Date/Time of Define-XML document generation: 2021-01-24T17:47:32

Define-XML version: 2.1.0

Define-XML Context: Other

Stylesheet version: 2019-02-11

Study Name: CDISCPILOT01
Study Description: Study Data Tabulation Model Metadata Submission Guidelines Sample Study
Protocol Name: CDISCPILOT01
Metadata Name: Data Definitions for MSGv2.0 SDTM datasets.
Metadata Description: This metadata version contains only a subset of SDTM domains available in the SDTMIG 3.3. The data contained do not represent the data which would appear together in an actual regulatory submission.

[Comment] Standard's Conformance Notes: 1) The SDTM v1.7/SDTMIG v3.3 datasets were evaluated manually and programmatically by the CDISC SDS MSG Team. At the completion of the SDTM-MSG v2.0, the CDISC SDTM v1.7/SDTMIG v3.3 conformance rules were recently published, but not available by any validation tools to validate. 2) The Define-XML document was evaluated manually and programmatically by the CDISC SDS MSG Team. At the completion of the SDTM-MSG v2.0, the CDISC Define-XML v2.1 conformance rules were not published, nor available by any validation tools to validate. Please ensure that any official regulatory submission of an Define-XML v2.1 document and accompanying data is done in accordance to the respective regulatory health authorities requirements/guidance.

Standards for Study CDISCPILOT01

Standards for Study CDISCPILOT01
Standard	Type	Status	Documentation
STDTMIG 3.3	IG	Final	[Comment] Study Data Tabulation Model Implementation Guide: Human Clinical Trials Version 3.3
SDTMIG-MD 1.1	IG	Final	[Comment] Study Data Tabulation Model Implementation Guide for Medical Devices Version 1.0
CDISC/NCI DEFINE-XML 2020-12-18	CT	Final	[Comment] This was the CDISC CT Package associated to the CDISC Define-XML Specification Version 2.1 when this sample submission was completed.
CDISC/NCI SDTM 2020-12-18	CT	Final	[Comment] This was the latest release of CDISC CT available when this sample submission was completed.

Datasets

Datasets
Dataset	Description	Class	Structure	Purpose	Keys	Documentation	Location
TA[STDTMIG 3.3]	Trial Arms	TRIAL DESIGN	One record per planned Element per Arm	Tabulation	STUDYID, ARMCD, TAETORD		ta.xml
TE[STDTMIG 3.3]	Trial Elements	TRIAL DESIGN	One record per planned Element	Tabulation	STUDYID, ETCD		te.xml
TI[STDTMIG 3.3]	Trial Inclusion/Exclusion Criteria	TRIAL DESIGN	One record per I/E criterion	Tabulation	STUDYID, IETESTCD, TIVERS		ti.xml
TS[STDTMIG 3.3]	Trial Summary	TRIAL DESIGN	One record per trial summary parameter value	Tabulation	STUDYID, TSPARMCD, TSVAL, TSSEQ		ts.xml
TV[STDTMIG 3.3]	Trial Visits	TRIAL DESIGN	One record per planned Visit per Arm	Tabulation	STUDYID, VISITNUM, ARMCD		tv.xml
DM[STDTMIG 3.3]	Demographics	SPECIAL PURPOSE	One record per subject	Tabulation	STUDYID, USUBJID		dm.xml
SE[STDTMIG 3.3]	Subject Elements	SPECIAL PURPOSE	One record per actual Element per subject	Tabulation	STUDYID, USUBJID, SESTDTC, ETCD		se.xml
SV[STDTMIG 3.3]	Subject Visits	SPECIAL PURPOSE	One record per actual visit per subject	Tabulation	STUDYID, USUBJID, SVSTDTC, VISITNUM		sv.xml
CM[STDTMIG 3.3]	Concomitant Medications	INTERVENTIONS	One record per recorded medication occurrence or constant-dosing interval per subject	Tabulation	STUDYID, USUBJID, CMSTDTC, CMTRT		cm.xml
EC[STDTMIG 3.3]	Exposure as Collected	INTERVENTIONS	One record per constant-dosing interval per mood per subject	Tabulation	STUDYID, USUBJID, ECTRT, ECSTDTC		ec.xml
EX[STDTMIG 3.3]	Exposure	INTERVENTIONS	One record per constant dosing interval per subject	Tabulation	STUDYID, USUBJID, EXTRT, EXSTDTC		ex.xml
AE[STDTMIG 3.3]	Adverse Events	EVENTS	One record per adverse event per subject	Tabulation	STUDYID, USUBJID, AEDECOD, AESTDTC, AELNKID		ae.xml
DS[STDTMIG 3.3]	Disposition	EVENTS	One record per disposition status or protocol milestone per subject	Tabulation	STUDYID, USUBJID, DSSTDTC, DSCAT, DSSCAT, DSDECOD		ds.xml
MH[STDTMIG 3.3]	Medical History	EVENTS	One record per medical history event per subject	Tabulation	STUDYID, USUBJID, MHTERM, MHSTDTC		mh.xml
DD[STDTMIG 3.3]	Death Details	FINDINGS	One record per death detail per subject	Tabulation	STUDYID, USUBJID, DDTESTCD		dd.xml
FT[STDTMIG 3.3]	Functional Tests	FINDINGS	One record per functional test finding per timepoint per visit per subject	Tabulation	STUDYID, USUBJID, FTTESTCD, FTREPNUM, VISITNUM		ft.xml
IE[STDTMIG 3.3]	Inclusion/Exclusion Criteria Not Met	FINDINGS	One record per inclusion/exclusion criterion not met per subject	Tabulation	STUDYID, USUBJID, IETESTCD		ie.xml
LB[STDTMIG 3.3]	Laboratory Test Results	FINDINGS	One record per analyte per visit per subject	Tabulation	STUDYID, USUBJID, LBCAT, LBTESTCD, LBDTC, VISITNUM		lb.xml
NV[STDTMIG 3.3][No Data]	Nervous System Findings	FINDINGS	One record per finding per visit per subject	Tabulation	STUDYID, USUBJID, NVTESTCD, VISITNUM	[Comment] Per protocol, electroencephalograms are only performed after such an event were to occur. No subjects within the trial had an occurrence of an electroencephalogram event. Therefore, no data exists for the NV dataset and as such was not submitted.
OE[STDTMIG 3.3]	Ophthalmic Examinations	FINDINGS	One record per ophthalmic finding per visit per subject	Tabulation	STUDYID, USUBJID, OETESTCD, OELOC, OELAT, VISITNUM		oe.xml
QSPH[STDTMIG 3.3]	Questionnaires (PHQ-9) (Questionnaires)	FINDINGS	One record per questionnaire finding per visit per subject	Tabulation	STUDYID, USUBJID, QSTESTCD, VISITNUM	[Comment] QSPH contains the PATIENT HEALTH QUESTIONNAIRE-9 (PHQ-9) questionnaire data.	qsph.xml
QSSL[STDTMIG 3.3]	Questionnaires (SQLS) (Questionnaires)	FINDINGS	One record per questionnaire finding per visit per subject	Tabulation	STUDYID, USUBJID, QSTESTCD, VISITNUM	[Comment] QSSL contains the SATISFACTION WITH LIFE SURVEY (SWLS) questionnaire data.	qssl.xml
RS[STDTMIG 3.3]	Disease Response and Clin Classification	FINDINGS	One record per response assessment or clinical classification assessment per time point per visit per subject per assessor per medical evaluator	Tabulation	STUDYID, USUBJID, RSTESTCD, VISITNUM		rs.xml
VS[STDTMIG 3.3]	Vital Signs	FINDINGS	One record per vital sign measurement per visit per subject	Tabulation	STUDYID, USUBJID, VSTESTCD, VSPOS, VISITNUM, VSREPNUM		vs.xml
FA[STDTMIG 3.3]	Findings About Events or Interventions	FINDINGS ABOUT	One record per finding per object per subject	Tabulation	STUDYID, USUBJID, FATESTCD, FALNKGRP, FAOBJ, FADTC	[Comment] The FA domain contains Findings About Injection Site Reaction Adverse Events	fa.xml
RELREC[STDTMIG 3.3]	Related Records	RELATIONSHIP	One record per related record, group of records or dataset	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID		relrec.xml
SUPPDM[STDTMIG 3.3]	Supplemental Qualifiers for DM (Demographics)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM		suppdm.xml
SUPPEC[STDTMIG 3.3]	Supplemental Qualifiers for EC (Exposure as Collected)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM		suppec.xml
SUPPNV[STDTMIG 3.3][No Data]	Supplemental Qualifiers for NV (Nervous System Findings)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	[Comment] Per protocol, electroencephalograms are only performed after such an event were to occur. No subjects within the trial had an occurrence of an electroencephalogram event. Therefore, no data exists for the NV dataset and as such SUPPNV was not submitted.
SUPPOE[STDTMIG 3.3][No Data]	Supplemental Qualifiers for OE (Ophthalmic Examinations)	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	[Comment] No subjects within the trial had an ophthalmic examination of clinical significance to report. Therefore, no data exists for the SUPPOE dataset and as such was not submitted.
DI[STDTMIG 3.3]	Device Identifiers	STUDY REFERENCE	One record per device identifier per device	Tabulation	STUDYID, SPDEVID, DIPARMCD		di.xml

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Trial Arms (TA)

TA (Trial Arms) - [STDTMIG 3.3]Location: ta.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN	Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Trial Arms • "TA" = "Trial Arms"	[Origin] Assigned (Source: Sponsor)
ARMCD	Planned Arm Code	text	Topic	8	Arm Code • "PLACEBO" = "Placebo" • "ZAN_LOW" = "Zanomaline Low Dose (54 mg)" • "ZAN_HIGH" = "Zanomaline High Dose (81 mg)"	[Origin] Assigned (Source: Sponsor)
ARM	Description of Planned Arm	text	Synonym Qualifier	28	Arm • "Placebo" • "Zanomaline Low Dose (54 mg)" • "Zanomaline High Dose (81 mg)"	[Origin] Protocol (Source: Sponsor)
TAETORD	Planned Order of Element within Arm	integer	Timing	8		[Origin] Assigned (Source: Sponsor)
ETCD	Element Code	text	Record Qualifier	7	Element Code • "HIGH" = "Zanomaline 81 mg" • "LOW" = "Zanomaline 54 mg" • "PLACEBO" = "Placebo" • "SCREEN" = "Screening" • "TITRATE" = "Zanomaline 54 mg Titration"	[Origin] Assigned (Source: Sponsor)
ELEMENT	Description of Element	text	Synonym Qualifier	26	Element • "Screening" • "Placebo" • "Zanomaline 54 mg" • "Zanomaline 54 mg Titration" • "Zanomaline 81 mg"	[Origin] Protocol (Source: Sponsor)
TABRANCH	Branch	text	Rule	200		[Origin] Protocol (Source: Sponsor)
TATRANS	Transition Rule	text	Rule	200		[Origin] Protocol (Source: Sponsor)
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Protocol (Source: Sponsor) [Method]EPOCH from SE where date >= SESTDTC and date < SEENDTC

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Trial Elements (TE)

TE (Trial Elements) - [STDTMIG 3.3]Location: te.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN	Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Trial Elements • "TE" = "Trial Elements"	[Origin] Assigned (Source: Sponsor)
ETCD	Element Code	text	Topic	7	Element Code • "HIGH" = "Zanomaline 81 mg" • "LOW" = "Zanomaline 54 mg" • "PLACEBO" = "Placebo" • "SCREEN" = "Screening" • "TITRATE" = "Zanomaline 54 mg Titration"	[Origin] Assigned (Source: Sponsor)
ELEMENT	Description of Element	text	Synonym Qualifier	26	Element • "Screening" • "Placebo" • "Zanomaline 54 mg" • "Zanomaline 54 mg Titration" • "Zanomaline 81 mg"	[Origin] Protocol (Source: Sponsor)
TESTRL	Rule for Start of Element	text	Rule	200		[Origin] Protocol (Source: Sponsor)
TEENRL	Rule for End of Element	text	Rule	200		[Origin] Protocol (Source: Sponsor)

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Trial Inclusion/Exclusion Criteria (TI)

TI (Trial Inclusion/Exclusion Criteria) - [STDTMIG 3.3]Location: ti.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN	Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Trial Inclusion/Exclusion Criteria • "TI" = "Trial Inclusion"	[Origin] Assigned (Source: Sponsor)
IETESTCD	Incl/Excl Criterion Short Name	text	Topic	7	Incl/Excl Criterion Short Name [33 Terms]	[Origin] Assigned (Source: Sponsor)
IETEST	Inclusion/Exclusion Criterion	text	Synonym Qualifier	196	Inclusion/Exclusion Criterion [33 Terms]	[Origin] Protocol (Source: Sponsor)
IECAT	Inclusion/Exclusion Category	text	Grouping Qualifier	9	Category for Inclusion/Exclusion • "EXCLUSION" = "Exclusion" • "INCLUSION" = "Inclusion"	[Origin] Assigned (Source: Sponsor)
TIVERS	Protocol Criteria Versions	text	Record Qualifier	200		[Origin] Assigned (Source: Sponsor)

