Date/Time of Define-XML document generation: 2021-06-03T19:32:34Z

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
XB	Sequencing Data	FINDINGS	One record per microbiology specimen finding per time point per visit per subject	Tabulation	STUDYID, USUBJID, XBTESTCD, XBDTC	xb.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 • "DM" = "Demographics" • "EX" = "Exposure" • "XB" = "Microbiology Specimen"	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 • "DM" = "Demographics" • "EX" = "Exposure" • "XB" = "Microbiology Specimen"	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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Sequencing Data (XB)

XB (Sequencing Data) - FINDINGS Location: xb.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 • "DM" = "Demographics" • "EX" = "Exposure" • "XB" = "Microbiology Specimen"	Assigned "XB"
USUBJID	Unique Subject Identifier	text	Req	22		Derived Unique subject identifier derived usingCOMP.USUBJID
SPDEVID	Sponsor Device Identifier	text	Perm	45		Assigned Set to missing
XBSEQ	Sequence Number	integer	Req	8		Derived Sequence Number derived using COMP.SEQ
XBGRPID	Group ID	text	Exp	1		Assigned Set to missing
XBREFID	Reference ID	text	Perm	10		eDT
XBTESTCD	Microbiology Test or Finding Short Name	text	Req	8	Microbiology Specimen Test Code • "WGSCLINE" = "SARS CoV2 lineage phylogenetic analysis"	Assigned
XBTEST	Microbiology Test or Finding Name	text	Req	40	Microbiology Specimen Test Name • "SARS CoV2 lineage phylogenetic analysis"	Assigned
XBCAT	Category for Microbiology Finding	text	Perm	25	Category for Microbiology Finding • "VIROLOGY"	Assigned
XBORRES	Result or Finding in Original Units	text	Exp	9		eDT
XBSTRESC	Character Result/Finding in Std Format	text	Exp	13		Assigned IF XBORRES is IND then Assign INDETERMINATE, else set to value to XBORRES
XBRESCAT	Result Category	text	Exp	1		Assigned Set to missing
XBSTAT	Completion Status	text	Perm	8	ND • "NOT DONE" = "NOT DONE"	Assigned Assign NOT DONE for records with missing XBORRES
XBSPEC	Specimen Type	text	Perm	22	Specimen Type in Microbiology Specimen • "NASAL_SWAB" • "NASAL_SWAB_SELF"	CRF Annotated CRF [87 ]
XBLOC	Specimen Collection Location	text	Perm	1		Assigned Set to missing
XBMETHOD	Method of Test or Examination	text	Exp	24	Method of Test or Examination in Microbiology Specimen • "Next generation sequence"	Assigned
XBBLFL	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 [6 Terms]	Derived Epoch derivation using COMP.EPOCH
XBDTC	Date/Time of Specimen Collection	datetime	Exp		ISO 8601	CRF Annotated CRF [87 ]
XBDY	Study Day of MB Specimen Collection	integer	Perm	8		Derived DY derivation using COMP.DY

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AGEU [C66781]

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

DOMAIN [C66734]

Permitted Value (Code)	Display Value (Decode)
DM [C49572]	Demographics
EX [C49587]	Exposure
XB [*]	Microbiology Specimen

* 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

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

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

NY1 [C66742]

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

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

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

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 Microbiology Finding

Permitted Value (Code)
VIROLOGY

Method of Test or Examination in Microbiology Specimen [C85492]

Permitted Value (Code)
Next generation sequence [*]

* Extended Value

Specimen Type in Microbiology Specimen [C78734]

Permitted Value (Code)
NASAL_SWAB [*]
NASAL_SWAB_SELF [*]

* Extended Value

Microbiology Specimen Test Name [C120528]

Permitted Value (Code)
SARS CoV2 lineage phylogenetic analysis [*]

* Extended Value

Microbiology Specimen Test Code [C120527]

Permitted Value (Code)	Display Value (Decode)
WGSCLINE [*]	SARS CoV2 lineage phylogenetic analysis

* Extended Value

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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
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
XB.EPOCH	Computation	Epoch derivation using COMP.EPOCH
XB.USUBJID	Computation	Unique subject identifier derived usingCOMP.USUBJID
XB.XBBLFL	Computation	Last non-missing value on or before DM.RFSTDTC is flagged as Y COMM.BLFL
XB.XBDY	Computation	DY derivation using COMP.DY
XB.XBSEQ	Computation	Sequence Number derived using COMP.SEQ
XB.XBSTAT	Computation	Assign NOT DONE for records with missing XBORRES
XB.XBSTRESC	Computation	IF XBORRES is IND then Assign INDETERMINATE, else set to value to XBORRES

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Datasets

Demographics (DM)

Exposure (EX)

Sequencing Data (XB)

CodeLists

External Dictionaries

Methods