Date/Time of Define-XML document generation: 2020-11-18T01:15:24Z

Define-XML version: 2.0.0

Stylesheet version: 2018-11-21

Standard: SDTM-IG 3.2
Study Name: C4591001
Study Description: A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults
Protocol Name: C4591001
Metadata Name: Study C4591001 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, DOMAIN, ELEMENT	te.xpt
TI	Trial Inclusion/Exclusion Criteria	TRIAL DESIGN	One record per I/E criterion	Tabulation	STUDYID, DOMAIN, TIVERS, IETEST	ti.xpt
TS	Trial Summary	TRIAL DESIGN	One record per trial summary parameter value	Tabulation	STUDYID, DOMAIN, TSGRPID, TSPARM, TSVAL, TSVAL1	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
DI	Device Identifiers	SPECIAL PURPOSE	One record per device identifier per device	Tabulation	STUDYID, SPDEVID, DIPARMCD	di.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	STUDYID, USUBJID, ETCD, SESTDTC	se.xpt
SV	Subject Visits	SPECIAL PURPOSE	One record per actual visit per subject	Tabulation	STUDYID, USUBJID, VISITNUM, VISIT, SVSTDTC	sv.xpt
CM	Concomitant Medications	INTERVENTIONS	One record per recorded medication occurrence or constant-dosing interval per subject	Tabulation	STUDYID, USUBJID, CMCAT, 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, ECMOOD	ec.xpt
EX	Exposure	INTERVENTIONS	One record per constant dosing interval per subject	Tabulation	STUDYID, USUBJID, EXTRT, EXSTDTC	ex.xpt
PR	Procedures	INTERVENTIONS	One record per recorded procedure per occurrence per subject	Tabulation	STUDYID, USUBJID, PRCAT, PRDECOD, PROCCUR	pr.xpt
AE	Adverse Events	EVENTS	One record per adverse event per subject	Tabulation	STUDYID, USUBJID, AECAT, AESCAT, AEDECOD, AESTDTC, AESPID	ae.xpt
CE	Clinical Events	EVENTS	One record per event per subject	Tabulation	STUDYID, USUBJID, CECAT, CESCAT, CETPTREF, CETERM, CESTDTC, VISITNUM	ce.xpt
DS	Disposition	EVENTS	One record per disposition status or protocol milestone per subject	Tabulation	STUDYID, USUBJID, DSDECOD, DSSTDTC, DSDTC, DSSEQ	ds.xpt
DV	Protocol Deviations	EVENTS	One record per protocol deviation per subject	Tabulation	STUDYID, USUBJID, DVTERM, DVSTDTC, DVSPID	dv.xpt
HO	Healthcare Encounters	EVENTS	One record per healthcare encounter per subject	Tabulation	STUDYID, USUBJID, HOCAT, HOTERM, VISITNUM, HOSTDTC	ho.xpt
MH	Medical History	EVENTS	One record per medical history event per subject	Tabulation	STUDYID, USUBJID, MHCAT, MHTERM, MHDTC, MHSPID, MHENRTPT	mh.xpt
DD	Death Details	FINDINGS	One record per finding per subject	Tabulation	STUDYID, USUBJID, DDTESTCD, DDDTC	dd.xpt
FACE	Findings About Events or Interventions (FA)	FINDINGS	One record per finding per object per time point per time point reference per visit per subject	Tabulation	STUDYID, USUBJID, FACAT, FASCAT, FATESTCD, FAOBJ, FADTC, VISITNUM, FATPTREF, FATPTNUM, FASEQ	face.xpt
FAHO	Findings About Events or Interventions (FA)	FINDINGS	One record per finding per object per time point per time point reference per visit per subject	Tabulation	STUDYID, USUBJID, FACAT, FATESTCD, FAOBJ, FADTC, VISITNUM	faho.xpt
IE	Inclusion/Exclusion Criteria Not Met	FINDINGS	One record per inclusion/exclusion criterion not met per subject	Tabulation	STUDYID, USUBJID, IETESTCD	ie.xpt
IS	Immunogenicity Specimen 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, LBCAT, LBSCAT, LBTESTCD, LBDTC, LBSPEC, VISITNUM	lb.xpt
MB	Microbiology Specimen	FINDINGS	One record per microbiology specimen finding per time point per visit per subject	Tabulation	STUDYID, USUBJID, MBCAT, MBTESTCD, MBDTC, VISITNUM, MBSPEC, SPDEVID, MBSEQ	mb.xpt
MO	Morphology	FINDINGS	One record per Morphology finding per location per time point per visit per subject	Tabulation	STUDYID, USUBJID, MOCAT, MOTESTCD, MODTC, MOMETHOD	mo.xpt
VS	Vital Signs	FINDINGS	One record per vital sign measurement per time point per visit per subject	Tabulation	STUDYID, USUBJID, VSCAT, VSSCAT, VSTESTCD, VISITNUM, VSTPTREF, VSTPTNUM, VSDTC, VSSEQ	vs.xpt
RELREC	Related Records	RELATIONSHIP	One record per related record, group of records or datasets	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID	relrec.xpt
SUPPAE	Supplemental Qualifiers for Adverse Events (Adverse Events)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppae.xpt
SUPPCE	Supplemental Qualifiers for Clinical Events (Clinical Events)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppce.xpt
SUPPCM	Supplemental Qualifiers for Concomitant Medications (Concomitant Medications)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppcm.xpt
SUPPDM	Supplemental Qualifiers for Demographics (Demographics)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppdm.xpt
SUPPDS	Supplemental Qualifiers for Disposition (Disposition)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppds.xpt
SUPPDV	Supplemental Qualifiers for Protocol Deviations (Protocol Deviations)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppdv.xpt
SUPPEC	Supplemental Qualifiers for Exposure as Collected (Exposure as Collected)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppec.xpt
SUPPEX	Supplemental Qualifiers for Exposure (Exposure)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppex.xpt
SUPPFACE	Supplemental Qualifiers for Findings About Events or Interventions (SUPPFA)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppface.xpt
SUPPHO	Supplemental Qualifiers for Healthcare Encounters (Healthcare Encounters)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppho.xpt
SUPPIE	Supplemental Qualifiers for Inclusion/Exclusion Criteria Not Met (Inclusion/Exclusion Criteria Not Met)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppie.xpt
SUPPIS	Supplemental Qualifiers for Immunogenicity Specimen Assessments (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 for Laboratory Test Results (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 for Microbiology Specimen (Microbiology Specimen)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppmb.xpt
SUPPMH	Supplemental Qualifiers for Medical History (Medical History)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppmh.xpt
SUPPMO	Supplemental Qualifiers for Morphology (Morphology)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppmo.xpt
SUPPPR	Supplemental Qualifiers for Procedures (Procedures)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	supppr.xpt
SUPPVS	Supplemental Qualifiers for Vital Signs (Vital Signs)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppvs.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	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned DOMAIN='TA'
ARMCD	Planned Arm Code	text	Req	9	ARMCD [9 Terms]	Assigned See ARMCD codelist
ARM	Description of Planned Arm	text	Req	27	ARM [9 Terms]	Assigned
TAETORD	Planned Order of Element within Arm	integer	Req	8		Assigned Values will be assigned 1 for Screening, 2 for first vaccination, 3 for second vaccination, and 4 for follow-up
ETCD	Element Code	text	Req	8	Element Code [10 Terms]	Assigned See ETCD codelist
ELEMENT	Description of Element	text	Perm	18	ELEMENT [10 Terms]	Protocol
TABRANCH	Branch	text	Exp	23		Protocol
TATRANS	Transition Rule	text	Exp	1		Assigned Blank
EPOCH	Epoch	text	Req	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Assigned See EPOCH codelist

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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	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned DOMAIN='TE'
ETCD	Element Code	text	Req	8	Element Code [10 Terms]	Assigned See ETCD codelist
ELEMENT	Description of Element	text	Req	18	ELEMENT [10 Terms]	Protocol See ELEMENT codelist
TESTRL	Rule for Start of Element	text	Req	36		Protocol
TEENRL	Rule for End of Element	text	Perm	38		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	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned DOMAIN='TI'
IETESTCD	Inclusion/Exclusion Criterion Short Name	text	Req	7	Inclusion/Exclusion Criterion Short Name [49 Terms]	Assigned See IETESTCD Codelist
IETEST	Inclusion/Exclusion Criterion	text	Req	200		Protocol
IECAT	Inclusion/Exclusion Category	text	Req	9	Inclusion/Exclusion Category • "INCLUSION" = "INCLUSION" • "EXCLUSION" = "EXCLUSION"	Assigned
TIVERS	Protocol Criteria Versions	text	Perm	3		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	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned DOMAIN='TS'
TSSEQ	Sequence Number	integer	Req	8		Assigned
TSGRPID	Group ID	text	Req	9		Assigned
TSPARMCD	Trial Summary Parameter Short Name	text	Req	8	TSPARMCD [51 Terms]	Assigned
TSPARM	Trial Summary Parameter	text	Req	40	TSPARM [51 Terms]	Assigned
TSVAL	Parameter Value	text	Exp	192		Assigned
TSVAL1	Parameter Value 1	text	Exp	98		Assigned
TSVALNF	Parameter Null Flavor	text	Perm	2		Assigned
TSVALCD	Parameter Value Code	text	Exp	11		Assigned
TSVCDREF	Name of the Reference Terminology	text	Exp	18		Assigned
TSVCDVER	Version of the Reference Terminology	text	Exp	10		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	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned DOMAIN='TV'
VISITNUM	Visit Number	integer	Req	8	Visit Number [25 Terms]	Assigned For the complete algorithm see the reference
VISIT	Visit Name	text	Perm	21		Protocol
VISITDY	Planned Study Day of Visit	integer	Perm	8		Protocol
ARMCD	Planned Arm Code	text	Exp	9		Assigned See ARMCD codelist
TVSTRL	Visit Start Rule	text	Req	71		Protocol
TVENRL	Visit End Rule	text	Perm	42		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	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned Default to CO
RDOMAIN	Related Domain Abbreviation	text		4	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived USUBJID= DM.USUBJID
COSEQ	Sequence Number	integer	Req	8		Derived Use SDTM utility util_seq_key_gen
IDVAR	Identifying Variable	text		8		Assigned
IDVARVAL	Identifying Variable Value	text		22		Assigned
COREF	Comment Reference	text		21		Assigned Assign value from visit
COVAL	Comment	text	Req	200		CRF Annotated CRF [21 22 72 81 82 84 93 94 ]
VISITNUM	Visit Number	integer		8		Assigned Data Value
VISIT	Visit Name	text		21		Assigned Data Value
CODTC	Date/Time of Comment	datetime			ISO 8601	CRF Annotated CRF [72 82 ]
CODY	Study Day of Visit/Collection/Exam	integer		8		Derived Actual study day of visit/collection/exam expressed in integer days relative to sponsor- defined RFSTDTC in Demographics.

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Device Identifiers (DI)

DI (Device Identifiers) - SPECIAL PURPOSE Location: di.xpt
Variable	Where Condition	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	Req	8		Protocol
DOMAIN		Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "DI"
SPDEVID		Sponsor Device Identifier	text	Req	45		Assigned Assign a unique integer value based on device trade name else Concatenate device manufacturer and the device model
DISEQ		Sequence Number	integer	Exp	8		Derived Sequential number identifying records within each USUBJID in the domain.
DIPARMCD		Device Identifier Element Short Name	text	Req	8	DIPARMCD • "DEVTYPE" = "Device Type" • "MANUF" = "Manufacturer" • "MODEL" = "Model Number" • "TRADENAM" = "Trade Name"	Assigned
DIPARM		Device Identifier Element Name	text	Req	12	DIPARM • "Device Type" • "Manufacturer" • "Model Number" • "Trade Name"	Assigned
DIVALVLM		Device Identifier Element Value	text	Req	50
	DIPARMCD = "DEVTYPE" (Device Type)	Device Identifier Element Value	text		50		CRF Annotated CRF [21 22 94 ]
	DIPARMCD = "TRADENAM" (Trade Name)	Device Identifier Element Value	text		50		CRF Annotated CRF [22 94 ]
	DIPARMCD IN ( "MANUF" (Manufacturer), "MODEL" (Model Number) )	Device Identifier Element Value	text		50		eDT

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Demographics (DM)

DM (Demographics) - SPECIAL PURPOSE Location: dm.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPDM (Supplemental Qualifiers for Demographics)
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "DM"
USUBJID	Unique Subject Identifier	text	Req	22		Derived Unique subject identifier derived usingCOMP.USUBJID
SUBJID	Subject Identifier for the Study	text	Req	8		CRF Annotated CRF [24 ]
RFSTDTC	Subject Reference Start Date/Time	datetime	Exp		ISO 8601	Derived First date/time of study drug else Randomization date/time OR Enrollment date/time for subject.Null for screen failures.
RFENDTC	Subject Reference End Date/Time	datetime	Exp		ISO 8601	Derived Maximum of Visit date/Maximum of disposition date, whichever is greater.Null for Screen Failures.
RFXSTDTC	Date/Time of First Study Treatment	datetime	Exp		ISO 8601	Derived First date/time of study drug exposure date
RFXENDTC	Date/Time of Last Study Treatment	datetime	Exp		ISO 8601	Derived Latest date/time of study drug exposure
RFICDTC	Date/Time of Informed Consent	datetime	Exp		ISO 8601	Derived Date/time of informed consent obtained
RFPENDTC	Date/Time of End of Participation	datetime	Exp		ISO 8601	Derived Set to Date/time when subject ended participation in a trial.
DTHDTC	Date/Time of Death	datetime	Exp		ISO 8601	Derived Date/time of death when Disposition mentioned as 'DEATH'.
DTHFL	Subject Death Flag	text	Exp	1	NY1 • "Y" = "Y"	Derived Populate Death flag is 'Y' when Standardized Disposition Term is 'DEATH'
SITEID	Study Site Identifier	text	Req	4		Assigned Rename SITEMNEMONIC as SITEID
INVID	Investigator Identifier	text	Perm	7		Assigned Assigned from source database by merging on StudyID and SiteID
INVNAM	Investigator Name	text	Perm	37		Assigned Assigned from source database by merging on StudyID and SiteID
BRTHDTC	Date/Time of Birth	datetime	Perm		ISO 8601	CRF Annotated CRF [24 ]
AGE	Age	integer	Exp	8		Derived If AGEU=YEARS then AGE=int((Informed Consent date - birthdate)/365.25)
AGEU	Age Units	text	Exp	5	AGEU • "YEARS" = "YEARS"	Assigned Rename AGEU_001 as AGEU
SEX	Sex	text	Req	1	SEX • "F" = "F" • "M" = "M"	CRF Annotated CRF [24 ]
RACE	Race	text	Exp	41	RACE [7 Terms]	CRF Annotated CRF [24 ]
ETHNIC	Ethnicity	text	Perm	22	ETHNIC • "HISPANIC OR LATINO" = "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" = "NOT HISPANIC OR LATINO" • "NOT REPORTED" = "NOT REPORTED"	CRF Annotated CRF [24 ]
ARMCD	Planned Arm Code	text	Req	9		Assigned Assigned from Trial Arms based on Randomization file.
ARM	Description of Planned Arm	text	Req	27		Assigned Assigned from Trial Arms based on Randomization file.
ACTARMCD	Actual Arm Code	text	Req	1		Assigned To be derived for submission from ADSL.
ACTARM	Description of Actual Arm	text	Req	1		Assigned To be derived for submission from ADSL.
COUNTRY	Country	text	Req	3	ISO3166(CL.ISO3166) ISO3166	Assigned Assigned from source database by merging on StudyID and SiteID

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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	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned DOMAIN='SE'
USUBJID	Unique Subject Identifier	text	Req	22		Derived Concatenate SE.STUDYID, SUBJECTNUMBERSTR in each corresponding raw datasets separated by "/".
SESEQ	Sequence Number	integer	Req	8		Derived Sort by variable USUBJID, TAETORD, ETCD, SESTDTC, SEENDTC. Restart the numbering at each USUBJID with 1 (order sequentially).
ETCD	Element Code	text	Req	8	Element Code [10 Terms]	Assigned See ETCD codelist
ELEMENT	Description of Element	text	Perm	18	ELEMENT [10 Terms]	Assigned Merge with SDTM.TE by ETCD to get values of ELEMENT.
TAETORD	Planned Order of Element within Arm	integer	Perm	8		Assigned If ETCD='SCRN' then TAETORD=1;if ETCD contains 'VAX' and 60748<=RAW.SM_SV001.VISITID<60751 or 60765<=VISITID<60766 then TAETORD=2;if ETCD contains 'VAX' and 60751<=RAW.SM_SV001.VISITID<60752 or 60766<=VISITID<60767 or VISITID=1165454 then TAETORD=3;if ETCD='FUP' then TAETORD=4.
EPOCH	Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Assigned If ETCD='SCRN', then EPOCH='SCREENING';If ETCD contains 'VAX' then EPOCH='VACCINATION';If ETCD contains 'FUP' then EPOCH='FOLLOW-UP'.
SESTDTC	Start Date/Time of Element	datetime	Req		ISO 8601	Derived If EPOCH='SCREENING' then SESTDTC=DM.RFICDTC;if EPOCH='VACCINATION' and TAETORD=2 then SESTDTC=DM.RFXSTDTC;if EPOCH='VACCINATION' and TAETORD=3 then SESTDTC is second vaccination date;If EPOCH='FOLLOW-UP' then SESTDTC is the date of first follow-up visit.
SEENDTC	End Date/Time of Element	datetime	Exp		ISO 8601	Derived If EPOCH='SCREENING', if DM.RFXSTDTC not missing then SEENDTC=DM.RFXSTDTC else use latest date between DM.RFPENDTC;If SDTM.SE.EPOCH='VACCINATION' and TAETORD=2, set to SESTDTC when TAETORD=3 it is not missing, otherwise set to max(DM.RFPENDTC, DM.RFENDTC);If SDTM.SE.EPOCH='VACCINATION' and TAETORD=3, for phase 1, set to SESTDTC when TAETORD=4 if it is not missing, otherwise set to max(DM.RFPENDTC, DM.RFENDTC).If EPOCH='FOLLOW-UP' then set to DM.RFPENDTC.
SESTDY	Study Day of Start of Observation	integer	Perm	8		Derived Calculation of SESTDY = (Numeric version of SESTDTC - Numeric version of DM.RFSTDTC). Note: Add 1 if calculation is greater than or equal to 0.
SEENDY	Study Day of End of Observation	integer	Perm	8		Derived Calculation of SEENDY = (Numeric version of SEENDTC - Numeric version of DM.RFSTDTC). Note: Add 1 if calculation is greater than or equal to 0.

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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	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "SV"
USUBJID	Unique Subject Identifier	text	Req	22		Derived Unique subject identifier derived using COMP.USUBJID
SVREFID	Reference ID	text	Perm	16		CRF Annotated CRF [17 18 19 20 ]
VISITNUM	Visit Number	integer	Req	8		Assigned Assigned from source database.COMM.VISITNUM
VISIT	Visit Name	text	Perm	21		Assigned Assigned from source database.COMM.VISIT
EPOCH	Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived Epoch derivation using COMP.EPOCH
SVSTDTC	Start Date/Time of Visit	datetime	Exp		ISO 8601	CRF Annotated CRF [17 18 19 20 28 29 30 31 ]
SVENDTC	End Date/Time of Visit	datetime	Exp		ISO 8601	CRF Annotated CRF [17 18 20 28 ]
SVSTDY	Study Day of Start of Visit	integer	Perm	8		Derived STDY derivation using COMP.STDY
SVENDY	Study Day of End of Visit	integer	Perm	8		Derived ENDY derivation using COMP.ENDY

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Concomitant Medications (CM)

CM (Concomitant Medications) - INTERVENTIONS Location: cm.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPCM (Supplemental Qualifiers for Concomitant Medications)
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "CM"
USUBJID	Unique Subject Identifier	text	Req	22		Derived Unique subject identifier derived using COMP.USUBJID
CMSEQ	Sequence Number	integer	Req	8		Derived Sequential number derived using COMP.SEQ
CMSPID	Sponsor-Defined Identifier	text	Perm	2		CRF Annotated CRF [14 15 73 103 ]
CMTRT	Reported Name of Drug, Med, or Therapy	text	Req	100		CRF Annotated CRF [14 15 73 103 ]
CMDECOD	Standardized Medication Name	text	Perm	100	WHO DD WHO DD 202003	Assigned
CMCAT	Category for Medication	text	Perm	37	Category for Medication • "CONCOMITANT IMMUNOSUPPRESSIVE THERAPY" = "CONCOMITANT IMMUNOSUPPRESSIVE THERAPY" • "CORTICOSTEROIDS" = "CORTICOSTEROIDS" • "GENERAL CONCOMITANT MEDICATIONS" = "GENERAL CONCOMITANT MEDICATIONS" • "VACCINATIONS" = "VACCINATIONS"	Assigned
CMSCAT	Subcategory for Medication	text	Perm	19	CMSCAT • "VASOPRESSORS AGENTS" = "VASOPRESSORS AGENTS"	Assigned
CMCLAS	Medication Class	text	Perm	66	WHO DD WHO DD 202003	Assigned
CMCLASCD	Medication Class Code	text	Perm	8	WHO DD WHO DD 202003	Assigned
CMDOSE	Dose per Administration	integer	Perm	8		CRF Annotated CRF [14 73 ]
CMDOSTXT	Dose Description	text	Perm	19		CRF Annotated CRF [14 73 ]
CMDOSU	Dose Units	text	Perm	6	UNIT [33 Terms]	CRF Annotated CRF [14 73 ]
CMDOSFRQ	Dosing Frequency per Interval	text	Perm	10	FREQ [9 Terms]	CRF Annotated CRF [14 73 ]
CMROUTE	Route of Administration	text	Perm	24	ROUTE [14 Terms]	CRF Annotated CRF [14 73 ]
EPOCH	Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived Epoch derivation using COMP.EPOCH
CMSTDTC	Start Date/Time of Medication	datetime	Perm		ISO 8601	CRF Annotated CRF [14 15 73 103 ]
CMENDTC	End Date/Time of Medication	datetime	Perm		ISO 8601	CRF Annotated CRF [73 103 ]
CMSTDY	Study Day of Start of Medication	integer	Perm	8		Derived STDY derivation using COMP.STDY
CMENDY	Study Day of End of Medication	integer	Perm	8		Derived ENDY derivation using COMP.ENDY
CMENRTPT	End Relative to Reference Time Point	text	Perm	7	ENRTPT • "ONGOING" = "ONGOING"	Derived Set to 'ONGOING' when X_CMONGO_001_C is 'Y' else NULL
CMENTPT	End Reference Time Point	text	Perm	22		Derived CMENTPT = 'LAST SUBJECT ENCOUNTER' when CMENRTPT = 'ONGOING'

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Exposure as Collected (EC)