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Trial Summary (TS)

TS (Trial Summary) - [STDTMIG 3.3]Location: ts.xml
Variable	Where Condition	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN		Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Trial Summary • "TS" = "Trial Summary"	[Origin] Assigned (Source: Sponsor)
TSSEQ		Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within each TSPARM, restarting at 1 for per TSPARM, applied to sorted data.
TSGRPID		Group ID	text	Identifier	200		[Origin] Assigned (Source: Sponsor)
TSPARMCD		Trial Summary Parameter Short Name	text	Topic	8	Trial Summary Parameter Test Code [44 Terms]	[Origin] Assigned (Source: Sponsor)
TSPARM		Trial Summary Parameter	text	Synonym Qualifier	40	Trial Summary Parameter Test Name [44 Terms]	[Origin] Protocol (Source: Sponsor)
TSVALVLM		Parameter Value	text	Result Qualifier	200
	TSPARMCD IN ( "ADAPT" (Adaptive Study Design Indicator), "ADDON" (Test Product Added to Existing Treatment), "HLTSUBJI" (Healthy Subject Indicator), "RANDOM" (Randomization) )	Trial Summary Yes No Responses	text		1	No Yes Response, subset for variables with only "Y" or "N" val • "N" = "No" • "Y" = "Yes"	[Origin] Protocol (Source: Sponsor)
	TSPARMCD IN ( "ACTSUB" (Actual Subject Number), "AGEMAX" (Planned Maximum Age of Subjects), "AGEMIN" (Planned Minimum Age of Subjects), "DOSE" (Dose), "NARMS" (Planned Number of Arms), "PLANSUB" (Planned Subject Number) )	Planned Maximum Age of Subjects	integer		8		[Origin] Protocol (Source: Sponsor)
	TSPARMCD IN ( "DCUTDTC" (Data Cutoff Date), "SENDTC" (Clinical Study End Date), "SSTDTC" (Study Start Date) )	Trial Summary Date Responses	date			ISO 8601	[Origin] Assigned (Source: Sponsor)
	TSPARMCD = "DOSFRM" (Pharmaceutical Dosage Form)	Dose Form	text		9	Dose Form, subset used for EC and EX • "INJECTION" = "Injectable Dosage Form"	[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "DOSFRQ" (Dose Frequency)	Dosing Frequency	text		2	Frequency, subset used for EC and EX • "QD" = "Daily"	[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "DOSU" (Dosage Form Unit)	Dose Units	text		2	Unit, subset to be used for EXDOSU • "mg" = "Milligram"	[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "FCNTRY" (Planned Country of Investigational Site)	Planned Country of Investigational Sites	text		200	Country Codes ISO 3166-1 Alpha-3 2013-11-15	[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "INDIC" (Trial Indication)	Trial Disease/Condition Indication	text		200	Trial Summary Medical Dictionary SNOMED 2019-09-01	[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "INTMODEL" (Intervention Model)	Intervention Model	text		8	Intervention Model Response • "PARALLEL" = "Parallel"	[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "INTTYPE" (Intervention Type)	Intervention Type	text		4	Intervention Type Response • "DRUG" = "Drug"	[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "TS_DURATION"	Trial Length	text		200		[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "OBJPRIM" (Trial Primary Objective)	Trial Primary Objective	text		200		[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "OBJSEC" (Trial Secondary Objective)	Trial Secondary Objective	text		200		[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "OUTMSPRI" (Primary Outcome Measure)	Primary Outcome Measure	text		200		[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "PCLAS" (Pharmacological Class of Investigational Therapy)	Pharmacologic Class	text		200		[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "TS_FLOAT"	Randomization Quotient	text		200		[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "REGID" (Clinical Trial Registry Identifier)	Registry Identifier	text		200		[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "ROUTE" (Route of Administration)	Route of Administration	text		12	Route of Administration, subset to be used for EC and EX • "SUBCUTANEOUS" = "Subcutaneous Route of Administration"	[Origin] Protocol (Source: Sponsor)
	TSPARMCD IN ( "SDTIGVER" (Study Data Tabulation Model Implementation Guide Version), "SDTMVER" (Study Data Tabulation Model Version) )	SDTM IG Version	float		2 [1]		[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "SEXPOP" (Sex of Study Group)	Sex of Participants	text		1	Sex Male Female • "F" = "Female" • "M" = "Male"	[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "SPONSOR" (Clinical Study Sponsor)	Clinical Study Sponsor	text		200		[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "STOPRULE" (Study Stop Rule)	Study Stop Rules	text		200		[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "STYPE" (Study Type)	Study Type	text		14	Study Type Response • "INTERVENTIONAL" = "Interventional"	[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "TBLIND" (Trial Blinding Schema)	Trial Blinding Schema	text		12	Trial Blinding Schema Response • "DOUBLE BLIND" = "Double Blind"	[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "TCNTRL" (Control Type)	Control Type	text		7	Control Type Response • "PLACEBO" = "Placebo"	[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "TDIGRP" (Diagnosis Group)	Diagnosis Group	text		200	Trial Summary Medical Dictionary SNOMED 2019-09-01	[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "TINDTP" (Clinical Study by Intent)	Trial Intent Type	text		9	Trial Intent Type Response • "TREATMENT" = "Treatment"	[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "TITLE" (Trial Title)	Trial Title	text		200		[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "TPHASE" (Trial Phase)	Trial Phase Classification	text		14	Trial Phase Response • "PHASE II TRIAL" = "Phase II Trial"	[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "TRT" (Protocol Agent)	Investigational Therapy or Treatment	text		200		[Origin] Protocol (Source: Sponsor)
	TSPARMCD = "TTYPE" (Trial Type)	Trial Type	text		15	Trial Type Response • "EFFICACY" = "Efficacy" • "PHARMACOKINETIC" = "Pharmacokinetic" • "SAFETY" = "Safety"	[Origin] Protocol (Source: Sponsor)
TSVALNF		Parameter Null Flavor	text	Result Qualifier	4	Null Flavors ISO 21090 NullFlavor 2017	[Origin] Assigned (Source: Sponsor)
TSVALCD		Parameter Value Code	text	Result Qualifier	200		[Origin] Assigned (Source: Sponsor)
TSVCDREF		Name of the Reference Terminology	text	Result Qualifier	200		[Origin] Assigned (Source: Sponsor)
TSVCDVER		Version of the Reference Terminology	text	Result Qualifier	200		[Origin] Assigned (Source: Sponsor)

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Trial Visits (TV)

TV (Trial Visits) - [STDTMIG 3.3]Location: tv.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN	Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Trial Visits • "TV" = "Trial Visits"	[Origin] Assigned (Source: Sponsor)
VISITNUM	Visit Number	float	Topic	8 [2]		[Origin] Assigned (Source: Sponsor)
VISIT	Visit Name	text	Synonym Qualifier	200		[Origin] Protocol (Source: Sponsor)
ARMCD	Planned Arm Code	text	Record Qualifier	8	Arm Code • "PLACEBO" = "Placebo" • "ZAN_LOW" = "Zanomaline Low Dose (54 mg)" • "ZAN_HIGH" = "Zanomaline High Dose (81 mg)"	[Origin] Assigned (Source: Sponsor)
TVSTRL	Visit Start Rule	text	Rule	200		[Origin] Protocol (Source: Sponsor)
TVENRL	Visit End Rule	text	Rule	200		[Origin] Protocol (Source: Sponsor)

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Demographics (DM)

DM (Demographics) - [STDTMIG 3.3]Location: dm.xml
Variable	Where Condition	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPDM (Supplemental Qualifiers for DM)
STUDYID		Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN		Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Demographics • "DM" = "Demographics"	[Origin] Assigned (Source: Sponsor)
USUBJID		Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
SUBJID		Subject Identifier for the Study	text	Topic	4		[Origin] Assigned (Source: Sponsor)
RFSTDTC		Subject Reference Start Date/Time	date	Record Qualifier		ISO 8601	[Origin] Derived (Source: Sponsor) [Method]The first date/time of study drug. Null for screen failures.
RFENDTC		Subject Reference End Date/Time	date	Record Qualifier		ISO 8601	[Origin] Derived (Source: Sponsor) [Method]The Date of Study Completion or Early Termination. Null for screen failures.
RFXSTDTC		Date/Time of First Study Treatment	date	Record Qualifier		ISO 8601	[Origin] Derived (Source: Sponsor) [Method]The first date/time of study drug administration. Null for subjects with no treatment data.
RFXENDTC		Date/Time of Last Study Treatment	date	Record Qualifier		ISO 8601	[Origin] Derived (Source: Sponsor) [Method]The last date/time of study drug administration. Null for subjects with no treatment data.
RFICDTC		Date/Time of Informed Consent	date	Record Qualifier		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [5 ]
RFPENDTC		Date/Time of End of Participation	date	Record Qualifier		ISO 8601	[Origin] Derived (Source: Sponsor) [Method]The latest date of assessment for the subject as determined by the End of Study Form, any scheduled assessments, Adverse Events, or Concomitant Medications.
DTHDTC		Date/Time of Death	date	Record Qualifier		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [26 ]
DTHFL		Subject Death Flag	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or null values • "Y" = "Yes"	[Origin] Derived (Source: Sponsor) [Method]If DTHDTC is populated then DTHFL='Y'
SITEID		Study Site Identifier	text	Record Qualifier	3	Site Identifier [6 Terms]	[Origin] Assigned (Source: Sponsor)
BRTHDTC		Date/Time of Birth	date	Record Qualifier		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [5 ]
AGE		Age	integer	Record Qualifier	8		[Origin] Collected (Source: Investigator) Annotated CRF [5 ]
AGEU		Age Units	text	Variable Qualifier	5	Age Unit in Years • "YEARS" = "Years"	[Origin] Assigned (Source: Sponsor)
SEX		Sex	text	Record Qualifier	1	Sex Male Female • "F" = "Female" • "M" = "Male"	[Origin] Collected (Source: Investigator) Annotated CRF [5 ]
RACEVLM		Race	text	Record Qualifier	41
	RACE ≠ "MULTIPLE"	Race	text		41	Race • "AMERICAN INDIAN OR ALASKA NATIVE" = "American Indian Or Alaska Native" • "ASIAN" = "Asian" • "BLACK OR AFRICAN AMERICAN" = "Black Or African American" • "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "Native Hawaiian Or Other Pacific Islander" • "WHITE" = "White"	[Origin] Collected (Source: Investigator) Annotated CRF [5 ]
	RACE = "MULTIPLE"	Race	text		8	Race Multiple Selections • "MULTIPLE" = "Multiple"	[Origin] Assigned (Source: Sponsor) Annotated CRF [5 ]
ETHNIC		Ethnicity	text	Record Qualifier	22	Ethnic Group Hispanic • "HISPANIC OR LATINO" = "Hispanic or Latino" • "NOT HISPANIC OR LATINO" = "Not Hispanic or Latino"	[Origin] Collected (Source: Investigator) Annotated CRF [5 ]
ARMCD		Planned Arm Code	text	Record Qualifier	8	Arm Code • "PLACEBO" = "Placebo" • "ZAN_LOW" = "Zanomaline Low Dose (54 mg)" • "ZAN_HIGH" = "Zanomaline High Dose (81 mg)"	[Origin] Assigned (Source: Sponsor)
ARM		Description of Planned Arm	text	Synonym Qualifier	28	Arm • "Placebo" • "Zanomaline Low Dose (54 mg)" • "Zanomaline High Dose (81 mg)"	[Origin] Assigned (Source: Sponsor)
ACTARMCD		Actual Arm Code	text	Record Qualifier	8	Arm Code • "PLACEBO" = "Placebo" • "ZAN_LOW" = "Zanomaline Low Dose (54 mg)" • "ZAN_HIGH" = "Zanomaline High Dose (81 mg)"	[Origin] Assigned (Source: Sponsor)
ACTARM		Description of Actual Arm	text	Synonym Qualifier	28	Arm • "Placebo" • "Zanomaline Low Dose (54 mg)" • "Zanomaline High Dose (81 mg)"	[Origin] Assigned (Source: Sponsor)
ARMNRS		Reason Arm and/or Actual Arm is Null	text	Record Qualifier	14	Arm Null Reason • "SCREEN FAILURE" = "Trial Screen Failure"	[Origin] Assigned (Source: Sponsor)
ACTARMUD		Description of Unplanned Actual Arm	text	Record Qualifier	200		[Origin] Assigned (Source: Sponsor)
COUNTRY		Country	text	Record Qualifier	3	Country Codes ISO 3166-1 Alpha-3 2013-11-15	[Origin] Assigned (Source: Sponsor)

