Date/Time of Define-XML document generation: 2021-05-04T18:18:13Z

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
DM	Demographics	SPECIAL PURPOSE	One record per subject	Tabulation	STUDYID, USUBJID	dm.xpt
EX	Exposure	INTERVENTIONS	One record per constant dosing interval per subject	Tabulation	STUDYID, USUBJID, EXTRT, EXSTDTC	ex.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
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
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, RELTYPE, 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
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
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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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
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [17 Terms]	Assigned "DM"
USUBJID	Unique Subject Identifier	text	Req	22		Derived Concatenation of STUDYID, SITEID and SUBJID
SUBJID	Subject Identifier for the Study	text	Req	8		CRF Annotated CRF [25 ]
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 [25 ]
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 [25 ]
RACE	Race	text	Exp	41	RACE [7 Terms]	CRF Annotated CRF [25 ]
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 [25 ]
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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Exposure (EX)

EX (Exposure) - INTERVENTIONS Location: ex.xpt
Variable	Label / Description	Type	Role	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Req	8		Protocol
DOMAIN	Domain Abbreviation	text	Req	2	DOMAIN [17 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 [106 108 ]
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 [106 108 ]
EXDOSU	Dose Units	text	Exp	7	EXDOSU • "mcg" = "Microgram" • "SYRINGE" = "SYRINGE" • "mL" = "Milliliter" • "ug" = "Microgram"	CRF Annotated CRF [106 108 ]
EXDOSFRM	Dose Form	text	Exp	9	FRM • "INJECTION" = "INJECTION"	CRF Annotated CRF [106 108 ]
EXROUTE	Route of Administration	text	Perm	13	ROUTE [14 Terms]	CRF Annotated CRF [106 108 ]
EXLOC	Location of Dose Administration	text	Perm	14	LOC [12 Terms]	CRF Annotated CRF [106 108 ]
EXLAT	Laterality	text	Perm	5	Laterality • "LEFT" = "LEFT" • "RIGHT" = "RIGHT"	CRF Annotated CRF [106 108 ]
EXADJ	Reason for Dose Adjustment	text	Perm	40	EXADJ [7 Terms]	CRF Annotated CRF [106 108 ]
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 [6 Terms]	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 [106 108 ]
EXENDTC	End Date/Time of Treatment	datetime	Exp		ISO 8601	CRF Annotated CRF [106 108 ]
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" • "VACCINATION 4" = "VACCINATION 4" • "UNPLANNED VACCINATION" = "UNPLANNED VACCINATION"	Assigned Related vaccination number to assist with Reactogenicity assessment