EC (Exposure as Collected) - INTERVENTIONS Location: ec.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPEC (Supplemental Qualifiers for Exposure as Collected)
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "EC"
USUBJID	Unique Subject Identifier	text	Req	22		Derived DM.USUBJID
ECSEQ	Sequence Number	integer	Req	8		Derived Sequential number identifying records within each USUBJID in the domain.
ECLNKID	Link ID	text	Perm	34		Derived Concatenate Link Group ID, Location and Laterality when Link Group ID is present
ECLNKGRP	Link Group ID	text	Perm	13		Derived Related vaccination number to assist with Reactogenicity assessment
ECTRT	Name of Treatment	text	Req	15		CRF Annotated CRF [99 101 ]
ECMOOD	Mood	text	Perm	9		Derived Set to "SCHEDULED" for Planned Dose records, "PERFORMED" for Actual Dose Records
ECCAT	Category of Treatment	text	Perm	23	Category of Treatment • "INVESTIGATIONAL PRODUCT" = "INVESTIGATIONAL PRODUCT"	Assigned
ECSCAT	Subcategory of Treatment	text	Perm	11	Subcategory of Treatment • "VACCINATION" = "VACCINATION"	Assigned
ECDOSE	Dose	integer	Exp	8		CRF Annotated CRF [99 101 ]
ECDOSU	Dose Units	text	Exp	7	ECDOSU • "mcg" = "Microgram" • "SYRINGE" = "SYRINGE"	CRF Annotated CRF [99 101 ]
ECDOSFRM	Dose Form	text	Exp	9	FRM • "INJECTION" = "INJECTION"	CRF Annotated CRF [99 101 ]
ECROUTE	Route of Administration	text	Perm	13	ROUTE [14 Terms]	CRF Annotated CRF [99 101 ]
ECLOC	Location of Dose Administration	text	Perm	14	LOC [12 Terms]	CRF Annotated CRF [99 101 ]
ECLAT	Laterality	text	Perm	5	Laterality • "LEFT" = "LEFT" • "RIGHT" = "RIGHT"	CRF Annotated CRF [99 101 ]
ECADJ	Reason for Dose Adjustment	text	Perm	40	ECADJ [7 Terms]	CRF Annotated CRF [99 101 ]
VISITNUM	Visit Number	integer	Perm	8		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
VISIT	Visit Name	text	Perm	21		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
EPOCH	Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived --DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
ECSTDTC	Start Date/Time of Treatment	datetime	Exp		ISO 8601	CRF Annotated CRF [99 101 ]
ECENDTC	End Date/Time of Treatment	datetime	Exp		ISO 8601	CRF Annotated CRF [99 101 ]
ECSTDY	Study Day of Start of Treatment	integer	Perm	8		Derived Study day of start of event relative to the sponsor-defined RFSTDTC. --STDY= (date portion of --STDTC) - (date portion of DM.RFSTDTC) + 1 where --STDTC is on or after DM.RFSTDTC; Else --STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC)
ECENDY	Study Day of End of Treatment	integer	Perm	8		Derived Study day of end of event relative to the sponsor-defined RFSTDTC. --ENDY= (date portion of --ENDTC) - (date portion of DM.RFSTDTC) + 1 where --ENDTC is on or after DM.RFSTDTC; Else --ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC)
ECTPTREF	Time Point Reference	text	Perm	13	TPTREF • "VACCINATION 1" = "VACCINATION 1" • "VACCINATION 2" = "VACCINATION 2" • "VACCINATION 3" = "VACCINATION 3"	Assigned Related vaccination number to assist with Reactogenicity assessment

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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
Related Supplemental Qualifiers Dataset: SUPPEX (Supplemental Qualifiers for Exposure)
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "EX"
USUBJID	Unique Subject Identifier	text	Req	22		Derived DM.USUBJID
EXSEQ	Sequence Number	integer	Req	8		Derived Sequential number identifying records within each USUBJID in the domain.
EXLNKID	Link ID	text	Perm	34		Derived Concatenate Link Group ID, Location and Laterality when Link Group ID is present
EXLNKGRP	Link Group ID	text	Perm	13		Derived Related vaccination number to assist with Reactogenicity assessment
EXTRT	Name of Treatment	text	Req	8		CRF Annotated CRF [99 101 ]
EXCAT	Category of Treatment	text	Perm	23	Category of Treatment • "INVESTIGATIONAL PRODUCT" = "INVESTIGATIONAL PRODUCT"	Assigned
EXSCAT	Subcategory of Treatment	text	Perm	11	Subcategory of Treatment • "VACCINATION" = "VACCINATION"	Assigned
EXDOSE	Dose	integer	Exp	8		CRF Annotated CRF [99 101 ]
EXDOSU	Dose Units	text	Exp	7	EXDOSU • "mcg" = "Microgram" • "SYRINGE" = "SYRINGE"	CRF Annotated CRF [99 101 ]
EXDOSFRM	Dose Form	text	Exp	9	FRM • "INJECTION" = "INJECTION"	CRF Annotated CRF [99 101 ]
EXROUTE	Route of Administration	text	Perm	13	ROUTE [14 Terms]	CRF Annotated CRF [99 101 ]
EXLOC	Location of Dose Administration	text	Perm	14	LOC [12 Terms]	CRF Annotated CRF [99 101 ]
EXLAT	Laterality	text	Perm	5	Laterality • "LEFT" = "LEFT" • "RIGHT" = "RIGHT"	CRF Annotated CRF [99 101 ]
EXADJ	Reason for Dose Adjustment	text	Perm	40	EXADJ [7 Terms]	CRF Annotated CRF [99 101 ]
VISITNUM	Visit Number	integer	Perm	8		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
VISIT	Visit Name	text	Perm	21		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
EPOCH	Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived --DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
EXSTDTC	Start Date/Time of Treatment	datetime	Exp		ISO 8601	CRF Annotated CRF [99 101 ]
EXENDTC	End Date/Time of Treatment	datetime	Exp		ISO 8601	CRF Annotated CRF [99 101 ]
EXSTDY	Study Day of Start of Treatment	integer	Perm	8		Derived Sequential number identifying records within each USUBJID in the domain.
EXENDY	Study Day of End of Treatment	integer	Perm	8		Derived Study day of end of event relative to the sponsor-defined RFSTDTC. --ENDY= (date portion of --ENDTC) - (date portion of DM.RFSTDTC) + 1 where --ENDTC is on or after DM.RFSTDTC; Else --ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC)
EXTPTREF	Time Point Reference	text	Perm	13	TPTREF • "VACCINATION 1" = "VACCINATION 1" • "VACCINATION 2" = "VACCINATION 2" • "VACCINATION 3" = "VACCINATION 3"	Assigned Related vaccination number to assist with Reactogenicity assessment

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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 for Procedures)
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "PR"
USUBJID	Unique Subject Identifier	text	Req	22		Derived DM.USUBJID
PRSEQ	Sequence Number	integer	Req	8		Derived Sequential number identifying records within each USUBJID in the domain.
PRSPID	Sponsor-Defined Identifier	text	Perm	1		CRF Annotated CRF [74 79 80 ]
PRTRT	Reported Name of Procedure	text	Req	42		CRF Annotated CRF [74 79 80 96 ]
PRDECOD	Standardized Procedure Name	text	Perm	22	MedDRA MedDRA 23.1	Assigned
PRCAT	Category	text	Perm	26	Category for Procedures • "GENERAL NON-DRUG TREATMENT" = "GENERAL NON-DRUG TREATMENT"	Assigned
PRPRESP	Pre-specified	text	Perm	1		CRF Annotated CRF [74 79 80 ] Assign as "Y"
PROCCUR	Occurrence	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	Assigned Set to "Y" when PR.PRTRT is not missing and PR.PRPRESP = "Y"
PRSTAT	Completion Status	text	Perm	8	ND • "NOT DONE" = "NOT DONE"	Derived Assigned "NOT DONE" when there is no occurrence, but it is Pre-specified.
VISITNUM	Visit Number	integer	Perm	8		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
VISIT	Visit Name	text	Perm	21		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
EPOCH	Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived --DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
PRDTC	Date/Time of Collection	datetime	Perm		ISO 8601	Assigned Set to coded term from Source when not recoding and take hierarchy terms from master, else use verbatim to get dictionary terms from master
PRSTDTC	Start Date/Time of Procedure	datetime	Exp		ISO 8601	CRF Annotated CRF [74 79 80 96 ]
PRENDTC	End Date/Time of Procedure	datetime	Perm		ISO 8601	CRF Annotated CRF [74 79 80 ]
PRDY	Study Day of Visit/Collection/Exam	integer	Perm	8		Derived Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
PRSTDY	Study Day of Start of Procedure	integer	Perm	8		Derived Study day of start of event relative to the sponsor-defined RFSTDTC. --STDY= (date portion of --STDTC) - (date portion of DM.RFSTDTC) + 1 where --STDTC is on or after DM.RFSTDTC; Else --STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC)
PRENDY	Study Day of End of Procedure	integer	Perm	8		Derived Study day of end of event relative to the sponsor-defined RFSTDTC. --ENDY= (date portion of --ENDTC) - (date portion of DM.RFSTDTC) + 1 where --ENDTC is on or after DM.RFSTDTC; Else --ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC)
PRENRTPT	End Relative to Reference Time Point	text	Perm	7	STENRF • "BEFORE" = "BEFORE" • "ONGOING" = "ONGOING"	Derived Set to "ONGOING" according to the end of the event as being on the reference time point.
PRENTPT	End Reference Time Point	text	Perm	22		Derived Set PRENTPT to "LAST SUBJECT ENCOUNTER" when PR.PRENRTPT is not missing

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Adverse Events (AE)

AE (Adverse Events) - EVENTS Location: ae.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: SUPPAE (Supplemental Qualifiers for Adverse Events)
STUDYID		Study Identifier	text	Req	8		Protocol
DOMAIN		Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned if AE.AE.DOMAIN: ("AE") else AE.VSD.DOMAIN: (Direct move from seq_gen_key.domain where domain = '&DSN')
USUBJID		Unique Subject Identifier	text	Req	22		Derived if AE.AE.USUBJID: (Unique subject identifier derived using COMP.USUBJID) else AE.VSD.USUBJID: (Unique subject identifier derived usingCOMP.USUBJID)
AESEQ		Sequence Number	integer	Req	8		Derived if AE.AE.AESEQ: (Sequence Number derived using COMP.SEQ) else AE.VSD.AESEQ: (Sequential number derived using COMP.SEQ)
AEREFID		Reference ID	text	Perm	10		CRF Annotated CRF [11 67 ]
AESPID		Sponsor-Defined Identifier	text	Perm	2		CRF Annotated CRF [10 ]
AELNKGRP		Link Group ID	text	Perm	57		Derived Concatenation of vaccination number, location and laterality (for administration site events), and event term.
AETERM		Reported Term for the Adverse Event	text	Req	100		CRF Annotated CRF [10 67 95 ]
AELLT		Lowest Level Term	text	Exp	57	MedDRA MedDRA 23.1	Assigned
AELLTCD		Lowest Level Term Code	integer	Exp	8	MedDRA MedDRA 23.1	Assigned
AEDECOD		Dictionary-Derived Term	text	Req	51	MedDRA MedDRA 23.1	Assigned
AEPTCD		Preferred Term Code	integer	Exp	8	MedDRA MedDRA 23.1	Assigned
AEHLT		High Level Term	text	Exp	74	MedDRA MedDRA 23.1	Assigned
AEHLTCD		High Level Term Code	integer	Exp	8	MedDRA MedDRA 23.1	Assigned
AEHLGT		High Level Group Term	text	Exp	86	MedDRA MedDRA 23.1	Assigned
AEHLGTCD		High Level Group Term Code	integer	Exp	8	MedDRA MedDRA 23.1	Assigned
AECAT		Category for Adverse Event	text	Perm	16	Category for Adverse Event • "ADVERSE EVENT" = "ADVERSE EVENT" • "MEDICATION ERROR" = "MEDICATION ERROR" • "REACTOGENICITY" = "REACTOGENICITY"	Assigned
AESCAT		Subcategory for Adverse Event	text	Perm	19	Subcategory for Adverse Event • "ACUTE REACTIONS" = "ACUTE REACTIONS" • "ADMINISTRATION SITE" = "ADMINISTRATION SITE" • "SYSTEMIC" = "SYSTEMIC"	Assigned
AEPRESP		Pre-Specified Adverse Event	text	Perm	1	NY1 • "Y" = "Y"	Assigned Set to 'Y' when AECAT = 'REACTOGENICITY' for pre-specified reactogenicity events.
AEBODSYS		Body System or Organ Class	text	Exp	67	MedDRA MedDRA 23.1	Assigned
AEBDSYCD		Body System or Organ Class Code	integer	Exp	8	MedDRA MedDRA 23.1	Assigned
AESOC		Primary System Organ Class	text	Exp	67	MedDRA MedDRA 23.1	Assigned
AESOCCD		Primary System Organ Class Code	integer	Exp	8	MedDRA MedDRA 23.1	Assigned
AELOC		Location of Event	text	Perm	14	LOC [12 Terms]	CRF Annotated CRF [95 ]
AELAT		Laterality	text	Perm	5	Laterality • "LEFT" = "LEFT" • "RIGHT" = "RIGHT"	CRF Annotated CRF [95 ]
AESER		Serious Event	text	Exp	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [10 ]
AEACN		Action Taken with Study Treatment	text	Exp	16	ACN • "DOSE NOT CHANGED" = "DOSE NOT CHANGED" • "DRUG WITHDRAWN" = "DRUG WITHDRAWN" • "NOT APPLICABLE" = "NOT APPLICABLE"	CRF Annotated CRF [10 67 ]
AEREL		Causality	text	Exp	11	AEREL • "NOT RELATED" = "NOT RELATED" • "RELATED" = "RELATED"	CRF Annotated CRF [10 ]
AERELNST		Relationship to Non-Study Treatment	text	Perm	30	AERELNST • "CONCOMITANT DRUG TREATMENT" = "CONCOMITANT DRUG TREATMENT" • "CONCOMITANT NON-DRUG TREATMENT" = "CONCOMITANT NON-DRUG TREATMENT" • "OTHER" = "OTHER"	CRF Annotated CRF [10 ]
AEOUT		Outcome of Adverse Event	text	Perm	32	OUT [6 Terms]	CRF Annotated CRF [11 ]
AESCONG		Congenital Anomaly or Birth Defect	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [10 ]
AESDISAB		Persist or Signif Disability/Incapacity	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [10 ]
AESDTH		Results in Death	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [10 ]
AESHOSP		Requires or Prolongs Hospitalization	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [10 ]
AESLIFE		Is Life Threatening	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [10 ]
AESMIE		Other Medically Important Serious Event	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [10 ]
AECONTRT		Concomitant or Additional Trtmnt Given	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [11 67 ]
AETOXGR		Standard Toxicity Grade	text	Perm	1	TOXGRV4 • "1" = "1" • "2" = "2" • "3" = "3" • "4" = "4"	CRF Annotated CRF [10 ]
EPOCH		Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived Epoch derivation using COMP.EPOCH
AESTDTCVLM		Start Date/Time of Adverse Event	datetime	Exp		ISO 8601
	AECAT = "REACTOGENICITY" (REACTOGENICITY)	Start Date/Time of Adverse Event	datetime			ISO 8601	Assigned Earliest reported date of the symptom
	AECAT ≠ "REACTOGENICITY" (REACTOGENICITY)	Start Date/Time of Adverse Event	datetime			ISO 8601	CRF Annotated CRF [10 67 ]
AEENDTCVLM		End Date/Time of Adverse Event	datetime	Exp		ISO 8601
	AECAT = "REACTOGENICITY" (REACTOGENICITY)	End Date/Time of Adverse Event	datetime			ISO 8601	Assigned Latest reported date of the symptom
	AECAT ≠ "REACTOGENICITY" (REACTOGENICITY)	End Date/Time of Adverse Event	datetime			ISO 8601	CRF Annotated CRF [10 67 ]
AESTDY		Study Day of Start of Adverse Event	integer	Perm	8		Derived if AE.VSD.AESTDY: (DY derivation using COMP.DY) else AE.AE.AESTDY: (STDY derivation using COMP.STDY)
AEENDY		Study Day of End of Adverse Event	integer	Perm	8		Derived if AE.VSD.AEENDY: (DY derivation using COMP.DY) else AE.AE.AEENDY: (ENDY derivation using COMP.ENDY)
AEDUR		Duration of Adverse Event	text	Perm	4		Derived AEENDTC - AESTDTC + 1 less the protocol-defined assessment interval (number of days occurring past the assessment interval)
AETPTREF		Time Point Reference	text	Perm	13		Assigned Related vaccination number
AERFTDTC		Date/Time of Reference Time Point	datetime	Perm		ISO 8601	Derived Date/time of related vaccination
AEENRTPT		End Relative to Reference Time Point	text	Perm	7		CRF Annotated CRF [10 67 95 ]
AEENTPT		End Reference Time Point	text	Perm	22		Assigned

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Clinical Events (CE)

CE (Clinical Events) - EVENTS Location: ce.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: SUPPCE (Supplemental Qualifiers for Clinical Events)
STUDYID		Study Identifier	text	Req	8		Protocol
DOMAIN		Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "CE"
USUBJID		Unique Subject Identifier	text	Req	22		Derived Unique subject identifier derived usingCOMP.USUBJID
CESEQ		Sequence Number	integer	Req	8		Derived Sequential number derived using COMP.SEQ
CEGRPID		Group ID	text	Perm	33		Derived Concatenation of vaccination number and sub-category.
CELNKGRP		Link Group ID	text	Perm	57		Derived Concatenation of vaccination number, location and laterality (for administration site events), and event term.
CETERMVLM		Reported Term for the Clinical Event	text	Req	99
	CECAT = "SEVERE COVID-19 ILLNESS"	Reported Term for the Clinical Event	text		100		CRF Annotated CRF [38 39 ]
	CECAT = "REACTOGENICITY"	Reported Term for the Clinical Event	text		100		eDT
	CECAT = "EFFICACY" and CEPRESP IN ( "Y" (Y) ) and CEOCCUR IN ( "Y" (Y), "N" (N) )	Reported Term for the Clinical Event	text		100		CRF Annotated CRF [85 87 ]
	CECAT = "EFFICACY" and CEPRESP ≠ "Y" (Y) and CEOCCUR NOT IN ( "Y" (Y), "N" (N) )	Reported Term for the Clinical Event	text		100		CRF Annotated CRF [37 ]
	CECAT = "EFFICACY" and CEPRESP ≠ "Y" (Y) and CEOCCUR IN ( "Y" (Y), "N" (N) )	Reported Term for the Clinical Event	text		100		Derived For every subject excluding SCRFAIL and NOTASSIGN assign CETERM=‘COVID-19 like illness’ If SUPPDM.QVAL where QNAM="CDECASE" ne NULL then assign as CETERM='COVID-19 confirmed' and bring all Pre-specified symptoms for subject for corresponding visit.
CELLT		Lowest Level Term	text	Perm	49	MedDRA MedDRA 23.1	Assigned
CELLTCD		Lowest Level Term Code	integer	Perm	8	MedDRA MedDRA 23.1	Assigned
CEDECOD		Dictionary-Derived Term	text	Perm	39	MedDRA MedDRA 23.1	Assigned
CEPTCD		Preferred Term Code	integer	Perm	8	MedDRA MedDRA 23.1	Assigned
CEHLT		High Level Term	text	Perm	63	MedDRA MedDRA 23.1	Assigned
CEHLTCD		High Level Term Code	integer	Perm	8	MedDRA MedDRA 23.1	Assigned
CEHLGT		High Level Group Term	text	Perm	66	MedDRA MedDRA 23.1	Assigned
CEHLGTCD		High Level Group Term Code	integer	Perm	8	MedDRA MedDRA 23.1	Assigned
CECAT		Category for Clinical Event	text	Perm	23	Clinical Events Category • "EFFICACY" • "REACTOGENICITY" • "SEVERE COVID-19 ILLNESS"	Assigned
CESCAT		Subcategory for Clinical Event	text	Perm	40	Subcategory for Clinical Event • "ADMINISTRATION SITE" = "ADMINISTRATION SITE" • "SIGNIFICANT ACUTE HEPATIC DYSFUNCTION" = "SIGNIFICANT ACUTE HEPATIC DYSFUNCTION" • "SIGNIFICANT ACUTE RENAL DYSFUNCTION" = "SIGNIFICANT ACUTE RENAL DYSFUNCTION" • "SYSTEMIC" = "SYSTEMIC" • "SIGNS AND SYMPTOMS OF DISEASE" = "SIGNS AND SYMPTOMS OF DISEASE"	Assigned
CEPRESP		Clinical Event Pre-Specified	text	Perm	1	NY1 • "Y" = "Y"	Assigned Set to 'Y' for pre-specified events.
CEOCCURVLM		Clinical Event Occurrence	text	Perm	1	NY • "N" = "N" • "Y" = "Y"
	CETERM NOT IN ( "COVID-19 confirmed", "COVID-19 like illness" )	Clinical Event Occurrence	text		1	NY • "N" = "N" • "Y" = "Y"	Assigned
	CETERM = "Covid-19 confirmed"	Clinical Event Occurrence	text		1	NY • "N" = "N" • "Y" = "Y"	Predecessor: SUPPDM.QVAL where QNAM="CDECASE"
	CETERM = "COVID-19 like illness"	Clinical Event Occurrence	text		1	NY • "N" = "N" • "Y" = "Y"	Derived If subject reported at least one pre-specified signs and symptoms for COVID-19 in the contingent visit then assign CEOCCUR value as “Y” else "N".
CESTAT		Completion Status	text	Perm	8	ND • "NOT DONE" = "NOT DONE"	Assigned CESTAT = "NOT DONE" record is generated if a symptom was not assessed.
CEREASND		Reason Clinical Event Not Collected	text	Perm	41		Assigned Assigned when no diary assessment is available.
CEBODSYS		Body System or Organ Class	text	Perm	67	MedDRA MedDRA 23.1	Assigned
CEBDSYCD		Body System or Organ Class Code	integer	Perm	8	MedDRA MedDRA 23.1	Assigned
CESOC		Primary System Organ Class	text	Perm	67	MedDRA MedDRA 23.1	Assigned
CESOCCD		Primary System Organ Class Code	integer	Perm	8	MedDRA MedDRA 23.1	Assigned
CELOC		Location of Event	text	Perm	14	LOC [12 Terms]	CRF Annotated CRF [95 ]
CELAT		Laterality	text	Perm	5	Laterality • "LEFT" = "LEFT" • "RIGHT" = "RIGHT"	CRF Annotated CRF [95 ]
CESEV		Severity/Intensity	text	Perm	8		Assigned Maximum severity reported by subject or investigator for the event
CETOXGR		Toxicity Grade	text	Perm	1		CRF Annotated CRF [37 38 39 ]
VISITNUM		Visit Number	integer	Perm	8		Assigned Assigned from source database.COMM.VISITNUM
VISIT		Visit Name	text	Perm	21		Assigned Assigned from source database.COMM.VISIT
EPOCH		Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived Epoch derivation using COMP.EPOCH
CEDTC		Date/Time of Event Collection	datetime	Perm		ISO 8601	CRF Annotated CRF [37 85 87 ]
CESTDTCVLM		Start Date/Time of Clinical Event	datetime	Perm		ISO 8601
	CECAT = "EFFICACY"	Start Date/Time of Clinical Event	datetime			ISO 8601	CRF Annotated CRF [85 87 ]
	CECAT = "REACTOGENICITY"	Start Date/Time of Clinical Event	datetime			ISO 8601	eDT
	CECAT = "SEVERE COVID-19 ILLNESS"	Start Date/Time of Clinical Event	datetime			ISO 8601	CRF Annotated CRF [38 39 ]
CEENDTCVLM		End Date/Time of Clinical Event	datetime	Perm		ISO 8601
	CECAT = "EFFICACY"	End Date/Time of Clinical Event	datetime			ISO 8601	CRF Annotated CRF [85 87 ]
	CECAT = "REACTOGENICITY"	End Date/Time of Clinical Event	datetime			ISO 8601	Derived Latest reported date of the symptom
	CECAT = "SEVERE COVID-19 ILLNESS"	End Date/Time of Clinical Event	datetime			ISO 8601	CRF Annotated CRF [38 39 ]
CEDY		Study Day of Event Collection	integer	Perm	8		Derived DY derivation using COMP.DY
CESTDY		Study Day of Start of Observation	integer	Perm	8		Derived if CE.VSD.CESTDY: (DY derivation using COMP.DY) else CE.IDT.CESTDY: (STDY derivation using COMP.STDY)
CEENDY		Study Day of End of Observation	integer	Perm	8		Derived if CE.VSD.CEENDY: (DY derivation using COMP.DY) else CE.IDT.CEENDY: (ENDY derivation using COMP.ENDY)
CEDUR		Duration	text	Perm	3		Derived CEENDTC - CESTDTC + 1, except if end date occurs after the protocol-specified assessment interval, then duration will be set to the duration of the assessment interval.
CETPT		Planned Time Point Name	text	Perm	5		Assigned Last planned day of diary
CETPTNUM		Planned Time Point Number	integer	Perm	8		Assigned Last planned day of diary
CETPTREF		Time Point Reference	text	Perm	13		Assigned Related vaccination number
CERFTDTC		Date/Time of Reference Time Point	datetime	Perm		ISO 8601	Derived Date/time of related vaccination
CEEVINTX		Evaluation Interval Text	text	Perm	17		Assigned Assigned as 'SINCE VACCINATION'
CEENRTPTVLM		End Relative to Reference Time Point	text	Perm	7
	CECAT = "REACTOGENICITY"	End Relative to Reference Time Point	text		20	STENRF • "BEFORE" = "BEFORE" • "ONGOING" = "ONGOING"	Derived Set to "ONGOING" when X_CEONGO_008_C="Y";when X_CEONGO_008_C="N" set to "BEFORE".
	CECAT = "EFFICACY"	End Relative to Reference Time Point	text		20	STENRF • "BEFORE" = "BEFORE" • "ONGOING" = "ONGOING"	CRF Annotated CRF [85 87 ]
	CECAT = "SEVERE COVID-19 ILLNESS"	End Relative to Reference Time Point	text		20	STENRF • "BEFORE" = "BEFORE" • "ONGOING" = "ONGOING"	CRF Annotated CRF [38 39 ]
CEENTPTVLM		End Reference Time Point	text	Perm	22
	CECAT ≠ "REACTOGENICITY"	End Reference Time Point	text		30		Derived Set CEENTPT to 'LAST SUBJECT ENCOUNTER' when CE.CEENRTPT is not missing
	CECAT = "REACTOGENICITY"	End Reference Time Point	text		30		Assigned Last day of diary period