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Subject Elements (SE)

SE (Subject Elements) - [STDTMIG 3.3]Location: se.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN	Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Subject Element • "SE" = "Subject Elements"	[Origin] Assigned (Source: Sponsor)
USUBJID	Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
SESEQ	Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
ETCD	Element Code	text	Topic	7	Element Code • "HIGH" = "Zanomaline 81 mg" • "LOW" = "Zanomaline 54 mg" • "PLACEBO" = "Placebo" • "SCREEN" = "Screening" • "TITRATE" = "Zanomaline 54 mg Titration"	[Origin] Assigned (Source: Sponsor)
ELEMENT	Description of Element	text	Synonym Qualifier	26	Element • "Screening" • "Placebo" • "Zanomaline 54 mg" • "Zanomaline 54 mg Titration" • "Zanomaline 81 mg"	[Origin] Protocol (Source: Sponsor)
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Derived (Source: Sponsor) [Method]EPOCH from SE where date >= SESTDTC and date < SEENDTC
SESTDTC	Start Date/Time of Element	date	Timing		ISO 8601	[Origin] Derived (Source: Sponsor) [Method]SESTDTC if set to the --DTC for that subject which exists in the data for the defined start of the Element, such as DSSTDTC when DSDECOD=INFORMED CONSENT OBTAINED for Screening Elements or min(EXSTDTC) for Dosing Elements.
SEENDTC	End Date/Time of Element	date	Timing		ISO 8601	[Origin] Derived (Source: Sponsor) [Method]SEENDTC is set to the start of the next Element, or RFPENDTC for the last Element.
SESTDY	Study Day of Start of Element	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.
SEENDY	Study Day of End of Element	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.

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Subject Visits (SV)

SV (Subject Visits) - [STDTMIG 3.3]Location: sv.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN	Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Subject Visits • "SV" = "Subject Visits"	[Origin] Assigned (Source: Sponsor)
USUBJID	Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
VISITNUM	Visit Number	float	Topic	8 [2]		[Origin] Assigned (Source: Sponsor)
VISIT	Visit Name	text	Synonym Qualifier	200		[Origin] Assigned (Source: Sponsor)
SVSTDTC	Start Date/Time of Visit	date	Timing		ISO 8601	[Origin] Derived (Source: Sponsor) [Method]For each scheduled visit, SVSTDTC = the first (min) date associated with a subject for that visit. For unplanned visits, SVSTDTC is the date of the visit.
SVENDTC	End Date/Time of Visit	date	Timing		ISO 8601	[Origin] Derived (Source: Sponsor) [Method]For each scheduled visit, SVENDTC = the last (max) date associated with a subject for that visit. For unplanned visits, SVENDTC is the date of the visit.
SVSTDY	Study Day of Start of Visit	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.
SVENDY	Study Day of End of Visit	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.
SVUPDES	Description of Unplanned Visit	text	Synonym Qualifier	200		[Origin] Assigned (Source: Sponsor)

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Concomitant Medications (CM)

CM (Concomitant Medications) - [STDTMIG 3.3]Location: cm.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN	Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Concomitant Meds • "CM" = "Concomitant/Prior Medications"	[Origin] Assigned (Source: Sponsor)
USUBJID	Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
CMSEQ	Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
CMTRT	Reported Name of Drug, Med, or Therapy	text	Topic	200		[Origin] Collected (Source: Investigator) Annotated CRF [25 ]
CMINDC	Indication	text	Record Qualifier	200		[Origin] Collected (Source: Investigator) Annotated CRF [25 ] [Comment] If the CM is not taken for a 'Primary Study Condition' then CMINDC would be 'Prophylaxis or Non-therapeutic use'
CMDOSE	Dose per Administration	float	Record Qualifier	5 [3]		[Origin] Collected (Source: Investigator) Annotated CRF [25 ]
CMDOSU	Dose Units	text	Variable Qualifier	6	Unit, subset to be used for CMDOSU • "mg" = "Milligram" • "ng" = "Nanogram" • "TABLET" = "Tablet"	[Origin] Collected (Source: Investigator) Annotated CRF [25 ]
CMDOSFRQ	Dosing Frequency per Interval	text	Variable Qualifier	3	Frequency, subset used for CM [6 Terms]	[Origin] Collected (Source: Investigator) Annotated CRF [25 ]
CMROUTE	Route of Administration	text	Variable Qualifier	24	Route of Administration, subset to be used for CM [6 Terms]	[Origin] Collected (Source: Investigator) Annotated CRF [25 ]
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Derived (Source: Sponsor) [Method]EPOCH from SE where date >= SESTDTC and date < SEENDTC
CMSTDTC	Start Date/Time of Medication	partialDate	Timing		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [25 ]
CMENDTC	End Date/Time of Medication	partialDate	Timing		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [25 ]
CMSTDY	Study Day of Start of Medication	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.
CMENDY	Study Day of End of Medication	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.
CMENRTPT	End Relative to Reference Time Point	text	Timing	7	Relation to Reference Period, subset used for AE and CM. • "ONGOING" = "Ongoing"	[Origin] Collected (Source: Investigator) Annotated CRF [25 ]
CMENTPT	End Reference Time Point	date	Timing		ISO 8601	[Origin] Derived (Source: Sponsor) [Method]If CMENRTPT is populated, CMENTPT is DM.RFPENDTC for the subject.

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Exposure as Collected (EC)

EC (Exposure as Collected) - [STDTMIG 3.3]Location: ec.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPEC (Supplemental Qualifiers for EC)
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN	Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Exposure as Collected • "EC" = "Exposure as Collected"	[Origin] Assigned (Source: Sponsor)
USUBJID	Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
SPDEVID	Sponsor Device Identifier	text	Identifier	200		[Origin] Assigned (Source: Sponsor)
ECSEQ	Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
ECTRT	Name of Treatment	text	Topic	10	Study Treatment • "PLACEBO" = "Placebo" • "ZANOMALINE" = "Zanomaline"	[Origin] Assigned (Source: Sponsor)
ECPRESP	Pre-Specified	text	Variable Qualifier	1	No Yes Response, subset for variables with only "Y" or "N" val • "N" = "No" • "Y" = "Yes"	[Origin] Assigned (Source: Sponsor)
ECOCCUR	Occurrence	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or "N" val • "N" = "No" • "Y" = "Yes"	[Origin] Collected (Source: Investigator) Annotated CRF [14 ]
ECDOSE	Dose	integer	Record Qualifier	8		[Origin] Assigned (Source: Investigator) Annotated CRF [14 ]
ECDOSU	Dose Units	text	Variable Qualifier	2	Unit, subset to be used for ECDOSU • "mL" = "Milliliter"	[Origin] Assigned (Source: Investigator) Annotated CRF [14 ]
ECDOSFRM	Dose Form	text	Variable Qualifier	9	Dose Form, subset used for EC and EX • "INJECTION" = "Injectable Dosage Form"	[Origin] Assigned (Source: Sponsor)
ECDOSFRQ	Dosing Frequency per Interval	text	Variable Qualifier	2	Frequency, subset used for EC and EX • "QD" = "Daily"	[Origin] Assigned (Source: Sponsor)
ECROUTE	Route of Administration	text	Variable Qualifier	12	Route of Administration, subset to be used for EC and EX • "SUBCUTANEOUS" = "Subcutaneous Route of Administration"	[Origin] Assigned (Source: Sponsor)
ECLOT	Lot Number	text	Record Qualifier	200		[Origin] Collected (Source: Investigator) Annotated CRF [14 ]
ECPSTRG	Pharmaceutical Strength	float	Record Qualifier	4 [1]		[Origin] Assigned (Source: Sponsor)
ECPSTRGU	Pharmaceutical Strength Units	text	Variable Qualifier	3	Unit, subset to be used for ECPSTRGU • "g/L" = "Gram per Liter"	[Origin] Assigned (Source: Sponsor)
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Derived (Source: Sponsor) [Method]EPOCH from SE where date >= SESTDTC and date < SEENDTC
ECSTDTC	Start Date/Time of Treatment	date	Timing		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [14 ]
ECENDTC	End Date/Time of Treatment	date	Timing		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [14 ]
ECSTDY	Study Day of Start of Treatment	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.
ECENDY	Study Day of End of Treatment	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.

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Exposure (EX)

EX (Exposure) - [STDTMIG 3.3]Location: ex.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN	Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Exposure • "EX" = "Exposure"	[Origin] Assigned (Source: Sponsor)
USUBJID	Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
SPDEVID	Sponsor Device Identifier	text	Identifier	200		[Origin] Predecessor: EC.SPDEVID
EXSEQ	Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
EXTRT	Name of Treatment	text	Topic	10	Study Treatment • "PLACEBO" = "Placebo" • "ZANOMALINE" = "Zanomaline"	[Origin] Predecessor: ECTRT
EXDOSE	Dose	integer	Record Qualifier	8		[Origin] Derived (Source: Sponsor) [Method]EXDOSE = ECDOSE * ECPSTRG expressed in mg.
EXDOSU	Dose Units	text	Variable Qualifier	2	Unit, subset to be used for EXDOSU • "mg" = "Milligram"	[Origin] Protocol (Source: Sponsor)
EXDOSFRM	Dose Form	text	Variable Qualifier	9	Dose Form, subset used for EC and EX • "INJECTION" = "Injectable Dosage Form"	[Origin] Predecessor: ECDOSFRM
EXDOSFRQ	Dosing Frequency per Interval	text	Variable Qualifier	2	Frequency, subset used for EC and EX • "QD" = "Daily"	[Origin] Predecessor: ECDOSFRQ
EXROUTE	Route of Administration	text	Variable Qualifier	12	Route of Administration, subset to be used for EC and EX • "SUBCUTANEOUS" = "Subcutaneous Route of Administration"	[Origin] Predecessor: ECROUTE
EXLOT	Lot Number	text	Record Qualifier	200		[Origin] Predecessor: ECLOT
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Predecessor: EC.EPOCH
EXSTDTC	Start Date/Time of Treatment	date	Timing		ISO 8601	[Origin] Predecessor: ECSTDTC
EXENDTC	End Date/Time of Treatment	date	Timing		ISO 8601	[Origin] Predecessor: ECENDTC
EXSTDY	Study Day of Start of Treatment	integer	Timing	8		[Origin] Predecessor: ECSTDY
EXENDY	Study Day of End of Treatment	integer	Timing	8		[Origin] Predecessor: ECENDY

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Adverse Events (AE)

