	Pre-Specified Healthcare Encounter	text	1		Assigned
EPOCH	Epoch	text	9		Derived Set to maximum SE.EPOCH where --STDTC is greater or equal to SESTDTC and Less than or equal to SEENDTC
HOSTDTC	Start Date/Time of Healthcare Encounter	datetime		ISO 8601	Derived Set to hospital admin date if HO.HOTERM="HOSPITAL", or set to first MEDICAL ATTENDED date if HO.HOTERM="MEDICAL ATTENDED", set to null otherwise
HOENDTC	End Date/Time of Healthcare Encounter	datetime		ISO 8601	Derived Set to hospital discharge date if HO.HOTERM="HOSPITAL", or set to last MEDICAL ATTENDED date if HO.HOTERM="MEDICAL ATTENDED", set to null otherwise
HOSTDY	Study Day of Start of Observation	integer	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	8		Derived --ENDTC - DM.RFSTDTC if --ENDTC < RFSTDTC, --ENDTC - DM.RFSTDTC + 1 if --ENDTC >= RFSTDTC
HODUR	Duration of Healthcare Encounter	text	8		CRF Annotated Case Report Form [40 ]

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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 MH)
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
SUBJID	Subject Identifier for the Study	text		9		Assigned Subject identified assigned during screening
MHSEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
MHSPID	Sponsor-Defined Identifier	text	Identifier	3		Assigned
MHTERM	Reported Term for the Medical History	text	Topic	64		CRF Annotated Case Report Form [10 ]
MHLLT	Lowest Level Term	text	Variable Qualifier	65	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
MHDECOD	Dictionary-Derived Term	text	Synonym Qualifier	40	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
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	7	Category for Medical History • "GENERAL"	Assigned
MHBODSYS	Body System or Organ Class	text	Record Qualifier	67	Medical Dictionary for Regulatory Activities MedDRA 23.0	Assigned
MHSOC	Primary System Organ Class	text	Variable 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	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --STDTC is greater or equal to SESTDTC and Less than or equal to SEENDTC
MHSTDTC	Start Date/Time of Medical History Event	text	Timing	10		CRF Annotated Case Report Form [10 ]
MHENDTC	End Date/Time of Medical History Event	text	Timing	10		CRF Annotated Case Report Form [10 ]
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"	Derived Set to ONGOING or UNKNOWN based on CRF
MHENTPT	End Reference Time Point	date	Timing		ISO 8601	Assigned

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Visit Events (VE)

VE (Visit Events) - EVENTS Location: ve.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPVE (Supplemental Qualifiers VE)
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
VESEQ	Sequence Number	integer		8		Assigned Order within each USUBJID and generated the key sequence of the domain
VETERM	Reported Term	text		47		CRF Annotated Case Report Form [46 ]
VEDECOD	Dictionary-Derived Term	text		24	Dictionary-Derived Term in Visit Events • "MISSED ASSESSMENT" • "MISSED ASSESSMENT, OTHER" • "MISSED VISIT" • "STUDY TREATMENT NOT GIVEN, MISSED VISIT" • "VISIT PERFORMED OUT OF WINDOW"	CRF Annotated Case Report Form [46 ]
VISITNUM	Visit Number	integer	Timing	8		Assigned Set to TV.VISITNUM based on VISIT
VISIT	Visit Name	text	Timing	28		Assigned
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --DTC is greater or equal to SESTDTC and Less than or equal to SEENDTC.
VESTDTC	Start Date/Time of Observation	date			ISO 8601	CRF Annotated Case Report Form [46 ]
VESTDY	Study Day of Start of Observation	integer		8		Derived --STDTC - DM.RFSTDTC if --STDTC < DM.RFSTDTC, --STDTC - DM.RFSTDTC + 1 if --STDTC >= DM.RFSTDTC
VEREASOC	Reason for Occur Value	text		32		CRF Annotated Case Report Form [46 ]

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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
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
SUBJID	Subject Identifier	text		9		Assigned Subject identified assigned during screening
IESEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
IETESTCD	Inclusion/Exclusion Criterion Short Name	text	Topic	5		Assigned
IETEST	Inclusion/Exclusion Criterion	text	Synonym Qualifier	200		Assigned
IECAT	Inclusion/Exclusion Category	text	Grouping Qualifier	9	Category for Inclusion/Exclusion • "EXCLUSION" • "INCLUSION"	Assigned
IEORRES	I/E Criterion Original Result	text	Result Qualifier	1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [8 ]
IESTRESC	I/E Criterion Result in Std Format	text	Result Qualifier	1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [8 ]
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --DTC is greater or equal to SESTDTC and Less than or equal to SEENDTC.
IEDTC	Date/Time of Collection	date	Timing		ISO 8601	Assigned
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 Assessments (IS)

IS (Immunogenicity Specimen Assessments) - 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 IS)
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
ISSEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
ISREFID	Reference ID	text	Identifier	11		eDT
ISTESTCD	Immunogenicity Test/Exam Short Name	text	Topic	7	Immunogenicity Test/Exam Short Name [12 Terms]	Assigned
ISTEST	Immunogenicity Test or Examination Name	text	Synonym Qualifier	30	Immunogenicity Test or Examination Name [12 Terms]	Assigned
ISCAT	Category for Immunogenicity Test	text	Grouping Qualifier	40	Category for Immunogenicity Specimen Assessments • "Serum SARS-CoV-2 Binding Antibodies" • "Serum SARS-CoV-2 Neutralizing Antibodies"	Assigned
ISORRES	Results or Findings in Original Units	text	Result Qualifier	5		eDT
ISORRESU	Original Units	text	Variable Qualifier	7	Original Units for Immunogenicity Specimen Assessments [6 Terms]	eDT
ISORNRLO	Reference Range Lower Limit in Orig Unit	text		2		eDT
ISORNRHI	Reference Range Upper Limit in Orig Unit	text		5		eDT
ISSTRESC	Result or Finding in Standard Format	text	Result Qualifier	5		Assigned
ISSTRESN	Numeric Results/Findings in Std. Units	integer	Result Qualifier	8		Assigned
ISSTRESU	Standard Units	text	Variable Qualifier	7	Standard Units for Immunogenicity Specimen Assessments [6 Terms]	Assigned
ISSTAT	Completion Status	text	Record Qualifier	8		eDT
ISREASND	Reason Not Done	text		200		eDT
ISNAM	Vendor Name	text	Record Qualifier	8	Vendor Name for Immunogenicity Specimen Assessments • "BATTELLE" • "PPD VACCINE"	eDT
ISSPEC	Specimen Type	text	Record Qualifier	5	Specimen Type in Immunogenicity Specimen Assessments • "SERUM"	eDT
ISLLOQ	Lower Limit of Quantitation	integer	Variable Qualifier	8		eDT
VISITNUM	Visit Number	integer	Timing	8		Assigned Set to TV.VISITNUM based on VISIT
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
VISIT	Visit Name	text	Timing	28		Assigned
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --DTC is greater or equal to SESTDTC and Less than or equal to SEENDTC.
ISDTC	Date/Time of Collection	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [27 ]
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 Test Results (LB)

LB (Laboratory Test Results) - FINDINGS Location: lb.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPLB (Supplemental Qualifiers LB)
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
SUBJID	Subject Identifier for the Study	text		9		Assigned Subject identified assigned during screening
LBSEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
LBREFID	Specimen ID	text	Identifier	11		eDT
LBTESTCD	Lab Test or Examination Short Name	text	Topic	8	Laboratory Test Code [37 Terms]	Assigned
LBTEST	Lab Test or Examination Name	text	Synonym Qualifier	37	Laboratory Test Name [37 Terms]	eDT
LBCAT	Category for Lab Test	text	Grouping Qualifier	14	Category for Lab Test • "CHEMISTRY" • "COAGULATION" • "HEMATOLOGY" • "PREGNANCY TEST" • "SEROLOGY"	CRF Annotated Case Report Form [15 16 17 18 19 22 24 ]
LBORRES	Result or Finding in Original Units	text	Result Qualifier	13		eDT
LBORRESU	Original Units	text	Variable Qualifier	9	Original Units for LB [8 Terms]	eDT
LBORNRLO	Reference Range Lower Limit in Orig Unit	text	Variable Qualifier	4		eDT
LBORNRHI	Reference Range Upper Limit in Orig Unit	text	Variable Qualifier	5		eDT
LBSTRESC	Character Result/Finding in Std Format	text	Result Qualifier	13		Derived LBORRES converted to standard unit
LBSTRESN	Numeric Result/Finding in Standard Units	float	Result Qualifier	8		Assigned
LBSTRESU	Standard Units	text	Variable Qualifier	7	Standard Units for LB [10 Terms]	Assigned
LBSTNRLO	Reference Range Lower Limit-Std Units	float	Variable Qualifier	8		Derived LBORNRLO converted to standard unit
LBSTNRHI	Reference Range Upper Limit-Std Units	float	Variable Qualifier	8		Derived LBORNRHI converted to standard unit
LBSTNRC	Reference Range for Char Rslt-Std Units	text	Variable Qualifier	18		Assigned
LBNRIND	Reference Range Indicator	text	Variable Qualifier	8	Reference Range Indicator in LB • "LOW" • "NORMAL" • "ABNORMAL" • "HIGH"	Derived Reference Range Indicator based upon standard results and ranges
LBSTAT	Completion Status	text	Record Qualifier	8		CRF Annotated Case Report Form [15 16 17 18 19 24 ]
LBNAM	Vendor Name	text	Record Qualifier	6	Vendor Name for LB • "GCL-US"	eDT
LBLOINC	LOINC Code	text	Synonym Qualifier	7		eDT
LBSPEC	Specimen Type	text	Record Qualifier	6	Specimen Type in LB • "BLOOD" • "PLASMA" • "SERUM" • "URINE"	eDT
LBMETHOD	Method of Test or Examination	text	Record Qualifier	39	Method of Test or Examination in LB [15 Terms]	eDT
LBBLFL	Baseline Flag	text	Record Qualifier	1	No Yes Response (Yes only) • "Y"	Derived Set to 'Y' for last non missing measurement (including repeated and unscheduled assessments) where LBDTC on or before RFSTDTC by each LBCAT and LBTESTCD
LBFAST	Fasting Status	text	Record Qualifier	1	No Yes Response • "N" • "Y" • "U"	eDT
LBTOXGR	Standard Toxicity Grade	text	Variable Qualifier	8	Standard Toxicity Grade in Laboratory Test Results • "1" • "2" • "3" • "4"	eDT Toxicity Grade is based on results in std. unit and definition from CEBR Guideline
VISITNUM	Visit Number	float	Timing	8		Assigned Set to TV.VISITNUM based on VISIT
VISIT	Visit Name	text	Timing	28		Assigned
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --DTC is greater or equal to SESTDTC and Less than or equal to SEENDTC.
LBDTC	Date/Time of Specimen Collection	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [15 16 17 18 19 22 24 ]
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

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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 MB)
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
MBSEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
MBGRPID	Group ID	text	Identifier	1		Assigned
MBREFID	Reference ID	text	Identifier	11		eDT
MBTESTCD	Microbiology Test or Finding Short Name	text	Topic	8	Microbiology Specimen Test Code [22 Terms]	eDT
MBTEST	Microbiology Test or Finding Name	text	Synonym Qualifier	40	Microbiology Specimen Test Name [22 Terms]	eDT
MBCAT	Category for Microbiology Finding	text	Grouping Qualifier	10	Category for Microbiology Finding • "BIOFIRE" • "SARS-CoV-2"	eDT
MBSCAT	Subcategory for Microbiology Finding	text	Grouping Qualifier	19	Subcategory for Microbiology Finding • "NASAL1" • "NASAL2" • "NASOPHARYNGEAL SWAB" • "SARS" • "SWAB"	eDT
MBORRES	Result or Finding in Original Units	text	Result Qualifier	12		eDT
MBSTRESC	Character Result/Finding in Std Format	text	Result Qualifier	12	Result in MB • "DETECTED" • "NOT DETECTED" • "NEGATIVE" • "POSITIVE"	Assigned
MBRESCAT	Result Category	text	Variable Qualifier	1		eDT A missing value
MBSTAT	Completion Status	text	Record Qualifier	8		CRF Annotated Case Report Form [20 21 ]
MBNAM	Vendor Name	text	Record Qualifier	38	Vendor Name for Microbiology Specimen [7 Terms]	eDT
MBREASND	Reason Microbiology Not Performed	text		4		eDT
MBSPEC	Specimen Type	text	Record Qualifier	16	Specimen Type in Microbiology Specimen • "OTHER" • "SWABBED MATERIAL"	eDT
MBMETHOD	Method of Test or Examination	text	Record Qualifier	6	Method of Test or Examination in Microbiology Specimen • "RT-PCR"	eDT
MBBLFL	Baseline Flag	text	Record Qualifier	1	No Yes Response (Yes only) • "Y"	Derived Set to 'Y' for last non missing measurement (including repeated and unscheduled assessments) where MBDTC on or before RFSTDTC by each MBTESTCD
VISITNUM	Visit Number	float	Timing	8		Assigned Set to TV.VISITNUM based on VISIT
VISIT	Visit Name	text	Timing	28		Assigned
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --DTC is greater or equal to SESTDTC and Less than or equal to SEENDTC.
MBDTC	Date/Time of Specimen Collection	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [20 21 33 ]
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