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Disposition (DS)

DS (Disposition) - EVENTS Location: ds.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPDS (Supplemental Qualifiers for Disposition)
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "DS"
USUBJID	Unique Subject Identifier	text	Req	22		Derived DM.USUBJID
DSSEQ	Sequence Number	integer	Req	8		Derived Sequential numer identifying records within each USUBJID in the domain
DSREFID	Reference ID	text	Perm	6		CRF Annotated CRF [76 ]
DSTERM	Reported Term for the Disposition Event	text	Req	100		CRF Annotated CRF [16 25 26 27 76 97 109 ]
DSDECOD	Standardized Disposition Term	text	Req	49	NCOMPLT [18 Terms]	Assigned
DSCAT	Category for Disposition Event	text	Exp	18	DSCAT • "DISPOSITION EVENT" = "DISPOSITION EVENT" • "OTHER EVENT" = "OTHER EVENT" • "PROTOCOL MILESTONE" = "PROTOCOL MILESTONE"	Assigned
EPOCH	Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived --DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
DSDTC	Date/Time of Collection	datetime	Perm		ISO 8601	Assigned Assign corresponding visit date where collected.
DSSTDTC	Start Date/Time of Disposition Event	datetime	Exp		ISO 8601	CRF Annotated CRF [16 25 26 27 76 97 109 ]
DSDY	Study Day of Visit/Collection/Exam	integer	Perm	8		Derived Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
DSSTDY	Study Day of Start of Disposition Event	integer	Perm	8		Derived Study day of start of event relative to the sponsor-defined RFSTDTC. --STDY= (date portion of --STDTC) - (date portion of DM.RFSTDTC) + 1 where --STDTC is on or after DM.RFSTDTC; Else --STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC)

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Protocol Deviations (DV)

DV (Protocol Deviations) - EVENTS Location: dv.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPDV (Supplemental Qualifiers for Protocol Deviations)
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "DV"
USUBJID	Unique Subject Identifier	text	Req	22		Derived Unique subject identifier derived using COMP.USUBJID
DVSEQ	Sequence Number	integer	Req	8		Derived Sequence Number derived using COMP.SEQ
DVSPID	Sponsor-Defined Identifier	text	Perm	9		eDT
DVTERM	Protocol Deviation Term	text	Req	198		eDT
DVDECOD	Protocol Deviation Coded Term	text	Perm	23		Assigned Assigned DV.DVDECOD as per PD_Category
DVCAT	Category for Protocol Deviation	text	Perm	13	Category for Protocol Deviation • "Important" = "Important" • "Non-Important" = "Non-Important"	Derived If Potentially_Important_PDs = "YES" then DVCAT = "Important"Else if Potentially_Important_PDs = "NO" then DVCAT = "Non-Important"Else set DVCAT to blank
EPOCH	Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived Epoch derivation using COMP.EPOCH
DVSTDTC	Start Date/Time of Deviation	datetime	Perm		ISO 8601	eDT
DVSTDY	Study Day of Start of Deviation	integer	Perm	8		Derived STDY derivation using COMP.STDY

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Healthcare Encounters (HO)

HO (Healthcare Encounters) - EVENTS Location: ho.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPHO (Supplemental Qualifiers for Healthcare Encounters)
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "HO"
USUBJID	Unique Subject Identifier	text	Req	22		Derived DM.USUBJID
HOSEQ	Sequence Number	integer	Req	8		Derived Sequential number identifying records within each USUBJID in the domain.
HOGRPID	Group ID	text	Perm	3		Assigned Assign "HO2" where HOCAT="HEALTHCARE UTILIZATION ASSESSMENT" or "HO1" where HOCAT="HOSPITALIZATION STATUS"
HOLNKID	Link ID	text	Perm	22		Derived Unique identifier created to link related records in HO when HOOCCUR is "Y".
HOTERM	Reported Term for Healthcare Encounter	text	Req	80		CRF Annotated CRF [35 36 ]
HOCAT	Category for Healthcare Encounter	text	Perm	33	Category for Healthcare Encounter • "HEALTHCARE UTILIZATION ASSESSMENT" = "HEALTHCARE UTILIZATION ASSESSMENT" • "HOSPITALIZATION STATUS" = "HOSPITALIZATION STATUS"	Assigned
HOPRESP	Pre-Specified Healthcare Encounter	text	Perm	1	NY1 • "Y" = "Y"	CRF Annotated CRF [35 ]
HOOCCUR	Healthcare Encounter Occurrence	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [35 ]
HOSTAT	Completion Status	text	Perm	8	ND • "NOT DONE" = "NOT DONE"	Derived Assigned 'NOT DONE' when Original result is missing else Null.
VISITNUM	Visit Number	integer	Exp	8		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
VISIT	Visit Name	text	Perm	21		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
EPOCH	Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived --DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
HODTC	Date/Time of Event Collection	datetime	Perm		ISO 8601	Assigned Assign corresponding visit date where collected.
HOSTDTC	Start Date/Time of Healthcare Encounter	datetime	Exp		ISO 8601	CRF Annotated CRF [36 ]
HOENDTC	End Date/Time of Healthcare Encounter	datetime	Perm		ISO 8601	CRF Annotated CRF [36 ]
HODY	Study Day of Event Collection	integer	Perm	8		Derived Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
HOSTDY	Study Day of Start of Healthcare Encount	integer	Perm	8		Derived Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
HOENDY	Study Day of End of Healthcare Encounter	integer	Perm	8		Derived Study day of end of event relative to the sponsor-defined RFSTDTC. --ENDY= (date portion of --ENDTC) - (date portion of DM.RFSTDTC) + 1 where --ENDTC is on or after DM.RFSTDTC; Else --ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC)
HOEVINTX	Evaluation Interval Text	text	Perm	50		CRF Annotated CRF [35 ]
HOENRTPT	End Relative to Reference Time Point	text	Perm	7	ENRTPT • "ONGOING" = "ONGOING"	CRF Annotated CRF [36 ]
HOENTPT	End Reference Time Point	text	Perm	7		CRF Annotated CRF [36 ]

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Medical History (MH)

MH (Medical History) - EVENTS Location: mh.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPMH (Supplemental Qualifiers for Medical History)
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "MH"
USUBJID	Unique Subject Identifier	text	Req	22		Derived Unique subject identifier derived using COMP.USUBJID
MHSEQ	Sequence Number	integer	Req	8		Derived Sequential number derived using COMP.SEQ
MHSPID	Sponsor-Defined Identifier	text	Perm	2		CRF Annotated CRF [69 ]
MHTERM	Reported Term for the Medical History	text	Req	100		CRF Annotated CRF [69 ]
MHLLT	Lowest Level Term	text	Perm	69	MedDRA MedDRA 23.1	Assigned Assign value of MHLLT_001
MHLLTCD	Lowest Level Term Code	integer	Perm	8	MedDRA MedDRA 23.1	Assigned Assign value of MHLLTCD_001
MHDECOD	Dictionary-Derived Term	text	Perm	62	MedDRA MedDRA 23.1	Assigned Assign value of MHDECOD_001
MHPTCD	Preferred Term Code	integer	Perm	8	MedDRA MedDRA 23.1	Assigned Assign value of MHPTCD_001
MHHLT	High Level Term	text	Perm	82	MedDRA MedDRA 23.1	Assigned Assign value of MHHLT_001
MHHLTCD	High Level Term Code	integer	Perm	8	MedDRA MedDRA 23.1	Assigned Assign value of MHHLTCD_001
MHHLGT	High Level Group Term	text	Perm	86	MedDRA MedDRA 23.1	Assigned Assign value of MHHLGT_001
MHHLGTCD	High Level Group Term Code	integer	Perm	8	MedDRA MedDRA 23.1	Assigned Assign value of MHHLGTCD_001
MHCAT	Category for Medical History	text	Perm	23	Category for Medical History • "GENERAL MEDICAL HISTORY" = "GENERAL MEDICAL HISTORY"	Assigned
MHBODSYS	Body System or Organ Class	text	Perm	67	MedDRA MedDRA 23.1	Assigned Assign value of MHSOC_001
MHBDSYCD	Body System or Organ Class Code	integer	Perm	8	MedDRA MedDRA 23.1	Assigned Assign value of MHSOCCD_001
MHSOC	Primary System Organ Class	text	Perm	67	MedDRA MedDRA 23.1	Assigned Assign value of MHSOC_001
MHSOCCD	Primary System Organ Class Code	integer	Perm	8	MedDRA MedDRA 23.1	Assigned Assign value of MHSOCCD_001
VISITNUM	Visit Number	integer	Perm	8		Assigned Assigned from source database.COMM.VISITNUM
VISIT	Visit Name	text	Perm	21		Assigned Assigned from source database.COMM.VISIT
EPOCH	Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived Epoch derivation using COMP.EPOCH
MHDTC	Date/Time of History Collection	datetime	Perm		ISO 8601	Assigned Direct move from DOV
MHSTDTC	Start Date/Time of Medical History Event	datetime	Perm		ISO 8601	CRF Annotated CRF [69 ]
MHENDTC	End Date/Time of Medical History Event	datetime	Perm		ISO 8601	CRF Annotated CRF [69 ]
MHDY	Study Day of History Collection	integer	Perm	8		Derived DY derivation using COMP.DY
MHSTDY	Study Day of Start of Observation	integer	Perm	8		Derived STDY derivation using COMP.STDY
MHENDY	Study Day of End of Observation	integer	Perm	8		Derived ENDY derivation using COMP.ENDY
MHENRTPT	End Relative to Reference Time Point	text	Perm	7	STENRF • "BEFORE" = "BEFORE" • "ONGOING" = "ONGOING"	Derived Set to "ONGOING" when X_MHONGO_001_C="Y";when X_MHONGO_001_C="N" set to "BEFORE".
MHENTPT	End Reference Time Point	text	Perm	22		Derived Set MHENTPT to 'LAST SUBJECT ENCOUNTER' when MH.MHENRTPT is not missing

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Death Details (DD)

DD (Death Details) - FINDINGS Location: dd.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "DD"
USUBJID	Unique Subject Identifier	text	Req	22		Derived DM.USUBJID
DDSEQ	Sequence Number	integer	Req	8		Derived Sequential number identifying records within each USUBJID in the domain.
DDTESTCD	Death Detail Assessment Short Name	text	Req	6	Death Detail Assessment Short Name • "PRCDTH" = "PRIMARY CAUSE OF DEATH"	Assigned
DDTEST	Death Detail Assessment Name	text	Req	22		CRF Annotated CRF [23 ]
DDCAT	Category	text	Perm	19	Category for Device Identifiers • "DEATH DETAILS CODED" = "DEATH DETAILS CODED"	Assigned
DDORRES	Result or Finding as Collected	text	Exp	47		CRF Annotated CRF [23 ]
DDSTRESC	Character Result/Finding in Std Format	text	Exp	19		CRF Annotated CRF [23 ]
DDEVAL	Evaluator	text	Perm	12	EVAL • "INVESTIGATOR" = "INVESTIGATOR" • "STUDY SUBJECT" = "STUDY SUBJECT"	Assigned Set as "INVESTIGATOR"
EPOCH	Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived --DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
DDDTC	Date/Time of Collection	datetime	Exp		ISO 8601	CRF Annotated CRF [23 ]
DDDY	Study Day of Collection	integer	Perm	8		Derived Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)

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Findings About Events or Interventions (FACE)

FACE (Findings About Events or Interventions, FA) - FINDINGS 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 for Findings About Events or Interventions)
STUDYID		Study Identifier	text	Req	8		Protocol
DOMAIN		Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID		Unique Subject Identifier	text	Req	22		Derived DM.USUBJID
FASEQ		Sequence Number	integer	Req	12		Derived Sequential number identifying records within each USUBJID in the domain.
FAGRPID		Group ID	text	Perm	33		Derived Concatenation of vaccination number and sub-category
FAREFID		Reference ID	text	Perm	19		eDT
FALNKID		Link ID	text	Perm	77		Derived Concatenation of vaccination number, location and laterality (for administration site events), object of the finding (symptom), and diary day.
FALNKGRP		Link Group ID	text	Perm	71		Derived Concatenation of vaccination number, location and laterality (for administration site events), and object of the finding (symptom).
FATESTCD		Findings About Test Short Name	text	Req	8	Test Code for FACE [12 Terms]	Assigned
FATEST		Findings About Test Name	text	Req	20	Test name for FACE [12 Terms]	Assigned
FAOBJ		Object of the Observation	text	Req	22		CRF Annotated CRF [78 85 87 95 ]
FACAT		Category for Findings About	text	Perm	53	Category for FACE • "EFFICACY" = "EFFICACY" • "REACTOGENICITY" = "REACTOGENICITY" • "REACTOGENICITY - UNPLANNED ASSESSMENT" = "REACTOGENICITY - UNPLANNED ASSESSMENT"	Assigned
FASCAT		Subcategory for Findings About	text	Perm	19	Subcategory for FACE • "ADMINISTRATION SITE" = "ADMINISTRATION SITE" • "MEDICATIONS GIVEN" = "MEDICATIONS GIVEN" • "RESPIRATORY ILLNESS" = "RESPIRATORY ILLNESS" • "SYSTEMIC" = "SYSTEMIC"	Assigned
FAORRESVLM		Result or Finding in Original Units	text	Exp	10
	FATESTCD = "DIAMETER" (Diameter)	Result or Finding in Original Units	text		2		eDT
	FATESTCD = "MEDTFVPN" (Medication to Treat Fever or Pain)	Result or Finding in Original Units	text		1	NY • "N" = "N" • "Y" = "Y"	eDT
	FATESTCD = "OCCUR" (Occurrence Indicator) and FACAT = "REACTOGENICITY" (REACTOGENICITY)	Result or Finding in Original Units	text		1	NY • "N" = "N" • "Y" = "Y"	eDT
	FATESTCD = "STPDMEDP" (Stop Date Meds Given to Trt/Pnt Symptoms)	Result or Finding in Original Units	date			ISO 8601	eDT
	FATESTCD = "SEV" (Severity/Intensity) and FACAT = "REACTOGENICITY" (REACTOGENICITY)	Result or Finding in Original Units	text		8	Severity Response for FACE • "MILD" = "Mild" • "MODERATE" = "Moderate" • "SEVERE" = "Severe"	eDT
	FATESTCD = "G4CRIMET" (Grade 4 Criteria Met)	Result or Finding in Original Units	text		1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [78 ]
	FATESTCD = "SEV" (Severity/Intensity) and FACAT = "REACTOGENICITY - UNPLANNED ASSESSMENT" (REACTOGENICITY - UNPLANNED ASSESSMENT)	Result or Finding in Original Units	text		1	Severity Response for FACE • "MILD" = "Mild" • "MODERATE" = "Moderate" • "SEVERE" = "Severe"	CRF Annotated CRF [78 ]
	FATESTCD = "MAXDIAM" (Maximum Diameter) and FACAT = "REACTOGENICITY - UNPLANNED ASSESSMENT" (REACTOGENICITY - UNPLANNED ASSESSMENT)	Result or Finding in Original Units	text		6		CRF Annotated CRF [78 ]
	FATESTCD = "MINDIAM" (Minimum Diameter) and FACAT = "REACTOGENICITY - UNPLANNED ASSESSMENT" (REACTOGENICITY - UNPLANNED ASSESSMENT)	Result or Finding in Original Units	text		6		CRF Annotated CRF [78 ]
	FATESTCD = "REL" (Related to Study Treatment) and FACAT = "REACTOGENICITY - UNPLANNED ASSESSMENT" (REACTOGENICITY - UNPLANNED ASSESSMENT)	Result or Finding in Original Units	text		1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [78 ]
	FATESTCD = "FSYMDATE" (First Symptom Date)	Result or Finding in Original Units	date			ISO 8601	CRF Annotated CRF [85 87 ]
	FATESTCD = "LSYMDATE" (Last Symptom Resolved Date)	Result or Finding in Original Units	date			ISO 8601	CRF Annotated CRF [85 87 ]
	FATESTCD = "OCCUR" (Occurrence Indicator) and FACAT = "REACTOGENICITY - UNPLANNED ASSESSMENT" (REACTOGENICITY - UNPLANNED ASSESSMENT)	Result or Finding in Original Units	text		2	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [78 ]
	FATESTCD = "SYMONGO" (Symptom Ongoing)	Result or Finding in Original Units	text		2	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [85 87 ]
	FATESTCD = "OCCUR" (Occurrence Indicator) and FACAT = "EFFICACY" (EFFICACY)	Result or Finding in Original Units	text		2	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [85 87 ]
FAORRESU		Original Units	text	Perm	12	Units for FACE • "CALIPER UNIT" = "CALIPER UNIT" • "cm" = "Centimeter"	Assigned
FASTRESC		Character Result/Finding in Std Format	text	Exp	8		Assigned If FATESTCD = 'DIAMETER' then assign 0.5*FAORRES else assign FAORRES
FASTRESN		Numeric Result/Finding in Standard Units	float	Perm	3		Assigned FASTRESN=FASTRESC for numeric values
FASTRESU		Standard Units	text	Perm	2	Standard Units for FACE • "cm" = "Centimeter"	Assigned Standard units consistent with CDISC controlled terminology
FASTAT		Completion Status	text	Perm	8	ND • "NOT DONE" = "NOT DONE"	Derived FASTAT = "NOT DONE" record is generated for any missed symptoms/diary days. Set to "NOT DONE" when FA.FAORRES is missing, except the records where Derived Flag is 'Y'
FAREASND		Reason Not Performed	text	Perm	41		Assigned Assigned if no diary assessment is available
FALOC		Location of the Finding About	text	Perm	14	Anatomical Location for FACE • "DELTOID MUSCLE"	CRF Annotated CRF [78 ]
FALAT		Laterality of Location of Finding About	text	Perm	5	Laterality • "LEFT" = "LEFT" • "RIGHT" = "RIGHT"	CRF Annotated CRF [78 ]
FADRVFLVLM		Derived Flag	text	Perm	1		Derived Defaulted to "Y" for verbatim terms not pre specified
	FACAT ≠ "REACTOGENICITY" (REACTOGENICITY)	Derived Flag	text		1	NY • "N" = "N" • "Y" = "Y"	Derived Defaulted to "Y" for verbatim terms not pre specified
	FACAT = "REACTOGENICITY" (REACTOGENICITY)	Derived Flag	text		1	NY • "N" = "N" • "Y" = "Y"	Derived FADRVFL = 'Y' if record for missed diary day is derived
FAEVAL		Evaluator	text	Perm	13	EVAL • "INVESTIGATOR" = "INVESTIGATOR" • "STUDY SUBJECT" = "STUDY SUBJECT"	Assigned Indicates who did the assessment
VISITNUM		Visit Number	float	Exp	7		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
VISIT		Visit Name	text	Perm	21		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
EPOCH		Epoch	text	Perm	9	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived --DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
FADTCVLM		Date/Time of Collection	datetime	Perm		ISO 8601
	FACAT = "EFFICACY" (EFFICACY)	Date/Time of Collection	datetime			ISO 8601	CRF Annotated CRF [85 87 ]
	FACAT = "REACTOGENICITY" (REACTOGENICITY)	Date/Time of Collection	datetime			ISO 8601	eDT
	FACAT = "REACTOGENICITY - UNPLANNED ASSESSMENT" (REACTOGENICITY - UNPLANNED ASSESSMENT)	Date/Time of Collection	datetime			ISO 8601	CRF Annotated CRF [78 ]
FADY		Study Day of Collection	integer	Perm	3		Derived Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
FATPT		Planned Time Point Name	text	Perm	5		Assigned Diary day
FATPTNUM		Planned Time Point Number	integer	Perm	1		Assigned Numeric equivalent of Diary day
FATPTREF		Time Point Reference	text	Perm	13		Assigned Related vaccination number
FARFTDTC		Date/Time of Reference Time Point	datetime	Perm		ISO 8601	Derived Date/time of related vaccination
FAEVLINT		Evaluation Interval	text	Perm	4		Assigned FAEVLINT = '-P1D' for first day of diary
FAEVINTX		Evaluation Interval Text	text	Perm	17		Assigned FAEVINTX = 'SINCE VACCINATION' for Day 2 to end of diary period
FAENRTPT		End Relative to Reference Time Point	text	Perm	7	STENRF • "BEFORE" = "BEFORE" • "ONGOING" = "ONGOING"	Assigned
FAENTPT		End Reference Time Point	text	Perm	5		Assigned Last day of diary period