AE (Adverse Events) - [STDTMIG 3.3]Location: ae.xml
Variable	Where Condition	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN		Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Adverse Events • "AE" = "Adverse Events"	[Origin] Assigned (Source: Sponsor)
USUBJID		Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
AESEQ		Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
AELNKID		Link ID	text	Identifier	50		[Origin] Collected (Source: Investigator) Annotated CRF [22 23 ]
AETERMVLM		Reported Term for the Adverse Event	text	Topic	200
	AETERM = "INJECTION SITE REACTION"	Reported Term for the Adverse Event	text		200		[Origin] Assigned (Source: Sponsor) Annotated CRF [23 ] [Comment] Even though the variable is 'Assigned' an annotation has been added to page 23 to clarify the assignment.
	AETERM ≠ "INJECTION SITE REACTION"	Reported Term for the Adverse Event	text		200		[Origin] Collected (Source: Investigator) Annotated CRF [22 ]
AELLT[No Data]		Lowest Level Term	text	Variable Qualifier	1	Adverse Events Dictionary MedDRA 22.0	[Origin] Assigned (Source: Sponsor) [Comment] Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.
AELLTCD[No Data]		Lowest Level Term Code	text	Variable Qualifier	1	Adverse Events Dictionary MedDRA 22.0	[Origin] Assigned (Source: Sponsor) [Comment] Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.
AEDECOD[No Data]		Dictionary-Derived Term	text	Synonym Qualifier	1	Adverse Events Dictionary MedDRA 22.0	[Origin] Assigned (Source: Sponsor) [Comment] Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required. Note CDISC Conformance Rule CG0014 would fire for this variable due to the decision not to populate coding variables.
AEPTCD[No Data]		Preferred Term Code	text	Variable Qualifier	1	Adverse Events Dictionary MedDRA 22.0	[Origin] Assigned (Source: Sponsor) [Comment] Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.
AEHLT[No Data]		High Level Term	text	Variable Qualifier	1	Adverse Events Dictionary MedDRA 22.0	[Origin] Assigned (Source: Sponsor) [Comment] Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.
AEHLTCD[No Data]		High Level Term Code	text	Variable Qualifier	1	Adverse Events Dictionary MedDRA 22.0	[Origin] Assigned (Source: Sponsor) [Comment] Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.
AEHLGT[No Data]		High Level Group Term	text	Variable Qualifier	1	Adverse Events Dictionary MedDRA 22.0	[Origin] Assigned (Source: Sponsor) [Comment] Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.
AEHLGTCD[No Data]		High Level Group Term Code	text	Variable Qualifier	1	Adverse Events Dictionary MedDRA 22.0	[Origin] Assigned (Source: Sponsor) [Comment] Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.
AEBODSYS[No Data]		Body System or Organ Class	text	Record Qualifier	1	Adverse Events Dictionary MedDRA 22.0	[Origin] Assigned (Source: Sponsor) [Comment] Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.
AEBDSYCD[No Data]		Body System or Organ Class Code	text	Variable Qualifier	1	Adverse Events Dictionary MedDRA 22.0	[Origin] Assigned (Source: Sponsor) [Comment] Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.
AESOC[No Data]		Primary System Organ Class	text	Variable Qualifier	1	Adverse Events Dictionary MedDRA 22.0	[Origin] Assigned (Source: Sponsor) [Comment] Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.
AESOCCD[No Data]		Primary System Organ Class Code	text	Variable Qualifier	1	Adverse Events Dictionary MedDRA 22.0	[Origin] Assigned (Source: Sponsor) [Comment] Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.
AESEV		Severity/Intensity	text	Record Qualifier	8	Severity/Intensity Scale for Adverse Events • "MILD" = "Mild" • "MODERATE" = "Moderate" • "SEVERE" = "Severe"	[Origin] Collected (Source: Investigator) Annotated CRF [22 23 ]
AESER		Serious Event	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or "N" val • "N" = "No" • "Y" = "Yes"	[Origin] Collected (Source: Investigator) Annotated CRF [22 23 ] [Comment] Subject CDISC003 had an AE of Epistaxis on 2013-09-30 with AESER set to 'Y' without any of the individual serious qualifiers set to 'Y' also. The site was queried several times but the data were not updated. Note Conformance Rule CG0041 would fire for this subject.
AEACN		Action Taken with Study Treatment	text	Record Qualifier	16	Action Taken with Study Treatment [7 Terms]	[Origin] Collected (Source: Investigator) Annotated CRF [22 23 ]
AEREL		Causality	text	Record Qualifier	16	Relationship • "RELATED" = "Related" • "UNLIKELY RELATED" = "Unlikely Related" • "POSSIBLY RELATED" = "Possibly Related" • "NOT RELATED" = "Not Related"	[Origin] Collected (Source: Investigator) Annotated CRF [22 23 ]
AEOUT		Outcome of Adverse Event	text	Record Qualifier	32	Outcome of Event [6 Terms]	[Origin] Collected (Source: Investigator) Annotated CRF [22 23 ]
AESCAN		Involves Cancer	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or "N" val • "N" = "No" • "Y" = "Yes"	[Origin] Collected (Source: Investigator) Annotated CRF [22 23 ]
AESCONG		Congenital Anomaly or Birth Defect	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or "N" val • "N" = "No" • "Y" = "Yes"	[Origin] Collected (Source: Investigator) Annotated CRF [22 23 ]
AESDISAB		Persist or Signif Disability/Incapacity	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or "N" val • "N" = "No" • "Y" = "Yes"	[Origin] Collected (Source: Investigator) Annotated CRF [22 23 ]
AESDTH		Results in Death	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or "N" val • "N" = "No" • "Y" = "Yes"	[Origin] Collected (Source: Investigator) Annotated CRF [22 23 ]
AESHOSP		Requires or Prolongs Hospitalization	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or "N" val • "N" = "No" • "Y" = "Yes"	[Origin] Collected (Source: Investigator) Annotated CRF [22 23 ]
AESLIFE		Is Life Threatening	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or "N" val • "N" = "No" • "Y" = "Yes"	[Origin] Collected (Source: Investigator) Annotated CRF [22 23 ]
AESOD		Occurred with Overdose	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or "N" val • "N" = "No" • "Y" = "Yes"	[Origin] Collected (Source: Investigator) Annotated CRF [22 23 ]
EPOCH		Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Derived (Source: Sponsor) [Method]EPOCH from SE where date >= SESTDTC and date < SEENDTC
AESTDTC		Start Date/Time of Adverse Event	date	Timing		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [22 23 ]
AEENDTC		End Date/Time of Adverse Event	date	Timing		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [22 23 ]
AESTDY		Study Day of Start of Adverse Event	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.
AEENDY		Study Day of End of Adverse Event	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.
AEENRTPT		End Relative to Reference Time Point	text	Timing	7	Relation to Reference Period, subset used for AE and CM. • "ONGOING" = "Ongoing"	[Origin] Collected (Source: Investigator) Annotated CRF [22 23 ]
AEENTPT		End Reference Time Point	date	Timing		ISO 8601	[Origin] Derived (Source: Sponsor) [Method]If AEENRTPT is populated, AEENTPT is DM.RFPENDTC for the subject.

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Disposition (DS)

DS (Disposition) - [STDTMIG 3.3]Location: ds.xml
Variable	Where Condition	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN		Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Disposition • "DS" = "Disposition"	[Origin] Assigned (Source: Sponsor)
USUBJID		Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
DSSEQ		Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
DSLNKID		Link ID	text	Identifier	50		[Origin] Collected (Source: Investigator) Annotated CRF [27 28 ]
DSTERMVLM		Reported Term for the Disposition Event	text	Topic	200
	DSSCAT ≠ ""	Reported Term for the Disposition Event	text		200		[Origin] Collected (Source: Investigator) Annotated CRF [27 28 ]
	DSSCAT = ""	Reported Term for the Disposition Event	text		200		[Origin] Assigned (Source: Sponsor) Annotated CRF [5 ]
DSDECODVLM		Standardized Disposition Term	text	Synonym Qualifier	29
	DSSCAT ≠ ""	Standardized Disposition Term	text		29	Completion/Reason for Non-Completion [13 Terms]	[Origin] Collected (Source: Investigator) Annotated CRF [27 28 ]
	DSSCAT = ""	Standardized Disposition Term	text		29	Protocol Milestone • "INFORMED CONSENT OBTAINED" = "Informed Consent"	[Origin] Assigned (Source: Sponsor) Annotated CRF [5 ]
DSCAT		Category for Disposition Event	text	Grouping Qualifier	18	Category for Disposition Event • "DISPOSITION EVENT" = "Disposition Event" • "PROTOCOL MILESTONE" = "Protocol Milestone"	[Origin] Assigned (Source: Sponsor) Annotated CRF [5 27 28 ] [Comment] Variable is Assigned but there are annotations to help understand the data and so references to the proper pages are included
DSSCAT		Subcategory for Disposition Event	text	Grouping Qualifier	19	Subcategory for Disposition Event • "STUDY TREATMENT" = "Study Treatment" • "STUDY PARTICIPATION" = "Study Participation"	[Origin] Assigned (Source: Sponsor) Annotated CRF [27 28 ] [Comment] Variable is Assigned but there are annotations to help understand the data and so references to the proper pages are included
EPOCH		Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Derived (Source: Sponsor) [Method]EPOCH from SE where date >= SESTDTC and date < SEENDTC
DSSTDTC		Start Date/Time of Disposition Event	date	Timing		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [5 27 28 ]
DSSTDY		Study Day of Start of Disposition Event	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.

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Medical History (MH)

MH (Medical History) - [STDTMIG 3.3]Location: mh.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN	Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Medical History • "MH" = "Medical History"	[Origin] Assigned (Source: Sponsor)
USUBJID	Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
MHSEQ	Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
MHTERM	Reported Term for the Medical History	text	Topic	19	Medical History Term • "ALZHEIMER'S DISEASE" = "Alzheimer's Disease"	[Origin] Assigned (Source: Sponsor)
MHEVDTYP	Medical History Event Date Type	text	Variable Qualifier	13	Medical History Event Date Type, subset used for MHEVDTP • "SYMPTOM ONSET" = "Symptom Onset"	[Origin] Assigned (Source: Sponsor) Annotated CRF [7 ]
MHSTDTC	Start Date/Time of Medical History Event	date	Timing		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [7 ]
MHSTDY	Study Day of Start of Observation	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.

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Death Details (DD)

DD (Death Details) - [STDTMIG 3.3]Location: dd.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	12		[Origin] Assigned (Source: Sponsor)
DOMAIN	Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Death Diagnosis • "DD" = "Death Details"	[Origin] Assigned (Source: Sponsor)
USUBJID	Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
DDSEQ	Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
DDLNKID	Link ID	text	Identifier	50		[Origin] Collected (Source: Investigator) Annotated CRF [26 ]
DDTESTCD	Death Detail Assessment Short Name	text	Topic	6	Death Details Test Codes • "PRCDTH" = "Primary Cause of Death"	[Origin] Assigned (Source: Sponsor)
DDTEST	Death Detail Assessment Name	text	Synonym Qualifier	22	Death Details Tests • "Primary Cause of Death"	[Origin] Assigned (Source: Sponsor)
DDORRES	Result or Finding as Collected	text	Result Qualifier	200		[Origin] Collected (Source: Investigator) Annotated CRF [26 ]
DDSTRESC	Character Result/Finding in Std Format	text	Result Qualifier	200		[Origin] Predecessor: DDORRES
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Derived (Source: Sponsor) [Method]EPOCH from SE where date >= SESTDTC and date < SEENDTC
DDDTC	Date/Time of Collection	date	Timing		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [26 ]
DDDY	Study Day of Collection	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.

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Functional Tests (FT)

FT (Functional Tests) - [STDTMIG 3.3]Location: ft.xml
Variable	Where Condition	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN		Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Functional Tests • "FT" = "Functional Tests"	[Origin] Assigned (Source: Sponsor)
USUBJID		Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
FTSEQ		Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
FTTESTCD		Short Name of Test	text	Topic	7	Rey Auditory Verbal Learning Test Functional Test Code [34 Terms]	[Origin] Assigned (Source: Sponsor)
FTTEST		Name of Test	text	Synonym Qualifier	23	Rey Auditory Verbal Learning Test Functional Test Name [34 Terms]	[Origin] Assigned (Source: Sponsor)
FTCAT		Category	text	Grouping Qualifier	8	Category of Functional Test, subset used for FTCAT • "AVLT-REY" = "Rey Auditory Verbal Learning Functional Test"	[Origin] Assigned (Source: Sponsor) Annotated CRF [17 ]
FTSCAT		Subcategory	text	Grouping Qualifier	200		[Origin] Assigned (Source: Sponsor) Annotated CRF [17 ]
FTORRESVLM		Result or Finding in Original Units	text	Result Qualifier	12
	FTTESTCD IN ( "AVL0201" (AVLT-REY - List A Word 1), "AVL0202" (AVLT-REY - List A Word 2), "AVL0203" (AVLT-REY - List A Word 3), "AVL0204" (AVLT-REY - List A Word 4), "AVL0205" (AVLT-REY - List A Word 5), "AVL0206" (AVLT-REY - List A Word 6), "AVL0207" (AVLT-REY - List A Word 7), "AVL0208" (AVLT-REY - List A Word 8), "AVL0209" (AVLT-REY - List A Word 9), "AVL0210" (AVLT-REY - List A Word 10), "AVL0211" (AVLT-REY - List A Word 11), "AVL0212" (AVLT-REY - List A Word 12), "AVL0213" (AVLT-REY - List A Word 13), "AVL0214" (AVLT-REY - List A Word 14), "AVL0215" (AVLT-REY - List A Word 15) )	AVLT-REY List A Item 1-15	text		12	Rey Auditory Verbal Learning Test Functional Test Response • "RECALLED" = "Recalled" • "NOT RECALLED" = "Not Recalled"	[Origin] Collected (Source: Investigator) Annotated CRF [17 18 ]
	FTTESTCD IN ( "AVL0216" (AVLT-REY - List A Total), "AVL0217" (AVLT-REY - List A Intrusions) )	AVLT-REY List A Item 16-17	integer		8		[Origin] Collected (Source: Investigator) Annotated CRF [17 18 ]
	FTTESTCD IN ( "AVL0218" (AVLT-REY - List B Word 1), "AVL0219" (AVLT-REY - List B Word 2), "AVL0220" (AVLT-REY - List B Word 3), "AVL0221" (AVLT-REY - List B Word 4), "AVL0222" (AVLT-REY - List B Word 5), "AVL0223" (AVLT-REY - List B Word 6), "AVL0224" (AVLT-REY - List B Word 7), "AVL0225" (AVLT-REY - List B Word 8), "AVL0226" (AVLT-REY - List B Word 9), "AVL0227" (AVLT-REY - List B Word 10), "AVL0228" (AVLT-REY - List B Word 11), "AVL0229" (AVLT-REY - List B Word 12), "AVL0230" (AVLT-REY - List B Word 13), "AVL0231" (AVLT-REY - List B Word 14), "AVL0232" (AVLT-REY - List B Word 15) )	AVLT-REY List B Item 18-32	text		12	Rey Auditory Verbal Learning Test Functional Test Response • "RECALLED" = "Recalled" • "NOT RECALLED" = "Not Recalled"	[Origin] Collected (Source: Investigator) Annotated CRF [17 ]
	FTTESTCD IN ( "AVL0233" (AVLT-REY - List B Total), "AVL0234" (AVLT-REY - List B Intrusions) )	AVLT-REY List B Item 33-34	integer		8		[Origin] Collected (Source: Investigator) Annotated CRF [17 ]
FTSTRESC		Result or Finding in Standard Format	text	Result Qualifier	200		[Origin] Predecessor: FTORRES
FTSTRESN		Numeric Result/Finding in Standard Units	integer	Result Qualifier	8		[Origin] Derived (Source: Sponsor) [Method]If FTSTRESC is numeric then FTSTRESN=FTSTRESC in numeric format, else null.
FTLOBXFL		Last Observation Before Exposure Flag	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or null values • "Y" = "Yes"	[Origin] Derived (Source: Sponsor) [Method]Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise.
FTREPNUM		Repetition Number	integer	Record Qualifier	8		[Origin] Assigned (Source: Sponsor) Annotated CRF [17 18 ]
VISITNUM		Visit Number	float	Timing	8 [2]		[Origin] Assigned (Source: Sponsor)
VISIT		Visit Name	text	Timing	200		[Origin] Assigned (Source: Sponsor)
EPOCH		Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Derived (Source: Sponsor) [Method]EPOCH from SE where date >= SESTDTC and date < SEENDTC
FTDTC		Date/Time of Test	partialDatetime	Timing		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [17 18 ] [Comment] DataType is 'partialDatetime' instead of 'datetime' since datetime values are planned to be collected without seconds for this study.
FTDY		Study Day of Test	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.
FTTPT		Planned Time Point Name	text	Timing	200		[Origin] Assigned (Source: Sponsor)
FTTPTNUM		Planned Time Point Number	integer	Timing	8		[Origin] Assigned (Source: Sponsor)
FTELTM		Planned Elapsed Time from Time Point Ref	text	Timing	200		[Origin] Assigned (Source: Sponsor) Annotated CRF [18 ]
FTTPTREF		Time Point Reference	text	Timing	200		[Origin] Assigned (Source: Sponsor)