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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 RP)
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
SUBJID	Subject Identifier for the Study	text		9		Assigned
RPSEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
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 • "N" • "Y" • "U"	CRF Annotated Case Report Form [23 ]
RPORRESU	Original Units	text		2		Assigned Missing units as not applicable for categorical results "Y" and "N"
RPSTRESC	Character Result/Finding in Std. Format	text	Result Qualifier	1	No Yes Response • "N" • "Y" • "U"	Assigned
RPSTRESN	Numeric Result/Finding in Standard Units	integer		8		Assigned A missing value
RPSTRESU	Standard Units	text		2		Assigned Missing units as not applicable for categorical results "Y" and "N"
VISITNUM	Visit Number	integer	Timing	8		Assigned Set to TV.VISITNUM based on VISIT
VISIT	Visit Name	text	Timing	28		Assigned
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --DTC is greater or equal to SESTDTC and Less than or equal to SEENDTC.
RPDTC	Date/Time of Measurements	date	Timing		ISO 8601	CRF Annotated Case Report Form [23 ]
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 Status (SS)

SS (Subject Status) - FINDINGS Location: ss.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
SUBJID	Subject Identifier for the Study	text		9		Assigned Subject identified assigned during screening
SSSEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
SSTESTCD	Status Short Name	text	Topic	8	Status Short Name • "COVID" = "Exposed to COVID-19" • "COVIDSYM" = "Participant COVID-19 Symptomatic" • "CONTACT" = "Contact Attempted" • "CONSTAT" = "Contact Status"	Assigned
SSTEST	Status Name	text	Synonym Qualifier	32	Status Name • "Exposed to COVID-19" • "Participant COVID-19 Symptomatic" • "Contact Attempted" • "Contact Status"	Assigned
SSORRES	Result or Finding Original Result	text	Result Qualifier	1		CRF Annotated Case Report Form [3 28 ]
SSSTRESC	Character Result/Finding in Std Format	text	Result Qualifier	1		Assigned
VISITNUM	Visit Number	float	Timing	8		Assigned Set to TV.VISITNUM based on VISIT
VISIT	Visit Name	text	Timing	28		Assigned
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --STDTC is greater or equal to SESTDTC and Less than or equal to SEENDTC
SSDTC	Date/Time of Assessment	date	Timing		ISO 8601	CRF Annotated Case Report Form [28 ]
SSDY	Study Day of Assessment	integer	Timing	8		Derived --DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC

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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 - VS)
STUDYID	Study Identifier	text	Identifier	14		Protocol
DOMAIN	Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
SUBJID	Subject Identifier for the Study	text		9		Assigned Subject identified assigned during screening
VSSEQ	Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
VSLNKGRP	Link Group ID	text	Identifier	4		CRF Annotated Case Report Form [47 ]
VSTESTCD	Vital Signs Test Short Name	text	Topic	6	Vital Signs Test Code [9 Terms]	Assigned
VSTEST	Vital Signs Test Name	text	Synonym Qualifier	24	Vital Signs Test Name [9 Terms]	Assigned
VSCAT	Category for Vital Signs	text	Grouping Qualifier	14	Category for Vital Signs • "REACTOGENICITY"	Assigned
VSSCAT	Subcategory for Vital Signs	text	Grouping Qualifier	8	Subcategory for Vital Signs • "SYSTEMIC"	Assigned
VSORRES	Result or Finding in Original Units	text	Result Qualifier	5		CRF Annotated Case Report Form [11 12 13 47 ]
VSORRESU	Original Units	text	Variable Qualifier	11	Original Units for Vital Signs [10 Terms]	CRF Annotated Case Report Form [11 12 13 47 ]
VSSTRESC	Character Result/Finding in Std Format	text	Result Qualifier	5		Derived VSORRES value converted into standard units
VSSTRESN	Numeric Result/Finding in Standard Units	float	Result Qualifier	8		Derived Numeric representation of VSORRESU
VSSTRESU	Standard Units	text	Variable Qualifier	11	Standard Units for Vital Signs [7 Terms]	Assigned
VSSTAT	Completion Status	text	Record Qualifier	8		CRF Annotated Case Report Form [11 12 13 47 ]
VSREASND	Reason Not Performed	text	Record Qualifier	28		Assigned
VSLOC	Location of Vital Signs Measurement	text	Record Qualifier	11	Location of Vital Sign Measurement • "ORAL CAVITY"	CRF Annotated Case Report Form [11 12 13 ]
VSBLFL	Baseline Flag	text	Record Qualifier	1	No Yes Response (Yes only) • "Y"	Derived Set to 'Y' for last non missing measurement (including repeated and unscheduled assessments) where VSDTC on or before RFSTDTC by each VSTESTCD where VSCAT is not "REACTOGENICITY"
VISITNUM	Visit Number	float	Timing	8		Assigned Set to TV.VISITNUM based on VISIT
VISIT	Visit Name	text	Timing	28		Assigned
VISITDY	Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --DTC is greater or equal to SESTDTC and Less than or equal to SEENDTC.
VSDTC	Date/Time of Measurements	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [11 12 13 47 ]
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	49		Protocol
VSTPTNUM	Planned Time Point Number	float	Timing	8		Assigned
VSTPTREF	Time Point Reference	text	Timing	6		Assigned
VSRFTDTC	Date/Time of Reference Time Point	datetime	Timing		ISO 8601	Assigned
VSEVLINT	Evaluation Interval	text	Timing	4		Assigned
VSEVINTX	Evaluation Interval Text	text	Timing	17	Evaluation Interval • "SINCE VACCINATION"	Assigned

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Findings About Events or Interventions (FAAE)

FAAE (Findings About Events or Interventions, FA) - FINDINGS ABOUT Location: faae.xpt
Variable	Where Condition	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPFAAE (Supplemental Qualifiers)
STUDYID		Study Identifier	text	Identifier	14		Protocol
DOMAIN		Domain Abbreviation	text	Identifier	2		Assigned
USUBJID		Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
SUBJID		Subject Identifier for the Study	text		9		Assigned Subject identified assigned during screening
FASEQ		Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
FALNKGRP		Link Group ID	text	Identifier	4		CRF Annotated Case Report Form [51 52 53 54 55 56 57 58 59 60 61 62 ]
FATESTCD		Findings About Test Short Name	text	Topic	6	Findings About Events or Interventions Test Code • "LDIAM" = "Longest Diameter" • "OCCUR" = "Occurrence" • "SEV" = "Severity/Intensity"	Assigned
FATEST		Findings About Test Name	text	Synonym Qualifier	20	Findings About Events or Interventions Test Name • "Longest Diameter" • "Occurrence Indicator" • "Severity/Intensity"	Assigned
FAOBJ		Object of the Observation	text	Record Qualifier	39		Assigned
FACAT		Category for Findings About	text	Grouping Qualifier	17	Category for Findings About Events or Interventions • "REACTOGENICITY"	Assigned
FASCAT		Subcategory for Findings About	text	Grouping Qualifier	19	Subcategory for Findings About Events or Interventions • "ADMINISTRATION SITE" • "SYSTEMIC"	Assigned
FAORRESVLM		Result or Finding in Original Units	text	Result Qualifier	94		CRF Annotated Case Report Form [30 31 32 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 ]
	FATESTCD = "LDIAM" (Longest Diameter)	Longest diameter	integer		2		CRF Annotated Case Report Form [48 52 53 ]
	FATESTCD = "OCCUR" (Occurrence)	Occurrence Indicator	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [30 32 48 49 50 52 53 60 61 ]
	FATESTCD = "SEV" (Severity/Intensity)	Severity/Intensity	text		94		CRF Annotated Case Report Form [31 48 49 51 54 55 56 57 58 59 62 ]
FAORRESUVLM		Original Units	text	Variable Qualifier	2	Original Units for Findings About Events or Interventions • "mm"	CRF Annotated Case Report Form [52 53 ]
	FATESTCD = "LDIAM" (Longest Diameter)	Longest diameter	text		2	Longest diameter • "mm" = "Longest Diameter"
FASTRESCVLM		Character Result/Finding in Std Format	text	Result Qualifier	94		Assigned
	FATESTCD = "LDIAM" (Longest Diameter)	Longest diameter	integer		2
	FATESTCD = "OCCUR" (Occurrence)	Occurrence Indicator	text		1	No Yes Response • "N" • "Y" • "U"
	FATESTCD = "SEV" (Severity/Intensity)	Severity/Intensity	text		94
FASTRESN		Numeric Result/Finding in Standard Units	integer	Result Qualifier	8		Assigned
FASTRESUVLM		Standard Units	text	Variable Qualifier	2	Standard Units for Findings About Events or Interventions • "mm"	Assigned
	FATESTCD = "LDIAM" (Longest Diameter)	Longest diameter	text		2	Longest diameter • "mm" = "Longest Diameter"
FASTAT		Completion Status	text	Record Qualifier	8		Assigned 1.Not Done Check box was not included in ePRO. ePRO is based on Window Open and Close to collect data, Mapping assumptions are a.--STAT = NOT DONE if subject did not enter a symptom data within window open duration b.--STAT = Blank if subjid entered a symptom data within window open duration
VISITNUM		Visit Number	integer	Timing	8		Assigned Set to TV.VISITNUM based on VISIT
EPOCH		Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --DTC is greater or equal to SESTDTC and Less than or equal to SEENDTC.
FADTC		Date/Time of Collection	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [51 52 53 54 55 56 57 58 59 60 61 62 ]
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	49		Protocol
FATPTNUM		Planned Time Point Number	integer	Timing	8		Assigned
FATPTREF		Time Point Reference	text	Timing	6		Derived Set to DOSE 1 if symptom event occurred before dose 2 or dose 2 has not started yet, otherwise set to DOSE 2 if symptom event occurred after dose2
FARFTDTC		Date/Time of Reference Time Point	datetime	Timing		ISO 8601	Assigned
FAEVLINT		Evaluation Interval	text	Timing	4		Assigned

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Findings About Events or Interventions (FACE)