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Findings About Events or Interventions (FAHO)

FAHO (Findings About Events or Interventions, FA) - FINDINGS Location: faho.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "FA"
USUBJID	Unique Subject Identifier	text	Req	22		Derived DM.USUBJID
FASEQ	Sequence Number	integer	Req	12		Derived Sequential number identifying records within each USUBJID in the domain.
FALNKID	Link ID	text	Perm	22		Derived Unique identifier created to link related records in HO when FAORRES is not missing
FATESTCD	Findings About Test Short Name	text	Req	6	Vaccines Findings About Test Code • "NUMBER" = "NUMBER"	Assigned
FATEST	Findings About Test Name	text	Req	6	Vaccines Findings About Test Name • "Number" = "NUMBER"	Assigned
FAOBJ	Object of the Observation	text	Req	80		Assigned Assign value of HO.HOTERM
FACAT	Category for Findings About	text	Perm	22	Category for FAHO • "HEALTHCARE UTILIZATION" = "HEALTHCARE UTILIZATION"	Assigned
FAORRES	Result or Finding in Original Units	text	Exp	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [35 ]
FAORRESU	Original Units	text	Perm	15	Units for FAHO • "VISITS/CONTACTS" = "VISITS/CONTACTS"	Assigned
FASTRESC	Character Result/Finding in Std Format	text	Exp	1		Assigned Assign value of FAHO.FAORRES
FASTRESN	Numeric Result/Finding in Standard Units	integer	Perm	1		Derived Populate quantitative values of FAORRES
FASTRESU	Standard Units	text	Perm	15	UNIT [33 Terms]	Assigned Standard units consistent with CDISC controlled terminology
VISITNUM	Visit Number	integer	Exp	1		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
VISIT	Visit Name	text	Perm	21		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
EPOCH	Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived --DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
FADTC	Date/Time of Collection	datetime	Perm		ISO 8601	Assigned Assign corresponding visit date where collected.
FADY	Study Day of Collection	integer	Perm	3		Derived Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
FAEVINTX	Evaluation Interval Text	text	Perm	50		CRF Annotated CRF [35 ]

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Inclusion/Exclusion Criteria Not Met (IE)

IE (Inclusion/Exclusion Criteria Not Met) - FINDINGS Location: ie.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPIE (Supplemental Qualifiers for Inclusion/Exclusion Criteria Not Met)
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "IE"
USUBJID	Unique Subject Identifier	text	Req	22		Derived DM.USUBJID
IESEQ	Sequence Number	integer	Req	8		Derived Sequential number identifying records within each USUBJID in the domain.
IESPID	Sponsor-Defined Identifier	text	Perm	2		CRF Annotated CRF [41 43 45 48 50 52 54 55 56 57 58 59 ]
IETESTCD	Inclusion/Exclusion Criterion Short Name	text	Req	7	Inclusion/Exclusion Criterion Short Name [49 Terms]	Assigned
IETEST	Inclusion/Exclusion Criterion	text	Req	200		CRF Annotated CRF [41 43 45 47 48 50 52 54 55 56 57 58 59 ]
IECAT	Inclusion/Exclusion Category	text	Req	9	Inclusion/Exclusion Category • "INCLUSION" = "INCLUSION" • "EXCLUSION" = "EXCLUSION"	Assigned
IEORRES	I/E Criterion Original Result	text	Req	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [41 43 45 47 48 50 52 54 55 56 57 58 59 ]
IESTRESC	I/E Criterion Result in Std Format	text	Req	1	NY • "N" = "N" • "Y" = "Y"	Derived IE.IEORRES
VISITNUM	Visit Number	integer	Perm	8		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
VISIT	Visit Name	text	Perm	21		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
EPOCH	Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived --DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
IEDTC	Date/Time of Collection	datetime	Perm		ISO 8601	Assigned Assign corresponding visit date where collected.
IEDY	Study Day of Collection	integer	Perm	8		Derived Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of 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 for Immunogenicity Specimen Assessments)
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "IS"
USUBJID	Unique Subject Identifier	text	Req	22		Derived DM.USUBJID
ISSEQ	Sequence Number	integer	Req	8		Derived Sequential number identifying records within each USUBJID in the domain.
ISGRPID	Group ID	text	Perm	14		Assigned For Serology testing for prior COVID-19 infection at screening "PRIOR COVID-19 INFECTION" else "IMMUNOGENICITY"
ISREFID	Reference ID	text	Perm	12		eDT
ISTESTCD	Immunogenicity Test/Exam Short Name	text	Req	8	Immunogenicity Test/Exam Short Name • "C19NIG" = "N-binding antibody" • "C19RBDIG" = "COVID-19 RBD IgG" • "C19S1IGG" = "COVID-19 S1 IgG" • "C2NGNT50" = "SARS-CoV-2 serum neutralizing titer 50" • "C2NGNT90" = "SARS-CoV-2 serum neutralizing titer 90"	Assigned
ISTEST	Immunogenicity Test or Examination Name	text	Req	38		Assigned
ISCAT	Category for Immunogenicity Test	text	Perm	8	Category for Immunogenicity Test • "SEROLOGY" = "SEROLOGY"	Assigned
ISORRES	Results or Findings in Original Units	text	Exp	12		eDT
ISORRESU	Original Units	text	Perm	4	UNIT [33 Terms]	eDT
ISSTRESC	Result or Finding in Standard Format	text	Exp	12		Assigned For IS.ISORRES='POSITIVE', assign ISSTRESC as "POS"For IS.ISORRES='NEGATIVE', assign ISSTRESC as "NEG"Else assign from IS.ISORRES
ISSTRESN	Numeric Results/Findings in Std. Units	integer	Exp	8		Assigned ISSTRESN = numeric value of ISSTRESC, when ISSTRESC contains numeric data.
ISSTRESU	Standard Units	text	Exp	4	UNIT [33 Terms]	Assigned Standard units consistent with CDISC controlled terminology
ISSPEC	Specimen Type	text	Perm	5	SPECTYPE [7 Terms]	CRF Annotated CRF [72 82 ]
ISMETHOD	Method of Test or Examination	text	Perm	26		Assigned For "C19FSIGG" "C19NVAN" "C19RBDIG" "C19S1IGG" "C2NGNT50" "C2NGNT90" assign "Virus Neutralization Assay" For "C19NIG" assign "N-binding Antibody Assay" Else NULL
ISBLFL	Baseline Flag	text	Perm	1	NY1 • "Y" = "Y"	Derived Last non-missing value on or before DM.RFSTDTC is flagged as Y.
ISLLOQ	Lower Limit of Quantitation	integer	Exp	8		Assigned For C19RBDIG, then assign ISLLOQ as "1.1505" For C19S1IGG, then assign ISLLOQ as "1.2665" For C2NGNT50, then assign ISLLOQ as "20" For C2NGNT90, then assign ISLLOQ as "20" Otherwise set to NULL
VISITNUM	Visit Number	integer	Exp	8		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
VISIT	Visit Name	text	Perm	21		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
EPOCH	Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived --DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
ISDTC	Date/Time of Collection	datetime	Exp		ISO 8601	CRF Annotated CRF [72 82 ]
ISDY	Study Day of Visit/Collection/Exam	integer	Perm	8		Derived Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)

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Laboratory Test Results (LB)

LB (Laboratory Test Results) - FINDINGS Location: lb.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: SUPPLB (Supplemental Qualifiers for Laboratory Test Results)
STUDYID		Study Identifier	text	Req	8		Protocol
DOMAIN		Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "LB"
USUBJID		Unique Subject Identifier	text	Req	22		Derived DM.USUBJID
SPDEVID		Sponsor Device Identifier	text	Perm	45		Assigned Assign a unique integer value based on device trade name else Concatenate device manufacturer and the device model
LBSEQ		Sequence Number	integer	Req	8		Derived Sequential number identifying records within each USUBJID in the domain.
LBREFID		Specimen ID	text	Perm	10		eDT
LBSPIDVLM		Sponsor-Defined Identifier	text	Perm	4
	LBNAM ≠ "Covance"	Sponsor-Defined Identifier	text		8		CRF Annotated CRF [12 34 63 64 65 66 ]
	LBNAM = "Covance"	Sponsor-Defined Identifier	text		8		eDT
LBTESTCD		Lab Test or Examination Short Name	text	Req	7		Assigned
LBTEST		Lab Test or Examination Name	text	Req	39		CRF Annotated CRF [12 34 63 64 65 66 ]
LBCAT		Category for Lab Test	text	Exp	18	Category for Lab Test • "CLINICAL CHEMISTRY" = "CLINICAL CHEMISTRY" • "HEMATOLOGY" = "HEMATOLOGY" • "OXYGENATION PARAMETERS" = "OXYGENATION PARAMETERS" • "URINALYSIS" = "URINALYSIS"	Assigned
LBSCAT		Subcategory for Lab Test	text	Perm	15	Subcategory for Lab Test • "BLOOD CHEMISTRY" = "BLOOD CHEMISTRY" • "DIFFERENTIAL" = "DIFFERENTIAL" • "PREGNANCY" = "PREGNANCY" • "VIROLOGY" = "VIROLOGY"	Assigned
LBORRESVLM		Result or Finding in Original Units	text	Exp	16
	LBNAM ≠ "Covance"	Result or Finding in Original Units	text		30		CRF Annotated CRF [12 34 63 64 65 66 70 ]
	LBNAM = "Covance"	Result or Finding in Original Units	text		30		eDT
LBORRESUVLM		Original Units	text	Exp	10
	LBNAM ≠ "Covance"	Original Units	text		25	UNIT [33 Terms]	CRF Annotated CRF [12 34 63 64 65 ]
	LBNAM = "Covance"	Original Units	text		25	UNIT [33 Terms]	eDT
LBORNRLOVLM		Reference Range Lower Limit in Orig Unit	text	Exp	13
	LBNAM ≠ "Covance"	Reference Range Lower Limit in Orig Unit	text		20		CRF Annotated CRF [12 34 63 64 65 ]
	LBNAM = "Covance"	Reference Range Lower Limit in Orig Unit	text		20		eDT
LBORNRHIVLM		Reference Range Upper Limit in Orig Unit	text	Exp	17
	LBNAM ≠ "Covance"	Reference Range Upper Limit in Orig Unit	text		20		CRF Annotated CRF [12 34 63 64 65 ]
	LBCAT = "Covance"	Reference Range Upper Limit in Orig Unit	text		20		eDT
LBSTRESC		Character Result/Finding in Std Format	text	Exp	13		Derived Data collected in non-standard units is converted using standard conversion factors to standard units.
LBSTRESN		Numeric Result/Finding in Standard Units	integer	Exp	8		Derived Numeric value of LBSTRESC, when LBSTRESC contains numeric data.
LBSTRESU		Standard Units	text	Exp	10	UNIT [33 Terms]	Derived Standard units consistent with CDISC controlled terminology
LBSTNRLO		Reference Range Lower Limit-Std Units	float	Exp	8		Derived Derived based on low normal ranges from local and central labs using conversion factor
LBSTNRHI		Reference Range Upper Limit-Std Units	float	Exp	8		Derived Derived based on high normal ranges from local and central labs using conversion factor
LBNRIND		Reference Range Indicator	text	Exp	6	NRIND • "HIGH" = "HIGH" • "LOW" = "LOW" • "NORMAL" = "NORMAL"	Derived Reference Range Indicator based upon standard results and ranges
LBSTATVLM		Completion Status	text	Perm	8
	LBCAT = "OXYGENATION PARAMETERS" (OXYGENATION PARAMETERS) and LBNAM ≠ "Covance"	Completion Status	text		8	ND • "NOT DONE" = "NOT DONE"	Derived Assigned as "NOT DONE" when Original Result is missing
	LBNAM ≠ "Covance" and LBCAT ≠ "OXYGENATION PARAMETERS" (OXYGENATION PARAMETERS)	Completion Status	text		8	ND • "NOT DONE" = "NOT DONE"	CRF Annotated CRF [12 34 63 64 65 66 ]
	LBNAM = "Covance"	Completion Status	text		8	ND • "NOT DONE" = "NOT DONE"	eDT
LBREASND		Reason Test Not Done	text	Perm	28		eDT
LBNAMVLM		Vendor Name	text	Perm	130
	LBNAM ≠ "Covance"	Vendor Name	text		200		CRF Annotated CRF [12 34 63 64 65 66 ]
	LBNAM = "Covance"	Vendor Name	text		200		eDT
LBLOINC		LOINC Code	text	Perm	7		eDT
LBSPECVLM		Specimen Type	text	Perm	5
	LBNAM ≠ "Covance"	Specimen Type	text		40	SPECTYPE [7 Terms]	CRF Annotated CRF [12 34 61 62 63 64 65 66 ]
	LBNAM = "Covance"	Specimen Type	text		40	SPECTYPE [7 Terms]	eDT
LBBLFL		Baseline Flag	text	Exp	1	NY1 • "Y" = "Y"	Derived Last non-missing value on or before DM.RFSTDTC is flagged as Y.
VISITNUM		Visit Number	integer	Exp	8		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
VISIT		Visit Name	text	Perm	21		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
EPOCH		Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived --DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
LBDTCVLM		Date/Time of Specimen Collection	datetime	Exp		ISO 8601
	LBNAM ≠ "Covance"	Date/Time of Specimen Collection	datetime			ISO 8601	CRF Annotated CRF [12 34 61 62 63 64 65 66 70 ]
	LBNAM = "Covance"	Date/Time of Specimen Collection	datetime			ISO 8601	eDT
LBDY		Study Day of Specimen Collection	integer	Perm	8		Derived Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)

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Microbiology Specimen (MB)

MB (Microbiology Specimen) - FINDINGS Location: mb.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: SUPPMB (Supplemental Qualifiers for Microbiology Specimen)
STUDYID		Study Identifier	text	Req	8		Protocol
DOMAIN		Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "MB"
USUBJID		Unique Subject Identifier	text	Req	22		Derived Unique subject identifier derived usingCOMP.USUBJID
SPDEVID		Sponsor Device Identifier	text	Perm	45		Assigned Assign a unique integer value based on device trade name else Concatenate device manufacturer and the device model
MBSEQ		Sequence Number	integer	Req	8		Derived if MB.LB.MBSEQ: (Merge SM_LB003 and DI raw data set on the basis of MBSPID then derive SPDEVID) else MB.MIB.MBSEQ: (Sequence Number derived using COMP.SEQ)
MBGRPID		Group ID	text	Exp	1		Assigned
MBREFID		Reference ID	text	Perm	10		eDT
MBSPID		Sponsor-Defined Identifier	text	Perm	4		eDT
MBTESTCD		Microbiology Test or Finding Short Name	text	Req	8	Microbiology Specimen Test Code [7 Terms]	Assigned
MBTEST		Microbiology Test or Finding Name	text	Req	40	Microbiology Specimen Test Name [7 Terms]	CRF Annotated CRF [21 22 94 ]
MBCAT		Category for Microbiology Finding	text	Perm	25	Category for Microbiology Finding • "CLINICAL CHEMISTRY" • "CONFIRMATION OF INFECTION" • "VIROLOGY"	Assigned
MBSCAT		Subcategory for Microbiology Finding	text	Perm	15	Subcategory for Microbiology Finding • "BLOOD CHEMISTRY"	Assigned
MBORRESVLM		Result or Finding in Original Units	text	Exp	13
	MBCAT = "VIROLOGY"	Result or Finding in Original Units	text		200		eDT
	MBCAT ≠ "VIROLOGY"	Result or Finding in Original Units	text		200		CRF Annotated CRF [21 22 94 ]
MBSTRESCVLM		Character Result/Finding in Std Format	text	Exp	13
	MBCAT = "VIROLOGY"	Character Result/Finding in Std Format	text		200		Assigned For MB.MBORRES='POSITIVE', assign MBSTRESC as "POS" For MB.MBORRES='NEGATIVE', assign MBSTRESC as "NEG"For MB.MBORRES='IND', assign MBSTRESC as "INDETERMINATE" Else assign from MB.MBORRES
	MBCAT ≠ "VIROLOGY"	Character Result/Finding in Std Format	text		50		Derived Results from MBORRES in standard units
MBRESCAT		Result Category	text	Exp	1		Assigned
MBSTATVLM		Completion Status	text	Perm	8
	MBCAT ≠ "VIROLOGY"	Completion Status	text		8	ND • "NOT DONE" = "NOT DONE"	Derived if MB.MIB.MBSTAT: (Set to "NOT DONE" when MB.MBORRES is missing) else MB.VARD.MBSTAT: (Assigned 'NOT DONE' when RESULT is missing else Null.)
	MBCAT = "VIROLOGY"	Completion Status	text		8	ND • "NOT DONE" = "NOT DONE"	eDT
MBNAM		Vendor Name	text	Perm	7	Vendor Name for Microbiology Specimen • "Covance"	eDT
MBLOINC		LOINC Code	text	Perm	7		eDT
MBSPECVLM		Specimen Type	text	Perm	22
	MBCAT ≠ "VIROLOGY"	Specimen Type	text		50	Specimen Type in Microbiology Specimen • "BLOOD" • "NASAL_SWAB" • "NASAL_SWAB_SELF" • "RESPIRATORY SECRETIONS" • "SWABBED MATERIAL"	CRF Annotated CRF [21 22 61 62 81 84 93 94 ]
	MBCAT = "VIROLOGY"	Specimen Type	text		50	Specimen Type in Microbiology Specimen • "BLOOD" • "NASAL_SWAB" • "NASAL_SWAB_SELF" • "RESPIRATORY SECRETIONS" • "SWABBED MATERIAL"	eDT
MBLOC		Specimen Collection Location	text	Perm	24	Location of Specimen Collection for Microbiology Specimen • "LOWER RESPIRATORY SYSTEM" • "NASAL CAVITY" • "NASOPHARYNX" • "THROAT"	CRF Annotated CRF [22 94 ]
MBMETHOD		Method of Test or Examination	text	Exp	25	Method of Test or Examination in Microbiology Specimen • "IMMUNOCHROMATOGRAPHY" • "REVERSE TRANSCRIPTASE PCR"	Assigned For COVID Test Results from Local lab assign "IMMUNOCHROMATOGRAPHY" and from Central lab Assign as "REVERSE TRANSCRIPTASE PCR"
MBBLFL		Baseline Flag	text	Perm	1	NY1 • "Y" = "Y"	Derived Last non-missing value on or before DM.RFSTDTC is flagged as Y COMM.BLFL
VISITNUM		Visit Number	integer	Exp	8		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.01 for each unplanned visit between two scheduled visits
VISIT		Visit Name	text	Perm	21		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.01 for each unplanned visit between two scheduled visits
EPOCH		Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived Epoch derivation using COMP.EPOCH
MBDTCVLM		Date/Time of Specimen Collection	datetime	Exp		ISO 8601
	MBCAT ≠ "VIROLOGY"	Date/Time of Specimen Collection	datetime			ISO 8601	CRF Annotated CRF [21 22 61 62 81 84 93 94 ]
	MBCAT = "VIROLOGY"	Date/Time of Specimen Collection	datetime			ISO 8601	eDT
MBDY		Study Day of MB Specimen Collection	integer	Perm	8		Derived DY derivation using COMP.DY

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Morphology (MO)

MO (Morphology) - FINDINGS Location: mo.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPMO (Supplemental Qualifiers for Morphology)
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "MO"
USUBJID	Unique Subject Identifier	text	Req	22		Derived DM.USUBJID
MOSEQ	Sequence Number	integer	Req	8		Derived Sequential number identifying records within each USUBJID in the domain.
MOTESTCD	Test or Examination Short Name	text	Req	4	Test or Examination Short Name • "INTP" = "Interpretation"	Assigned
MOTEST	Test or Examination Name	text	Req	14	Test or Examination Name • "Interpretation"	Assigned
MOCAT	Category for Test	text	Perm	44	Category for Test • "CLINICAL ASSESSMENT OF RADIOGRAPHS - IMAGING" = "CLINICAL ASSESSMENT OF RADIOGRAPHS - IMAGING"	Assigned
MOORRES	Result or Finding in Original Units	text	Exp	13		CRF Annotated CRF [40 ]
MOSTRESC	Character Result/Finding in Std Format	text	Exp	13		Assigned MO.MOORRES
MOSTAT	Completion Status	text	Perm	8		Derived Assigned as "NOT DONE" when Original Result is missing
MOLOC	Location Used for Measurement	text	Perm	5	LOC [12 Terms]	CRF Annotated CRF [40 ]
MOMETHOD	Method of Procedure Test	text	Perm	7	METHOD • "CT SCAN" = "CT SCAN" • "IMMUNOCHROMATOGRAPHY" = "IMMUNOCHROMATOGRAPHY" • "OTHER" = "OTHER" • "REVERSE TRANSCRIPTASE PCR" = "REVERSE TRANSCRIPTASE PCR" • "X-RAY" = "X-RAY"	CRF Annotated CRF [40 ]
MOBLFL	Baseline Flag	text	Exp	1		Derived Last non-missing value on or before DM.RFSTDTC is flagged as Y.
VISITNUM	Visit Number	integer	Exp	8		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
VISIT	Visit Name	text	Perm	21		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.001 for each unplanned visit between two scheduled visits.
EPOCH	Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived --DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
MODTC	Date/Time of Test	datetime	Exp		ISO 8601	CRF Annotated CRF [40 ]
MODY	Study Day of Test	integer	Perm	8		Derived Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)

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Vital Signs (VS)