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Inclusion/Exclusion Criteria Not Met (IE)

IE (Inclusion/Exclusion Criteria Not Met) - [STDTMIG 3.3]Location: ie.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN	Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Inclusion/Exclusion • "IE" = "Inclusion/Exclusion Criteria Not Met"	[Origin] Assigned (Source: Sponsor)
USUBJID	Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
IESEQ	Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
IETESTCD	Inclusion/Exclusion Criterion Short Name	text	Topic	7	Incl/Excl Criterion Short Name [33 Terms]	[Origin] Collected (Source: Investigator) Annotated CRF [6 ] [Comment] Please see Appendix 1 of the cSDRG for complete versions of IETESTCD and IETEST.
IETEST	Inclusion/Exclusion Criterion	text	Synonym Qualifier	196	Inclusion/Exclusion Criterion [33 Terms]	[Origin] Assigned (Source: Sponsor) [Comment] Please see Appendix 1 of the cSDRG for complete versions of IETESTCD and IETEST.
IECAT	Inclusion/Exclusion Category	text	Grouping Qualifier	9	Category for Inclusion/Exclusion • "EXCLUSION" = "Exclusion" • "INCLUSION" = "Inclusion"	[Origin] Collected (Source: Investigator) Annotated CRF [6 ]
IEORRES	I/E Criterion Original Result	text	Result Qualifier	1	No Yes Response, subset for variables with only "Y" or "N" val • "N" = "No" • "Y" = "Yes"	[Origin] Derived (Source: Sponsor) Annotated CRF [6 ] [Method]If IECAT=INCLUSION then IEORRES=N, else if IECAT=EXCLUSION then IEORRES=Y
IESTRESC	I/E Criterion Result in Std Format	text	Result Qualifier	1	No Yes Response, subset for variables with only "Y" or "N" val • "N" = "No" • "Y" = "Yes"	[Origin] Predecessor: IEORRES
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Derived (Source: Sponsor) [Method]EPOCH from SE where date >= SESTDTC and date < SEENDTC
IEDTC	Date/Time of Collection	date	Timing		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [6 ]
IEDY	Study Day of Collection	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC. [Comment] IEDY is needed if IEDTC is included. Note RFSTDTC is not populated for not randomized subjects then IEDY could not be populated in those cases.

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Laboratory Test Results (LB)