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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 [17 Terms]	Assigned "AE"
USUBJID		Unique Subject Identifier	text	Req	22		Derived DM.USUBJID
AESEQ		Sequence Number	integer	Req	8		Derived Sequential number identifying records within each USUBJID in the domain.
AEREFID		Reference ID	text	Perm	10		CRF Annotated CRF [12 70 ]
AESPID		Sponsor-Defined Identifier	text	Perm	2		CRF Annotated CRF [11 ]
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 [11 70 102 ]
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 [102 ]
AELAT		Laterality	text	Perm	5	Laterality • "LEFT" = "LEFT" • "RIGHT" = "RIGHT"	CRF Annotated CRF [102 ]
AESEV		Severity/Intensity	text	Perm	8	Severity Response for AE • "MILD" = "Mild" • "MODERATE" = "Moderate" • "SEVERE" = "Severe"	Assigned Severity
AESER		Serious Event	text	Exp	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [11 ]
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 [11 70 ]
AEREL		Causality	text	Exp	11	AEREL • "NOT RELATED" = "NOT RELATED" • "RELATED" = "RELATED"	CRF Annotated CRF [11 ]
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 [11 ]
AEOUT		Outcome of Adverse Event	text	Perm	32	OUT [6 Terms]	CRF Annotated CRF [12 ]
AESCONG		Congenital Anomaly or Birth Defect	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [11 ]
AESDISAB		Persist or Signif Disability/Incapacity	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [11 ]
AESDTH		Results in Death	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [11 ]
AESHOSP		Requires or Prolongs Hospitalization	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [11 ]
AESLIFE		Is Life Threatening	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [11 ]
AESMIE		Other Medically Important Serious Event	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [11 ]
AECONTRT		Concomitant or Additional Trtmnt Given	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [12 70 ]
AETOXGR		Standard Toxicity Grade	text	Perm	1	TOXGRV4 • "1" = "1" • "2" = "2" • "3" = "3" • "4" = "4"	CRF Annotated CRF [11 ]
EPOCH		Epoch	text	Perm	11	EPOCH [6 Terms]	Derived --DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
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 [11 70 ]
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 [11 70 ]
AESTDY		Study Day of Start of Adverse 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)
AEENDY		Study Day of End of Adverse Event	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)
AEELTM		Planned Elapsed Time from Time Point Ref	durationDatetime			ISO 8601	Derived AESTDTC-AERFTDTC in ISO 8601 duration format. If a complete AESTDTC is available then: 1. If date is same as vaccination date and time is available: a. If occurred on vax date and time is prior to vaccination time, then i. if Vax 1 (occurred prior to 1st vaccination), set AEELTM to missing ii. if after Vax 1, then derive elapsed time in days relative to prior vaccination (e.g. occured on Vax 2 date but time is prior to vaccination, then compare event to Vax 1 date/time). b. If time is after vaccination, then derive elapsed time in hours or minutes as appropriate. 2. If date is same as vaccination but time is not available, then set AEELTM to missing. 3. If date is after vaccination, then derive elapsed time in days. If AESTDTC is unknown/missing or partial date, then set AEELTM to missing. Note for reactogenicity: since times are not collected in the diary, then elapsed time will be derived in days and will be missing for any events starting on Day 1 of the diary period.
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 [11 70 102 ]
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 [17 Terms]	Assigned "CE"
USUBJID		Unique Subject Identifier	text	Req	22		Derived DM.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.
CESPID		Sponsor-Defined Identifier	text	Perm	4		Assigned Sponser defined identifier
CETERMVLM		Reported Term for the Clinical Event	text	Req	99
	CECAT ≠ "REACTOGENICITY"	Reported Term for the Clinical Event	text		100		CRF Annotated CRF [40 41 42 91 93 102 ]
	CECAT = "REACTOGENICITY"	Reported Term for the Clinical Event	text		100		eDT
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 [6 Terms]	Assigned
CEPRESP		Clinical Event Pre-Specified	text	Perm	1	NY1 • "Y" = "Y"	Assigned Set to 'Y' for pre-specified events.
CEOCCUR		Clinical Event Occurrence	text	Perm	1	NY • "N" = "N" • "Y" = "Y"	Assigned
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 [102 ]
CELAT		Laterality	text	Perm	5	Laterality • "LEFT" = "LEFT" • "RIGHT" = "RIGHT"	CRF Annotated CRF [102 ]
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 [40 41 42 ]
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 [6 Terms]	Derived Epoch derivation using COMP.EPOCH
CEDTC		Date/Time of Event Collection	datetime	Perm		ISO 8601	CRF Annotated CRF [40 91 93 ]
CESTDTCVLM		Start Date/Time of Clinical Event	datetime	Perm		ISO 8601
	CECAT ≠ "REACTOGENICITY"	Start Date/Time of Clinical Event	datetime			ISO 8601	CRF Annotated CRF [41 42 91 93 ]
	CECAT = "REACTOGENICITY"	Start Date/Time of Clinical Event	datetime			ISO 8601	eDT
CEENDTCVLM		End Date/Time of Clinical Event	datetime	Perm		ISO 8601
	CECAT ≠ "REACTOGENICITY"	End Date/Time of Clinical Event	datetime			ISO 8601	CRF Annotated CRF [41 42 91 93 ]
	CECAT = "REACTOGENICITY"	End Date/Time of Clinical Event	datetime			ISO 8601	Derived Latest reported date of the symptom
CEDY		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)