VS (Vital Signs) - FINDINGS Location: vs.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: SUPPVS (Supplemental Qualifiers for Vital Signs)
STUDYID		Study Identifier	text	Req	8		Protocol
DOMAIN		Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned "VS"
USUBJID		Unique Subject Identifier	text	Req	22		Derived DM.USUBJID
VSSEQ		Sequence Number	integer	Req	8		Derived Sequential number identifying records within each USUBJID in the domain.
VSREFID		Reference ID	text	Perm	19		eDT
VSSPID		Sponsor-Defined Identifier	text	Perm	1		CRF Annotated CRF [75 104 105 106 107 108 ]
VSLNKID		Link ID	text	Perm	25		Derived Concatenation of vaccination number, "FEVER", and diary day for eDiary Temperature Records
VSLNKGRP		Link Group ID	text	Perm	19		Derived Concatenation of vaccination number and "FEVER" for Reactogenicity Temperature Records
VSTESTCD		Vital Signs Test Short Name	text	Req	6		Assigned
VSTEST		Vital Signs Test Name	text	Req	24	VSTEST [10 Terms]	Assigned
VSCAT		Category for Vital Signs	text	Perm	38	Category for Vital Signs • "GENERAL VITAL SIGNS" = "GENERAL VITAL SIGNS" • "REACTOGENICITY" = "REACTOGENICITY" • "REACTOGENICITY - UNPLANNED TEMPERATURE" = "REACTOGENICITY - UNPLANNED TEMPERATURE"	Assigned
VSSCAT		Subcategory for Vital Signs	text	Perm	8	Subcategory for Vital Signs • "SYSTEMIC" = "SYSTEMIC"	Assigned
VSPOS		Vital Signs Position of Subject	text	Perm	7	POSITION • "SITTING" = "SITTING"	CRF Annotated CRF [106 108 ]
VSORRESVLM		Result or Finding in Original Units	text	Exp	6
	VSCAT = "GENERAL VITAL SIGNS" (GENERAL VITAL SIGNS)	Result or Finding in Original Units	text		20		CRF Annotated CRF [75 105 106 107 108 ]
	VSCAT = "REACTOGENICITY - UNPLANNED TEMPERATURE" (REACTOGENICITY - UNPLANNED TEMPERATURE)	Result or Finding in Original Units	text		20		CRF Annotated CRF [104 ]
	VSCAT = "REACTOGENICITY" (REACTOGENICITY)	Result or Finding in Original Units	text		20		eDT
VSORRESUVLM		Original Units	text	Exp	11
	VSCAT = "GENERAL VITAL SIGNS" (GENERAL VITAL SIGNS)	Original Units	text		25	VSRESU [11 Terms]	CRF Annotated CRF [105 106 108 ]
	VSCAT = "REACTOGENICITY - UNPLANNED TEMPERATURE" (REACTOGENICITY - UNPLANNED TEMPERATURE)	Original Units	text		25	VSRESU [11 Terms]	CRF Annotated CRF [104 ]
	VSCAT = "REACTOGENICITY" (REACTOGENICITY)	Original Units	text		25	VSRESU [11 Terms]	eDT If VSTESTCD = "BMI" Assign "kg/m2" Else Original Units as collected
VSSTRESC		Character Result/Finding in Std Format	text	Exp	6		Derived Data collected in non-standard units (i.e. lbs, inches) is converted using standardconversion factors to standard units (kg, cm).
VSSTRESN		Numeric Result/Finding in Standard Units	integer	Exp	8		Derived Numeric value of VSSTRESC, when VSSTRESC contains numeric data.
VSSTRESU		Standard Units	text	Exp	11		Assigned Standardized unit used for VSSTRESC or VSSTRESN.
VSSTAT		Completion Status	text	Perm	8	ND • "NOT DONE" = "NOT DONE"	Assigned Assigned as "NOT DONE" when Original Result is missing
VSREASND		Reason Not Performed	text	Perm	41		Assigned Assign as "SUBJECT DID NOT COMPLETE ELECTRONIC DIARY" when eDiary is not collected
VSLOC		Location of Vital Signs Measurement	text	Perm	11	LOC [12 Terms]	CRF Annotated CRF [104 105 106 108 ]
VSBLFL		Baseline Flag	text	Exp	1	NY1 • "Y" = "Y"	Derived Last non-missing value on or before DM.RFSTDTC is flagged as Y.
VSDRVFL		Derived Flag	text	Perm	1	NY1 • "Y" = "Y"	Assigned VSDRVFL = 'Y' if record for missed diary day is derived
VSEVAL		Evaluator	text	Perm	13		Assigned If records from eDiary then Assign "STUDY SUBJECT" Else Assign "INVESTIGATOR"
VISITNUM		Visit Number	integer	Exp	8		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.01 for each unplanned visit between two scheduled visits
VISIT		Visit Name	text	Perm	21		Assigned Assigned from source database. Note:If Unplanned visits exist, VISIT is set to Null and VISITNUM is re-sequenced as nearest previous scheduled visit incremented by 0.01 for each unplanned visit between two scheduled visits
EPOCH		Epoch	text	Perm	11	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	Derived --DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
VSDTCVLM		Date/Time of Measurements	datetime	Exp		ISO 8601
	VSCAT = "GENERAL VITAL SIGNS" (GENERAL VITAL SIGNS)	Date/Time of Measurements	datetime			ISO 8601	CRF Annotated CRF [75 105 106 107 108 ]
	VSCAT = "REACTOGENICITY - UNPLANNED TEMPERATURE" (REACTOGENICITY - UNPLANNED TEMPERATURE)	Date/Time of Measurements	datetime			ISO 8601	CRF Annotated CRF [104 ]
	VSCAT = "REACTOGENICITY" (REACTOGENICITY)	Date/Time of Measurements	datetime			ISO 8601	eDT
VSDY		Study Day of Vital Signs	integer	Perm	8		Derived Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
VSTPT		Planned Time Point Name	text	Perm	5		Assigned Diary day
VSTPTNUM		Planned Time Point Number	integer	Perm	8		Assigned Numeric equivalent of Diary day
VSTPTREF		Time Point Reference	text	Perm	13		Assigned Related vaccination number
VSRFTDTC		Date/Time of Reference Time Point	datetime	Perm		ISO 8601	Derived Date/time of related vaccination
VSEVLINT		Evaluation Interval	text	Perm	4		Assigned VSEVLINT = '-P1D' for first day of diary
VSEVINTX		Evaluation Interval Text	text	Perm	17		Assigned VSEVINTX = 'SINCE VACCINATION' for Day 2 to end of diary period

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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	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	4	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived USUBJID= DM.USUBJID
IDVAR	Identifying Variable	text	Req	8		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	22		Assigned
RELTYPE	Relationship Type	text	Exp	4	RELTYPE • "MANY" = "MANY" • "ONE" = "ONE"	Assigned Single/Multiple
RELID	Relationship Identifier	text	Req	6		Derived Direct move from respective RELID

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Supplemental Qualifiers for Adverse Events (SUPPAE)

SUPPAE (Supplemental Qualifiers for Adverse Events, 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	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived USUBJID= DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	12		Assigned
QNAM	Qualifier Variable Name	text	Req	8		Assigned
QLABEL	Qualifier Variable Label	text	Req	36		Assigned
QVALVLM	Data Value	text	Req	80
➤ QNAM IN ("AECMGIV")	Concomitant Medication Given	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [11 67 ]
➤ QNAM IN ("DICTVER")	Dictionary Name and Version	text		200		Assigned Assign as "MedDRA v23.1"
➤ QNAM IN ("AEMEFL")	Medication Error Associated With AE	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [67 ]
➤ QNAM IN ("AEAENO")	Associated Adverse Event Identifier	text		200		CRF Annotated CRF [67 ]
➤ QNAM IN ("AENDGIV")	Was a Non-Drug Treatment given	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [11 67 ]
➤ QNAM IN ("AEMERES")	Is AE a Result of a Medication Error	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [10 ]
➤ QNAM IN ("AERELTXT")	Event Due to Other Specify	text		200		CRF Annotated CRF [10 ]
➤ QNAM IN ("AESUBJDC")	Discontinued because of this AE	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [11 67 ]
QORIG	Origin	text	Req	8		Assigned
QEVAL	Evaluator	text	Exp	22		Assigned

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Supplemental Qualifiers for Clinical Events (SUPPCE)

SUPPCE (Supplemental Qualifiers for Clinical Events, 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	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	12		Assigned
QNAM	Qualifier Variable Name	text	Req	8		Assigned
QLABEL	Qualifier Variable Label	text	Req	32		Assigned
QVALVLM	Data Value	text	Req	12
➤ QNAM IN ("ONGNXVIS")	Reported Ongoing at Next Visit	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [95 ]
➤ QNAM IN ("CEDRVFL")	Derived Flag	text		200	NY1 • "Y" = "Y"	Derived if SUPPCE.IDT.QVAL: (Assign as Y for when CETERM= 'COVID-19 confirmed') else SUPPCE.VSD.QVAL: (Will be 'Y' for records derived as 'NOT DONE' due to missed/unavailable diary assessments)
➤ QNAM IN ("CEEVAL")	Evaluator	text		200		Assigned o QVAL is based on source of CESEV value - if max value is from CISR form or unplanned temperature CRF then 'INVESTIGATOR' (else do not output a record)if same max value in both diary and CISR form, then do not generate CEEVAL recordo QORIG= 'ASSIGNED' o QEVAL= 'CLINICAL STUDY SPONSOR'
➤ QNAM IN ("RCENDTC")	Reported Clinical Event End Date	text		200		CRF Annotated CRF [95 ]
➤ QNAM IN ("DICTVER")	Dictionary Name and Version	text		200		Assigned Assign as "MedDRA v23.1"
QORIG	Origin	text	Req	8		Assigned
QEVAL	Evaluator	text	Exp	22		Assigned

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Supplemental Qualifiers for Concomitant Medications (SUPPCM)

SUPPCM (Supplemental Qualifiers for Concomitant Medications, 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	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	2		Assigned
QNAM	Qualifier Variable Name	text	Req	8		Assigned
QLABEL	Qualifier Variable Label	text	Req	28		Assigned
QVALVLM	Data Value	text	Req	75
➤ QNAM IN ("CMCLSCD1")	Medication Class Code 1	text		200	WHO DD WHO DD 202003	Assigned
➤ QNAM IN ("CMCLSCD2")	Medication Class Code 2	text		200	WHO DD WHO DD 202003	Assigned
➤ QNAM IN ("CMCLAS1")	Medication Class 1	text		200	WHO DD WHO DD 202003	Assigned
➤ QNAM IN ("CMCLAS2")	Medication Class 2	text		200	WHO DD WHO DD 202003	Assigned
➤ QNAM IN ("DICTVER")	Dictionary Name and Version	text		200		Assigned Assign as "WHO DDE v202003"
➤ QNAM IN ("CMCODE")	Standardized Medication Code	text		200	WHO DD WHO DD 202003	Assigned
QORIG	Origin	text	Req	8		Assigned
QEVAL	Evaluator	text	Exp	22		Assigned

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Supplemental Qualifiers for Demographics (SUPPDM)

SUPPDM (Supplemental Qualifiers for Demographics, 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	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	1		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	1		Assigned
QNAM	Qualifier Variable Name	text	Req	5		Assigned
QLABEL	Qualifier Variable Label	text	Req	5		Assigned
QVALVLM	Data Value	text	Req	41
➤ QNAM IN ("RACE3")	Race3	text		200	RACE [7 Terms]	CRF Annotated CRF [24 ]
➤ QNAM IN ("RACE2")	Race2	text		200	RACE [7 Terms]	CRF Annotated CRF [24 ]
➤ QNAM IN ("RACE1")	Race1	text		200	RACE [7 Terms]	CRF Annotated CRF [24 ]
➤ QNAM IN ("RACE4")	Race4	text		200	RACE [7 Terms]	CRF Annotated CRF [24 ]
➤ QNAM IN ("CDECASE")	Clinical disease endpoint case flag	text		1	NY • "N" = "N" • "Y" = "Y"	Derived CBER Requirement: Populated from the ADaM primary endpoint case flag for the first primary efficacy endpoint as defined in the protocol and by the variable derivation for ADC19EF.AVALC where PARAMCD="C19ONST".
QORIG	Origin	text	Req	3		Assigned
QEVAL	Evaluator	text	Exp	1		Assigned

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Supplemental Qualifiers for Disposition (SUPPDS)

SUPPDS (Supplemental Qualifiers for Disposition, Disposition) - RELATIONSHIP Location: suppds.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: DS (Disposition)
STUDYID	Study Identifier	text	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	1		Assigned
QNAM	Qualifier Variable Name	text	Req	8		Assigned
QLABEL	Qualifier Variable Label	text	Req	19		Assigned
QVALVLM	Data Value	text	Req	75
➤ QNAM IN ("DSPHASE")	Disposition Phase	text		200	EPOCH • "FOLLOW-UP" = "FOLLOW-UP" • "SCREENING" = "SCREENING" • "VACCINATION" = "VACCINATION"	CRF Annotated CRF [25 26 27 ]
➤ QNAM IN ("DSRANGRP")	Randomization Group	text		200	DSGRP [13 Terms]	CRF Annotated CRF [76 ]
QORIG	Origin	text	Req	3		Assigned
QEVAL	Evaluator	text	Exp	1		Assigned

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Supplemental Qualifiers for Protocol Deviations (SUPPDV)

SUPPDV (Supplemental Qualifiers for Protocol Deviations, 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	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	1		Assigned
QNAM	Qualifier Variable Name	text	Req	7		Assigned
QLABEL	Qualifier Variable Label	text	Req	39		Assigned
QVALVLM	Data Value	text	Req	50
➤ QNAM IN ("CAPE")	Confirmed Analysis Population Exclusion	text		200		eDT
➤ QNAM IN ("ACTSITE")	Actual Site of Deviation Occurrence	text		200		eDT
➤ QNAM IN ("DESGTOR")	Visit Designator	text		200		eDT
➤ QNAM IN ("DVTERM1")	Protocol Deviation Term 1	text		200		Assigned o QVAL= If the DVTERM is greater than 200 characters, then the term will be split into multiple terms i.e. DVTERM, DVTERM1, DVTERM2... DVTERMn and DVTERM1-DVTERMn will be moved to SUPPDVo QORIG='ASSIGNED'o QEVAL=''
➤ QNAM IN ("SOURCE")	Source of the data	text		200		Assigned o QVAL=ICON/ANPDo QORIG='ASSIGNED'o QEVAL='CLINICAL STUDY SPONSOR'
QORIG	Origin	text	Req	8		Assigned
QEVAL	Evaluator	text	Exp	22		Assigned

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Supplemental Qualifiers for Exposure as Collected (SUPPEC)

SUPPEC (Supplemental Qualifiers for Exposure as Collected, Exposure as Collected) - RELATIONSHIP Location: suppec.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: EC (Exposure as Collected)
STUDYID	Study Identifier	text	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	1		Assigned
QNAM	Qualifier Variable Name	text	Req	8		Assigned
QLABEL	Qualifier Variable Label	text	Req	37		Assigned
QVALVLM	Data Value	text	Req	200
➤ QNAM IN ("ECOBSVT")	Timeframe Subject Was Observed	text		200	ECOBST • "THE PROTOCOL SPECIFIED OBSERVATION PERIOD" = "THE PROTOCOL SPECIFIED OBSERVATION PERIOD"	CRF Annotated CRF [99 101 ]
➤ QNAM IN ("ECOBSV")	Observed Post Dose For Specified Time	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [99 101 ]
➤ QNAM IN ("ECDOSAJO")	Reason Dose Adjusted Other Specify	text		200		CRF Annotated CRF [101 ]
➤ QNAM IN ("ECCD")	Standardized Medication Code	text		200	WHO DD WHO DD 202003	Assigned
➤ QNAM IN ("ECDECOD")	Standardized Medication Name	text		200	WHO DD WHO DD 202003	Assigned
➤ QNAM IN ("ECTDV")	Temporary Delay of Vaccination	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [99 101 ]
➤ QNAM IN ("FDDTC")	Date of First Delay	text		200		CRF Annotated CRF [99 101 ]
➤ QNAM IN ("ECADJ2")	Reason for Dose Adjustment 2	text		200		CRF Annotated CRF [99 101 ]
➤ QNAM IN ("ECADJ1")	Reason for Dose Adjustment 1	text		200		CRF Annotated CRF [99 101 ]
➤ QNAM IN ("ECDOSADJ")	Dose Adjusted From Planned	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [101 ]
➤ QNAM IN ("ECOBSVD")	Details Of Subject Observation	text		200		CRF Annotated CRF [99 101 ]
QORIG	Origin	text	Req	8		Assigned
QEVAL	Evaluator	text	Exp	22		Assigned

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Supplemental Qualifiers for Exposure (SUPPEX)

SUPPEX (Supplemental Qualifiers for Exposure, Exposure) - RELATIONSHIP Location: suppex.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: EX (Exposure)
STUDYID	Study Identifier	text	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	1		Assigned
QNAM	Qualifier Variable Name	text	Req	8		Assigned
QLABEL	Qualifier Variable Label	text	Req	37		Assigned
QVALVLM	Data Value	text	Req	200
➤ QNAM IN ("EXOBSVT")	Timeframe Subject Was Observed	text		200	EXOBST • "THE PROTOCOL SPECIFIED OBSERVATION PERIOD" = "THE PROTOCOL SPECIFIED OBSERVATION PERIOD"	CRF Annotated CRF [99 101 ]
➤ QNAM IN ("EXOBSVD")	Details Of Subject Observation	text		200		CRF Annotated CRF [99 101 ]
➤ QNAM IN ("EXOBSV")	Observed Post Dose For Specified Time	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [99 101 ]
➤ QNAM IN ("EXDOSAJO")	Reason Dose Adjusted Other Specify	text		200		CRF Annotated CRF [101 ]
➤ QNAM IN ("EXCD")	Standardized Medication code	text		200	WHO DD WHO DD 202003	Assigned
➤ QNAM IN ("EXDECOD")	Standardized Medication Name	text		200	WHO DD WHO DD 202003	Assigned
➤ QNAM IN ("FDDTC")	Date of First Delay	text		200		CRF Annotated CRF [99 101 ]
➤ QNAM IN ("EXTDV")	Temporary Delay of Vaccination	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [99 101 ]
➤ QNAM IN ("EXADJ2")	Reason for Dose Adjustment 2	text		200		CRF Annotated CRF [99 101 ]
➤ QNAM IN ("EXADJ1")	Reason for Dose Adjustment 1	text		200		CRF Annotated CRF [99 101 ]
➤ QNAM IN ("EXDOSADJ")	Dose Adjusted From Planned	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [101 ]
QORIG	Origin	text	Req	8		Assigned
QEVAL	Evaluator	text	Exp	22		Assigned

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Supplemental Qualifiers for Findings About Events or Interventions (SUPPFACE)

SUPPFACE (Supplemental Qualifiers for Findings About Events or Interventions, 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	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	12		Assigned
QNAM	Qualifier Variable Name	text	Req	6		Assigned
QLABEL	Qualifier Variable Label	text	Req	30		Assigned
QVALVLM	Data Value	text	Req	24
➤ QNAM IN ("FALANG")	Language Version of Instrument	text		200		eDT
➤ QNAM IN ("CLTYP")	Collection Type	text		200		Assigned Type of collection instrument
QORIG	Origin	text	Req	8		Assigned
QEVAL	Evaluator	text	Exp	22		Assigned

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Supplemental Qualifiers for Healthcare Encounters (SUPPHO)

SUPPHO (Supplemental Qualifiers for Healthcare Encounters, Healthcare Encounters) - RELATIONSHIP Location: suppho.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: HO (Healthcare Encounters)
STUDYID	Study Identifier	text	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	11		Assigned
QNAM	Qualifier Variable Name	text	Req	7		Assigned
QLABEL	Qualifier Variable Label	text	Req	37		Assigned
QVALVLM	Data Value	text	Req	19
➤ QNAM IN ("HCUIDIS")	Disease Name	text		200		CRF Annotated CRF [35 ]
➤ QNAM IN ("HCUICU")	Been in ICU due to COVID-19 illness?	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [35 ]
➤ QNAM IN ("HCUHSP")	Hospitalized due to COVID-19 illness?	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [35 ]
QORIG	Origin	text	Req	3		Assigned
QEVAL	Evaluator	text	Exp	1		Assigned

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Supplemental Qualifiers for Inclusion/Exclusion Criteria Not Met (SUPPIE)

SUPPIE (Supplemental Qualifiers for Inclusion/Exclusion Criteria Not Met, Inclusion/Exclusion Criteria Not Met) - RELATIONSHIP Location: suppie.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: IE (Inclusion/Exclusion Criteria Not Met)
STUDYID	Study Identifier	text	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	1		Assigned
QNAM	Qualifier Variable Name	text	Req	6		Assigned
QLABEL	Qualifier Variable Label	text	Req	7		Assigned
QVALVLM	Data Value	text	Req	198
➤ QNAM IN ("IEDESC")	Details	text		200		CRF Annotated CRF [41 43 45 48 50 52 54 55 56 57 58 59 ]
QORIG	Origin	text	Req	3		Assigned
QEVAL	Evaluator	text	Exp	1		Assigned

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Supplemental Qualifiers for Immunogenicity Specimen Assessments (SUPPIS)

SUPPIS (Supplemental Qualifiers for Immunogenicity Specimen Assessments, 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	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	12		Assigned
QNAM	Qualifier Variable Name	text	Req	7		Assigned
QLABEL	Qualifier Variable Label	text	Req	11		Assigned
QVALVLM	Data Value	text	Req	4
➤ QNAM IN ("ETRKDOR")	Data Origin	text		200		CRF Annotated CRF [72 82 ]
QORIG	Origin	text	Req	3		Assigned
QEVAL	Evaluator	text	Exp	1		Assigned

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Supplemental Qualifiers for Laboratory Test Results (SUPPLB)

SUPPLB (Supplemental Qualifiers for Laboratory Test Results, 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	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	3		Assigned
QNAM	Qualifier Variable Name	text	Req	8		Assigned
QLABEL	Qualifier Variable Label	text	Req	26		Assigned
QVALVLM	Data Value	text	Req	7
➤ QNAM IN ("LBUNEVFL")	Not Evaluable Flag	text		200		Derived LBUNEVFL=Not Evaluable Flag. This is set to "Y" whenever there is no conversion into standard unit, and the -ORRES values are directly copied into -STRES.
➤ QNAM IN ("LBUID")	Lab ID	text		200		eDT
➤ QNAM IN ("LBTSTID")	Laboratory Test Identifier	text		200		eDT
➤ QNAM IN ("LBSTTYPE")	Standardized Unit	text		200		Derived Carries information on standardized unit - whether sponsored preferred unit or standard unit is used.
➤ QNAM IN ("LBSCATYN")	Lab Sub-Panel Collected	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [61 62 ]
QORIG	Origin	text	Req	7		Assigned
QEVAL	Evaluator	text	Exp	22		Assigned

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Supplemental Qualifiers for Microbiology Specimen (SUPPMB)