FACE (Findings About Events or Interventions, FA) - FINDINGS ABOUT Location: face.xpt
Variable	Where Condition	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPFACE (Supplemental Qualifiers)
STUDYID		Study Identifier	text	Identifier	14		Protocol
DOMAIN		Domain Abbreviation	text	Identifier	2		Assigned
USUBJID		Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
SUBJID		Subject Identifier for the Study	text		9		Assigned Subject identified assigned during screening
FASEQ		Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
FALNKGRP		Link Group ID	text	Identifier	4		CRF Annotated Case Report Form [31 32 48 49 50 ]
FATESTCD		Findings About Test Short Name	text	Topic	6	FACE Test Code • "LDIAM" = "Longest Diameter" • "OCCUR" = "Occurrence" • "SEV" = "Severity/Intensity"	Assigned
FATEST		Findings About Test Name	text	Synonym Qualifier	20	FACE Test Name • "Longest Diameter" • "Occurrence Indicator" • "Severity/Intensity"	Assigned
FAOBJ		Object of the Observation	text	Record Qualifier	39		Assigned
FACAT		Category for Findings About	text	Grouping Qualifier	17	Category for FACE • "REACTOGENICITY"	Assigned
FASCAT		Subcategory for Findings About	text	Grouping Qualifier	19	Subcategory for FACE • "ADMINISTRATION SITE" • "SYSTEMIC"	Assigned
FAORRESVLM		Result or Finding in Original Units	text	Result Qualifier	94		CRF Annotated Case Report Form [30 31 32 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 ]
	FATESTCD = "OCCUR" (Occurrence)	Occurrence Indicator	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [30 32 48 49 50 52 53 60 61 ]
	FATESTCD = "SEV" (Severity/Intensity)	Severity/Intensity	text		92		CRF Annotated Case Report Form [31 48 49 51 54 55 56 57 58 59 62 ]
	FATESTCD = "LDIAM" (Longest Diameter)	Longest diameter	integer		3		CRF Annotated Case Report Form [48 52 53 ]
FAORRESUVLM		Original Units	text	Variable Qualifier	2	Original Units for FACE • "mm"	CRF Annotated Case Report Form [48 ]
	FATESTCD = "LDIAM" (Longest Diameter)	Longest diameter	text		2	Longest diameter • "mm" = "Longest Diameter"
FASTRESCVLM		Character Result/Finding in Std Format	text	Result Qualifier	94		Assigned
	FATESTCD = "OCCUR" (Occurrence)	Occurrence Indicator	text		1	No Yes Response • "N" • "Y" • "U"
	FATESTCD = "SEV" (Severity/Intensity)	Severity/Intensity	text		92
	FATESTCD = "LDIAM" (Longest Diameter)	Longest diameter	integer		3
FASTRESN		Numeric Result/Finding in Standard Units	integer	Result Qualifier	8		Assigned
FASTRESUVLM		Standard Units	text	Variable Qualifier	2	Standard Units for FACE • "mm"	Assigned
	FATESTCD = "LDIAM" (Longest Diameter)	Longest diameter	text		2	Longest diameter • "mm" = "Longest Diameter"
FASTAT		Completion Status	text	Record Qualifier	8		Assigned 1.Not Done Check box was not included in ePRO. ePRO is based on Window Open and Close to collect data, Mapping assumptions are a.--STAT = NOT DONE if subject did not enter a symptom data within window open duration b.--STAT = Blank if subjid entered a symptom data within window open duration
FALOC		Location of the Finding About	text	Record Qualifier	34	Location of Findings Measurement for FACE [9 Terms]	CRF Annotated Case Report Form [31 ]
FAEVAL		Evaluator	text	Record Qualifier	12	Evaluator for FACE • "INVESTIGATOR"	CRF Annotated Case Report Form [31 32 ]
VISITNUM		Visit Number	integer	Timing	8		Assigned Set to TV.VISITNUM based on VISIT
EPOCH		Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --DTC is greater or equal to SESTDTC and Less than or equal to SEENDTC.
FADTC		Date/Time of Collection	datetime	Timing		ISO 8601	CRF Annotated Case Report Form [31 32 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
FATPT		Planned Time Point Name	text	Timing	49		Protocol
FATPTNUM		Planned Time Point Number	float	Timing	8		Assigned
FATPTREF		Time Point Reference	text	Timing	6		Derived Set to DOSE 1 if symptom event occurred before dose 2 or dose 2 has not started yet, otherwise set to DOSE 2 if symptom event occurred after dose2
FARFTDTC		Date/Time of Reference Time Point	datetime	Timing		ISO 8601	Assigned
FAEVLINT		Evaluation Interval	text	Timing	4		Assigned
FAEVINTX		Evaluation Interval Text	text	Timing	17	Evaluation Interval • "SINCE VACCINATION"	Assigned

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Findings About Events or Interventions (FAOT)

FAOT (Findings About Events or Interventions, FA) - FINDINGS ABOUT Location: faot.xpt
Variable	Where Condition	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPFAOT (Supplemental Qualifiers)
STUDYID		Study Identifier	text	Identifier	14		Protocol
DOMAIN		Domain Abbreviation	text	Identifier	2		Assigned
USUBJID		Unique Subject Identifier	text	Identifier	25		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 3.4.1
SUBJID		Subject Identifier for the Study	text		9		Assigned Subject identified assigned during screening
FASEQ		Sequence Number	integer	Identifier	8		Assigned Order within each USUBJID and generated the key sequence of the domain
FATESTCD		Findings About Test Short Name	text	Topic	6	Findings About Events or Interventions Test Code [6 Terms]	Assigned
FATEST		Findings About Test Name	text	Synonym Qualifier	20	Findings About Events or Interventions Test Name [6 Terms]	Assigned
FAOBJ		Object of the Observation	text	Record Qualifier	39		Assigned
FACAT		Category for Findings About	text	Grouping Qualifier	17	Category for Findings About Events or Interventions • "COVID-19 SYMPTOMS"	Assigned
FAORRESVLM		Result or Finding in Original Units	text	Result Qualifier	94		CRF Annotated Case Report Form [14 30 32 48 49 50 52 53 60 61 ]
	FATESTCD = "ASSESS" (Assessment)	Assessment	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [14 ]
	FATESTCD = "CHGHLTH" (Changes in health since last time)	Changes in health since last time	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [63 ]
	FATESTCD = "COVIDEXP" (Exposure with SARS-CoV-2 or COVID-19)	Exposure with SARS-CoV-2 or COVID-19	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [63 ]
	FATESTCD = "HLTHPCT" (Healthcare provided contact)	Healthcare provided contact	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [63 ]
	FATESTCD = "NEWSYMP" (Experience new symptoms of COVID-19)	Experience new symptoms of COVID-19	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [63 ]
	FATESTCD = "OCCUR" (Occurrence)	Occurrence Indicator	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [30 32 48 49 50 52 53 60 61 ]
FASTRESCVLM		Character Result/Finding in Std Format	text	Result Qualifier	94		Assigned
	FATESTCD = "ASSESS" (Assessment)	Assessment	text		1	No Yes Response • "N" • "Y" • "U"
	FATESTCD = "CHGHLTH" (Changes in health since last time)	Changes in health since last time	text		1	No Yes Response • "N" • "Y" • "U"
	FATESTCD = "COVIDEXP" (Exposure with SARS-CoV-2 or COVID-19)	Exposure with SARS-CoV-2 or COVID-19	text		1	No Yes Response • "N" • "Y" • "U"
	FATESTCD = "HLTHPCT" (Healthcare provided contact)	Healthcare provided contact	text		1	No Yes Response • "N" • "Y" • "U"
	FATESTCD = "NEWSYMP" (Experience new symptoms of COVID-19)	Experience new symptoms of COVID-19	text		1	No Yes Response • "N" • "Y" • "U"
	FATESTCD = "OCCUR" (Occurrence)	Occurrence Indicator	text		1	No Yes Response • "N" • "Y" • "U"
VISITNUM		Visit Number	float	Timing	8		Assigned Set to TV.VISITNUM based on VISIT
VISIT		Visit Name	text	Timing	28		Assigned
VISITDY		Planned Study Day of Visit	integer	Timing	8		Protocol
EPOCH		Epoch	text	Timing	9	Epoch • "SCREENING" • "TREATMENT" • "FOLLOW-UP"	Derived Set to maximum SE.EPOCH where --DTC is greater or equal to SESTDTC and Less than or equal to SEENDTC.
FADTC		Date/Time of Collection	date	Timing		ISO 8601	CRF Annotated Case Report Form [14 ]
FADY		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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Related Records (RELREC)

RELREC (Related Records) - RELATIONSHIP Location: relrec.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2	Related Domain Abbreviation in Related Records • "AE" • "CE" • "FA" • "HO" • "VS"	Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
IDVAR	Identifying Variable	text	Record Qualifier	8	Identifying Variable in Related Records [6 Terms]	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	6		Assigned
RELTYPE	Relationship Type	text	Identifier	1		Assigned
RELID	Relationship Identifier	text	Identifier	3		Assigned

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Supplemental Qualifiers AE (SUPPAE)

SUPPAE (Supplemental Qualifiers 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	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers AE • "AESEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	1		Assigned
QNAM	Qualifier Variable Name	text	Topic	7	Qualifier Variable Name for Supplemental Qualifiers AE [9 Terms]	Assigned (Source: Sponsor)
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	27		Assigned (Source: Sponsor)
QVALVLM	Data Value	text	Result Qualifier	86
➤ QNAM = "AETRTEM"	Treatment Emergent Flag	text		1	No Yes Response • "N" • "Y" • "U"	Derived Set to "Y" if any adverse event with start date (AE.AESTDTC) occurring on or after the first dose of study drug (SDTM.DM.RFSTDTC); If AE.AESTDTC is partial, uses SUPPAE.AESTDTCI instead
➤ QNAM = "AEMAFL"	Medically-attended AE?	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [40 ]
➤ QNAM = "HOSPID"	HO Sponsor-Defined Identifier	text		6		Derived Set to HO.HOSPID if AE leading to hospitalization and /or ICU
➤ QNAM = "DSSPID"	DS Sponsor-Defined Identifier	text		30		Derived Set to DS.DSSPID if AE leading to discontinue treatment (where DS.DSSCAT="STUDY TREATMENT") or end of study (where DS.DSSCAT="END OF STUDY")
➤ QNAM = "AESOFL"	Solicited Adverse Reaction?	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [40 ]
➤ QNAM = "REMOVEFL"	AR Remove Flag	text		1	No Yes Response (Yes only) • "Y"	Derived Set to "Y" if SUPPAE.QNAM="AESOLFL" and SUPPAE.QVAL="Y", and AE.AESER ne "Y" and the event was not last and beyond day 7
➤ QNAM = "AEDICNM"	Coder Dictionary Name	text		6		Assigned Coder Dictionary Name: MedDRA
➤ QNAM = "AEDICVR"	Coder Dictionary Version	float		4		Assigned Coder Dictionary Version: 23.0
QORIG	Origin	text	Result Qualifier	12		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned A missing value

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Supplemental Qualifiers CE (SUPPCE)

SUPPCE (Supplemental Qualifiers 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	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers CE • "CESEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	2		Assigned
QNAM	Qualifier Variable Name	text	Topic	6	Qualifier Variable Name for Supplemental Qualifiers CE [7 Terms]	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	23		Assigned
QVALVLM	Data Value	text	Result Qualifier	23
➤ QNAM = "AESPID"	AE Sponsor-Defined Identifier	text		14		Derived set to "AE-" + AE log number by subject identifier
➤ QNAM = "REASND"	Reason of Missing CESTDTC / CEENDTC	text		23		Derived Set to "MISSED DIARY ASSESSMENT" if subject unreported symptom assessment at least one day during observed period (7-days) after each vaccination
➤ QNAM = "AESEVX"	AE Severity/Intensity	text		30		Derived Set to Severity/Intensity captured from AE where Solicited AE flag is "Y" and AEDECOD is pre-define solicited symptom event
➤ QNAM = "MAAEFL"	Medically-attended Flag	text		1		Derived Set to Y if required any medical attention during observed period (7-days) after each vaccination
➤ QNAM = "HOSPID"	HO Sponsor-Defined Identifier	text		30		Derived Set to HO.HOSPID if reactogenicity leading to medical attention
➤ QNAM = "DSSPID"	DS Sponsor-Defined Identifier	text		30		Derived Set to DS.DSSPID If reactogenicity leading to discontinue treatment (where DS.DSSCAT="STUDY TREATMENT") or end of study (where DS.DSSCAT="END OF STUDY")
➤ QNAM = "CEEVAL"	CE Evaluator	text		13		Derived Set to 'STUDY SUBJECT' if from eDiary, else set to 'INVESTIGATOR'
QORIG	Origin	text	Result Qualifier	7		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned A missing value

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Supplemental Qualifiers CM (SUPPCM)

SUPPCM (Supplemental Qualifiers 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	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers CM • "CMSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	2		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers CM [19 Terms]	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	38		Assigned
QVALVLM	Data Value	text	Result Qualifier	86
➤ QNAM = "CMDICNM"	Coder Dictionary Medication Name	text		17	Coder Dictionary Medication Name • "WHODRUG-GLOBAL-B3"	Assigned
➤ QNAM = "ATCLEV3T"	ATC Level 3	text		67	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "ATCLEV4T"	ATC Level 4	text		73	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "ATCLEV4C"	ATC Level 4 Code	text		5	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "ATCLEV2T"	ATC Level 2	text		64	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMSOL"	Medication taken for Solicited Event ?	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [35 36 ]
➤ QNAM = "ATCLEV1C"	ATC Level 1 Code	text		1	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMDICVR"	Coder Dictionary Version	integer		6	Coder Dictionary Version • 202003	Assigned
➤ QNAM = "ATCLEV2C"	ATC Level 2 Code	text		3	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMPROTCD"	Name of Medication Product Code	text		13		Assigned
➤ QNAM = "CMONGOYN"	Ongoing	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [35 36 ]
➤ QNAM = "ATCLEV1T"	ATC Level 1	text		63	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "ATCLEV3C"	ATC Level 3 Code	text		4	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMTRADCD"	Trade Name of Medication Code	text		13	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMTRADE"	Trade Name of Medication	text		78	Medications Dictionary WHODD GLOBALB3Mar20	Assigned
➤ QNAM = "CMTRTTN"	Medication Trade Name	text		78	Medications Dictionary WHODD GLOBALB3Mar20	CRF Annotated Case Report Form [35 36 ]
➤ QNAM = "CMUOTHSP"	Dose Unit Other, Specify	text		29		CRF Annotated Case Report Form [35 36 ]
➤ QNAM = "CMFOTHSP"	Other Frequency, Specify	text		86		CRF Annotated Case Report Form [35 36 ]
➤ QNAM = "CMROTHSP"	Other Route of Admin, Specify	text		23		CRF Annotated Case Report Form [35 36 ]
QORIG	Origin	text	Result Qualifier	12		Assigned
QEVAL	Evaluator	text	Result Qualifier	6	Evaluator for Supplemental Qualifiers CM • "VENDOR"	Assigned