CESTDY		Study Day of Start of Observation	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)
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" or "BEFORE" according to the end of the event as being on the reference time point.
	CECAT ≠ "REACTOGENICITY"	End Relative to Reference Time Point	text		20	STENRF • "BEFORE" = "BEFORE" • "ONGOING" = "ONGOING"	CRF Annotated CRF [41 42 91 93 102 ]
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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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 [17 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
FAOBJVLM		Object of the Observation	text	Req	22
	FACAT ≠ "REACTOGENICITY" (REACTOGENICITY)	Object of the Observation	text		8		CRF Annotated CRF [81 91 93 102 119 120 121 122 123 124 125 126 127 128 129 130 131 ]
	FACAT = "REACTOGENICITY" (REACTOGENICITY)	Object of the Observation	text		22		eDT
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) 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 [81 ]
	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 [81 ]
	FATESTCD = "MAXDIAM" (Maximum Diameter) and FACAT ≠ "REACTOGENICITY" (REACTOGENICITY)	Result or Finding in Original Units	text		6		CRF Annotated CRF [81 ]
	FATESTCD = "MINDIAM" (Minimum Diameter) and FACAT ≠ "REACTOGENICITY" (REACTOGENICITY)	Result or Finding in Original Units	text		6		CRF Annotated CRF [81 ]
	FATESTCD = "REL" (Causality) and FACAT = "REACTOGENICITY - UNPLANNED ASSESSMENT" (REACTOGENICITY - UNPLANNED ASSESSMENT)	Result or Finding in Original Units	text		1	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [81 ]
	FATESTCD = "FSYMDATE" (First Symptom Date)	Result or Finding in Original Units	date			ISO 8601	CRF Annotated CRF [91 93 ]
	FATESTCD = "LSYMDATE" (Last Symptom Resolved Date)	Result or Finding in Original Units	date			ISO 8601	CRF Annotated CRF [91 92 ]
	FATESTCD = "OCCUR" (Occurrence) and FACAT ≠ "REACTOGENICITY" (REACTOGENICITY)	Result or Finding in Original Units	text		2	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [81 91 93 ]
	FATESTCD = "SYMONGO" (Symptom Ongoing)	Result or Finding in Original Units	text		2	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [91 93 ]
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 [81 ]
FALAT		Laterality of Location of Finding About	text	Perm	5	Laterality • "LEFT" = "LEFT" • "RIGHT" = "RIGHT"	CRF Annotated CRF [81 ]
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	18		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 [6 Terms]	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 ≠ "REACTOGENICITY" (REACTOGENICITY)	Date/Time of Collection	datetime			ISO 8601	CRF Annotated CRF [81 91 93 ]
	FACAT = "REACTOGENICITY" (REACTOGENICITY)	Date/Time of Collection	datetime			ISO 8601	eDT
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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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 [17 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 [78 111 112 113 114 115 ]
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	Vital Signs Test Short Name [10 Terms]	Assigned
VSTEST		Vital Signs Test Name	text	Req	24	Vital Signs Test Name [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" • "REACTOGENICITY - ADVERSE EVENT" = "REACTOGENICITY - ADVERSE EVENT"	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 [113 115 ]
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 [78 112 113 114 115 ]
	VSCAT ≠ "GENERAL VITAL SIGNS" (GENERAL VITAL SIGNS)	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 [112 113 115 ]
	VSCAT ≠ "GENERAL VITAL SIGNS" (GENERAL VITAL SIGNS)	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 [111 112 113 115 ]
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
VISITVLM		Visit Name	text	Perm	21
	VSCAT = "GENERAL VITAL SIGNS" (GENERAL VITAL SIGNS)	Visit Name	text		64		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
	VSCAT ≠ "GENERAL VITAL SIGNS" (GENERAL VITAL SIGNS)	Visit Name	text		20		eDT
EPOCH		Epoch	text	Perm	11	EPOCH [6 Terms]	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 [78 112 113 114 115 ]
	VSCAT ≠ "GENERAL VITAL SIGNS" (GENERAL VITAL SIGNS)	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 [17 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 [17 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 [12 70 ]
➤ 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 [70 ]
➤ QNAM IN ("AEAENO")	Associated Adverse Event Identifier	text		200		CRF Annotated CRF [70 ]
➤ QNAM IN ("AENDGIV")	Was a Non-Drug Treatment given	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [12 70 ]
➤ QNAM IN ("AEMERES")	Is AE a Result of a Medication Error	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [11 ]
➤ QNAM IN ("AERELTXT")	Event Due to Other Specify	text		200		CRF Annotated CRF [11 ]
➤ QNAM IN ("AESUBJDC")	Discontinued because of this AE	text		200	NY • "N" = "N" • "Y" = "Y"	CRF Annotated CRF [12 70 ]
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 [17 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	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 [102 ]
➤ QNAM IN ("CEDRVFL")	Derived Flag	text		200	NY • "N" = "N" • "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 [102 ]
➤ 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 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 [17 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 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 [17 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