SUPPMB (Supplemental Qualifiers for Microbiology Specimen, 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	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	12		Assigned
QNAM	Qualifier Variable Name	text	Req	8		Assigned
QLABEL	Qualifier Variable Label	text	Req	26		Assigned
QVALVLM	Data Value	text	Req	50
➤ QNAM IN ("TRADEOTH")	Other Trade Name	text		200		CRF Annotated CRF [22 ]
➤ QNAM IN ("ETRKDOR")	Data Origin	text		200		CRF Annotated CRF [81 84 93 ]
QORIG	Origin	text	Req	7		Assigned
QEVAL	Evaluator	text	Exp	22		Assigned

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Supplemental Qualifiers for Medical History (SUPPMH)

SUPPMH (Supplemental Qualifiers for Medical History, 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	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	2		Assigned
QNAM	Qualifier Variable Name	text	Req	7		Assigned
QLABEL	Qualifier Variable Label	text	Req	27		Assigned
QVALVLM	Data Value	text	Req	12
➤ QNAM IN ("DICTVER")	Dictionary Name and Version	text		200		Assigned Assign as "MedDRA v23.1"
QORIG	Origin	text	Req	8		Assigned
QEVAL	Evaluator	text	Exp	22		Assigned

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Supplemental Qualifiers for Morphology (SUPPMO)

SUPPMO (Supplemental Qualifiers for Morphology, Morphology) - RELATIONSHIP Location: suppmo.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: MO (Morphology)
STUDYID	Study Identifier	text	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	11		Assigned
QNAM	Qualifier Variable Name	text	Req	8		Assigned
QLABEL	Qualifier Variable Label	text	Req	29		Assigned
QVALVLM	Data Value	text	Req	200
➤ QNAM IN ("METHOTH")	Imaging Method Other Detail	text		200		CRF Annotated CRF [40 ]
➤ QNAM IN ("LOCOTH")	Location of Assessment Detail	text		200		CRF Annotated CRF [40 ]
➤ QNAM IN ("ASPECIFY")	Overall Assessment Detail	text		200		CRF Annotated CRF [40 ]
QORIG	Origin	text	Req	3		Assigned
QEVAL	Evaluator	text	Exp	1		Assigned

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Supplemental Qualifiers for Procedures (SUPPPR)

SUPPPR (Supplemental Qualifiers for Procedures, Procedures) - RELATIONSHIP Location: supppr.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: PR (Procedures)
STUDYID	Study Identifier	text	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	1		Assigned
QNAM	Qualifier Variable Name	text	Req	8		Assigned
QLABEL	Qualifier Variable Label	text	Req	31		Assigned
QVALVLM	Data Value	text	Req	44
➤ QNAM IN ("PRLLT")	Lowest Level Term	text		200	MedDRA MedDRA 23.1	Assigned
➤ QNAM IN ("PRHLTCD")	High Level Term Code	text		200	MedDRA MedDRA 23.1	Assigned
➤ QNAM IN ("PRHLT")	High Level Term	text		200	MedDRA MedDRA 23.1	Assigned
➤ QNAM IN ("PRLLTCD")	Lowest Level Term Code	text		200	MedDRA MedDRA 23.1	Assigned
➤ QNAM IN ("PRHLGTCD")	High Level Group Term Code	text		200	MedDRA MedDRA 23.1	Assigned
➤ QNAM IN ("PRHLGT")	High Level Group Term	text		200	MedDRA MedDRA 23.1	Assigned
➤ QNAM IN ("PRBODSYS")	Body System or Organ Class	text		200	MedDRA MedDRA 23.1	Assigned
➤ QNAM IN ("PRBDSYCD")	Body System or Organ Class Code	text		200	MedDRA MedDRA 23.1	Assigned
➤ QNAM IN ("DICTVER")	Dictionary Name and Version	text		200		Assigned Assign as "MedDRA v23.1"
➤ QNAM IN ("PRSOCCD")	Primary System Organ Class Code	text		200	MedDRA MedDRA 23.1	Assigned
➤ QNAM IN ("PRSOC")	Primary System Organ Class	text		200	MedDRA MedDRA 23.1	Assigned
➤ QNAM IN ("PRPTCD")	Preferred Term Code	text		200	MedDRA MedDRA 23.1	Assigned
QORIG	Origin	text	Req	8		Assigned
QEVAL	Evaluator	text	Exp	22		Assigned

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Supplemental Qualifiers for Vital Signs (SUPPVS)

SUPPVS (Supplemental Qualifiers for Vital Signs, 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	Req	8		Protocol
RDOMAIN	Related Domain Abbreviation	text	Req	2	DOMAIN [51 Terms]	Assigned
USUBJID	Unique Subject Identifier	text	Exp	22		Derived DM.USUBJID
IDVAR	Identifying Variable	text	Exp	5		Assigned
IDVARVAL	Identifying Variable Value	text	Exp	12		Assigned
QNAM	Qualifier Variable Name	text	Req	8		Assigned
QLABEL	Qualifier Variable Label	text	Req	29		Assigned
QVALVLM	Data Value	text	Req	10
➤ QNAM IN ("VSCOLSRT")	Collected Summary Result Type	text		200		Assigned Result type
➤ QNAM IN ("CLTYP")	Collection Type	text		200		Assigned Type of collection instrument
QORIG	Origin	text	Req	8		Assigned
QEVAL	Evaluator	text	Exp	22		Assigned

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ACN [C66767]

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

Category for Adverse Event

Permitted Value (Code)	Display Value (Decode)
ADVERSE EVENT	ADVERSE EVENT
MEDICATION ERROR	MEDICATION ERROR
REACTOGENICITY	REACTOGENICITY

AEREL

Permitted Value (Code)	Display Value (Decode)
NOT RELATED	NOT RELATED
RELATED	RELATED

AERELNST

Permitted Value (Code)	Display Value (Decode)
CONCOMITANT DRUG TREATMENT	CONCOMITANT DRUG TREATMENT
CONCOMITANT NON-DRUG TREATMENT	CONCOMITANT NON-DRUG TREATMENT
OTHER	OTHER

Subcategory for Adverse Event

Permitted Value (Code)	Display Value (Decode)
ACUTE REACTIONS	ACUTE REACTIONS
ADMINISTRATION SITE	ADMINISTRATION SITE
SYSTEMIC	SYSTEMIC

AGEU [C66781]

Permitted Value (Code)	Display Value (Decode)
YEARS [C29848]	YEARS

ARM

Permitted Value (Code)	Display Value (Decode)
BNT162b1 Phase 1 (100 mcg)	BNT162b1 Phase 1 (100 mcg)
BNT162b1 Phase 1 (10 mcg)	BNT162b1 Phase 1 (10 mcg)
BNT162b1 Phase 1 (20 mcg)	BNT162b1 Phase 1 (20 mcg)
BNT162b1 Phase 1 (30 mcg)	BNT162b1 Phase 1 (30 mcg)
BNT162b2 Phase 1 (10 mcg)	BNT162b2 Phase 1 (10 mcg)
BNT162b2 Phase 1 (20 mcg)	BNT162b2 Phase 1 (20 mcg)
BNT162b2 Phase 1 (30 mcg)	BNT162b2 Phase 1 (30 mcg)
BNT162b2 Phase 2/3 (30 mcg)	BNT162b2 Phase 2/3 (30 mcg)
Placebo	Placebo

ARMCD

Permitted Value (Code)	Display Value (Decode)
B1_10	BNT162b1 Phase 1 (10 mcg)
B1_100	BNT162b1 Phase 1 (100 mcg)
B1_20	BNT162b1 Phase 1 (20 mcg)
B1_30	BNT162b1 Phase 1 (30 mcg)
B2_10	BNT162b2 Phase 1 (10 mcg)
B2_20	BNT162b2 Phase 1 (20 mcg)
B2_30	BNT162b2 Phase 1 (30 mcg)
B2_P23_30	BNT162b2 Phase 2/3 (30 mcg)
PLACEBO	Placebo

Clinical Events Category

Permitted Value (Code)
EFFICACY
REACTOGENICITY
SEVERE COVID-19 ILLNESS

Subcategory for Clinical Event

Permitted Value (Code)	Display Value (Decode)
ADMINISTRATION SITE	ADMINISTRATION SITE
SIGNIFICANT ACUTE HEPATIC DYSFUNCTION	SIGNIFICANT ACUTE HEPATIC DYSFUNCTION
SIGNIFICANT ACUTE RENAL DYSFUNCTION	SIGNIFICANT ACUTE RENAL DYSFUNCTION
SYSTEMIC	SYSTEMIC
SIGNS AND SYMPTOMS OF DISEASE	SIGNS AND SYMPTOMS OF DISEASE

Category for Medication

Permitted Value (Code)	Display Value (Decode)
CONCOMITANT IMMUNOSUPPRESSIVE THERAPY	CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
CORTICOSTEROIDS	CORTICOSTEROIDS
GENERAL CONCOMITANT MEDICATIONS	GENERAL CONCOMITANT MEDICATIONS
VACCINATIONS	VACCINATIONS

CMSCAT

Permitted Value (Code)	Display Value (Decode)
VASOPRESSORS AGENTS	VASOPRESSORS AGENTS

Category for Device Identifiers

Permitted Value (Code)	Display Value (Decode)
DEATH DETAILS CODED	DEATH DETAILS CODED

Death Detail Assessment Short Name

Permitted Value (Code)	Display Value (Decode)
PRCDTH	PRIMARY CAUSE OF DEATH

DIPARM [C106480]

Permitted Value (Code)
Device Type [C53265]
Manufacturer [C25392]
Model Number [C99285]
Trade Name [C71898]

DIPARMCD [C106481]

Permitted Value (Code)	Display Value (Decode)
DEVTYPE [C53265]	Device Type
MANUF [C25392]	Manufacturer
MODEL [C99285]	Model Number
TRADENAM [C71898]	Trade Name

DOMAIN [C66734]

Permitted Value (Code)	Display Value (Decode)
AE [C49562]	Adverse Events
CE [C85441]	Clinical Events
CM [C49568]	Concomitant Medications
CO [C49569]	Comments
DD [C95087]	Death Details
DI [C102618]	Device Identifiers
DM [C49572]	Demographics
DS [C49576]	Disposition
DV [C49585]	Protocol Deviations
EC [C117466]	Exposure as Collected
EX [C49587]	Exposure
FA [C85442]	Findings About Events or Interventions
FACE [*]	Findings About Events or Interventions
FAHO [*]	Findings About Events or Interventions
HO [C117757]	Healthcare Encounters
IE [C61536]	Inclusion/Exclusion Criteria Not Met
IS [C112320]	Immunogenicity Specimen Assessments
LB [C49592]	Laboratory Test Results
MB [C49602]	Microbiology Specimen
MH [C49603]	Medical History
MO [C102671]	Morphology
PE [C49608]	Physical Examination
PR [C102700]	Procedures
RELREC [C147182]	Related Records
SE [C49616]	Subject Elements
SUPPAE [C147185]	Supplemental Qualifiers for Adverse Events
SUPPCE [C147191]	Supplemental Qualifiers for Clinical Events
SUPPCM [C147193]	Supplemental Qualifiers for Concomitant Medications
SUPPDM [C147200]	Supplemental Qualifiers for Demographics
SUPPDS [C147203]	Supplemental Qualifiers for Disposition
SUPPDV [C147206]	Supplemental Qualifiers for Protocol Deviations
SUPPEC [C147208]	Supplemental Qualifiers for Exposure as Collected
SUPPEX [C147211]	Supplemental Qualifiers for Exposure
SUPPFACE [*]	Supplemental Qualifiers for Findings About Events or Interventions
SUPPHO [C147216]	Supplemental Qualifiers for Healthcare Encounters
SUPPIE [C147218]	Supplemental Qualifiers for Inclusion/Exclusion Criteria Not Met
SUPPIS [C147219]	Supplemental Qualifiers for Immunogenicity Specimen Assessments
SUPPLB [C147220]	Supplemental Qualifiers for Laboratory Test Results
SUPPMB [C147222]	Supplemental Qualifiers for Microbiology Specimen
SUPPMH [C147223]	Supplemental Qualifiers for Medical History
SUPPMO [C165871]	Supplemental Qualifiers for Morphology
SUPPPE [C147234]	Supplemental Qualifiers for Physical Examination
SUPPPR [C147239]	Supplemental Qualifiers for Procedures
SUPPVS [C147268]	Supplemental Qualifiers for Vital Signs
SV [C49617]	Subject Visits
TA [C49618]	Trial Arms
TE [C49619]	Trial Elements
TI [C49620]	Trial Inclusion/Exclusion Criteria
TS [C53483]	Trial Summary
TV [C49621]	Trial Visits
VS [C49622]	Vital Signs

* Extended Value

DSCAT [C74558]

Permitted Value (Code)	Display Value (Decode)
DISPOSITION EVENT [C74590]	DISPOSITION EVENT
OTHER EVENT [C150824]	OTHER EVENT
PROTOCOL MILESTONE [C74588]	PROTOCOL MILESTONE

DSGRP

Permitted Value (Code)	Display Value (Decode)
Stage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO)	Stage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO)
Stage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO)	Stage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO)
Stage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO)	Stage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO)
Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)	Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)
Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)	Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)
Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO)	Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO)
Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO)	Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO)
Stage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO)	Stage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO)
Stage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO)	Stage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO)
Stage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)	Stage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)
Stage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)	Stage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)
Stage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO)	Stage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO)
Stage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO)	Stage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO)

Category for Protocol Deviation

Permitted Value (Code)	Display Value (Decode)
Important	Important
Non-Important	Non-Important

ECADJ

Permitted Value (Code)	Display Value (Decode)
ADVERSE EVENT(S)	ADVERSE EVENT(S)
ANTICIPATED NON-STUDY VACCINATION	ANTICIPATED NON-STUDY VACCINATION
FEVER OR ACUTE ILLNESS	FEVER OR ACUTE ILLNESS
MULTIPLE	MULTIPLE
OTHER SPECIFY	OTHER SPECIFY
RECENT NON-STUDY VACCINATION	RECENT NON-STUDY VACCINATION
RECENT SYSTEMIC CORTICOSTEROID TREATMENT	RECENT SYSTEMIC CORTICOSTEROID TREATMENT

Category of Treatment

Permitted Value (Code)	Display Value (Decode)
INVESTIGATIONAL PRODUCT	INVESTIGATIONAL PRODUCT

ECDOSU [C71620]

Permitted Value (Code)	Display Value (Decode)
mcg [*]	Microgram
SYRINGE [C48540]	SYRINGE

* Extended Value

ECOBST

Permitted Value (Code)	Display Value (Decode)
THE PROTOCOL SPECIFIED OBSERVATION PERIOD	THE PROTOCOL SPECIFIED OBSERVATION PERIOD

Subcategory of Treatment

Permitted Value (Code)	Display Value (Decode)
VACCINATION	VACCINATION

ELEMENT

Permitted Value (Code)	Display Value (Decode)
BNT162b1 (100 mcg)	BNT162b1 (100 mcg)
BNT162b1 (10 mcg)	BNT162b1 (10 mcg)
BNT162b1 (20 mcg)	BNT162b1 (20 mcg)
BNT162b1 (30 mcg)	BNT162b1 (30 mcg)
BNT162b2 (10 mcg)	BNT162b2 (10 mcg)
BNT162b2 (20 mcg)	BNT162b2 (20 mcg)
BNT162b2 (30 mcg)	BNT162b2 (30 mcg)
Follow-up	Follow-up
Placebo	Placebo
Screening	Screening

ENRTPT [C66728]

Permitted Value (Code)	Display Value (Decode)
ONGOING [C53279]	ONGOING

EPOCH [C99079]

Permitted Value (Code)	Display Value (Decode)
FOLLOW-UP [C99158]	FOLLOW-UP
SCREENING [C48262]	SCREENING
VACCINATION [*]	VACCINATION

* Extended Value

Element Code

Permitted Value (Code)	Display Value (Decode)
FUP	Follow-up
SCRN	Screening
VAXB1_10	BNT162b1 (10 mcg)
VAXB1100	BNT162b1 (100 mcg)
VAXB1_20	BNT162b1 (20 mcg)
VAXB1_30	BNT162b1 (30 mcg)
VAXB2_10	BNT162b2 (10 mcg)
VAXB2_20	BNT162b2 (20 mcg)
VAXB2_30	BNT162b2 (30 mcg)
VAXP	Placebo

ETHNIC [C66790]

Permitted Value (Code)	Display Value (Decode)
HISPANIC OR LATINO [C17459]	HISPANIC OR LATINO
NOT HISPANIC OR LATINO [C41222]	NOT HISPANIC OR LATINO
NOT REPORTED [C43234]	NOT REPORTED

EVAL [C78735]

Permitted Value (Code)	Display Value (Decode)
INVESTIGATOR [C25936]	INVESTIGATOR
STUDY SUBJECT [C41189]	STUDY SUBJECT

EXADJ

Permitted Value (Code)	Display Value (Decode)
ADVERSE EVENT(S)	ADVERSE EVENT(S)
ANTICIPATED NON-STUDY VACCINATION	ANTICIPATED NON-STUDY VACCINATION
FEVER OR ACUTE ILLNESS	FEVER OR ACUTE ILLNESS
MULTIPLE	MULTIPLE
OTHER SPECIFY	OTHER SPECIFY
RECENT NON-STUDY VACCINATION	RECENT NON-STUDY VACCINATION
RECENT SYSTEMIC CORTICOSTEROID TREATMENT	RECENT SYSTEMIC CORTICOSTEROID TREATMENT

Category of Treatment

Permitted Value (Code)	Display Value (Decode)
INVESTIGATIONAL PRODUCT	INVESTIGATIONAL PRODUCT

EXDOSU [C71620]

Permitted Value (Code)	Display Value (Decode)
mcg [*]	Microgram
SYRINGE [C48540]	SYRINGE

* Extended Value

EXOBST

Permitted Value (Code)	Display Value (Decode)
THE PROTOCOL SPECIFIED OBSERVATION PERIOD	THE PROTOCOL SPECIFIED OBSERVATION PERIOD

Subcategory of Treatment

Permitted Value (Code)	Display Value (Decode)
VACCINATION	VACCINATION

Category for FACE

Permitted Value (Code)	Display Value (Decode)
EFFICACY	EFFICACY
REACTOGENICITY	REACTOGENICITY
REACTOGENICITY - UNPLANNED ASSESSMENT	REACTOGENICITY - UNPLANNED ASSESSMENT

Test name for FACE [C142189]

Permitted Value (Code)	Display Value (Decode)
Diameter [*]	Diameter
First Symptom Date [*]	First Symptom Date
Grade 4 Criteria Met [*]	Grade 4 Criteria Met
Last Symptom Resolved Date [*]	Last Symptom Resolved Date
Maximum Diameter [*]	Maximum Diameter
Medication to Treat Fever or Pain [*]	Medication to Treat Fever or Pain
Minimum Diameter [*]	Minimum Diameter
Occurrence Indicator [C127786]	Occurrence Indicator
Related to Study Treatment [*]	Related to Study Treatment
Severity/Intensity [C25676]	Severity/Intensity
Stop Date Meds Given to Trt/Pnt Symptoms [*]	Stop Date Meds Given to Trt/Pnt Symptoms
Symptom Ongoing [*]	Symptom Ongoing

* Extended Value

Test Code for FACE [C142187]

Permitted Value (Code)	Display Value (Decode)
DIAMETER [*]	Diameter
FSYMDATE [*]	First Symptom Date
G4CRIMET [*]	Grade 4 Criteria Met
LSYMDATE [*]	Last Symptom Resolved Date
MAXDIAM [*]	Maximum Diameter
MEDTFVPN [*]	Medication to Treat Fever or Pain
MINDIAM [*]	Minimum Diameter
OCCUR [C127786]	Occurrence Indicator
REL [*]	Related to Study Treatment
SEV [C25676]	Severity/Intensity
STPDMEDP [*]	Stop Date Meds Given to Trt/Pnt Symptoms
SYMONGO [*]	Symptom Ongoing

* Extended Value

Category for FAHO

Permitted Value (Code)	Display Value (Decode)
HEALTHCARE UTILIZATION	HEALTHCARE UTILIZATION

Units for FAHO [C71620]

Permitted Value (Code)	Display Value (Decode)
VISITS/CONTACTS [*]	VISITS/CONTACTS

* Extended Value

Vaccines Findings About Test Name [C142189]

Permitted Value (Code)	Display Value (Decode)
Number [*]	NUMBER

* Extended Value

Vaccines Findings About Test Code [C142187]

Permitted Value (Code)	Display Value (Decode)
NUMBER [*]	NUMBER

* Extended Value

Anatomical Location for FACE [C74456]

Permitted Value (Code)
DELTOID MUSCLE [C32446]

Units for FACE [C71620]

Permitted Value (Code)	Display Value (Decode)
CALIPER UNIT [*]	CALIPER UNIT
cm [C49668]	Centimeter

* Extended Value

Severity Response for FACE [C165643]

Permitted Value (Code)	Display Value (Decode)
MILD [C70666]	Mild
MODERATE [C61376]	Moderate
SEVERE [C70667]	Severe

Subcategory for FACE

Permitted Value (Code)	Display Value (Decode)
ADMINISTRATION SITE	ADMINISTRATION SITE
MEDICATIONS GIVEN	MEDICATIONS GIVEN
RESPIRATORY ILLNESS	RESPIRATORY ILLNESS
SYSTEMIC	SYSTEMIC

Standard Units for FACE [C71620]

Permitted Value (Code)	Display Value (Decode)
cm [C49668]	Centimeter

FREQ [C71113]

Permitted Value (Code)	Display Value (Decode)
BID [C64496]	BID
EVERY WEEK [C67069]	EVERY WEEK
ONCE [C64576]	ONCE
PRN [C64499]	PRN
QD [C25473]	QD
QID [C64530]	QID
QM [C64498]	QM
TID [C64527]	TID
UNKNOWN [C17998]	UNKNOWN

FRM [C66726]

Permitted Value (Code)	Display Value (Decode)
INJECTION [C42946]	INJECTION

Category for Healthcare Encounter

Permitted Value (Code)	Display Value (Decode)
HEALTHCARE UTILIZATION ASSESSMENT	HEALTHCARE UTILIZATION ASSESSMENT
HOSPITALIZATION STATUS	HOSPITALIZATION STATUS

Inclusion/Exclusion Category [C66797]