LB (Laboratory Test Results) - [STDTMIG 3.3]Location: lb.xml
Variable	Where Condition	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN		Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Laboratory Data • "LB" = "Laboratory Test Results"	[Origin] Assigned (Source: Sponsor)
USUBJID		Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
LBSEQ		Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Vendor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
LBTESTCD		Lab Test or Examination Short Name	text	Topic	7	Laboratory Test Code [40 Terms]	[Origin] Assigned (Source: Sponsor)
LBTEST		Lab Test or Examination Name	text	Synonym Qualifier	39	Laboratory Test Name [40 Terms]	[Origin] Assigned (Source: Sponsor)
LBCAT		Category for Lab Test	text	Grouping Qualifier	10	Laboratory Test Category • "CHEMISTRY" = "Chemistry" • "HEMATOLOGY" = "Hematology" • "URINALYSIS" = "Urinalysis" • "OTHER" = "Other"	[Origin] Collected (Source: Vendor)
LBORRESVLM		Result or Finding in Original Units	text	Result Qualifier	6		[Origin] Collected (Source: Vendor)
	LBTESTCD IN ( "ALB" (Albumin Measurement), "BILI" (Total Bilirubin Measurement), "CA" (Calcium Measurement), "CREAT" (Creatinine Measurement), "K" (Potassium Measurement), "PHOS" (Phosphate Measurement), "PROT" (Total Protein Measurement), "URATE" (Urate Measurement) )	Lab Result or Finding in Original Units - Set 1	float		3 [1]
	LBTESTCD IN ( "HCT" (Hematocrit Measurement), "HGB" (Hemoglobin Measurement) )	Lab Result or Finding in Original Units - Set 2	float		4 [1]
	LBTESTCD IN ( "BASO" (Total Basophil Count), "EOS" (Eosinophil Count), "LYM" (Lymphocyte Count), "MONO" (Monocyte Count), "RBC" (Erythrocyte Count), "TSH" (Thyrotropin Measurement), "WBC" (Leukocyte Count) )	Lab Result or Finding in Original Units - Set 3	float		5 [2]
	LBTESTCD = "SPGRAV" (Specific Gravity)	Lab Result or Finding in Original Units - Specific Gravity	float		5 [3]
	LBTESTCD IN ( "ANISO" (Anisocyte Measurement), "KETONES" (Ketone Measurement), "MACROCY" (Macrocyte Count), "PH" (pH), "POIKILO" (Poikilocyte Measurement), "UROBIL" (Urobilinogen Measurement) )	Lab Result or Finding in Original Units - Set 4	integer		1
	LBTESTCD IN ( "ALT" (Alanine Aminotransferase Measurement), "AST" (Aspartate Aminotransferase Measurement), "GGT" (Gamma Glutamyl Transpeptidase Measurement), "MCH" (Erythrocyte Mean Corpuscular Hemoglobin), "MCHC" (Erythrocyte Mean Corpuscular Hemoglobin Concentration), "MCV" (Erythrocyte Mean Corpuscular Volume), "UREAN" (Urea Nitrogen Measurement) )	Lab Result or Finding in Original Units - Set 5	integer		3
	LBTESTCD IN ( "ALP" (Alkaline Phosphatase Measurement), "CHOL" (Cholesterol Measurement), "CK" (Creatine Kinase Measurement), "CL" (Chloride Measurement), "PLAT" (Platelet Count), "SODIUM" (Sodium Measurement), "VITB12" (Vitamin B12 Measurement) )	Lab Result or Finding in Original Units - Set 6	integer		4
	LBTESTCD = "COLOR" (Color Assessment)	Lab Result or Finding in Original Units - Color	text		6
	LBTESTCD = "GLUC" (Glucose Measurement)	Lab Result or Finding in Original Units - Glucose	text		3
LBORRESUVLM		Original Units	text	Variable Qualifier	7		[Origin] Collected (Source: Vendor)
	LBTESTCD = "ALT" (Alanine Aminotransferase Measurement)	Lab Result Units - ALT	text		3	Unit, subset to be used in VLM for tests with U/L as the unit • "U/L" = "Unit per Liter"
	LBTESTCD = "ALB" (Albumin Measurement)	Lab Result Units - ALB	text		4	Unit, subset to be used in VLM for tests with g/dL as the unit • "g/dL" = "Gram per Deciliter"
	LBTESTCD = "ALP" (Alkaline Phosphatase Measurement)	Lab Result Units - ALP	text		3	Unit, subset to be used in VLM for tests with U/L as the unit • "U/L" = "Unit per Liter"
	LBTESTCD = "AST" (Aspartate Aminotransferase Measurement)	Lab Result Units - AST	text		3	Unit, subset to be used in VLM for tests with U/L as the unit • "U/L" = "Unit per Liter"
	LBTESTCD = "BASO" (Total Basophil Count)	Lab Result Units - BASO	text		6	Unit, subset to be used in VLM for tests with 10^9/L as the unit • "10^9/L" = "Billion per Liter"
	LBTESTCD = "BILI" (Total Bilirubin Measurement)	Lab Result Units - BILI	text		5	Unit, subset to be used in VLM for tests with mg/dL as the unit • "mg/dL" = "Milligram per Deciliter"
	LBTESTCD = "CA" (Calcium Measurement)	Lab Result Units - CA	text		5	Unit, subset to be used in VLM for tests with mg/dL as the unit • "mg/dL" = "Milligram per Deciliter"
	LBTESTCD = "CL" (Chloride Measurement)	Lab Result Units - CL	text		5	Unit, subset to be used in VLM for tests with mEq/L as the unit • "mEq/L" = "Milliequivalent Per Liter"
	LBTESTCD = "CHOL" (Cholesterol Measurement)	Lab Result Units - CHOL	text		5	Unit, subset to be used in VLM for tests with mg/dL as the unit • "mg/dL" = "Milligram per Deciliter"
	LBTESTCD = "CK" (Creatine Kinase Measurement)	Lab Result Units - CK	text		3	Unit, subset to be used in VLM for tests with U/L as the unit • "U/L" = "Unit per Liter"
	LBTESTCD = "CREAT" (Creatinine Measurement)	Lab Result Units - CREAT	text		5	Unit, subset to be used in VLM for tests with mg/dL as the unit • "mg/dL" = "Milligram per Deciliter"
	LBTESTCD = "EOS" (Eosinophil Count)	Lab Result Units - EOS	text		6	Unit, subset to be used in VLM for tests with 10^9/L as the unit • "10^9/L" = "Billion per Liter"
	LBTESTCD = "MCH" (Erythrocyte Mean Corpuscular Hemoglobin)	Lab Result Units - MCH	text		2	Unit, subset to be used in VLM for tests with pg as the unit • "pg" = "Picogram"
	LBTESTCD = "MCHC" (Erythrocyte Mean Corpuscular Hemoglobin Concentration)	Lab Result Units - MCHC	text		4	Unit, subset to be used in VLM for tests with g/dL as the unit • "g/dL" = "Gram per Deciliter"
	LBTESTCD = "MCV" (Erythrocyte Mean Corpuscular Volume)	Lab Result Units - MCV	text		2	Unit, subset to be used in VLM for tests with fL as the unit • "fL" = "Femtoliter"
	LBTESTCD = "RBC" (Erythrocyte Count)	Lab Result Units - RBC	text		7	Unit, subset to be used in VLM for tests with 10^12/L as the unit • "10^12/L" = "Million per Microliter"
	LBTESTCD = "GGT" (Gamma Glutamyl Transpeptidase Measurement)	Lab Result Units - GGT	text		3	Unit, subset to be used in VLM for tests with U/L as the unit • "U/L" = "Unit per Liter"
	LBTESTCD = "GLUC" (Glucose Measurement)	Lab Result Units - GLUC	text		5	Unit, subset to be used in VLM for tests with mg/dL as the unit • "mg/dL" = "Milligram per Deciliter"
	LBTESTCD = "HCT" (Hematocrit Measurement)	Lab Result Units - HCT	text		1	Unit, subset to be used in VLM for tests with % as the unit • "%" = "Percentage"
	LBTESTCD = "HGB" (Hemoglobin Measurement)	Lab Result Units - HGB	text		4	Unit, subset to be used in VLM for tests with g/dL as the unit • "g/dL" = "Gram per Deciliter"
	LBTESTCD = "WBC" (Leukocyte Count)	Lab Result Units - WBC	text		6	Unit, subset to be used in VLM for tests with 10^9/L as the unit • "10^9/L" = "Billion per Liter"
	LBTESTCD = "LYM" (Lymphocyte Count)	Lab Result Units - LYM	text		6	Unit, subset to be used in VLM for tests with 10^9/L as the unit • "10^9/L" = "Billion per Liter"
	LBTESTCD = "MONO" (Monocyte Count)	Lab Result Units - MONO	text		6	Unit, subset to be used in VLM for tests with 10^9/L as the unit • "10^9/L" = "Billion per Liter"
	LBTESTCD = "PHOS" (Phosphate Measurement)	Lab Result Units - PHOS	text		5	Unit, subset to be used in VLM for tests with mg/dL as the unit • "mg/dL" = "Milligram per Deciliter"
	LBTESTCD = "PLAT" (Platelet Count)	Lab Result Units - PLAT	text		6	Unit, subset to be used in VLM for tests with 10^9/L as the unit • "10^9/L" = "Billion per Liter"
	LBTESTCD = "K" (Potassium Measurement)	Lab Result Units - K	text		5	Unit, subset to be used in VLM for tests with mEq/L as the unit • "mEq/L" = "Milliequivalent Per Liter"
	LBTESTCD = "PROT" (Total Protein Measurement)	Lab Result Units - PROT	text		4	Unit, subset to be used in VLM for tests with g/dL as the unit • "g/dL" = "Gram per Deciliter"
	LBTESTCD = "SODIUM" (Sodium Measurement)	Lab Result Units - SODIUM	text		5	Unit, subset to be used in VLM for tests with mEq/L as the unit • "mEq/L" = "Milliequivalent Per Liter"
	LBTESTCD = "TSH" (Thyrotropin Measurement)	Lab Result Units - TSH	text		5	Unit, subset to be used in VLM for tests with mIU/L as the unit • "mIU/L" = "Microinternational Unit per Milliliter"
	LBTESTCD = "URATE" (Urate Measurement)	Lab Result Units - URATE	text		5	Unit, subset to be used in VLM for tests with mg/dL as the unit • "mg/dL" = "Milligram per Deciliter"
	LBTESTCD = "UREAN" (Urea Nitrogen Measurement)	Lab Result Units - UREAN	text		5	Unit, subset to be used in VLM for tests with mg/dL as the unit • "mg/dL" = "Milligram per Deciliter"
	LBTESTCD = "VITB12" (Vitamin B12 Measurement)	Lab Result Units - VITB12	text		4	Unit, subset to be used in VLM for tests with ng/L as the unit • "ng/L" = "Nanogram per Liter"
LBORNRLO		Reference Range Lower Limit in Orig Unit	text	Variable Qualifier	200		[Origin] Collected (Source: Vendor)
LBORNRHI		Reference Range Upper Limit in Orig Unit	text	Variable Qualifier	200		[Origin] Collected (Source: Vendor)
LBSTRESCVLM		Character Result/Finding in Std Format	text	Result Qualifier	8		[Origin] Derived (Source: Vendor) [Method]LBSTRESC is equal to LBORRES or the value in standard units if a conversion is necessary.
	LBTESTCD = "K" (Potassium Measurement)	Character Result/Finding in Std Format - K	float		2 [1]
	LBTESTCD = "RBC" (Erythrocyte Count)	Character Result/Finding in Std Format - RBC	float		3 [1]
	LBTESTCD IN ( "BASO" (Total Basophil Count), "EOS" (Eosinophil Count), "LYM" (Lymphocyte Count), "MONO" (Monocyte Count), "RBC" (Erythrocyte Count), "TSH" (Thyrotropin Measurement), "WBC" (Leukocyte Count) )	Character Result/Finding in Std Format - Set 1	float		3 [2]
	LBTESTCD = "BILI" (Total Bilirubin Measurement)	Character Result/Finding in Std Format - BILI	float		4 [2]
	LBTESTCD IN ( "SPGRAV" (Specific Gravity), "UREAN" (Urea Nitrogen Measurement) )	Character Result/Finding in Std Format - Set 2	float		4 [3]
	LBTESTCD = "CREAT" (Creatinine Measurement)	Character Result/Finding in Std Format - CREAT	float		5 [2]
	LBTESTCD = "URATE" (Urate Measurement)	Character Result/Finding in Std Format - URATE	float		6 [3]
	LBTESTCD = "MCHC" (Erythrocyte Mean Corpuscular Hemoglobin Concentration)	Character Result/Finding in Std Format - MCHC	float		6 [4]
	LBTESTCD IN ( "CA" (Calcium Measurement), "CHOL" (Cholesterol Measurement), "MCH" (Erythrocyte Mean Corpuscular Hemoglobin), "PHOS" (Phosphate Measurement) )	Character Result/Finding in Std Format - Set 3	float		6 [5]
	LBTESTCD = "VITB12" (Vitamin B12 Measurement)	Character Result/Finding in Std Format - VITB12	float		7 [4]
	LBTESTCD = "HGB" (Hemoglobin Measurement)	Character Result/Finding in Std Format - HGB	float		7 [5]
	LBTESTCD IN ( "ANISO" (Anisocyte Measurement), "KETONES" (Ketone Measurement), "MACROCY" (Macrocyte Count), "PH" (pH), "POIKILO" (Poikilocyte Measurement), "UROBIL" (Urobilinogen Measurement) )	Character Result/Finding in Std Format - Set 4	integer		1
	LBTESTCD IN ( "ALB" (Albumin Measurement), "ALT" (Alanine Aminotransferase Measurement), "AST" (Aspartate Aminotransferase Measurement), "GGT" (Gamma Glutamyl Transpeptidase Measurement), "PROT" (Total Protein Measurement) )	Character Result/Finding in Std Format - Set 5	integer		2
	LBTESTCD IN ( "ALP" (Alkaline Phosphatase Measurement), "CL" (Chloride Measurement), "MCV" (Erythrocyte Mean Corpuscular Volume), "PLAT" (Platelet Count), "SODIUM" (Sodium Measurement) )	Character Result/Finding in Std Format - Set 6	integer		3
	LBTESTCD = "CK" (Creatine Kinase Measurement)	Character Result/Finding in Std Format - CK	integer		4
	LBTESTCD = "COLOR" (Color Assessment)	Character Result/Finding in Std Format - COLOR	text		1	Normal Abnormal Response, subset used in OE and NV. • "ABNORMAL" = "Abnormal" • "NORMAL" = "Normal"
	LBTESTCD = "GLUC" (Glucose Measurement)	Character Result/Finding in Std Format - GLUC	text		8
LBSTRESN		Numeric Result/Finding in Standard Units	float	Result Qualifier	8 [5]		[Origin] Derived (Source: Vendor) [Method]If --STRESC represents a numeric value then --STRESN is the numeric version of --STRESC, else null. "--" represents the domain code.
LBSTRESUVLM		Standard Units	text	Variable Qualifier	7		[Origin] Assigned (Source: Vendor)
	LBTESTCD = "ALT" (Alanine Aminotransferase Measurement)	Lab Result Standard Units - ALT	text		3	Unit, subset to be used in VLM for tests with U/L as the unit • "U/L" = "Unit per Liter"
	LBTESTCD = "ALB" (Albumin Measurement)	Lab Result Standard Units - ALB	text		3	Unit, subset to be used in VLM for tests with g/L as the unit • "g/L" = "Femtomole"
	LBTESTCD = "ALP" (Alkaline Phosphatase Measurement)	Lab Result Standard Units - ALP	text		3	Unit, subset to be used in VLM for tests with U/L as the unit • "U/L" = "Unit per Liter"
	LBTESTCD = "AST" (Aspartate Aminotransferase Measurement)	Lab Result Standard Units - AST	text		3	Unit, subset to be used in VLM for tests with U/L as the unit • "U/L" = "Unit per Liter"
	LBTESTCD = "BASO" (Total Basophil Count)	Lab Result Standard Units - BASO	text		6	Unit, subset to be used in VLM for tests with 10^9/L as the unit • "10^9/L" = "Billion per Liter"
	LBTESTCD = "BILI" (Total Bilirubin Measurement)	Lab Result Standard Units - BILI	text		6	Unit, subset to be used in VLM for tests with umol/L as the unit • "umol/L" = "Micromole per Liter"
	LBTESTCD = "CA" (Calcium Measurement)	Lab Result Standard Units - CA	text		6	Unit, subset to be used in VLM for tests with mmol/L as the unit • "mmol/L" = "Millimole per Liter"
	LBTESTCD = "CL" (Chloride Measurement)	Lab Result Standard Units - CL	text		6	Unit, subset to be used in VLM for tests with mmol/L as the unit • "mmol/L" = "Millimole per Liter"
	LBTESTCD = "CHOL" (Cholesterol Measurement)	Lab Result Standard Units - CHOL	text		6	Unit, subset to be used in VLM for tests with mmol/L as the unit • "mmol/L" = "Millimole per Liter"
	LBTESTCD = "CK" (Creatine Kinase Measurement)	Lab Result Standard Units - CK	text		3	Unit, subset to be used in VLM for tests with U/L as the unit • "U/L" = "Unit per Liter"
	LBTESTCD = "CREAT" (Creatinine Measurement)	Lab Result Standard Units - CREAT	text		6	Unit, subset to be used in VLM for tests with umol/L as the unit • "umol/L" = "Micromole per Liter"
	LBTESTCD = "EOS" (Eosinophil Count)	Lab Result Standard Units - EOS	text		6	Unit, subset to be used in VLM for tests with 10^9/L as the unit • "10^9/L" = "Billion per Liter"
	LBTESTCD = "MCH" (Erythrocyte Mean Corpuscular Hemoglobin)	Lab Result Standard Units - MCH	text		4	Unit, subset to be used in VLM for tests with fmol as the unit • "fmol" = "Femtomole"
	LBTESTCD = "MCHC" (Erythrocyte Mean Corpuscular Hemoglobin Concentration)	Lab Result Standard Units - MCHC	text		6	Unit, subset to be used in VLM for tests with mmol/L as the unit • "mmol/L" = "Millimole per Liter"
	LBTESTCD = "MCV" (Erythrocyte Mean Corpuscular Volume)	Lab Result Standard Units - MCV	text		2	Unit, subset to be used in VLM for tests with fL as the unit • "fL" = "Femtoliter"
	LBTESTCD = "RBC" (Erythrocyte Count)	Lab Result Standard Units - RBC	text		7	Unit, subset to be used in VLM for tests with 10^12/L as the unit • "10^12/L" = "Million per Microliter"
	LBTESTCD = "GGT" (Gamma Glutamyl Transpeptidase Measurement)	Lab Result Standard Units - GGT	text		3	Unit, subset to be used in VLM for tests with U/L as the unit • "U/L" = "Unit per Liter"
	LBTESTCD = "GLUC" (Glucose Measurement)	Lab Result Standard Units - GLUC	text		6	Unit, subset to be used in VLM for tests with mmol/L as the unit • "mmol/L" = "Millimole per Liter"
	LBTESTCD = "HGB" (Hemoglobin Measurement)	Lab Result Standard Units - HGB	text		6	Unit, subset to be used in VLM for tests with mmol/L as the unit • "mmol/L" = "Millimole per Liter"
	LBTESTCD = "WBC" (Leukocyte Count)	Lab Result Standard Units - WBC	text		6	Unit, subset to be used in VLM for tests with 10^9/L as the unit • "10^9/L" = "Billion per Liter"
	LBTESTCD = "LYM" (Lymphocyte Count)	Lab Result Standard Units - LYM	text		6	Unit, subset to be used in VLM for tests with 10^9/L as the unit • "10^9/L" = "Billion per Liter"
	LBTESTCD = "MONO" (Monocyte Count)	Lab Result Standard Units - MONO	text		6	Unit, subset to be used in VLM for tests with 10^9/L as the unit • "10^9/L" = "Billion per Liter"
	LBTESTCD = "PHOS" (Phosphate Measurement)	Lab Result Standard Units - PHOS	text		6	Unit, subset to be used in VLM for tests with mmol/L as the unit • "mmol/L" = "Millimole per Liter"
	LBTESTCD = "PLAT" (Platelet Count)	Lab Result Standard Units - PLAT	text		6	Unit, subset to be used in VLM for tests with 10^9/L as the unit • "10^9/L" = "Billion per Liter"
	LBTESTCD = "K" (Potassium Measurement)	Lab Result Standard Units - K	text		6	Unit, subset to be used in VLM for tests with mmol/L as the unit • "mmol/L" = "Millimole per Liter"
	LBTESTCD = "PROT" (Total Protein Measurement)	Lab Result Standard Units - PROT	text		3	Unit, subset to be used in VLM for tests with g/L as the unit • "g/L" = "Femtomole"
	LBTESTCD = "SODIUM" (Sodium Measurement)	Lab Result Standard Units - SODIUM	text		6	Unit, subset to be used in VLM for tests with mmol/L as the unit • "mmol/L" = "Millimole per Liter"
	LBTESTCD = "TSH" (Thyrotropin Measurement)	Lab Result Standard Units - TSH	text		4	Unit, subset to be used in VLM for tests with mU/L as the unit • "mU/L" = "Microunit per Milliliter"
	LBTESTCD = "URATE" (Urate Measurement)	Lab Result Standard Units - URATE	text		6	Unit, subset to be used in VLM for tests with umol/L as the unit • "umol/L" = "Micromole per Liter"
	LBTESTCD = "UREAN" (Urea Nitrogen Measurement)	Lab Result Standard Units - UREAN	text		6	Unit, subset to be used in VLM for tests with mmol/L as the unit • "mmol/L" = "Millimole per Liter"
	LBTESTCD = "VITB12" (Vitamin B12 Measurement)	Lab Result Standard Units - VITB12	text		6	Unit, subset to be used in VLM for tests with pmol/L as the unit • "pmol/L" = "Picomole per Liter"
LBSTNRLO		Reference Range Lower Limit-Std Units	float	Variable Qualifier	5 [3]		[Origin] Assigned (Source: Vendor)
LBSTNRHI		Reference Range Upper Limit-Std Units	float	Variable Qualifier	5 [2]		[Origin] Assigned (Source: Vendor)
LBNRIND		Reference Range Indicator	text	Variable Qualifier	8	Normal Range Indicator • "ABNORMAL" = "Abnormal" • "HIGH" = "High" • "LOW" = "Low" • "NORMAL" = "Normal"	[Origin] Collected (Source: Vendor)
LBLOBXFL		Last Observation Before Exposure Flag	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or null values • "Y" = "Yes"	[Origin] Derived (Source: Vendor) [Method]Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise.
VISITNUM		Visit Number	float	Timing	8 [2]		[Origin] Collected (Source: Vendor)
VISIT		Visit Name	text	Timing	200		[Origin] Collected (Source: Vendor)
EPOCH		Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Derived (Source: Vendor) [Method]EPOCH from SE where date >= SESTDTC and date < SEENDTC
LBDTC		Date/Time of Specimen Collection	partialDatetime	Timing		ISO 8601	[Origin] Collected (Source: Vendor) [Comment] DataType is 'partialDatetime' instead of 'datetime' since datetime values are planned to be collected without seconds for this study.
LBDY		Study Day of Specimen Collection	integer	Timing	8		[Origin] Derived (Source: Vendor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.