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Supplemental Qualifiers DM (SUPPDM)

SUPPDM (Supplemental Qualifiers 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	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
IDVAR	Identifying Variable	text	Record Qualifier	1		Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	1		Assigned
QNAM	Qualifier Variable Name	text	Topic	7	Qualifier Variable Name for Supplemental Qualifiers DM [7 Terms]	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	48
➤ QNAM = "PREVSCR"	Was this participant screened previously	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [6 ]
➤ QNAM = "PROTVER"	Protocol Version	text		11	Protocol Version • "AMENDMENT 1" • "AMENDMENT 2" • "AMENDMENT 3" • "AMENDMENT 5" • "ORIGINAL"	CRF Annotated Case Report Form [6 ]
➤ QNAM = "COHORT"	Cohort	text		48	Cohort • "COHORT 1: AGE >= 18 TO < 55 MRNA-1273 OR PLACEBO" • "COHORT 2: AGE >= 55 MRNA-1273 OR PLACEBO"	Assigned based on randomization number from IRT
➤ QNAM = "SENTL"	Sentinel participant	text		1	No Yes Response • "N" • "Y" • "U"	Assigned based on randomization number from IRT
➤ QNAM = "MULRACE"	Multiple Race	text		39	Multiple Race • "WHITE, AMERICAN INDIAN OR ALASKA NATIVE" • "WHITE, BLACK OR AFRICAN AMERICAN"	Derived If RACE='MULTIPLE', then set to 'WHITE' when checked, set to ' BLACK OR AFRICAN AMERICAN' when checked, set to 'ASIAN' when checked, set to 'AMERICAN INDIAN OR ALASKA NATIVE' '' when checked, set to 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERS' when checked, concatenate 'OTHER: ' with Race Other specify when checked. Concatenate all possible values above with ', '
➤ QNAM = "PREVNUM"	Previous Participant Number	text		9		CRF Annotated Case Report Form [6 ]
➤ QNAM = "RACEOTH"	If Race is Other, specify	text		9		CRF Annotated Case Report Form [5 ]
QORIG	Origin	text	Result Qualifier	12		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned A missing value

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Supplemental Qualifiers DS (SUPPDS)

SUPPDS (Supplemental Qualifiers DS, Disposition) - RELATIONSHIP Location: suppds.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: DS (Disposition)
STUDYID	Study Identifier	text	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	2		Assigned
USUBJID	Unique Subject Identifier	text	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
IDVAR	Identifying Variable	text	1		Assigned
IDVARVAL	Identifying Variable Value	text	1		Assigned
QNAM	Qualifier Variable Name	text	7	Qualifier Variable Name for Supplemental Qualifiers DS • "ENROLLYN" = "Was participant enrolled in the study" • "AESPID" = "AE Sponsor-Defined Identifier"	Assigned
QLABEL	Qualifier Variable Label	text	40		Assigned
QVALVLM	Data Value	text	48
➤ QNAM = "ENROLLYN"	Was participant enrolled in the study	text	1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [6 ]
➤ QNAM = "AESPID"	AE Sponsor-Defined Identifier	text	22		Derived Set to AESPID (AE log number) if discontinue treatment or end of study is due to AE or SAE
QORIG	Origin	text	12		Assigned
QEVAL	Evaluator	text	1		Assigned A missing value

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Supplemental Qualifiers DV (SUPPDV)

SUPPDV (Supplemental Qualifiers 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	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers DV • "DVSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	1		Assigned
QNAM	Qualifier Variable Name	text	Topic	7	Qualifier Variable Name for Supplemental Qualifiers DV [7 Terms]	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	29		Assigned
QVALVLM	Data Value	text	Result Qualifier	129		eDT
➤ QNAM = "DVSIG"	Significant	text		15	Significant • "NOT SIGNIFICANT" • "SIGNIFICANT"
➤ QNAM = "SEVDES"	Severity Code and Description	text		50	Severity Code and Description • "1 - Exclude from all analysis sets" • "3 - Exclude from per-protocol analysis set only" • "99 - Include in all analyses (minor PD)"
➤ QNAM = "SPECTPT"	Specify Timepoint	text		28
➤ QNAM IN ("DVTERM1", "DVTERM2", "DVTERM3")	Protocol Deviation Terms	text		200
QORIG	Origin	text	Result Qualifier	3		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned A missing value

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Supplemental Qualifiers ER (SUPPER)

SUPPER (Supplemental Qualifiers ER, Environmental and Social Factors) - RELATIONSHIP Location: supper.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: ER (Environmental and Social Factors)
STUDYID	Study Identifier	text	Identifier	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers ER • "ERSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	1		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers ER • "EXPOSEOT" = "Other exposure specify"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	22		Assigned
QVALVLM	Data Value	text	Result Qualifier	100		CRF Annotated Case Report Form [29 ]
➤ QNAM = "EXPOSEOT"	Other exposure specify	text		50		CRF Annotated Case Report Form [29 ]
QORIG	Origin	text	Result Qualifier	12		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned A missing value

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Supplemental Qualifiers (SUPPFAAE)

SUPPFAAE (Supplemental Qualifiers, 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 Events or Interventions)
STUDYID	Study Identifier	text	Identifier	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in SUPPFAAE • "FASEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	2		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for SUPPFAAE • "CRFTMPT" = "CRF Timepoint" • "CRFTMPTN" = "CRF Timepoint Number" • "AESPID" = "AE Sponsor-Defined Identifier" • "HOSPID" = "HO Sponsor-Defined Identifier" • "MAAEFL" = "Medically Attended Flag"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	20		Assigned
QVALVLM	Data Value	text	Result Qualifier	6
➤ QNAM = "CRFTMPTN"	CRF Timepoint Number	integer		2	CRF Timepoint Number [19 Terms]	CRF Annotated Case Report Form [48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 ]
➤ QNAM = "CRFTMPT"	CRF Timepoint	text		6	CRF Timepoint [19 Terms]	CRF Annotated Case Report Form [48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 ]
➤ QNAM = "AESPID"	AE Sponsor-Defined Identifier	text		14		Derived set to "AE-" + AE log number by subject identifier
➤ QNAM = "HOSPID"	HO Sponsor-Defined Identifier	text		6		Derived Set to HO.HOSPID if reactogenicity leading to medical attention
➤ QNAM = "MAAEFL"	Medically Attended Flag	text		1		CRF Annotated Case Report Form [40 50 61 ]
QORIG	Origin	text	Result Qualifier	12		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned A missing value

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Supplemental Qualifiers (SUPPFACE)

SUPPFACE (Supplemental Qualifiers, 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 Events or Interventions)
STUDYID	Study Identifier	text	Identifier	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in SUPPFACE • "FASEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	6		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for SUPPFACE [9 Terms]	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	26		Assigned
QVALVLM	Data Value	text	Result Qualifier	49
➤ QNAM = "CRFTMPT"	CRF Timepoint	text		49	CRF Timepoint [9 Terms]	CRF Annotated Case Report Form [48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 ]
➤ QNAM = "CRFTMPTN"	CRF Timepoint Number	float		2	CRF Timepoint Number [9 Terms]	CRF Annotated Case Report Form [48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 ]
➤ QNAM = "SREVL"	Rash evaluated?	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [31 ]
➤ QNAM = "LYMPHEVL"	Lymphadenopathy evaluated?	text		1	No Yes Response (Yes only) • "Y"	CRF Annotated Case Report Form [32 ]
➤ QNAM = "AESPID"	AE Sponsor-Defined Identifier	text		14		Derived set to "AE-" + AE log number by subject identifier
➤ QNAM = "HOSPID"	HO Sponsor-Defined Identifier	text		6		Derived Set to HO.HOSPID if reactogenicity leading to medical attention
➤ QNAM = "MAAEFL"	Medically Attended Flag	text		1		CRF Annotated Case Report Form [40 50 61 ]
➤ QNAM = "SITE1"	Investigator Site	text		1		CRF Annotated Case Report Form [31 32 ]
➤ QNAM = "SITE2"	Other Institution	text		1		CRF Annotated Case Report Form [31 32 ]
QORIG	Origin	text	Result Qualifier	12		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned A missing value

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Supplemental Qualifiers (SUPPFAOT)

SUPPFAOT (Supplemental Qualifiers, 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	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in SUPPFAOT • "FASEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	6		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for SUPPFAOT • "CLIN2" = "Study clinic contact 1" • "CLIN4A" = "Study clinic contact 3" • "SYMPOTH" = "Symptoms other" • "SYMPTDTC" = "Estimated date of first symptoms"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	32		Assigned
QVALVLM	Data Value	text	Result Qualifier	20
➤ QNAM = "SYMPTDTC"	Estimated date of first symptoms	date			ISO 8601	CRF Annotated Case Report Form [30 ]
➤ QNAM = "SYMPOTH"	Symptoms other	text		20		CRF Annotated Case Report Form [30 ]
➤ QNAM = "CLIN2"	Study clinic contact 1	text		77		CRF Annotated Case Report Form [63 ]
➤ QNAM = "CLIN4A"	Study clinic contact 3	text		77		CRF Annotated Case Report Form [64 ]
QORIG	Origin	text	Result Qualifier	12		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned A missing value

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Supplemental Qualifiers HO (SUPPHO)

SUPPHO (Supplemental Qualifiers HO, Healthcare Encounter) - RELATIONSHIP Location: suppho.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: HO (Healthcare Encounter)
STUDYID	Study Identifier	text	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	2		Assigned
USUBJID	Unique Subject Identifier	text	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
IDVAR	Identifying Variable	text	5		Assigned
IDVARVAL	Identifying Variable Value	text	1		Assigned
QNAM	Qualifier Variable Name	text	8	Qualifier Variable Name for Supplemental Qualifiers HO • "HOEVAL" = "Evaluator"	Assigned
QLABEL	Qualifier Variable Label	text	18		Assigned
QVALVLM	Data Value	text	30
➤ QNAM = "HOEVAL"	Evaluator	text	30		Derived Set to "STUDY SUBJECT" if source data is from e-Diary Set to "INVESTIGATOR" if source data is from AE
QORIG	Origin	text	12		Assigned
QEVAL	Evaluator	text	1		Assigned

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Supplemental Qualifiers IS (SUPPIS)

SUPPIS (Supplemental Qualifiers IS, Immunogenicity Specimen Assessments) - RELATIONSHIP Location: suppis.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: IS (Immunogenicity Specimen Assessments)
STUDYID	Study Identifier	text	Identifier	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers IS • "ISSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	1		Assigned
QNAM	Qualifier Variable Name	text	Topic	5	Qualifier Variable Name for Supplemental Qualifiers IS • "LLOQ" = "Lower Limit of Quantitation" • "LOD" = "Limit of Detection" • "RANGE" = "Range indicator" • "ULOQ" = "Upper Limit of Quantification"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	29		Assigned
QVALVLM	Data Value	text	Result Qualifier	18		eDT
➤ QNAM = "LOD"	Limit of Detection	float		9
➤ QNAM = "LLOQ"	Lower Limit of Quantitation	float		9
➤ QNAM = "ULOQ"	Upper Limit of Quantification	float		9
➤ QNAM = "RANGE"	Range indicator	text		18
QORIG	Origin	text	Result Qualifier	3		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned A missing value

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Supplemental Qualifiers LB (SUPPLB)