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

Inclusion/Exclusion Criterion Short Name

Permitted Value (Code)	Display Value (Decode)
EX01A00	Other medical or psychiatric condition incl. recent (within past year) or active suicidal ideation/behavior/lab abnormality that may increase the risk of study participation
EX02A00	Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
EX02A06	Phase 1 & 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
EX03A00	History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
EX04A00	Receipt of medications intended to prevent COVID-19
EX05A00	Stages 1 and 2 only: Previous clinical or microbiological diagnosis of COVID-19
EX05A05	Previous clinical or microbiological diagnosis of COVID-19
EX05A07	Previous clinical (based on COVID-19 symptoms/signs alone if no SARS-CoV-2 NAAT result) or microbiological (based on COVID-19 symptoms/signs and positive SARS-CoV-2 NAAT result) diagnosis of COVID-19
EX06A00	Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID-19
EX06A01	Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID-19 (full details in protocol).
EX06A05	Phase 1 only: Individuals at high risk for severe COVID-19 (full details in protocol)
EX07A00	Sentinel participants in Stage 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel)
EX07A05	Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel)
EX08A00	Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination
EX09A00	Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention
EX09A04	Sentinel participants in Stage 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention
EX09A05	Phase 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention
EX10A00	Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
EX11A00	Women who are pregnant or breastfeeding
EX12A00	Previous vaccination with any coronavirus vaccine
EX13A00	Individuals who receive immunosuppressive therapy, such as cytotoxic agents or systemic corticosteroids. Inhaled/nebulized, Intra-articular, intrabursal, or topical corticosteroids are permitted
EX13A01	Subjects who receive immunosuppressive therapy, such as cytotoxic agents or systemic corticosteroids
EX14A00	Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study
EX15A00	Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation
EX16A00	Previous participation in other studies involving study intervention containing lipid nanoparticles
EX17A00	Sentinel participants in Stage 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit
EX17A05	Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit
EX18A00	Sentinel participants in Stage 1 only: Screening hematology/blood chemistry lab >=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by Investigator
EX18A05	Phase 1 only: Screening hematology/blood chemistry lab >=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by Investigator
EX19A00	Sentinel participants in Stage 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at screening visit
EX19A05	Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at screening visit
EX20A00	Sentinel participants in Stage 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention
EX20A05	Phase 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention
EX21A00	Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members
EX21A06	Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members
EX22A01	Sentinel participants in Stage 1 only: Regular receipt of inhaled/nebulized corticosteroids
EX22A05	Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids
IN01A00	Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study stage)
IN01A05	Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study phase)
IN01A06	Male or female participants between the ages of 18 and 55 years, inclusive, and 65 and 85 years, inclusive (Phase 1), or >= 16 years (Phase 2/3), at randomization
IN01A07	Male or female participants between 18 and 55 years inclusive and 65 and 85 years inclusive (Phase 1) or >= 12 years (Phase 2/3) at randomization. Participants <18 years cannot be enrolled in EU
IN02A00	Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures
IN03A00	Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study
IN03A05	Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study
IN03A06	Healthy participants, determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for the study. Specific criteria apply for HIV/HCV/HBV
IN04A00	Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol
IN04A07	Capable of giving personal signed informed consent/have parent/legal guardian capable of giving signed informed consent, which includes compliance with requirements, restrictions in ICD and protocol
IN05A05	Participants who, in the judgment of the investigator, are at risk for acquiring COVID-19
IN05A06	Phase 2/3 only: Participants who, in the judgment of the investigator, are at higher risk for acquiring COVID-19

Category for Immunogenicity Test

Permitted Value (Code)	Display Value (Decode)
SEROLOGY	SEROLOGY

Immunogenicity Test/Exam Short Name [C120525]

Permitted Value (Code)	Display Value (Decode)
C19NIG [*]	N-binding antibody
C19RBDIG [*]	COVID-19 RBD IgG
C19S1IGG [*]	COVID-19 S1 IgG
C2NGNT50 [*]	SARS-CoV-2 serum neutralizing titer 50
C2NGNT90 [*]	SARS-CoV-2 serum neutralizing titer 90

* Extended Value

Laterality [C99073]

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

Category for Lab Test

Permitted Value (Code)	Display Value (Decode)
CLINICAL CHEMISTRY	CLINICAL CHEMISTRY
HEMATOLOGY	HEMATOLOGY
OXYGENATION PARAMETERS	OXYGENATION PARAMETERS
URINALYSIS	URINALYSIS

Subcategory for Lab Test

Permitted Value (Code)	Display Value (Decode)
BLOOD CHEMISTRY	BLOOD CHEMISTRY
DIFFERENTIAL	DIFFERENTIAL
PREGNANCY	PREGNANCY
VIROLOGY	VIROLOGY

LOC [C74456]

Permitted Value (Code)	Display Value (Decode)
AXILLA [C12674]	AXILLA
CHEST [C25389]	CHEST
DELTOID MUSCLE [C32446]	DELTOID MUSCLE
EAR [C12394]	EAR
FOREHEAD [C89803]	FOREHEAD
HEAD [C12419]	HEAD
LOWER RESPIRATORY SYSTEM [C33012]	LOWER RESPIRATORY SYSTEM
NASAL CAVITY [C12424]	NASAL CAVITY
NASOPHARYNX [C12423]	NASOPHARYNX
ORAL CAVITY [C12421]	ORAL CAVITY
OTHER [*]	OTHER
THROAT [C54272]	THROAT

* Extended Value

Category for Microbiology Finding

Permitted Value (Code)
CLINICAL CHEMISTRY
CONFIRMATION OF INFECTION
VIROLOGY

Location of Specimen Collection for Microbiology Specimen [C74456]

Permitted Value (Code)
LOWER RESPIRATORY SYSTEM [C33012]
NASAL CAVITY [C12424]
NASOPHARYNX [C12423]
THROAT [C54272]

Method of Test or Examination in Microbiology Specimen [C85492]

Permitted Value (Code)
IMMUNOCHROMATOGRAPHY [C154792]
REVERSE TRANSCRIPTASE PCR [C18136]

Vendor Name for Microbiology Specimen

Permitted Value (Code)
Covance

Subcategory for Microbiology Finding

Permitted Value (Code)
BLOOD CHEMISTRY

Specimen Type in Microbiology Specimen [C78734]

Permitted Value (Code)
BLOOD [C12434]
NASAL_SWAB [*]
NASAL_SWAB_SELF [*]
RESPIRATORY SECRETIONS [*]
SWABBED MATERIAL [C150895]

* Extended Value

Microbiology Specimen Test Name [C120528]

Permitted Value (Code)
Anti Hepatitis B Surface Antigen2 Qual [*]
Cepheid RT-PCR assay for SARS-CoV-2 [*]
HIV-1/2 Antibody [C74714]
Hepatitis B Virus Core Antibody [C96660]
Hepatitis C Virus Antibody [C92535]
Microbiology Specimen [*]
SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 [*]

* Extended Value

Microbiology Specimen Test Code [C120527]

Permitted Value (Code)	Display Value (Decode)
AHBSAG2 [*]	Anti Hepatitis B Surface Antigen2 Qual
HBCAB [C96660]	Hepatitis B Virus Core Antibody
HCAB [C92535]	Hepatitis C Virus Antibody
HIV12AB [C74714]	HIV-1/2 Antibody
MBALL [*]	Microbiology Specimen
RTCOV2NS [*]	Cepheid RT-PCR assay for SARS-CoV-2
SARSCOV2 [*]	SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2

* Extended Value

METHOD [C85492]

Permitted Value (Code)	Display Value (Decode)
CT SCAN [C17204]	CT SCAN
IMMUNOCHROMATOGRAPHY [C154792]	IMMUNOCHROMATOGRAPHY
OTHER [*]	OTHER
REVERSE TRANSCRIPTASE PCR [C18136]	REVERSE TRANSCRIPTASE PCR
X-RAY [C38101]	X-RAY

* Extended Value

Category for Medical History

Permitted Value (Code)	Display Value (Decode)
GENERAL MEDICAL HISTORY	GENERAL MEDICAL HISTORY

Category for Test

Permitted Value (Code)	Display Value (Decode)
CLINICAL ASSESSMENT OF RADIOGRAPHS - IMAGING	CLINICAL ASSESSMENT OF RADIOGRAPHS - IMAGING

Test or Examination Name

Permitted Value (Code)
Interpretation

Test or Examination Short Name

Permitted Value (Code)	Display Value (Decode)
INTP	Interpretation

NCOMPLT [C66727]

Permitted Value (Code)	Display Value (Decode)
ADVERSE EVENT [C41331]	ADVERSE EVENT
COMPLETED [C25250]	COMPLETED
DEATH [C28554]	DEATH
INFORMED CONSENT OBTAINED [*]	INFORMED CONSENT OBTAINED
LOST TO FOLLOW-UP [C48227]	LOST TO FOLLOW-UP
MEDICATION ERROR WITHOUT ASSOCIATED ADVERSE EVENT [*]	MEDICATION ERROR WITHOUT ASSOCIATED ADVERSE EVENT
NO LONGER MEETS ELIGIBILITY CRITERIA [*]	NO LONGER MEETS ELIGIBILITY CRITERIA
OTHER [C17649]	OTHER
PHYSICIAN DECISION [C48250]	PHYSICIAN DECISION
PREGNANCY [C25742]	PREGNANCY
PROTOCOL DEVIATION [C50996]	PROTOCOL DEVIATION
RANDOMIZED [*]	RANDOMIZED
REFUSED FURTHER STUDY PROCEDURES [*]	REFUSED FURTHER STUDY PROCEDURES
SCREEN FAILURE [C49628]	SCREEN FAILURE
STUDY TERMINATED BY SPONSOR [C49632]	STUDY TERMINATED BY SPONSOR
TREATMENT UNBLINDED [*]	TREATMENT UNBLINDED
WITHDRAWAL BY SUBJECT [C49634]	WITHDRAWAL BY SUBJECT
WITHDRAWAL OF CONSENT [*]	WITHDRAWAL OF CONSENT

* Extended Value

ND [C66789]

Permitted Value (Code)	Display Value (Decode)
NOT DONE [C49484]	NOT DONE

NRIND [C78736]

Permitted Value (Code)	Display Value (Decode)
HIGH [C78800]	HIGH
LOW [C78801]	LOW
NORMAL [C78727]	NORMAL

NY [C66742]

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

NY1 [C66742]

Permitted Value (Code)	Display Value (Decode)
Y [C49488]	Y

OUT [C66768]

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

POSITION [C71148]

Permitted Value (Code)	Display Value (Decode)
SITTING [C62122]	SITTING

Category for Procedures

Permitted Value (Code)	Display Value (Decode)
GENERAL NON-DRUG TREATMENT	GENERAL NON-DRUG TREATMENT

RACE [C74457]

Permitted Value (Code)	Display Value (Decode)
AMERICAN INDIAN OR ALASKA NATIVE [C41259]	AMERICAN INDIAN OR ALASKA NATIVE
ASIAN [C41260]	ASIAN
BLACK OR AFRICAN AMERICAN [C16352]	BLACK OR AFRICAN AMERICAN
MULTIPLE [*]	MULTIPLE
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER [C41219]	NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
NOT REPORTED [C43234]	NOT REPORTED
WHITE [C41261]	WHITE

* Extended Value

RELTYPE [C78737]

Permitted Value (Code)	Display Value (Decode)
MANY [C170512]	MANY
ONE [C66832]	ONE

ROUTE [C66729]

Permitted Value (Code)	Display Value (Decode)
AURICULAR (OTIC) [C38192]	AURICULAR (OTIC)
CUTANEOUS [C38675]	CUTANEOUS
INTRA-ARTICULAR [C38223]	INTRA-ARTICULAR
INTRADERMAL [C38238]	INTRADERMAL
INTRAMUSCULAR [C28161]	INTRAMUSCULAR
INTRAUTERINE [C38272]	INTRAUTERINE
INTRAVENOUS [C38276]	INTRAVENOUS
NASAL [C38284]	NASAL
OPHTHALMIC [C38287]	OPHTHALMIC
ORAL [C38288]	ORAL
RESPIRATORY (INHALATION) [C38216]	RESPIRATORY (INHALATION)
SUBCUTANEOUS [C38299]	SUBCUTANEOUS
TOPICAL [C38304]	TOPICAL
VAGINAL [C38313]	VAGINAL

SEX [C66731]

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

SPECTYPE [C78734]

Permitted Value (Code)	Display Value (Decode)
BLOOD [C12434]	BLOOD
NASAL_SWAB [*]	NASAL_SWAB
NASAL_SWAB_SELF [*]	NASAL_SWAB_SELF
RESPIRATORY SECRETIONS [*]	RESPIRATORY SECRETIONS
SERUM [C13325]	SERUM
SWABBED MATERIAL [C150895]	SWABBED MATERIAL
URINE [C13283]	URINE

* Extended Value

STENRF [C66728]

Permitted Value (Code)	Display Value (Decode)
BEFORE [C25629]	BEFORE
ONGOING [C53279]	ONGOING

TOXGRV4

Permitted Value (Code)	Display Value (Decode)
1	1
2	2
3	3
4	4

TPTREF

Permitted Value (Code)	Display Value (Decode)
VACCINATION 1	VACCINATION 1
VACCINATION 2	VACCINATION 2
VACCINATION 3	VACCINATION 3

TSPARM [C67152]

Permitted Value (Code)	Display Value (Decode)
Actual Number of Subjects [C98703]	Actual Number of Subjects
Adaptive Design [C146995]	Adaptive Design
Added on to Existing Treatments [C49703]	Added on to Existing Treatments
Clinical Study Sponsor [C70793]	Clinical Study Sponsor
Comparative Treatment Name [C68612]	Comparative Treatment Name
Control Type [C49647]	Control Type
Data Cutoff Date [C98717]	Data Cutoff Date
Data Cutoff Description [C98718]	Data Cutoff Description
Diagnosis Group [C49650]	Diagnosis Group
Exploratory Outcome Measure [C98724]	Exploratory Outcome Measure
Extension Trial Indicator [C139274]	Extension Trial Indicator
Healthy Subject Indicator [C98737]	Healthy Subject Indicator
Intervention Model [C98746]	Intervention Model
Intervention Type [C98747]	Intervention Type
Investigational Therapy or Treatment [C41161]	Investigational Therapy or Treatment
Number of Groups/Cohorts [C126063]	Number of Groups/Cohorts
Pediatric Investigation Plan Indicator [C126069]	Pediatric Investigation Plan Indicator
Pediatric Postmarket Study Indicator [C123631]	Pediatric Postmarket Study Indicator
Pediatric Study Indicator [C123632]	Pediatric Study Indicator
Pharmacologic Class [C98768]	Pharmacologic Class
Planned Country of Investigational Sites [C98770]	Planned Country of Investigational Sites
Planned Maximum Age of Subjects [C49694]	Planned Maximum Age of Subjects
Planned Minimum Age of Subjects [C49693]	Planned Minimum Age of Subjects
Planned Number of Arms [C98771]	Planned Number of Arms
Planned Number of Subjects [C49692]	Planned Number of Subjects
Primary Outcome Measure [C98772]	Primary Outcome Measure
Randomization Quotient [C98775]	Randomization Quotient
Rare Disease Indicator [C126070]	Rare Disease Indicator
Registry Identifier [C98714]	Registry Identifier
Route of Administration [C38114]	Route of Administration
SDTM IG Version [C156604]	SDTM IG Version
SDTM Version [C156605]	SDTM Version
Secondary Outcome Measure [C98781]	Secondary Outcome Measure
Sex of Participants [C49696]	Sex of Participants
Stratification Factor [C16153]	Stratification Factor
Study End Date [C90462]	Study End Date
Study Start Date [C69208]	Study Start Date
Study Stop Rules [C49698]	Study Stop Rules
Study Type [C142175]	Study Type
Therapeutic Area [C101302]	Therapeutic Area
Trial Blinding Schema [C49658]	Trial Blinding Schema
Trial Disease/Condition Indication [C112038]	Trial Disease/Condition Indication
Trial Exploratory Objective [C163559]	Trial Exploratory Objective
Trial Intent Type [C49652]	Trial Intent Type
Trial is Randomized [C25196]	Trial is Randomized
Trial Length [C49697]	Trial Length
Trial Phase Classification [C48281]	Trial Phase Classification
Trial Primary Objective [C85826]	Trial Primary Objective
Trial Secondary Objective [C85827]	Trial Secondary Objective
Trial Title [C49802]	Trial Title
Trial Type [C49660]	Trial Type

TSPARMCD [C66738]

Permitted Value (Code)	Display Value (Decode)
ACTSUB [C98703]	ACTSUB
ADAPT [C146995]	ADAPT
ADDON [C49703]	ADDON
AGEMAX [C49694]	AGEMAX
AGEMIN [C49693]	AGEMIN
COMPTRT [C68612]	COMPTRT
DCUTDESC [C98718]	DCUTDESC
DCUTDTC [C98717]	DCUTDTC
EXTTIND [C139274]	EXTTIND
FCNTRY [C98770]	FCNTRY
HLTSUBJI [C98737]	HLTSUBJI
INDIC [C112038]	INDIC
INTMODEL [C98746]	INTMODEL
INTTYPE [C98747]	INTTYPE
LENGTH [C49697]	LENGTH
NARMS [C98771]	NARMS
NCOHORT [C126063]	NCOHORT
OBJEXP [C163559]	OBJEXP
OBJPRIM [C85826]	OBJPRIM
OBJSEC [C85827]	OBJSEC
OUTMSEXP [C98724]	OUTMSEXP
OUTMSPRI [C98772]	OUTMSPRI
OUTMSSEC [C98781]	OUTMSSEC
PCLAS [C98768]	PCLAS
PDPSTIND [C123631]	PDPSTIND
PDSTIND [C123632]	PDSTIND
PIPIND [C126069]	PIPIND
PLANSUB [C49692]	PLANSUB
RANDOM [C25196]	RANDOM
RANDQT [C98775]	RANDQT
RDIND [C126070]	RDIND
REGID [C98714]	REGID
ROUTE [C38114]	ROUTE
SDTIGVER [C156604]	SDTIGVER
SDTMVER [C156605]	SDTMVER
SENDTC [C90462]	SENDTC
SEXPOP [C49696]	SEXPOP
SPONSOR [C70793]	SPONSOR
SSTDTC [C69208]	SSTDTC
STOPRULE [C49698]	STOPRULE
STRATFCT [C16153]	STRATFCT
STYPE [C142175]	STYPE
TBLIND [C49658]	TBLIND
TCNTRL [C49647]	TCNTRL
TDIGRP [C49650]	TDIGRP
THERAREA [C101302]	THERAREA
TINDTP [C49652]	TINDTP
TITLE [C49802]	TITLE
TPHASE [C48281]	TPHASE
TRT [C41161]	TRT
TTYPE [C49660]	TTYPE

UNIT [C71620]

Permitted Value (Code)	Display Value (Decode)
% [C25613]	%
10^12/L [C67308]	10^12/L
10^3/mm3 [*]	10^3/mm3
10^3/uL [*]	10^3/uL
10^6/cu mm [*]	10^6/cu mm
10^9/L [C67255]	10^9/L
cm [C49668]	cm
fL [C64780]	fL
g [C48155]	g
g/dL [C64783]	g/dL
g/L [C42576]	g/L
L/L [C105495]	L/L
mg [C28253]	mg
mg/day [C67399]	mg/day
mg/dL [C67015]	mg/dL
mg/L [C64572]	mg/L
mL [C28254]	mL
/mL [*]	/mL
mmol/L [C64387]	mmol/L
NA [*]	NA
NONE [*]	NONE
pg [C64551]	pg
SYRINGE [C48540]	SYRINGE
ug [C48152]	ug
ukat/L [C67397]	ukat/L
/uL [*]	/uL
U/L [C67456]	U/L
UML [*]	UML
U/mL [C77607]	U/mL
umol/L [C48508]	umol/L
VISITS/CONTACTS [*]	VISITS/CONTACTS
x10^3/uL [*]	x10^3/uL
x10^6/uL [*]	x10^6/uL

* Extended Value

Visit Number

Permitted Value (Code)	Display Value (Decode)
1165454	V4_WEEK3_VAX2_S_R
1165455	V5_WEEK1_POSTVAX2_S_R
1165456	V6_WEEK2_POSTVAX2_S_R
1165457	V7_MONTH1_S_R
60747	SCR
60748	V1_DAY1_VAX1_S
60749	V2_DAY2_POSTVAX1_S
60750	V3_WEEK1_POSTVAX1_S
60751	V4_WEEK3_VAX2_S
60752	V5_WEEK1_POSTVAX2_S
60753	V6_WEEK2_POSTVAX2_S
60754	V7_MONTH1_S
60755	V8_MONTH6_S
60756	V9_MONTH12_S
60757	V10_MONTH24_S
60765	V1_DAY1_VAX1_L
60766	V2_VAX2_L
60767	V3_MONTH1_POSTVAX2_L
60768	V4_MONTH6_L
60769	V5_MONTH12_L
60770	V6_MONTH24_L
60771	POT_COVID_ILL
60772	POT_COVID_CONVA
60776	End of Treatment
60777	Follow-Up

Category for Vital Signs

Permitted Value (Code)	Display Value (Decode)
GENERAL VITAL SIGNS	GENERAL VITAL SIGNS
REACTOGENICITY	REACTOGENICITY
REACTOGENICITY - UNPLANNED TEMPERATURE	REACTOGENICITY - UNPLANNED TEMPERATURE

VSRESU [C66770]

Permitted Value (Code)	Display Value (Decode)
F [C44277]	Degree Fahrenheit
% [C25613]	%
beats/min [C49673]	Beats per Minute
breaths/min [C49674]	Breaths per Minute
C [C42559]	C
cm [C49668]	cm
in [C48500]	Inch
kg [C28252]	kg
kg/m2 [C49671]	kg/m2
mmHg [C49670]	mmHg
LB [C48531]	Pound

Subcategory for Vital Signs

Permitted Value (Code)	Display Value (Decode)
SYSTEMIC	SYSTEMIC

VSTEST [C67153]

Permitted Value (Code)	Display Value (Decode)
Body Mass Index [C16358]	BMI
Diastolic Blood Pressure [C25299]	DIABP
Heart Rate [C49677]	HR
Height [C25347]	HEIGHT
Oxygen Saturation [C60832]	OXYSAT
Pulse Rate [C49676]	PULSE
Respiratory Rate [C49678]	RESP
Systolic Blood Pressure [C25298]	SYSBP
Temperature [C25206]	TEMP
Weight [C25208]	WEIGHT

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External Dictionaries

External Dictionaries
Reference Name	External Dictionary	Dictionary Version
ISO3166(CL.ISO3166)	ISO3166
MedDRA	MedDRA	23.1
National Drug File - Reference Terminology	NDF-RT	2020-03-02
Systematized Nomenclature of Medicine	SNOMED	2020-03-01
Unique Ingredient Identifier	UNII	2020-01-12
WHO DD	WHO DD	202003
Medications Dictionary	WHODD	GLOBALB3Mar20