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Nervous System Findings (NV)

NV (Nervous System Findings) - [STDTMIG 3.3][No Data]
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPNV (Supplemental Qualifiers for NV)
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN	Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Nervous System Findings • "NV" = "Nervous Sysytem Findings"	[Origin] Assigned (Source: Sponsor)
USUBJID	Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
NVSEQ	Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
NVTESTCD	Short Name of Nervous System Test	text	Topic	4	Nervous System Test Code • "INTP" = "Interpretation"	[Origin] Assigned (Source: Sponsor)
NVTEST	Name of Nervous System Test	text	Synonym Qualifier	14	Nervous System Test • "Interpretation"	[Origin] Assigned (Source: Sponsor)
NVORRES	Result or Finding in Original Units	text	Result Qualifier	8	Normal Abnormal Response, subset used in OE and NV. • "ABNORMAL" = "Abnormal" • "NORMAL" = "Normal"	[Origin] Collected (Source: Investigator) Annotated CRF [20 ]
NVSTRESC	Character Result/Finding in Std Format	text	Result Qualifier	8	Normal Abnormal Response, subset used in OE and NV. • "ABNORMAL" = "Abnormal" • "NORMAL" = "Normal"	[Origin] Predecessor: NVORRES
VISITNUM	Visit Number	float	Timing	8 [2]		[Origin] Assigned (Source: Sponsor)
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Derived (Source: Sponsor) [Method]EPOCH from SE where date >= SESTDTC and date < SEENDTC
NVDTC	Date/Time of Collection	date	Timing		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [20 ]
NVDY	Study Day of Visit/Collection/Exam	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.

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Ophthalmic Examinations (OE)

OE (Ophthalmic Examinations) - [STDTMIG 3.3]Location: oe.xml
Variable	Where Condition	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Supplemental Qualifiers Dataset: SUPPOE (Supplemental Qualifiers for OE)
STUDYID		Study Identifier	text	Identifier	12		[Origin] Assigned (Source: Sponsor)
DOMAIN		Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Ophthalmic Examinations • "OE" = "Ophthalmic Examinations"	[Origin] Assigned (Source: Sponsor)
USUBJID		Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
FOCID		Focus of Study-Specific Interest	text	Identifier	2	Ophthalmic Focus of Study Specific Interest • "OD" = "Right Eye" • "OS" = "Left Eye"	[Origin] Collected (Source: Investigator) Annotated CRF [21 ]
OESEQ		Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
OETESTCD		Short Name of Ophthalmic Test or Exam	text	Topic	8	Ophthalmic Exam Test Code • "ABDETAIL" = "Abnormality Detail" • "INTP" = "Interpretation"	[Origin] Assigned (Source: Sponsor)
OETEST		Name of Ophthalmic Test or Exam	text	Synonym Qualifier	18	Ophthalmic Exam Test • "Abnormality Detail" • "Interpretation"	[Origin] Assigned (Source: Sponsor)
OEORRESVLM		Result or Finding in Original Units	text	Result Qualifier	200		[Origin] Collected (Source: Investigator) Annotated CRF [21 ]
	OETESTCD = "INTP" (Interpretation)	Result or Finding in Original Units	text		8	Normal Abnormal Response, subset used in OE and NV. • "ABNORMAL" = "Abnormal" • "NORMAL" = "Normal"
	OETESTCD = "ABDETAIL" (Abnormality Detail)	Result or Finding in Original Units	text		200
OESTRESC		Character Result/Finding in Std Format	text	Result Qualifier	200		[Origin] Predecessor: OEORRES
OELOC		Location Used for the Measurement	text	Record Qualifier	21	Anatomical Location, subset used for OELOC • "CONJUNCTIVA" = "Conjunctiva" • "EYE" = "Eye" • "EYE, ANTERIOR CHAMBER" = "Anterior Chamber of the Eye" • "IRIS" = "Iris" • "CORNEA" = "Cornea"	[Origin] Collected (Source: Investigator) Annotated CRF [21 ]
OELAT		Laterality	text	Variable Qualifier	5	Laterality, subset to be used in OE • "LEFT" = "Left" • "RIGHT" = "Right"	[Origin] Collected (Source: Investigator) Annotated CRF [21 ]
OEMETHOD		Method of Test or Examination	text	Record Qualifier	9	Method, subset used for OEMETHOD • "SLIT LAMP" = "Slit-lamp Examination"	[Origin] Assigned (Source: Sponsor) Annotated CRF [21 ]
OELOBXFL		Last Observation Before Exposure Flag	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or null values • "Y" = "Yes"	[Origin] Derived (Source: Sponsor) [Method]Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise.
VISITNUM		Visit Number	float	Timing	8 [2]		[Origin] Assigned (Source: Sponsor)
VISIT		Visit Name	text	Timing	200		[Origin] Collected (Source: Investigator) Annotated CRF [21 ]
EPOCH		Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Derived (Source: Sponsor) [Method]EPOCH from SE where date >= SESTDTC and date < SEENDTC
OEDTC		Date/Time of Collection	text	Timing	200		[Origin] Collected (Source: Investigator) Annotated CRF [21 ]
OEDY		Study Day of Visit/Collection/Exam	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.

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Questionnaires (PHQ-9) (QSPH)

QSPH (Questionnaires (PHQ-9), Questionnaires) - [STDTMIG 3.3]Location: qsph.xml
Variable	Where Condition	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN		Domain Abbreviation	text	Identifier	4	SDTM Domain Abbreviation, subset used for Questionnaires • "QS" = "Questionnaires"	[Origin] Assigned (Source: Sponsor)
USUBJID		Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
QSSEQ		Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
QSTESTCD		Question Short Name	text	Topic	7	Patient Health Questionnaire - 9 Item Questionnaire Test Code [11 Terms]	[Origin] Assigned (Source: Sponsor)
QSTEST		Question Name	text	Synonym Qualifier	40	Patient Health Questionnaire - 9 Item Questionnaire Test Name [11 Terms]	[Origin] Assigned (Source: Sponsor)
QSCAT		Category of Question	text	Grouping Qualifier	5	Category of Questionnaire for PHQ-9 • "PHQ-9" = "Patient Health Questionnaire - 9 Item"	[Origin] Assigned (Source: Sponsor) Annotated CRF [15 ]
QSORRESVLM		Finding in Original Units	text	Result Qualifier	23		[Origin] Collected (Source: Investigator) Annotated CRF [15 ]
	QSTESTCD IN ( "PHQ0101" (PHQ01-Little Interest/Pleasure in Things), "PHQ0102" (PHQ01-Feeling Down Depressed or Hopeless), "PHQ0103" (PHQ01-Trouble Falling or Staying Asleep), "PHQ0104" (PHQ01-Feeling Tired or Little Energy), "PHQ0105" (PHQ01-Poor Appetite or Overeating), "PHQ0106" (PHQ01-Feeling Bad About Yourself), "PHQ0107" (PHQ01-Trouble Concentrating on Things), "PHQ0108" (PHQ01-Moving Slowly or Fidgety/Restless), "PHQ0109" (PHQ01-Thoughts You Be Better Off Dead) )	PHQ-9 Questions 1-9	text		23	Patient Health Questionnaire Responses • "Not at all" • "Several days" • "More than half the days" • "Nearly every day"
	QSTESTCD = "PHQ0110" (PHQ01-Difficult to Work/Take Care Things)	PHQ-9 Question 10	text		20	Patient Health Questionnaire Responses-Question 10 • "Not difficult at all" • "Somewhat difficult" • "Very difficult" • "Extremely Difficult"
	QSTESTCD = "PHQ0111" (PHQ01-Total Score)	PHQ-9 Question Total	integer		8
QSSTRESCVLM		Character Result/Finding in Std Format	text	Result Qualifier	20
	QSTESTCD IN ( "PHQ0101" (PHQ01-Little Interest/Pleasure in Things), "PHQ0102" (PHQ01-Feeling Down Depressed or Hopeless), "PHQ0103" (PHQ01-Trouble Falling or Staying Asleep), "PHQ0104" (PHQ01-Feeling Tired or Little Energy), "PHQ0105" (PHQ01-Poor Appetite or Overeating), "PHQ0106" (PHQ01-Feeling Bad About Yourself), "PHQ0107" (PHQ01-Trouble Concentrating on Things), "PHQ0108" (PHQ01-Moving Slowly or Fidgety/Restless), "PHQ0109" (PHQ01-Thoughts You Be Better Off Dead) )	PHQ-9 Questions 1-9, Standardized	integer		8	Patient Health Questionnaire Responses Standardized • 0 = "Not at all" • 1 = "Several days" • 2 = "More than half the days" • 3 = "Nearly every day"	[Origin] Derived (Source: Sponsor) Annotated CRF [15 ] [Method]If QSORRES="Not at all" then 0 If QSORRES="Several days" then 1 If QSORRES="More than half the days" then 2 If QSORRES="Nearly every day" then 3
	QSTESTCD = "PHQ0110" (PHQ01-Difficult to Work/Take Care Things)	PHQ-9 Question 10, Standardized	text		20	Patient Health Questionnaire Responses-Question 10 • "Not difficult at all" • "Somewhat difficult" • "Very difficult" • "Extremely Difficult"	[Origin] Derived (Source: Sponsor) Annotated CRF [15 ] [Method]QSSTRESC=QSORRES
	QSTESTCD = "PHQ0111" (PHQ01-Total Score)	PHQ-9 Question Total, Standardized	integer		8		[Origin] Predecessor: QSORRES where QSTESTCD EQ PHQ0111 Annotated CRF [15 ]
QSSTRESN		Numeric Finding in Standard Units	integer	Result Qualifier	8		[Origin] Derived (Source: Sponsor) Annotated CRF [15 ] [Method]If QSSTRESC is numeric then QSSTRESN=QSSTRESC in numeric format, else null.
QSLOBXFL		Last Observation Before Exposure Flag	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or null values • "Y" = "Yes"	[Origin] Derived (Source: Sponsor) [Method]Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise.
VISITNUM		Visit Number	float	Timing	8 [2]		[Origin] Assigned (Source: Sponsor)
VISIT		Visit Name	text	Timing	200		[Origin] Assigned (Source: Sponsor)
EPOCH		Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Derived (Source: Sponsor) [Method]EPOCH from SE where date >= SESTDTC and date < SEENDTC
QSDTC		Date/Time of Finding	date	Timing		ISO 8601	[Origin] Assigned (Source: Sponsor)
QSDY		Study Day of Finding	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.
QSEVLINT		Evaluation Interval	durationDatetime	Timing		ISO 8601	[Origin] Assigned (Source: Sponsor) Annotated CRF [15 ]