SUPPLB (Supplemental Qualifiers LB, Laboratory Test Results) - RELATIONSHIP Location: supplb.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: LB (Laboratory Test Results)
STUDYID	Study Identifier	text	Identifier	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers LB • "LBSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	2		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers LB [8 Terms]	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	37		Assigned
QVALVLM	Data Value	text	Result Qualifier	18
➤ QNAM = "CNVU"	Conventional Units	text		9	Conventional Units [8 Terms]	eDT
➤ QNAM = "CNVRESC"	Conventional Text Result	text		13		eDT
➤ QNAM = "CNVRESN"	Conventional Numeric Result	float		5		eDT
➤ QNAM = "RPTRTYP"	Reported Result Type	text		33	Reported Result Type • "Greater Than (quantifiable limit)" • "Less Than (quantifiable limit)" • "Numeric" • "Range" • "Text"	eDT
➤ QNAM = "CNVRESNP"	Conventional Numeric Result Precision	float		4	Conventional Numeric Result Precision • 8.0 • 8.1 • 8.2	eDT
➤ QNAM = "CNVNRLO"	Conventional Reference Range Low	text		18		eDT
➤ QNAM = "CNVNRHI"	Conventional Reference Range High	float		5		eDT
➤ QNAM = "PANELOTH"	Lab Panel Other, Specify	text		15		CRF Annotated Case Report Form [22 ]
QORIG	Origin	text	Result Qualifier	12		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned A missing value

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Supplemental Qualifiers MB (SUPPMB)

SUPPMB (Supplemental Qualifiers 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	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers MB • "MBSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	2		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers MB [6 Terms]	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	32		Assigned
QVALVLM	Data Value	text	Result Qualifier	102
➤ QNAM = "CNVNRLO"	Conventional Reference Range Low	text		12	Conventional Reference Range Low • "NOT DETECTED"	eDT
➤ QNAM = "CNVRESC"	Conventional Text Result	text		12	Conventional Text Result • "DETECTED" • "NOT DETECTED"	eDT
➤ QNAM = "RPTRTYP"	Reported Result Type	text		10	Reported Result Type • "Text"	eDT
➤ QNAM = "LDTSTOTH"	Diagnostic Test Other, Specify	text		200		CRF Annotated Case Report Form [33 ]
➤ QNAM = "LOCALFL"	Local Labs Flag	text		1	No Yes Response (Yes only) • "Y"	Derived Set to "Y" if data is collected from local diagnostic test form
➤ QNAM = "LDTTYPE"	Type of Diagnostic Test	text		20	Type of Diagnostic Test • "UNKNOWN"	CRF Annotated Case Report Form [33 ]
QORIG	Origin	text	Result Qualifier	12		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned A missing value

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Supplemental Qualifiers MH (SUPPMH)

SUPPMH (Supplemental Qualifiers 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	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers MH • "MHSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	2		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers MH • "MHDICNM" = "Coder Dictionary Name" • "MHDICVR" = "Coder Dictionary Version"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	29		Assigned
QVALVLM	Data Value	text	Result Qualifier	6
➤ QNAM = "MHDICNM"	Coder Dictionary Name	text		6	Coder Dictionary Name • "MedDRA"	Assigned
➤ QNAM = "MHDICVR"	Coder Dictionary Version	float		4	Coder Dictionary Version • 22.0 • 23.0	Assigned
QORIG	Origin	text	Result Qualifier	12		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned A missing value

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Supplemental Qualifiers PR (SUPPPR)

SUPPPR (Supplemental Qualifiers PR, Procedures) - RELATIONSHIP Location: supppr.xpt
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: PR (Procedures)
STUDYID	Study Identifier	text	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	2		Assigned
USUBJID	Unique Subject Identifier	text	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
IDVAR	Identifying Variable	text	5		Assigned
IDVARVAL	Identifying Variable Value	text	1		Assigned
QNAM	Qualifier Variable Name	text	8	Qualifier Variable Name for Supplemental Qualifiers PR • "PRINDOTH" = "Specify Other"	Assigned
QLABEL	Qualifier Variable Label	text	18		Assigned
QVALVLM	Data Value	text	200
➤ QNAM = "PRINDOTH"	Specify Other	text	200		CRF Annotated Case Report Form [38 ]
QORIG	Origin	text	12		Assigned
QEVAL	Evaluator	text	1		Assigned

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Supplemental Qualifiers RP (SUPPRP)

SUPPRP (Supplemental Qualifiers 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	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers RP • "RPSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	1		Assigned
QNAM	Qualifier Variable Name	text	Topic	7	Qualifier Variable Name for Supplemental Qualifiers RP • "CBENDTC" = "Date of Last Menstruation, Post-menop." • "CBRSN" = "Childbearing Potential No, Reason" • "CBSP" = "Partner Medically Sterile, Other Specify" • "CBSTDTC" = "Date of Surgery, if Surgically Sterile"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	18		CRF Annotated Case Report Form [23 ]
➤ QNAM = "CBRSN"	Childbearing Potential No, Reason	text		18	Childbearing Potential No, Reason • "PARTNER STERILE" • "POST-MENOPAUSAL" • "SURGICALLY STERILE"	CRF Annotated Case Report Form [23 ]
➤ QNAM = "CBENDTC"	Date of Last Menstruation, Post-menop.	text		10		CRF Annotated Case Report Form [23 ]
➤ QNAM = "CBENDUNK"	Date of Last Menstruation, Unknown	text		10		CRF Annotated Case Report Form [23 ]
➤ QNAM = "CBSTDTC"	Date of Surgery, if Surgically Sterile	text		10
➤ QNAM = "CBSDAUNK"	Date of Surgery, Unknown	text		10		CRF Annotated Case Report Form [23 ]
➤ QNAM = "CBSP"	Partner Medically Sterile, Other Specify	text		9		CRF Annotated Case Report Form [23 ]
QORIG	Origin	text	Result Qualifier	12		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned A missing value

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Supplemental Qualifiers VE (SUPPVE)

SUPPVE (Supplemental Qualifiers VE, Visit Events) - RELATIONSHIP Location: suppve.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: VE (Visit Events)
STUDYID	Study Identifier	text	Identifier	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers VE • "VESEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	1		Assigned
QNAM	Qualifier Variable Name	text	Topic	8	Qualifier Variable Name for Supplemental Qualifiers VE • "MISSASS" = "Missed Assessments"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	18		Assigned
QVALVLM	Data Value	text	Result Qualifier	200		CRF Annotated Case Report Form [45 46 ]
➤ QNAM = "MISSASS"	Missed Assessments	text		200		CRF Annotated Case Report Form [45 46 ]
QORIG	Origin	text	Result Qualifier	12		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned A missing value

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Supplemental Qualifiers - VS (SUPPVS)

SUPPVS (Supplemental Qualifiers - 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	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		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 3.4.1
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers - VS • "VSSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	2		Assigned
QNAM	Qualifier Variable Name	text	Topic	7	Qualifier Variable Name for Supplemental Qualifiers - VS • "MEDTAK" = "Medication taken today for pain or fever" • "MEDTAKP" = "Prevent Pain or Fever from Occurring" • "MEDTAKT" = "Treat Pain or Fever already Occurred"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	1		CRF Annotated Case Report Form [47 ]
➤ QNAM = "MEDTAK"	Medication taken today for pain or fever	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [47 ]
➤ QNAM = "MEDTAKT"	Treat Pain or Fever already Occurred	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [47 ]
➤ QNAM = "MEDTAKP"	Prevent Pain or Fever from Occurring	text		1	No Yes Response • "N" • "Y" • "U"	CRF Annotated Case Report Form [47 ]
QORIG	Origin	text	Result Qualifier	12		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned A missing value

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Supplemental Qualifiers XM (SUPPXM)

SUPPXM (Supplemental Qualifiers XM, Multiple Participations) - RELATIONSHIP Location: suppxm.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: XM (Multiple Participations)
STUDYID	Study Identifier	text	Identifier	14		Protocol
RDOMAIN	Related Domain Abbreviation	text	Identifier	2		Assigned
USUBJID	Unique Subject Identifier	text	Identifier	25		Derived The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
IDVAR	Identifying Variable	text	Record Qualifier	5	Identifying Variable in Supplemental Qualifiers XM • "XMSEQ"	Assigned
IDVARVAL	Identifying Variable Value	text	Record Qualifier	1		Assigned
QNAM	Qualifier Variable Name	text	Topic	7	Qualifier Variable Name for Supplemental Qualifiers XM • "MULRACE" = "Multiple Race" • "PREVSCR" = "Was this participant screened previously" • "PROTVER" = "Protocol Version"	Assigned
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		Assigned
QVALVLM	Data Value	text	Result Qualifier	40
➤ QNAM = "PROTVER"	Protocol Version	text		11	Protocol Version • "AMENDMENT 1" • "ORIGINAL"	CRF Annotated Case Report Form [6 ]
➤ QNAM = "PREVSCR"	Was this participant screened previously	text		1	No Yes Response (No Only) • "N"	CRF Annotated Case Report Form [6 ]
➤ QNAM = "MULRACE"	Multiple Race	text		40		Derived If RACE='MULTIPLE', then set to 'WHITE' when checked, set to ' BLACK OR AFRICAN AMERICAN' when checked, set to 'ASIAN' when checked, set to 'AMERICAN INDIAN OR ALASKA NATIVE' '' when checked, set to 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERS' when checked, concatenate 'OTHER: ' with Race Other specify when checked. Concatenate all possible values above with ', '
➤ QNAM = "RACEOTH"	If Race is Other, specify	text		9		CRF Annotated Case Report Form [5 ]
QORIG	Origin	text	Result Qualifier	12		Assigned
QEVAL	Evaluator	text	Result Qualifier	1		Assigned A missing value

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Description of Actual Arm

Permitted Value (Code)
Placebo
mRNA-1273 100 ug
mRNA-1273 50 ug

Actual Arm Code

Permitted Value (Code)	Display Value (Decode)
A100	mRNA-1273 100 ug
A50	mRNA-1273 50 ug
PLA	Placebo

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)
NOT RECOVERED/NOT RESOLVED [C49494]
RECOVERED/RESOLVED [C49498]
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 100 ug
mRNA-1273 50 ug

Planned Arm Code

Permitted Value (Code)	Display Value (Decode)
A100	mRNA-1273 100 ug
A50	mRNA-1273 50 ug
PLA	Placebo

Category for Clinical Event

Permitted Value (Code)
REACTOGENICITY

Subcategory for Clinical Event

Permitted Value (Code)
ADMINISTRATION SITE
SYSTEMIC

Clinical Events

Permitted Value (Code)
Arthralgia
Chills
Erythema
Fatigue
Fever
Headache
Lymphadenopathy
Myalgia
Nausea/Vomiting
Pain
Rash
Solicited Rash
Swelling
Underarm Gland Swelling or Tenderness

Standard Toxicity Grade in Clinical Events

Permitted Value (Code)
0
1
2
3
4

Category for Medication

Permitted Value (Code)
Prior/Concomitant Medication and 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]
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)
INTRAMUSCULAR [C28161]
INTRAOCULAR [C38255]
INTRAVENOUS [C38276]
INTRAVENOUS BOLUS [C38274]
NASAL [C38284]
ORAL [C38288]
OTHER [*]
RECTAL [C38295]
SUBCUTANEOUS [C38299]
TOPICAL [C38304]
TRANSDERMAL [C38305]
VAGINAL [C38313]

* Extended Value

Identifying Variable in Comments

Permitted Value (Code)
FASEQ
LBSEQ
MBSEQ

Related Domain Abbreviation in Comments

Permitted Value (Code)
FA
LB
MB

Country

Permitted Value (Code)
USA

Category for Disposition Event [C74558]

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

Standardized Disposition Term

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

Subcategory for Disposition Event [C170443]

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

* Extended Value

Category for Protocol Deviation

Permitted Value (Code)
ICH/GCP Deviation
Protocol Deviation

Subcategory for Protocol Deviation

Permitted Value (Code)
ICF Process/Timing
Informed Consent
Inclusion Criteria
Exclusion Criteria
Concomitant Medication
Study Treatment Admin/Dispense
Study Treatment Compliance
Missing Endpoint Assessments
Study Procedures/Assessments
Visit Scheduling
Inv Record Keeping Source Docs

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
mRNA-1273 50 ug
mRNA-1273 100 ug
Follow up

Relation to Reference Period (ENRTPT) [C66728]

Permitted Value (Code)
ONGOING [C53279]

Epoch [C99079]

Permitted Value (Code)
SCREENING [C48262]
TREATMENT [C101526]
FOLLOW-UP [C99158]

Category for Environmental and Social Factors

Permitted Value (Code)
COVID-19 EXPOSURE

How was the Participant Exposed?