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Methods

Methods
Method	Type	Description
AE.AEENDY	Computation	if AE.VSD.AEENDY: (DY derivation using COMP.DY) else AE.AE.AEENDY: (ENDY derivation using COMP.ENDY)
AE.AERFTDTC	Computation	Date/time of related vaccination
AE.AESEQ	Computation	if AE.AE.AESEQ: (Sequence Number derived using COMP.SEQ) else AE.VSD.AESEQ: (Sequential number derived using COMP.SEQ)
AE.AESTDY	Computation	if AE.VSD.AESTDY: (DY derivation using COMP.DY) else AE.AE.AESTDY: (STDY derivation using COMP.STDY)
AE.EPOCH	Computation	Epoch derivation using COMP.EPOCH
AE.USUBJID	Computation	if AE.AE.USUBJID: (Unique subject identifier derived using COMP.USUBJID) else AE.VSD.USUBJID: (Unique subject identifier derived usingCOMP.USUBJID)
AE.VSD.AEDUR	Computation	AEENDTC - AESTDTC + 1 less the protocol-defined assessment interval (number of days occurring past the assessment interval)
AE.VSD.AELNKGRP	Computation	Concatenation of vaccination number, location and laterality (for administration site events), and event term.
CE.CEENDY	Computation	if CE.VSD.CEENDY: (DY derivation using COMP.DY) else CE.IDT.CEENDY: (ENDY derivation using COMP.ENDY)
CE.CEOCCUR	Computation	If subject reported at least one pre-specified signs and symptoms for COVID-19 in the contingent visit then assign CEOCCUR value as “Y” else "N".
CE.CESEQ	Computation	Sequential number derived using COMP.SEQ
CE.CESTDY	Computation	if CE.VSD.CESTDY: (DY derivation using COMP.DY) else CE.IDT.CESTDY: (STDY derivation using COMP.STDY)
CE.CETERM	Computation	For every subject excluding SCRFAIL and NOTASSIGN assign CETERM=‘COVID-19 like illness’ If SUPPDM.QVAL where QNAM="CDECASE" ne NULL then assign as CETERM='COVID-19 confirmed' and bring all Pre-specified symptoms for subject for corresponding visit.
CE.EPOCH	Computation	Epoch derivation using COMP.EPOCH
CE.IDT.CEDY	Computation	DY derivation using COMP.DY
CE.IDT.CEENRTPT	Computation	Set to "ONGOING" when X_CEONGO_008_C="Y";when X_CEONGO_008_C="N" set to "BEFORE".
CE.IDT.CEENTPT	Computation	Set CEENTPT to 'LAST SUBJECT ENCOUNTER' when CE.CEENRTPT is not missing
CE.USUBJID	Computation	Unique subject identifier derived usingCOMP.USUBJID
CE.VSD.CEDUR	Computation	CEENDTC - CESTDTC + 1, except if end date occurs after the protocol-specified assessment interval, then duration will be set to the duration of the assessment interval.
CE.VSD.CEENDTC	Computation	Latest reported date of the symptom
CE.VSD.CEGRPID	Computation	Concatenation of vaccination number and sub-category.
CE.VSD.CELNKGRP	Computation	Concatenation of vaccination number, location and laterality (for administration site events), and event term.
CE.VSD.CERFTDTC	Computation	Date/time of related vaccination
CM.CM.CMENDY	Computation	ENDY derivation using COMP.ENDY
CM.CM.CMENRTPT	Computation	Set to 'ONGOING' when X_CMONGO_001_C is 'Y' else NULL
CM.CM.CMENTPT	Computation	CMENTPT = 'LAST SUBJECT ENCOUNTER' when CMENRTPT = 'ONGOING'
CM.CM.CMSEQ	Computation	Sequential number derived using COMP.SEQ
CM.CM.CMSTDY	Computation	STDY derivation using COMP.STDY
CM.CM.EPOCH	Computation	Epoch derivation using COMP.EPOCH
CM.CM.USUBJID	Computation	Unique subject identifier derived using COMP.USUBJID
CO.CODY	Computation	Actual study day of visit/collection/exam expressed in integer days relative to sponsor- defined RFSTDTC in Demographics.
CO.COSEQ	Computation	Use SDTM utility util_seq_key_gen
CO.USUBJID	Computation	USUBJID= DM.USUBJID
DD.DD.DDDY	Computation	Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
DD.DD.DDSEQ	Computation	Sequential number identifying records within each USUBJID in the domain.
DD.DD.EPOCH	Computation	--DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
DD.DD.USUBJID	Computation	DM.USUBJID
DI.DISEQ	Computation	Sequential number identifying records within each USUBJID in the domain.
DM.DM.AGE	Computation	If AGEU=YEARS then AGE=int((Informed Consent date - birthdate)/365.25)
DM.DM.DTHDTC	Computation	Date/time of death when Disposition mentioned as 'DEATH'.
DM.DM.DTHFL	Computation	Populate Death flag is 'Y' when Standardized Disposition Term is 'DEATH'
DM.DM.RFENDTC	Computation	Maximum of Visit date/Maximum of disposition date, whichever is greater.Null for Screen Failures.
DM.DM.RFICDTC	Computation	Date/time of informed consent obtained
DM.DM.RFPENDTC	Computation	Set to Date/time when subject ended participation in a trial.
DM.DM.RFSTDTC	Computation	First date/time of study drug else Randomization date/time OR Enrollment date/time for subject.Null for screen failures.
DM.DM.RFXENDTC	Computation	Latest date/time of study drug exposure
DM.DM.RFXSTDTC	Computation	First date/time of study drug exposure date
DM.DM.USUBJID	Computation	Unique subject identifier derived usingCOMP.USUBJID
DS.DS.DSDY	Computation	Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
DS.DS.DSSEQ	Computation	Sequential numer identifying records within each USUBJID in the domain
DS.DS.DSSTDY	Computation	Study day of start of event relative to the sponsor-defined RFSTDTC. --STDY= (date portion of --STDTC) - (date portion of DM.RFSTDTC) + 1 where --STDTC is on or after DM.RFSTDTC; Else --STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC)
DS.DS.EPOCH	Computation	--DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
DS.DS.USUBJID	Computation	DM.USUBJID
DV.DV.DVCAT	Computation	If Potentially_Important_PDs = "YES" then DVCAT = "Important"Else if Potentially_Important_PDs = "NO" then DVCAT = "Non-Important"Else set DVCAT to blank
DV.DV.DVSEQ	Computation	Sequence Number derived using COMP.SEQ
DV.DV.DVSTDY	Computation	STDY derivation using COMP.STDY
DV.DV.EPOCH	Computation	Epoch derivation using COMP.EPOCH
DV.DV.USUBJID	Computation	Unique subject identifier derived using COMP.USUBJID
EC.EC.ECENDY	Computation	Study day of end of event relative to the sponsor-defined RFSTDTC. --ENDY= (date portion of --ENDTC) - (date portion of DM.RFSTDTC) + 1 where --ENDTC is on or after DM.RFSTDTC; Else --ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC)
EC.EC.ECLNKGRP	Computation	Related vaccination number to assist with Reactogenicity assessment
EC.EC.ECLNKID	Computation	Concatenate Link Group ID, Location and Laterality when Link Group ID is present
EC.EC.ECMOOD	Computation	Set to "SCHEDULED" for Planned Dose records, "PERFORMED" for Actual Dose Records
EC.EC.ECSEQ	Computation	Sequential number identifying records within each USUBJID in the domain.
EC.EC.ECSTDY	Computation	Study day of start of event relative to the sponsor-defined RFSTDTC. --STDY= (date portion of --STDTC) - (date portion of DM.RFSTDTC) + 1 where --STDTC is on or after DM.RFSTDTC; Else --STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC)
EC.EC.EPOCH	Computation	--DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
EC.EC.USUBJID	Computation	DM.USUBJID
EX.EC.EPOCH	Computation	--DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
EX.EC.EXENDY	Computation	Study day of end of event relative to the sponsor-defined RFSTDTC. --ENDY= (date portion of --ENDTC) - (date portion of DM.RFSTDTC) + 1 where --ENDTC is on or after DM.RFSTDTC; Else --ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC)
EX.EC.EXLNKGRP	Computation	Related vaccination number to assist with Reactogenicity assessment
EX.EC.EXLNKID	Computation	Concatenate Link Group ID, Location and Laterality when Link Group ID is present
EX.EC.EXSEQ	Computation	Sequential number identifying records within each USUBJID in the domain.
EX.EC.EXSTDY	Computation	Sequential number identifying records within each USUBJID in the domain.
EX.EC.USUBJID	Computation	DM.USUBJID
FACE.EPOCH	Computation	--DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
FACE.FADY	Computation	Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
FACE.FASEQ	Computation	Sequential number identifying records within each USUBJID in the domain.
FACE.SOD.FADRVFL	Computation	Defaulted to "Y" for verbatim terms not pre specified
FACE.SOD.FASTAT	Computation	FASTAT = "NOT DONE" record is generated for any missed symptoms/diary days. Set to "NOT DONE" when FA.FAORRES is missing, except the records where Derived Flag is 'Y'
FACE.USUBJID	Computation	DM.USUBJID
FACE.VSD.FADRVFL	Computation	FADRVFL = 'Y' if record for missed diary day is derived
FACE.VSD.FAGRPID	Computation	Concatenation of vaccination number and sub-category
FACE.VSD.FALNKGRP	Computation	Concatenation of vaccination number, location and laterality (for administration site events), and object of the finding (symptom).
FACE.VSD.FALNKID	Computation	Concatenation of vaccination number, location and laterality (for administration site events), object of the finding (symptom), and diary day.
FACE.VSD.FARFTDTC	Computation	Date/time of related vaccination
FAHO.HCU.EPOCH	Computation	--DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
FAHO.HCU.FADY	Computation	Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
FAHO.HCU.FALNKID	Computation	Unique identifier created to link related records in HO when FAORRES is not missing
FAHO.HCU.FASEQ	Computation	Sequential number identifying records within each USUBJID in the domain.
FAHO.HCU.FASTRESN	Computation	Populate quantitative values of FAORRES
FAHO.HCU.USUBJID	Computation	DM.USUBJID
HO.EPOCH	Computation	--DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
HO.HCU.HODY	Computation	Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
HO.HCU.HOLNKID	Computation	Unique identifier created to link related records in HO when HOOCCUR is "Y".
HO.HOSEQ	Computation	Sequential number identifying records within each USUBJID in the domain.
HO.HOS.HOENDY	Computation	Study day of end of event relative to the sponsor-defined RFSTDTC. --ENDY= (date portion of --ENDTC) - (date portion of DM.RFSTDTC) + 1 where --ENDTC is on or after DM.RFSTDTC; Else --ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC)
HO.HOS.HOSTDY	Computation	Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
HO.HOSTAT	Computation	Assigned 'NOT DONE' when Original result is missing else Null.
HO.USUBJID	Computation	DM.USUBJID
IE.IE.EPOCH	Computation	--DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
IE.IE.IEDY	Computation	Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
IE.IE.IESEQ	Computation	Sequential number identifying records within each USUBJID in the domain.
IE.IE.IESTRESC	Computation	IE.IEORRES
IE.IE.USUBJID	Computation	DM.USUBJID
IS.VARD.EPOCH	Computation	--DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
IS.VARD.ISBLFL	Computation	Last non-missing value on or before DM.RFSTDTC is flagged as Y.
IS.VARD.ISDY	Computation	Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
IS.VARD.ISSEQ	Computation	Sequential number identifying records within each USUBJID in the domain.
IS.VARD.USUBJID	Computation	DM.USUBJID
LB.EPOCH	Computation	--DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
LB.LBBLFL	Computation	Last non-missing value on or before DM.RFSTDTC is flagged as Y.
LB.LBDY	Computation	Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
LB.LB.LBNRIND	Computation	Reference Range Indicator based upon standard results and ranges
LB.LB.LBSTNRHI	Computation	Derived based on high normal ranges from local and central labs using conversion factor
LB.LB.LBSTNRLO	Computation	Derived based on low normal ranges from local and central labs using conversion factor
LB.LBSEQ	Computation	Sequential number identifying records within each USUBJID in the domain.
LB.LBSTRESC	Computation	Data collected in non-standard units is converted using standard conversion factors to standard units.
LB.LBSTRESN	Computation	Numeric value of LBSTRESC, when LBSTRESC contains numeric data.
LB.LBSTRESU	Computation	Standard units consistent with CDISC controlled terminology
LB.OXY.LBSTAT	Computation	Assigned as "NOT DONE" when Original Result is missing
LB.USUBJID	Computation	DM.USUBJID
MB.EPOCH	Computation	Epoch derivation using COMP.EPOCH
MB.LB.MBSTRESC	Computation	Results from MBORRES in standard units
MB.MBBLFL	Computation	Last non-missing value on or before DM.RFSTDTC is flagged as Y COMM.BLFL
MB.MBDY	Computation	DY derivation using COMP.DY
MB.MBSEQ	Computation	if MB.LB.MBSEQ: (Merge SM_LB003 and DI raw data set on the basis of MBSPID then derive SPDEVID) else MB.MIB.MBSEQ: (Sequence Number derived using COMP.SEQ)
MB.MBSTAT.Derived	Computation	if MB.MIB.MBSTAT: (Set to "NOT DONE" when MB.MBORRES is missing) else MB.VARD.MBSTAT: (Assigned 'NOT DONE' when RESULT is missing else Null.)
MB.USUBJID	Computation	Unique subject identifier derived usingCOMP.USUBJID
MH.MH.EPOCH	Computation	Epoch derivation using COMP.EPOCH
MH.MH.MHDY	Computation	DY derivation using COMP.DY
MH.MH.MHENDY	Computation	ENDY derivation using COMP.ENDY
MH.MH.MHENRTPT	Computation	Set to "ONGOING" when X_MHONGO_001_C="Y";when X_MHONGO_001_C="N" set to "BEFORE".
MH.MH.MHENTPT	Computation	Set MHENTPT to 'LAST SUBJECT ENCOUNTER' when MH.MHENRTPT is not missing
MH.MH.MHSEQ	Computation	Sequential number derived using COMP.SEQ
MH.MH.MHSTDY	Computation	STDY derivation using COMP.STDY
MH.MH.USUBJID	Computation	Unique subject identifier derived using COMP.USUBJID
MO.CAR.EPOCH	Computation	--DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
MO.CAR.MOBLFL	Computation	Last non-missing value on or before DM.RFSTDTC is flagged as Y.
MO.CAR.MODY	Computation	Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
MO.CAR.MOSEQ	Computation	Sequential number identifying records within each USUBJID in the domain.
MO.CAR.MOSTAT	Computation	Assigned as "NOT DONE" when Original Result is missing
MO.CAR.USUBJID	Computation	DM.USUBJID
PR.EPOCH	Computation	--DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
PR.PRDY	Computation	Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
PR.PR.PRENDY	Computation	Study day of end of event relative to the sponsor-defined RFSTDTC. --ENDY= (date portion of --ENDTC) - (date portion of DM.RFSTDTC) + 1 where --ENDTC is on or after DM.RFSTDTC; Else --ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC)
PR.PR.PRENRTPT	Computation	Set to "ONGOING" according to the end of the event as being on the reference time point.
PR.PR.PRENTPT	Computation	Set PRENTPT to "LAST SUBJECT ENCOUNTER" when PR.PRENRTPT is not missing
PR.PRSEQ	Computation	Sequential number identifying records within each USUBJID in the domain.
PR.PRSTAT	Computation	Assigned "NOT DONE" when there is no occurrence, but it is Pre-specified.
PR.PRSTDY	Computation	Study day of start of event relative to the sponsor-defined RFSTDTC. --STDY= (date portion of --STDTC) - (date portion of DM.RFSTDTC) + 1 where --STDTC is on or after DM.RFSTDTC; Else --STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC)
PR.USUBJID	Computation	DM.USUBJID
RELREC.RELID	Computation	Direct move from respective RELID
RELREC.USUBJID	Computation	USUBJID= DM.USUBJID
SE.SE.SEENDTC	Computation	If EPOCH='SCREENING', if DM.RFXSTDTC not missing then SEENDTC=DM.RFXSTDTC else use latest date between DM.RFPENDTC;If SDTM.SE.EPOCH='VACCINATION' and TAETORD=2, set to SESTDTC when TAETORD=3 it is not missing, otherwise set to max(DM.RFPENDTC, DM.RFENDTC);If SDTM.SE.EPOCH='VACCINATION' and TAETORD=3, for phase 1, set to SESTDTC when TAETORD=4 if it is not missing, otherwise set to max(DM.RFPENDTC, DM.RFENDTC).If EPOCH='FOLLOW-UP' then set to DM.RFPENDTC.
SE.SE.SEENDY	Computation	Calculation of SEENDY = (Numeric version of SEENDTC - Numeric version of DM.RFSTDTC). Note: Add 1 if calculation is greater than or equal to 0.
SE.SE.SESEQ	Computation	Sort by variable USUBJID, TAETORD, ETCD, SESTDTC, SEENDTC. Restart the numbering at each USUBJID with 1 (order sequentially).
SE.SE.SESTDTC	Computation	If EPOCH='SCREENING' then SESTDTC=DM.RFICDTC;if EPOCH='VACCINATION' and TAETORD=2 then SESTDTC=DM.RFXSTDTC;if EPOCH='VACCINATION' and TAETORD=3 then SESTDTC is second vaccination date;If EPOCH='FOLLOW-UP' then SESTDTC is the date of first follow-up visit.
SE.SE.SESTDY	Computation	Calculation of SESTDY = (Numeric version of SESTDTC - Numeric version of DM.RFSTDTC). Note: Add 1 if calculation is greater than or equal to 0.
SE.SE.USUBJID	Computation	Concatenate SE.STUDYID, SUBJECTNUMBERSTR in each corresponding raw datasets separated by "/".
SUPPAE.USUBJID	Computation	USUBJID= DM.USUBJID
SUPPCE.CEDRVFL	Computation	if SUPPCE.IDT.QVAL: (Assign as Y for when CETERM= 'COVID-19 confirmed') else SUPPCE.VSD.QVAL: (Will be 'Y' for records derived as 'NOT DONE' due to missed/unavailable diary assessments)
SUPPCE.USUBJID	Computation	DM.USUBJID
SUPPCM.CM.USUBJID	Computation	DM.USUBJID
SUPPDM.CDECASE	Computation	CBER Requirement: Populated from the ADaM primary endpoint case flag for the first primary efficacy endpoint as defined in the protocol and by the variable derivation for ADC19EF.AVALC where PARAMCD="C19ONST".
SUPPDM.DM.USUBJID	Computation	DM.USUBJID
SUPPDS.DS.USUBJID	Computation	DM.USUBJID
SUPPDV.DV.USUBJID	Computation	DM.USUBJID
SUPPEC.EC.USUBJID	Computation	DM.USUBJID
SUPPEX.EC.USUBJID	Computation	DM.USUBJID
SUPPFACE.VSD.USUBJID	Computation	DM.USUBJID
SUPPHO.HCU.USUBJID	Computation	DM.USUBJID
SUPPIE.IE.USUBJID	Computation	DM.USUBJID
SUPPIS.VARD.USUBJID	Computation	DM.USUBJID
SUPPLB.LB.LBSTTYPE	Computation	Carries information on standardized unit - whether sponsored preferred unit or standard unit is used.
SUPPLB.LB.LBUNEVFL	Computation	LBUNEVFL=Not Evaluable Flag. This is set to "Y" whenever there is no conversion into standard unit, and the -ORRES values are directly copied into -STRES.
SUPPLB.LB.USUBJID	Computation	DM.USUBJID
SUPPMB.USUBJID	Computation	DM.USUBJID
SUPPMH.MH.USUBJID	Computation	DM.USUBJID
SUPPMO.CAR.USUBJID	Computation	DM.USUBJID
SUPPPR.PR.USUBJID	Computation	DM.USUBJID
SUPPVS.USUBJID	Computation	DM.USUBJID
SV.SV.EPOCH	Computation	Epoch derivation using COMP.EPOCH
SV.SV.SVENDY	Computation	ENDY derivation using COMP.ENDY
SV.SV.SVSTDY	Computation	STDY derivation using COMP.STDY
SV.SV.USUBJID	Computation	Unique subject identifier derived using COMP.USUBJID
VS.EPOCH	Computation	--DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
VS.USUBJID	Computation	DM.USUBJID
VS.VSBLFL	Computation	Last non-missing value on or before DM.RFSTDTC is flagged as Y.
VS.VSD.VSLNKID	Computation	Concatenation of vaccination number, "FEVER", and diary day for eDiary Temperature Records
VS.VSDY	Computation	Study day of collection measured as integer days. --DY= (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where --DTC is on or after DM.RFSTDTC; Else --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC)
VS.VSLNKGRP	Computation	Concatenation of vaccination number and "FEVER" for Reactogenicity Temperature Records
VS.VSRFTDTC	Computation	Date/time of related vaccination
VS.VSSEQ	Computation	Sequential number identifying records within each USUBJID in the domain.
VS.VS.VSSTRESC	Computation	Data collected in non-standard units (i.e. lbs, inches) is converted using standardconversion factors to standard units (kg, cm).
VS.VS.VSSTRESN	Computation	Numeric value of VSSTRESC, when VSSTRESC contains numeric data.

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Datasets

Trial Arms (TA)

Trial Elements (TE)

Trial Inclusion/Exclusion Criteria (TI)

Trial Summary (TS)

Trial Visits (TV)

Comments (CO)

Device Identifiers (DI)

Demographics (DM)

Subject Elements (SE)

Subject Visits (SV)

Concomitant Medications (CM)

Exposure as Collected (EC)

Exposure (EX)

Procedures (PR)

Adverse Events (AE)

Clinical Events (CE)

Disposition (DS)

Protocol Deviations (DV)

Healthcare Encounters (HO)

Medical History (MH)

Death Details (DD)

Findings About Events or Interventions (FACE)

Findings About Events or Interventions (FAHO)

Inclusion/Exclusion Criteria Not Met (IE)

Immunogenicity Specimen Assessments (IS)

Laboratory Test Results (LB)

Microbiology Specimen (MB)

Morphology (MO)

Vital Signs (VS)

Related Records (RELREC)

Supplemental Qualifiers for Adverse Events (SUPPAE)

Supplemental Qualifiers for Clinical Events (SUPPCE)

Supplemental Qualifiers for Concomitant Medications (SUPPCM)

Supplemental Qualifiers for Demographics (SUPPDM)

Supplemental Qualifiers for Disposition (SUPPDS)

Supplemental Qualifiers for Protocol Deviations (SUPPDV)

Supplemental Qualifiers for Exposure as Collected (SUPPEC)

Supplemental Qualifiers for Exposure (SUPPEX)

Supplemental Qualifiers for Findings About Events or Interventions (SUPPFACE)

Supplemental Qualifiers for Healthcare Encounters (SUPPHO)

Supplemental Qualifiers for Inclusion/Exclusion Criteria Not Met (SUPPIE)

Supplemental Qualifiers for Immunogenicity Specimen Assessments (SUPPIS)

Supplemental Qualifiers for Laboratory Test Results (SUPPLB)

Supplemental Qualifiers for Microbiology Specimen (SUPPMB)

Supplemental Qualifiers for Medical History (SUPPMH)

Supplemental Qualifiers for Morphology (SUPPMO)

Supplemental Qualifiers for Procedures (SUPPPR)

Supplemental Qualifiers for Vital Signs (SUPPVS)

CodeLists

External Dictionaries

Methods