Severity Response for AE [C66769]

Permitted Value (Code)	Display Value (Decode)
MILD [C41338]	Mild
MODERATE [C41339]	Moderate
SEVERE [C41340]	Severe

AGEU [C66781]

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

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
SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION	SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION

DOMAIN [C66734]

Permitted Value (Code)	Display Value (Decode)
AE [C49562]	Adverse Events
CE [C85441]	Clinical Events
DI [C102618]	Device Identifiers
DM [C49572]	Demographics
DS [C49576]	Disposition
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
LB [C49592]	Laboratory Test Results
MB [C49602]	Microbiology Specimen
RELREC [C147182]	Related Records
SUPPAE [C147185]	Supplemental Qualifiers for Adverse Events
SUPPCE [C147191]	Supplemental Qualifiers for Clinical Events
SUPPFACE [*]	Supplemental Qualifiers for Findings About Events or Interventions
VS [C49622]	Vital Signs

* Extended Value

EPOCH [C99079]

Permitted Value (Code)	Display Value (Decode)
FOLLOW-UP [C99158]	FOLLOW-UP
SCREENING [C48262]	SCREENING
VACCINATION [*]	VACCINATION
REPEAT SCREENING 1 [*]	REPEAT SCREENING 1
OPEN LABEL FOLLOW-UP [*]	OPEN LABEL FOLLOW-UP
OPEN LABEL TREATMENT [C102256]	OPEN LABEL TREATMENT

* Extended Value

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
mL [C28254]	Milliliter
ug [C48152]	Microgram

* Extended Value

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
Related to Study Treatment [*]	Causality
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
REL [*]	Causality
SEV [C25676]	Severity/Intensity
STPDMEDP [*]	Stop Date Meds Given to Trt/Pnt Symptoms
SYMONGO [*]	Symptom Ongoing

* 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

FRM [C66726]

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

Laterality [C99073]

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

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

ND [C66789]

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

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

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

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
VACCINATION 4	VACCINATION 4
UNPLANNED VACCINATION	UNPLANNED VACCINATION

Category for Vital Signs

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

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

Vital Signs Test Name [C67153]

Permitted Value (Code)
Body Mass Index [C16358]
Diastolic Blood Pressure [C25299]
Heart Rate [C49677]
Height [C25347]
Oxygen Saturation [C60832]
Pulse Rate [C49676]
Respiratory Rate [C49678]
Systolic Blood Pressure [C25298]
Temperature [C25206]
Weight [C25208]

Vital Signs Test Short Name [C66741]

Permitted Value (Code)	Display Value (Decode)
BMI [C16358]	Body Mass Index
DIABP [C25299]	Diastolic Blood Pressure
HR [C49677]	Heart Rate
HEIGHT [C25347]	Height
OXYSAT [C60832]	Oxygen Saturation
PULSE [C49676]	Pulse Rate
RESP [C49678]	Respiratory Rate
SYSBP [C25298]	Systolic Blood Pressure
TEMP [C25206]	Temperature
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.AEELTM	Computation	AESTDTC-AERFTDTC in ISO 8601 duration format. If a complete AESTDTC is available then: 1. If date is same as vaccination date and time is available: a. If occurred on vax date and time is prior to vaccination time, then i. if Vax 1 (occurred prior to 1st vaccination), set AEELTM to missing ii. if after Vax 1, then derive elapsed time in days relative to prior vaccination (e.g. occured on Vax 2 date but time is prior to vaccination, then compare event to Vax 1 date/time). b. If time is after vaccination, then derive elapsed time in hours or minutes as appropriate. 2. If date is same as vaccination but time is not available, then set AEELTM to missing. 3. If date is after vaccination, then derive elapsed time in days. If AESTDTC is unknown/missing or partial date, then set AEELTM to missing. Note for reactogenicity: since times are not collected in the diary, then elapsed time will be derived in days and will be missing for any events starting on Day 1 of the diary period.
AE.AEENDY	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)
AE.AERFTDTC	Computation	Date/time of related vaccination
AE.AESEQ	Computation	Sequential number identifying records within each USUBJID in the domain.
AE.AESTDY	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)
AE.EPOCH	Computation	--DTC element will be used to determine EPOCH value. If --DTC element is partial and Null then EPOCH will be NULL.
AE.USUBJID	Computation	DM.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.CESEQ	Computation	Sequential number derived using COMP.SEQ
CE.CESTDY	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)
CE.EPOCH	Computation	Epoch derivation using COMP.EPOCH
CE.IDT.CEDY	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)
CE.IDT.CEENRTPT	Computation	Set to "ONGOING" or "BEFORE" according to the end of the event as being on the reference time point.
CE.IDT.CEENTPT	Computation	Set CEENTPT to 'LAST SUBJECT ENCOUNTER' when CE.CEENRTPT is not missing
CE.USUBJID	Computation	DM.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
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	Concatenation of STUDYID, SITEID and SUBJID
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
RELREC.RELID	Computation	Direct move from respective RELID
RELREC.USUBJID	Computation	USUBJID= DM.USUBJID
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	USUBJID= DM.USUBJID
SUPPFACE.VSD.USUBJID	Computation	DM.USUBJID
SUPPVS.USUBJID	Computation	DM.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

Demographics (DM)

Exposure (EX)

Adverse Events (AE)

Clinical Events (CE)

Findings About Events or Interventions (FACE)

Vital Signs (VS)

Related Records (RELREC)

Supplemental Qualifiers for Adverse Events (SUPPAE)

Supplemental Qualifiers for Clinical Events (SUPPCE)

Supplemental Qualifiers for Findings About Events or Interventions (SUPPFACE)

Supplemental Qualifiers for Vital Signs (SUPPVS)

CodeLists

External Dictionaries

Methods