Permitted Value (Code)
Family member
Health Care Facility
Other exposure
Social setting
The participant had close contact with a person known to have SARS-CoV-2 infection or COVID-19
Travel
Work

Element Code

Permitted Value (Code)	Display Value (Decode)
SCREEN	Screening
PBO	Placebo
V-50	mRNA-1273 50 ug
V-100	mRNA-1273 100 ug
FU	Follow up
UNPLAN	Unplanned

Ethnic Group [C66790]

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

Evaluation Interval

Permitted Value (Code)
SINCE VACCINATION

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 Events or Interventions

Permitted Value (Code)
REACTOGENICITY

Original Units for Findings About Events or Interventions [C71620]

Permitted Value (Code)
mm [*]

* Extended Value

Subcategory for Findings About Events or Interventions

Permitted Value (Code)
ADMINISTRATION SITE
SYSTEMIC

Standard Units for Findings About Events or Interventions [C71620]

Permitted Value (Code)
mm [*]

* Extended Value

Findings About Events or Interventions Test Name

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

Findings About Events or Interventions Test Code

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

Category for FACE

Permitted Value (Code)
REACTOGENICITY

Evaluator for FACE [C78735]

Permitted Value (Code)
INVESTIGATOR [*]

* Extended Value

Location of Findings Measurement for FACE [C74456]

Permitted Value (Code)
CHEST AND ABDOMEN [*]
LEFT ARM AT INJECTION SITE [*]
LEFT CHEEK [*]
LEFT DELTOID (INJECTION SITE) [*]
LEFT FOREARM AND RIGHT UPPER THIGH [*]
LEFT TORSO REGION [*]
NO RASH [*]
RASH ON RIGHT KNEE NON-URTICARIAL [*]
TORSO (CENTER) [*]

* Extended Value

Original Units for FACE [C71620]

Permitted Value (Code)
mm [*]

* Extended Value

Subcategory for FACE

Permitted Value (Code)
ADMINISTRATION SITE
SYSTEMIC

Standard Units for FACE [C71620]

Permitted Value (Code)
mm [*]

* Extended Value

FACE Test Name

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

FACE Test Code

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

Longest diameter

Permitted Value (Code)	Display Value (Decode)
mm [C28251]	Longest Diameter

Longest diameter

Permitted Value (Code)	Display Value (Decode)
mm [C28251]	Longest Diameter

Category for Findings About Events or Interventions

Permitted Value (Code)
COVID-19 SYMPTOMS

Findings About Events or Interventions Test Name

Permitted Value (Code)
Assessment
Occurrence Indicator
Changes in health since last time
Exposure with SARS-CoV-2 or COVID-19
Healthcare provided contact
Experience new symptoms of COVID-19

Findings About Events or Interventions Test Code

Permitted Value (Code)	Display Value (Decode)
ASSESS	Assessment
OCCUR	Occurrence
CHGHLTH	Changes in health since last time
COVIDEXP	Exposure with SARS-CoV-2 or COVID-19
HLTHPCT	Healthcare provided contact
NEWSYMP	Experience new symptoms of COVID-19

Longest diameter

Permitted Value (Code)	Display Value (Decode)
mm [C28251]	Longest Diameter

Longest diameter

Permitted Value (Code)	Display Value (Decode)
mm [C28251]	Longest Diameter

Category for Inclusion/Exclusion [C66797]

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

Category for Immunogenicity Specimen Assessments

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

Vendor Name for Immunogenicity Specimen Assessments

Permitted Value (Code)
BATTELLE
PPD VACCINE

Original Units for Immunogenicity Specimen Assessments [C71620]

Permitted Value (Code)
AU/mL [C70504]
MN50 [*]
MN Endpoint Titer [*]
PsVNT50 [*]
PsVNT80 [*]
ug/mL [*]

* Extended Value

Specimen Type in Immunogenicity Specimen Assessments [C78734]

Permitted Value (Code)
SERUM [C13325]

Standard Units for Immunogenicity Specimen Assessments [C71620]

Permitted Value (Code)
AU/mL [C70504]
MN50 [*]
MN Endpoint Titer [*]
PsVNT50 [*]
PsVNT80 [*]
ug/mL [*]

* Extended Value

Immunogenicity Test or Examination Name [C120526]

Permitted Value (Code)
All Immunogenicity Assessments [*]
MN50 [*]
MN Endpoint Titer [*]
PsVNT50 [*]
PsVNT80 [*]
VAC58 Nucleocapsid IgG Antibody [*]
VAC58 Spike IgG Antibody [*]
VAC58 Spike IgG subclass 1 [*]
VAC58 Spike IgG subclass 2 [*]
VAC58 Spike IgG subclass 3 [*]
VAC58 Spike IgG subclass 4 [*]
VAC58 Spike IgM Antibody [*]

* Extended Value

Immunogenicity Test/Exam Short Name [C120525]

Permitted Value (Code)	Display Value (Decode)
ISALL [*]	All Immunogenicity Assessments
MN50 [*]	MN50
MNET [*]	MN Endpoint Titer
PSVNT50 [*]	PsVNT50
PSVNT80 [*]	PsVNT80
V58IG1ES [*]	VAC58 Spike IgG subclass 1
V58IG2ES [*]	VAC58 Spike IgG subclass 2
V58IG3ES [*]	VAC58 Spike IgG subclass 3
V58IG4ES [*]	VAC58 Spike IgG subclass 4
V58IGGEN [*]	VAC58 Nucleocapsid IgG Antibody
V58IGGES [*]	VAC58 Spike IgG Antibody
V58IGMES [*]	VAC58 Spike IgM Antibody

* Extended Value

Category for Lab Test

Permitted Value (Code)
CHEMISTRY
COAGULATION
HEMATOLOGY
PREGNANCY TEST
SEROLOGY

Method of Test or Examination in LB [C85492]

Permitted Value (Code)
CALCULATION [C54125]
CHEMILUMINESCENCE [*]
CHEMILUMINESCENCE IMMUNOASSAY [*]
DIRECT CURRENT IMPEDANCE FLOW CYTOMETRY [*]
ELECTROCHEMILUMINESCENT [*]
ENDPOINT PHOTOMETRIC [*]
ENZYMATIC [*]
FLUORESCENT FLOW CYTOMETRY [*]
IMMUNODIFFUSION [C158239]
INSTRUMENT CALCULATED [*]
JAFFE [*]
MANUAL [*]
OPTICAL CLOT DETECTION [*]
PHOTOMETRIC [*]
RT-PCR [*]

* Extended Value

Vendor Name for LB

Permitted Value (Code)
GCL-US

Reference Range Indicator in LB [C78736]

Permitted Value (Code)
LOW [C78801]
NORMAL [C78727]
ABNORMAL [C78802]
HIGH [C78800]

Original Units for LB [C71620]

Permitted Value (Code)
% [C25613]
Seconds [*]
U/L [C67456]
g/dL [C64783]
mIU/mL [*]
mg/dL [C67015]
x 10^3/uL [*]
x 10^6/uL [*]

* Extended Value

Specimen Type in LB [C78734]

Permitted Value (Code)
BLOOD [C12434]
PLASMA [C13356]
SERUM [C13325]
URINE [C13283]

Standard Units for LB [C71620]

Permitted Value (Code)
% [C25613]
10^12/L [C67308]
10^9/L [C67255]
IU/L [C67376]
L/L [C105495]
U/L [C67456]
g/L [C42576]
mmol/L [C64387]
sec [C42535]
umol/L [C48508]

Laboratory Test Name [C67154]

Permitted Value (Code)
Activated Partial Thromboplastin Time [C38462]
Alanine Aminotransferase [C64433]
Alkaline Phosphatase [C64432]
All Lab Tests [*]
Aspartate Aminotransferase [C64467]
Basophils [C64470]
Basophils/Leukocytes [C64471]
Bilirubin [C38037]
Choriogonadotropin Beta [C64851]
Creatinine [C64547]
Direct Bilirubin [C64481]
Eosinophils [C64550]
Eosinophils/Leukocytes [C64604]
Erythrocytes [C51946]
Follicle Stimulating Hormone [C74783]
HCV Viral Load [*]
HIV-1/2 Antibody [*]
Hematocrit [C64796]
Hemoglobin [C64848]
Hepatitis B Virus Surface Antigen [*]
Hepatitis C Virus Antibody [*]
Human Immunodeficiency Virus [*]
Immature Granulocytes [C96675]
Immature Granulocytes/Leukocytes [C100445]
Leukocytes [C51948]
Lymphocytes [C51949]
Lymphocytes/Leukocytes [C64820]
Monocytes [C64823]
Monocytes/Leukocytes [C64824]
Neutrophils [C63321]
Neutrophils/Leukocytes [C64827]
Platelets [C51951]
Platelets, Estimated [C135440]
Prothrombin Intl. Normalized Ratio [C64805]
Prothrombin Time [C62656]
Urea Nitrogen [C125949]
Urea Nitrogen/Creatinine [C125950]

* Extended Value

Laboratory Test Code [C65047]

Permitted Value (Code)	Display Value (Decode)
ALP [C64432]	Alkaline Phosphatase
ALT [C64433]	Alanine Aminotransferase
APTT [C38462]	Activated Partial Thromboplastin Time
AST [C64467]	Aspartate Aminotransferase
BASO [C64470]	Basophils
BASOLE [C64471]	Basophils/Leukocytes
BILDIR [C64481]	Direct Bilirubin
BILI [C38037]	Bilirubin
CREAT [C64547]	Creatinine
EOS [C64550]	Eosinophils
EOSLE [C64604]	Eosinophils/Leukocytes
FSH [C74783]	Follicle Stimulating Hormone
GRANIM [C96675]	Immature Granulocytes
GRANIMLE [C100445]	Immature Granulocytes/Leukocytes
HBSAG [*]	Hepatitis B Virus Surface Antigen
HCAB [*]	Hepatitis C Virus Antibody
HCG [C64851]	Choriogonadotropin Beta
HCT [C64796]	Hematocrit
HCVVLD [*]	HCV Viral Load
HGB [C64848]	Hemoglobin
HIV [*]	Human Immunodeficiency Virus
HIV12AB [*]	HIV-1/2 Antibody
INR [C64805]	Prothrombin Intl. Normalized Ratio
LBALL [*]	All Lab Tests
LYM [C51949]	Lymphocytes
LYMLE [C64820]	Lymphocytes/Leukocytes
MONO [C64823]	Monocytes
MONOLE [C64824]	Monocytes/Leukocytes
NEUT [C63321]	Neutrophils
NEUTLE [C64827]	Neutrophils/Leukocytes
PLAT [C51951]	Platelets
PLATEST [C135440]	Platelets, Estimated
PT [C62656]	Prothrombin Time
RBC [C51946]	Erythrocytes
UREAN [C125949]	Urea Nitrogen
UREANCRT [C125950]	Urea Nitrogen/Creatinine
WBC [C51948]	Leukocytes

* Extended Value

Standard Toxicity Grade in Laboratory Test Results

Permitted Value (Code)
1
2
3
4

Category for Microbiology Finding

Permitted Value (Code)
BIOFIRE
SARS-CoV-2

Method of Test or Examination in Microbiology Specimen [C85492]

Permitted Value (Code)
RT-PCR [*]

* Extended Value

Vendor Name for Microbiology Specimen

Permitted Value (Code)
ADVENT HEALTH SHAWNEE MISSION
PARTIAL THROMBOPLASTIN TIME, ACTIVATED
QUEST DIAGNOSTICS
SHANNON MEDICAL CENTER
ViraCor-IBT Laboratories
Viracor Eurofins
WRIGHTSVILLE FAMILY PRACTICE

Result in MB

Permitted Value (Code)
DETECTED
NOT DETECTED
NEGATIVE
POSITIVE

Subcategory for Microbiology Finding

Permitted Value (Code)
NASAL1
NASAL2
NASOPHARYNGEAL SWAB
SARS
SWAB

Specimen Type in Microbiology Specimen [C78734]

Permitted Value (Code)
OTHER [*]
SWABBED MATERIAL [C150895]

* Extended Value

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)
B30854A [*]	Adenovirus
B30854B [*]	Bordetella pertussis
B30854D [*]	Chlamydophila pneumoniae
B30854E [*]	Coronavirus 229E
B30854F [*]	Coronavirus HKU1
B30854G [*]	Coronavirus NL63
B30854H [*]	Coronavirus OC43
B30854I [*]	Human metapneumovirus
B30854J [*]	Human Rhinovirus/Enterovirus
B30854K [*]	Influenza A
B30854L [*]	Influenza A subtype H1
B30854M [*]	Influenza A subtype H1/2009
B30854N [*]	Influenza A subtype H3
B30854O [*]	Influenza B
B30854P [*]	Mycoplasma pneumoniae
B30854Q [*]	Parainfluenza Virus 1
B30854R [*]	Parainfluenza Virus 2
B30854S [*]	Parainfluenza Virus 3
B30854T [*]	Parainfluenza Virus 4
B30854U [*]	Respiratory Syncytial Virus
MBALL [*]	All Microbiology Specimen
SARSCOV2 [C171532]	Severe Acute Resp Syndrome Coronavirus 2

* Extended Value

Category for Medical History

Permitted Value (Code)
GENERAL

No Yes Response (No Only) [C66742]

Permitted Value (Code)
N [C49487]

No Yes Response [C66742]

Permitted Value (Code)
N [C49487]
Y [C49488]
U [C17998]

Procedure Indication

Permitted Value (Code)
ADVERSE EVENT
DIAGNOSTIC
MEDICAL HISTORY
OTHER

Coder Dictionary Medication Name

Permitted Value (Code)
WHODRUG-GLOBAL-B3

Coder Dictionary Version

Permitted Value (Code)
202003

Cohort

Permitted Value (Code)
COHORT 1: AGE >= 18 TO < 55 MRNA-1273 OR PLACEBO
COHORT 2: AGE >= 55 MRNA-1273 OR PLACEBO

Multiple Race

Permitted Value (Code)
WHITE, AMERICAN INDIAN OR ALASKA NATIVE
WHITE, BLACK OR AFRICAN AMERICAN

Protocol Version

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

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
99 - Include in all analyses (minor PD)

CRF Timepoint

Permitted Value (Code)
DAY 10
DAY 11
DAY 12
DAY 13
DAY 14
DAY 15
DAY 16
DAY 17
DAY 18
DAY 19
DAY 20
DAY 21
DAY 22
DAY 23
DAY 24
DAY 25
DAY 7
DAY 8
DAY 9

CRF Timepoint Number

Permitted Value (Code)
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25

CRF Timepoint

Permitted Value (Code)
DAY 1
DAY 1, 1 HOUR AFTER VACCINATION (AT STUDY CLINIC)
DAY 1, AFTER VACCINATION (AT HOME)
DAY 2
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7

CRF Timepoint Number

Permitted Value (Code)
1
1.1
1.2
2
3
4
5
6
7

Conventional Numeric Result Precision

Permitted Value (Code)
8.0
8.1
8.2

Conventional Units

Permitted Value (Code)
%
G/DL
MG/DL
MIU/ML
SECONDS
U/L
X 10^3/UL
X 10^6/UL

Reported Result Type

Permitted Value (Code)
Greater Than (quantifiable limit)
Less Than (quantifiable limit)
Numeric
Range
Text

Conventional Reference Range Low

Permitted Value (Code)
NOT DETECTED

Conventional Text Result

Permitted Value (Code)
DETECTED
NOT DETECTED

Type of Diagnostic Test

Permitted Value (Code)
UNKNOWN

Reported Result Type

Permitted Value (Code)
Text

Coder Dictionary Name

Permitted Value (Code)
MedDRA

Coder Dictionary Version

Permitted Value (Code)
22.0
23.0

Childbearing Potential No, Reason

Permitted Value (Code)
PARTNER STERILE
POST-MENOPAUSAL
SURGICALLY STERILE

Protocol Version

Permitted Value (Code)
AMENDMENT 1
ORIGINAL

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 [*]
WHITE [C41261]

* Extended Value

Identifying Variable in Related Records

Permitted Value (Code)
AELNKGRP
CELNKGRP
FALNKGRP
VSLNKGRP
AESPID
HOSPID

Related Domain Abbreviation in Related Records

Permitted Value (Code)
AE
CE
FA
HO
VS

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

Sex [C66731]

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

Status Name [C124306]

Permitted Value (Code)
Exposed to COVID-19 [*]
Participant COVID-19 Symptomatic [*]
Contact Attempted [*]
Contact Status [*]

* Extended Value

Status Short Name [C124305]

Permitted Value (Code)	Display Value (Decode)
COVID [*]	Exposed to COVID-19
COVIDSYM [*]	Participant COVID-19 Symptomatic
CONTACT [*]	Contact Attempted
CONSTAT [*]	Contact Status

* Extended Value

Relation to Reference Period [C66728]

Permitted Value (Code)
ONGOING [C53279]

Identifying Variable in Supplemental Qualifiers AE

Permitted Value (Code)
AESEQ

Qualifier Variable Name for Supplemental Qualifiers AE

Permitted Value (Code)	Display Value (Decode)
AETRTEM	Treatment Emergent Flag
AEMAFL	Medically-attended AE?
HOSPID	HO Sponsor-Defined Identifier
DSSPID	DS Sponsor-Defined Identifier
AESOFL	Solicited Adverse Reaction?
REMOVEFL	AR Remove Flag
AEDICNM	Coder Dictionary Name
AEDICVR	Coder Dictionary Version
AESAENRX	SAE Narrative

Identifying Variable in Supplemental Qualifiers CE

Permitted Value (Code)
CESEQ

Qualifier Variable Name for Supplemental Qualifiers CE

Permitted Value (Code)	Display Value (Decode)
AESEVX	AE Severity/Intensity
AESPID	AE Sponsor-Defined Identifier
CEEVAL	Evaluator
DSSPID	DS Sponsor-Defined Identifier
HOSPID	HO Sponsor-Defined Identifier
MAAEFL	Medically Attended Flag
REASND	Reason of Missing CESTDCT/CEENDTC

Evaluator for Supplemental Qualifiers CM [C78735]

Permitted Value (Code)
VENDOR [C68608]

Identifying Variable in Supplemental Qualifiers CM

Permitted Value (Code)
CMSEQ

Qualifier Variable Name for Supplemental Qualifiers CM

Permitted Value (Code)	Display Value (Decode)
ATCLEV1C	ATC Level 1 Code
ATCLEV1T	ATC Level 1
ATCLEV2C	ATC Level 2 Code
ATCLEV2T	ATC Level 2
ATCLEV3C	ATC Level 3 Code
ATCLEV3T	ATC Level 3
ATCLEV4C	ATC Level 4 Code
ATCLEV4T	ATC Level 4
CMDICNM	Coder Dictionary Medication Name
CMDICVR	Coder Dictionary Version
CMFOTHSP	Other Frequency, Specify
CMONGOYN	Ongoing
CMPROTCD	Name of Medication Product Code
CMROTHSP	Other Route of Admin, Specify
CMSOL	Medication taken for Solicited Event ?
CMTRADCD	Trade Name of Medication Code
CMTRADE	Trade Name of Medication
CMTRTTN	Medication Trade Name
CMUOTHSP	Dose Unit Other, Specify

Qualifier Variable Name for Supplemental Qualifiers DM

Permitted Value (Code)	Display Value (Decode)
COHORT	Cohort
MULRACE	Multiple Race
PREVNUM	Previous Participant Number
PREVSCR	Was this participant screened previously
PROTVER	Protocol Version
RACEOTH	If Race is Other, specify
SENTL	Sentinel participant

Qualifier Variable Name for Supplemental Qualifiers DS

Permitted Value (Code)	Display Value (Decode)
ENROLLYN	Was participant enrolled in the study
AESPID	AE Sponsor-Defined Identifier

Identifying Variable in Supplemental Qualifiers DV

Permitted Value (Code)
DVSEQ

Qualifier Variable Name for Supplemental Qualifiers DV

Permitted Value (Code)	Display Value (Decode)
DVSIG	Significant
DVTERMX	Protocol Deviation Termx
SEVDES	Severity Code and Description
SPECTPT	Specify Timepoint
DVTERM1	Protocol Deviation Term 1
DVTERM2	Protocol Deviation Term 2
DVTERM3	Protocol Deviation Term 3

Identifying Variable in Supplemental Qualifiers ER

Permitted Value (Code)
ERSEQ

Qualifier Variable Name for Supplemental Qualifiers ER

Permitted Value (Code)	Display Value (Decode)
EXPOSEOT	Other exposure specify

Identifying Variable in SUPPFAAE

Permitted Value (Code)
FASEQ

Qualifier Variable Name for SUPPFAAE

Permitted Value (Code)	Display Value (Decode)
CRFTMPT	CRF Timepoint
CRFTMPTN	CRF Timepoint Number
AESPID	AE Sponsor-Defined Identifier
HOSPID	HO Sponsor-Defined Identifier
MAAEFL	Medically Attended Flag

Identifying Variable in SUPPFACE

Permitted Value (Code)
FASEQ

Qualifier Variable Name for SUPPFACE

Permitted Value (Code)	Display Value (Decode)
AESPID	AE Sponsor-Defined Identifier
CRFTMPT	CRF Timepoint
CRFTMPTN	CRF Timepoint Number
HOSPID	HO Sponsor-Defined Identifier
LYMPHEVL	Lymphadenopathy evaluated?
MAAEFL	Medically Attended Flag
SITE1	Investigator Site
SITE2	Other Institution
SREVL	Rash evaluated?

Identifying Variable in SUPPFAOT

Permitted Value (Code)
FASEQ

Qualifier Variable Name for SUPPFAOT

Permitted Value (Code)	Display Value (Decode)
CLIN2	Study clinic contact 1
CLIN4A	Study clinic contact 3
SYMPOTH	Symptoms other
SYMPTDTC	Estimated date of first symptoms

Qualifier Variable Name for Supplemental Qualifiers HO

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

Identifying Variable in Supplemental Qualifiers IS

Permitted Value (Code)
ISSEQ

Qualifier Variable Name for Supplemental Qualifiers IS

Permitted Value (Code)	Display Value (Decode)
LLOQ	Lower Limit of Quantitation
LOD	Limit of Detection
RANGE	Range indicator
ULOQ	Upper Limit of Quantification

Identifying Variable in Supplemental Qualifiers LB

Permitted Value (Code)
LBSEQ

Qualifier Variable Name for Supplemental Qualifiers LB

Permitted Value (Code)	Display Value (Decode)
CNVNRHI	Conventional Reference Range High
CNVNRLO	Conventional Reference Range Low
CNVRESC	Conventional Text Result
CNVRESN	Conventional Numeric Result
CNVRESNP	Conventional Numeric Result Precision
CNVU	Conventional Units
PANELOTH	Lab Panel Other, Specify
RPTRTYP	Reported Result Type

Identifying Variable in Supplemental Qualifiers MB

Permitted Value (Code)
MBSEQ

Qualifier Variable Name for Supplemental Qualifiers MB

Permitted Value (Code)	Display Value (Decode)
CNVNRLO	Conventional Reference Range Low
CNVRESC	Conventional Text Result
LDTSTOTH	Diagnostic Test Other, Specify
LDTTYPE	Type of Diagnostic Test
LOCALFL	Local Labs Flag
RPTRTYP	Reported Result Type

Identifying Variable in Supplemental Qualifiers MH

Permitted Value (Code)
MHSEQ

Qualifier Variable Name for Supplemental Qualifiers MH

Permitted Value (Code)	Display Value (Decode)
MHDICNM	Coder Dictionary Name
MHDICVR	Coder Dictionary Version

Qualifier Variable Name for Supplemental Qualifiers PR

Permitted Value (Code)	Display Value (Decode)
PRINDOTH	Specify Other

Identifying Variable in Supplemental Qualifiers RP

Permitted Value (Code)
RPSEQ

Qualifier Variable Name for Supplemental Qualifiers RP

Permitted Value (Code)	Display Value (Decode)
CBENDTC	Date of Last Menstruation, Post-menop.
CBRSN	Childbearing Potential No, Reason
CBSP	Partner Medically Sterile, Other Specify
CBSTDTC	Date of Surgery, if Surgically Sterile

Identifying Variable in Supplemental Qualifiers VE

Permitted Value (Code)
VESEQ

Qualifier Variable Name for Supplemental Qualifiers VE

Permitted Value (Code)	Display Value (Decode)
MISSASS	Missed Assessments

Identifying Variable in Supplemental Qualifiers - VS

Permitted Value (Code)
VSSEQ

Qualifier Variable Name for Supplemental Qualifiers - VS

Permitted Value (Code)	Display Value (Decode)
MEDTAK	Medication taken today for pain or fever
MEDTAKP	Prevent Pain or Fever from Occurring
MEDTAKT	Treat Pain or Fever already Occurred

Identifying Variable in Supplemental Qualifiers XM

Permitted Value (Code)
XMSEQ

Qualifier Variable Name for Supplemental Qualifiers XM

Permitted Value (Code)	Display Value (Decode)
MULRACE	Multiple Race
PREVSCR	Was this participant screened previously
PROTVER	Protocol Version

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

Dictionary-Derived Term in Visit Events

Permitted Value (Code)
MISSED ASSESSMENT
MISSED ASSESSMENT, OTHER
MISSED VISIT
STUDY TREATMENT NOT GIVEN, MISSED VISIT
VISIT PERFORMED OUT OF WINDOW

Category for Vital Signs

Permitted Value (Code)
REACTOGENICITY

Location of Vital Sign Measurement [C74456]

Permitted Value (Code)
ORAL CAVITY [C12421]

Original Units for Vital Signs [C66770]

Permitted Value (Code)
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)
SYSTEMIC

Standard Units for Vital Signs [C66770]

Permitted Value (Code)
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)
Body Mass Index [C16358]
Diastolic Blood Pressure [C25299]
Height [C25347]
Pulse Rate [C49676]
Respiratory Rate [C49678]
Systolic Blood Pressure [C25298]
Temperature [C25206]
Vital Signs Collection [*]
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
PULSE [C49676]	Pulse Rate
RESP [C49678]	Respiratory Rate
SYSBP [C25298]	Systolic Blood Pressure
TEMP [C25206]	Temperature
VSALL [*]	Vital Signs Collection
WEIGHT [C25208]	Weight

* Extended Value

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

Go to the top of the Define-XML document

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
AEREFID	Computation	Set to "DOSE 1" concatenate date time of Dose 1 if AE Onset date time is before dose 2 date time or dose 2 date time is missing, otherwise set to "DOSE 2" concatenate date time of Dose 2
AESPID	Computation	set to "AE-" + AE log number by subject identifier
AETRTM	Computation	Set to "Y" if any adverse event with start date (AE.AESTDTC) occurring on or after the first dose of study drug (SDTM.DM.RFSTDTC); If AE.AESTDTC is partial, uses SUPPAE.AESTDTCI instead
CEDTC	Computation	Last symptom event assessment date time based on CETPTREF within observed period (7 days)
CEDUR	Computation	Number of days with symptom event occurred within observed period (7 Days) based on CETPTREF
CEENDTC	Computation	Date of last occurrence of event of each vaccine
CESTDTC	Computation	First symptom event occured date time based on CETPTREF within observed period (7 days)
CMENRTPT	Computation	Set to ONGOING if Ongoing checked
CMENTPT	Computation	Set to DM.RFPENDTC if CMENRTPT is non-missing
DTHLF	Computation	Set to 'Y' if reason of discontinue treatment, and /or end of study is death or outcome of an AE is fatal, otherwise, set to missing
RFENDTC	Computation	Set to the last non-missing study drug exposure date/time
RFPENDTC	Computation	Set to date of completed, or discontinued from study, or last assessment date if subject is still ongoing
RFSTDTC	Computation	Set to the first non-missing study drug exposure date/time
RFXENDTC	Computation	Set to the last non-missing study drug exposure date/time
RFXSTDTC	Computation	Set to the first non-missing study drug exposure date/time
EPOCH	Computation	Set to maximum SE.EPOCH where --DTC is greater or equal to SESTDTC and Less than or equal to SEENDTC.
ECREFID	Computation	Set to "DOSE 1" if VISIT="VISIT 1 DAY 1" or "DOSE 2" if VISIT="VISIT 4 DAY 29"
ECTRT	Computation	Set to Placebo or mRNA-1273 after merging by randomization ID from randomization file
XXENDY	Computation	--ENDTC - DM.RFSTDTC if --ENDTC < RFSTDTC, --ENDTC - DM.RFSTDTC + 1 if --ENDTC >= RFSTDTC
EXDOSE	Computation	Set to 0 if EXTRT = "PLACEBO" or set to Actual dose from IRT
EXTRT	Computation	Set to Placebo or mRNA-1273 after merging by randomization ID from randomization file
FATPTREF	Computation	Set to DOSE 1 if symptom event occurred before dose 2 or dose 2 has not started yet, otherwise set to DOSE 2 if symptom event occurred after dose2
HOENDTC	Computation	Set to hospital discharge date if HO.HOTERM="HOSPITAL", or set to last MEDICAL ATTENDED date if HO.HOTERM="MEDICAL ATTENDED", set to null otherwise
HOOCCUR	Computation	Set to "Y" if HO.HOTERM="MEDICAL ATTENDED", set to "Y" if HOTERM="ADMITTED TO ICU" and HODUR>0, set to null if HO.HOTERM="HOSPITAL", otherwise, set to "N"
HOREFID	Computation	If data source is from adverse event, then Set to "DOSE 1" concatenate date time of Dose 1 if AE Onset date time is before dose 2 date time or dose 2 date time is missing, otherwise set to "DOSE 2" concatenate date time of Dose 2; If data source is from e-Diary, then Set "DOSE 1" data time of Dose 1 if Medical Attended event occurred before dose 2 date time or dose 2 date time is missing, otherwise, set to "DOSE 2" concatenate date time of Dose 2
HOSTDTC	Computation	Set to hospital admin date if HO.HOTERM="HOSPITAL", or set to first MEDICAL ATTENDED date if HO.HOTERM="MEDICAL ATTENDED", set to null otherwise
HOTERM	Computation	Set to "HOSPITAL" if an event captured in AE form indicates this event requires hospitalization, set to "ADMITTED TO ICU" if an event captured in AE form indicates this event requires ICU, set to "MEDICAL ATTENDED" if an AR symptom indicates this AR symptom requires MEDICAL ATTENDED
LBBLFL	Computation	Set to 'Y' for last non missing measurement (including repeated and unscheduled assessments) where LBDTC on or before RFSTDTC by each LBCAT and LBTESTCD
LBNRINC	Computation	Reference Range Indicator based upon standard results and ranges
LBSTNRHI	Computation	LBORNRHI converted to standard unit
LBSTNRLO	Computation	LBORNRLO converted to standard unit
LBSTRESC	Computation	LBORRES converted to standard unit
MBBLFL	Computation	Set to 'Y' for last non missing measurement (including repeated and unscheduled assessments) where MBDTC on or before RFSTDTC by each MBTESTCD
MHENRTPT	Computation	Set to ONGOING or UNKNOWN based on CRF
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-50, V-100, PBO), end date is last dose date if non missing + 28 or the end of participation date which ever come to first
SESTDTC	Computation	For Screening element (SCREEN), start date is Informed Consent date; For first dose element (V-50, V-100, PBO) start date is first dose date; and for Follow-up element (FU), start date is visit date 28 days after last vaccination.
EPOCH	Computation	Set to maximum SE.EPOCH where --STDTC is greater or equal to SESTDTC and Less than or equal to SEENDTC
XXSTDY	Computation	--STDTC - DM.RFSTDTC if --STDTC < DM.RFSTDTC, --STDTC - DM.RFSTDTC + 1 if --STDTC >= DM.RFSTDTC
AEDSID	Computation	Set to DS.DSSPID if AE leading to discontinue treatment (where DS.DSSCAT="STUDY TREATMENT") or end of study (where DS.DSSCAT="END OF STUDY")
AEHOID	Computation	Set to HO.HOSPID if AE leading to hospitalization and /or ICU
REMOVEFL	Computation	Set to "Y" if SUPPAE.QNAM="AESOLFL" and SUPPAE.QVAL="Y", and AE.AESER ne "Y" and the event was not last and beyond day 7
AESEVX	Computation	Set to Severity/Intensity captured from AE where Solicited AE flag is "Y" and AEDECOD is pre-define solicited symptom event
AESPID	Computation	set to "AE-" + AE log number by subject identifier
CEEVAL	Computation	Set to 'STUDY SUBJECT' if from eDiary, else set to 'INVESTIGATOR'
CERSN	Computation	Set to "MISSED DIARY ASSESSMENT" if subject unreported symptom assessment at least one day during observed period (7-days) after each vaccination
DSSPID	Computation	Set to DS.DSSPID If reactogenicity leading to discontinue treatment (where DS.DSSCAT="STUDY TREATMENT") or end of study (where DS.DSSCAT="END OF STUDY")
HOSPID	Computation	Set to HO.HOSPID if reactogenicity leading to medical attention
MAAEFL	Computation	Set to Y if required any medical attention during observed period (7-days) after each vaccination
QVAL	Computation	If RACE='MULTIPLE', then set to 'WHITE' when checked, set to ' BLACK OR AFRICAN AMERICAN' when checked, set to 'ASIAN' when checked, set to 'AMERICAN INDIAN OR ALASKA NATIVE' '' when checked, set to 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERS' when checked, concatenate 'OTHER: ' with Race Other specify when checked. Concatenate all possible values above with ', '
AESPID	Computation	Set to AESPID (AE log number) if discontinue treatment or end of study is due to AE or SAE
QVAL	Computation	Set to "STUDY SUBJECT" if source data is from e-Diary Set to "INVESTIGATOR" if source data is from AE
LOCALFL	Computation	Set to "Y" if data is collected from local diagnostic test form
SVENDTC	Computation	Set to visit date taking the last one recorded
SVSTDTC	Computation	Set to visit date taking the first one recorded
USUBJID	Computation	The compound identifier is formed by studyid, siteid and subjid separated by hyphen '-'
VSSTRESC	Computation	VSORRES value converted into standard units
VSSTRESN	Computation	Numeric representation of VSORRESU
VSBLFL	Computation	Set to 'Y' for last non missing measurement (including repeated and unscheduled assessments) where VSDTC on or before RFSTDTC by each VSTESTCD where VSCAT is not "REACTOGENICITY"
XXDY	Computation	--DTC - DM.RFSTDTC if --DTC < DM.RFSTDTC, --DTC - DM.RFSTDTC + 1 if --DTC >= DM.RFSTDTC
AELNKGRP	Computation	Assigned values from 1010 to 1150 for each event term with Dose 1 and assigned values from 2010 to 2150 for each event term with Dose 2

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Datasets

Trial Arms (TA)

Trial Elements (TE)

Trial Inclusion/Exclusion Criteria (TI)

Trial Summary (TS)

Trial Visits (TV)

Comments (CO)

Demographics (DM)

Subject Elements (SE)

Subject Visits (SV)

Multiple Participations (XM)

Concomitant Medications (CM)

Exposure as Collected (EC)

Exposure (EX)

Procedures (PR)

Adverse Events (AE)

Clinical Events (CE)

Disposition (DS)

Protocol Deviations (DV)

Environmental and Social Factors (ER)

Healthcare Encounter (HO)

Medical History (MH)

Visit Events (VE)

Inclusion/Exclusion Criteria Not Met (IE)

Immunogenicity Specimen Assessments (IS)

Laboratory Test Results (LB)

Microbiology Specimen (MB)

Reproductive System Findings (RP)

Subject Status (SS)

Vital Signs (VS)

Findings About Events or Interventions (FAAE)

Findings About Events or Interventions (FACE)

Findings About Events or Interventions (FAOT)

Related Records (RELREC)

Supplemental Qualifiers AE (SUPPAE)

Supplemental Qualifiers CE (SUPPCE)

Supplemental Qualifiers CM (SUPPCM)

Supplemental Qualifiers DM (SUPPDM)

Supplemental Qualifiers DS (SUPPDS)

Supplemental Qualifiers DV (SUPPDV)

Supplemental Qualifiers ER (SUPPER)

Supplemental Qualifiers (SUPPFAAE)

Supplemental Qualifiers (SUPPFACE)

Supplemental Qualifiers (SUPPFAOT)

Supplemental Qualifiers HO (SUPPHO)

Supplemental Qualifiers IS (SUPPIS)

Supplemental Qualifiers LB (SUPPLB)

Supplemental Qualifiers MB (SUPPMB)

Supplemental Qualifiers MH (SUPPMH)

Supplemental Qualifiers PR (SUPPPR)

Supplemental Qualifiers RP (SUPPRP)

Supplemental Qualifiers VE (SUPPVE)

Supplemental Qualifiers - VS (SUPPVS)

Supplemental Qualifiers XM (SUPPXM)

CodeLists

External Dictionaries

Methods