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Questionnaires (SQLS) (QSSL)

QSSL (Questionnaires (SQLS), Questionnaires) - [STDTMIG 3.3]Location: qssl.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN	Domain Abbreviation	text	Identifier	4	SDTM Domain Abbreviation, subset used for Questionnaires • "QS" = "Questionnaires"	[Origin] Assigned (Source: Sponsor)
USUBJID	Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
QSSEQ	Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
QSTESTCD	Question Short Name	text	Topic	8	Satisfaction With Life Scale Questionnaire Test Code • "SWLS0101" = "SWLS01-Have Gotten Important Things" • "SWLS0102" = "SWLS01-I Am Satisfied with My Life" • "SWLS0103" = "SWLS01-Live Life Over Change Nothing" • "SWLS0104" = "SWLS01-My Life Conditions are Excellent" • "SWLS0105" = "SWLS01-My Life is Close to Ideal"	[Origin] Assigned (Source: Sponsor)
QSTEST	Question Name	text	Synonym Qualifier	39	Satisfaction With Life Scale Questionnaire Test Name • "SWLS01-Have Gotten Important Things" • "SWLS01-I Am Satisfied with My Life" • "SWLS01-Live Life Over Change Nothing" • "SWLS01-My Life Conditions are Excellent" • "SWLS01-My Life is Close to Ideal"	[Origin] Assigned (Source: Sponsor)
QSCAT	Category of Question	text	Grouping Qualifier	4	Category of Questionnaire for SWLS • "SWLS" = "Satisfaction With Life Scale Questionnaire"	[Origin] Assigned (Source: Sponsor) Annotated CRF [16 ]
QSORRES	Finding in Original Units	text	Result Qualifier	26	SWLS-Responses [7 Terms]	[Origin] Collected (Source: Investigator) Annotated CRF [16 ]
QSSTRESC	Character Result/Finding in Std Format	text	Result Qualifier	1	SWLS-Responses Standardized [7 Terms]	[Origin] Derived (Source: Sponsor) Annotated CRF [16 ] [Method]If QSORRES="Strongly disagree" then 1 If QSORRES="Disagree" then 2 If QSORRES="Slightly disagree" then 3 If QSORRES="Neither agree nor disagree" then 4 If QSORRES="Slightly agree" then 5 If QSORRES="Agree" then 6 If QSORRES="Strongly agree" then 7
QSSTRESN	Numeric Finding in Standard Units	integer	Result Qualifier	8		[Origin] Derived (Source: Sponsor) Annotated CRF [16 ] [Method]If QSSTRESC is numeric then QSSTRESN=QSSTRESC in numeric format, else null.
QSLOBXFL	Last Observation Before Exposure Flag	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or null values • "Y" = "Yes"	[Origin] Derived (Source: Sponsor) [Method]Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise.
VISITNUM	Visit Number	float	Timing	8 [2]		[Origin] Assigned (Source: Sponsor)
VISIT	Visit Name	text	Timing	200		[Origin] Assigned (Source: Sponsor)
EPOCH	Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Derived (Source: Sponsor) [Method]EPOCH from SE where date >= SESTDTC and date < SEENDTC
QSDTC	Date/Time of Finding	date	Timing		ISO 8601	[Origin] Assigned (Source: Sponsor)
QSDY	Study Day of Finding	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.

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Disease Response and Clin Classification (RS)

RS (Disease Response and Clin Classification) - [STDTMIG 3.3]Location: rs.xml
Variable	Where Condition	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN		Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Disease Response and Clin Classification • "RS" = "Disease Response and Clin Classification"	[Origin] Assigned (Source: Sponsor)
USUBJID		Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
RSSEQ		Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
RSTESTCD		Assessment Short Name	text	Topic	8	Hamilton Depression Rating Scale - 17 Item Clinical Classification Test Code [19 Terms]	[Origin] Assigned (Source: Sponsor)
RSTEST		Assessment Name	text	Synonym Qualifier	37	Hamilton Depression Rating Scale - 17 Item Clinical Classification Test Name [19 Terms]	[Origin] Assigned (Source: Sponsor)
RSCAT		Category for Assessment	text	Grouping Qualifier	7	Category of Clinical Classification, subset to be used for RSCAT • "HAMD 17" = "Hamilton Depression Rating Scale 17 Item Clinical Classification"	[Origin] Assigned (Source: Sponsor) Annotated CRF [19 ]
RSORRESVLM		Result or Finding in Original Units	text	Result Qualifier	198		[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD101" (HAMD1-Depressed Mood)	HAMD-17 Question 1	text		111	Hamilton Depression Rating Scale - 17 Item - Question 1 • "Absent." • "These feeling states indicated only on questioning." • "These feeling states spontaneously reported verbally." • "Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and tendency to weep." • "Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal communication."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD102" (HAMD1-Feelings of Guilt)	HAMD-17 Question 2	text		93	Hamilton Depression Rating Scale - 17 Item - Question 2 • "Absent." • "Self reproach, feels he/she has let people down." • "Ideas of guilt or rumination over past errors or sinful deeds." • "Present illness is a punishment. Delusions of guilt." • "Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD103" (HAMD1-Suicide)	HAMD-17 Question 3	text		66	Hamilton Depression Rating Scale - 17 Item - Question 3 • "Absent." • "Feels life is not worth living." • "Wishes he/she were dead or any thoughts of possible death to self." • "Ideas or gestures of suicide." • "Attempts at suicide (any serious attempt rate 4)."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD104" (HAMD1-Insomnia Early - Early Night)	HAMD-17 Question 4	text		74	Hamilton Depression Rating Scale - 17 Item - Question 4 • "No difficulty falling asleep." • "Complains of occasional difficulty falling asleep, i.e. more than 1/2 hour" • "Complains of nightly difficulty falling asleep."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD105" (HAMD1-Insomnia Middle - Middle Night)	HAMD-17 Question 5	text		90	Hamilton Depression Rating Scale - 17 Item - Question 5 • "No difficulty." • "Patient complains of being restless and disturbed during the night." • "Waking during the night - any getting out of bed rates 2 (except for purposes of voiding)."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD106" (HAMD1-Insomnia Early Hours - Morning)	HAMD-17 Question 6	text		60	Hamilton Depression Rating Scale - 17 Item - Question 6 • "No difficulty." • "Waking in early hours of the morning but goes back to sleep." • "Unable to fall asleep again if he/she gets out of bed."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD107" (HAMD1-Work and Activities)	HAMD-17 Question 7	text		198	Hamilton Depression Rating Scale - 17 Item - Question 7 • "No difficulty." • "Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies." • "Loss of interest in activity, hobbies or work - either directly reported by the patient or indirect in listlessness, indecision and vacillation (feels he/she has to push self to work or activities)." • "Decrease in actual time spent in activities or decrease in productivity. Rate 3 if the patient does not spend at least three hours a day in activities (job or hobbies) excluding routine chores." • "Stopped working because of present illness. Rate 4 if patient engages in no activities except routine chores, or if patient fails to perform routine chores unassisted."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD108" (HAMD1-Retardation)	HAMD-17 Question 8	text		41	Hamilton Depression Rating Scale - 17 Item - Question 8 • "Normal speech and thought." • "Slight retardation during the interview." • "Obvious retardation during the interview." • "Interview difficult." • "Complete stupor."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD109" (HAMD1-Agitation)	HAMD-17 Question 9	text		57	Hamilton Depression Rating Scale - 17 Item - Question 9 • "None." • "Fidgetiness." • "Playing with hands, hair, etc." • "Moving about, cannot sit still." • "Hand wringing, nail biting, hair-pulling, biting of lips."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD110" (HAMD1-Anxiety Psychic)	HAMD-17 Question 10	text		49	Hamilton Depression Rating Scale - 17 Item - Question 10 • "No difficulty." • "Subjective tension and irritability." • "Worrying about minor matters." • "Apprehensive attitude apparent in face or speech." • "Fears expressed without questioning."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD111" (HAMD1-Anxiety Somatic)	HAMD-17 Question 11	text		15	Hamilton Depression Rating Scale - 17 Item - Question 11 • "Absent." • "Mild." • "Moderate." • "Severe." • "Incapacitating."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD112" (HAMD1-Somatic Symptoms GI)	HAMD-17 Question 12	text		141	Hamilton Depression Rating Scale - 17 Item - Question 12 • "None." • "Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen." • "Difficulty eating without staff urging. Requests or requires laxatives or medication for bowels or medication for gastro-intestinal symptoms."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD113" (HAMD1-General Somatic Symptoms)	HAMD-17 Question 13	text		102	Hamilton Depression Rating Scale - 17 Item - Question 13 • "None." • "Heaviness in limbs, back or head. Backaches, headaches, muscle aches. Loss of energy and fatigability." • "Any clear-cut symptom rates 2."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD114" (HAMD1-Genital Symptoms)	HAMD-17 Question 14	text		7	Hamilton Depression Rating Scale - 17 Item - Question 14 • "Absent." • "Mild." • "Severe."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD115" (HAMD1-Hypochondriasis)	HAMD-17 Question 15	text		44	Hamilton Depression Rating Scale - 17 Item - Question 15 • "Not present." • "Self-absorption (bodily)." • "Preoccupation with health." • "Frequent complaints, requests for help, etc." • "Hypochondriacal delusions."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD116A" (HAMD1-Loss of WT According to Patient)	HAMD-17 Question 16A	text		53	Hamilton Depression Rating Scale - 17 Item - Question 16A • "No weight loss." • "Probable weight loss associated with present illness." • "Definite (according to patient) weight loss." • "Not assessed."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD116B" (HAMD1-Loss of WT According to WK Meas)	HAMD-17 Question 16B	text		42	Hamilton Depression Rating Scale - 17 Item - Question 16B • "Less than 1 lb weight loss in week." • "Greater than 1 lb weight loss within week." • "Greater than 2 lb weight loss in week." • "Not assessed."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD117" (HAMD1-Insight)	HAMD-17 Question 17	text		100	Hamilton Depression Rating Scale - 17 Item - Question 17 • "Acknowledges being depressed and ill." • "Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc." • "Denies being ill at all."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD118" (HAMD1-Total Score)	HAMD-17 Question 18	integer		8		[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
RSSTRESCVLM		Character Result/Finding in Std Format	text	Result Qualifier	8		[Origin] Derived (Source: Sponsor) [Method]RSSTRESC is the corresponding numeric value of RSORRES according the values shown on the HAMD-17 CRF page.
	RSTESTCD = "HAMD101" (HAMD1-Depressed Mood)	HAMD-17 Question 1 Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 1 Standardized • 0 = "Absent." • 1 = "These feeling states indicated only on questioning." • 2 = "These feeling states spontaneously reported verbally." • 3 = "Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and tendency to weep." • 4 = "Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal communication."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD102" (HAMD1-Feelings of Guilt)	HAMD-17 Question 2 Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 2 Standardized • 0 = "Absent." • 1 = "Self reproach, feels he/she has let people down." • 2 = "Ideas of guilt or rumination over past errors or sinful deeds." • 3 = "Present illness is a punishment. Delusions of guilt." • 4 = "Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD103" (HAMD1-Suicide)	HAMD-17 Question 3 Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 3 Standardized • 0 = "Absent." • 1 = "Feels life is not worth living." • 2 = "Wishes he/she were dead or any thoughts of possible death to self." • 3 = "Ideas or gestures of suicide." • 4 = "Attempts at suicide (any serious attempt rate 4)."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD104" (HAMD1-Insomnia Early - Early Night)	HAMD-17 Question 4 Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 4 Standardized • 0 = "No difficulty falling asleep." • 1 = "Complains of occasional difficulty falling asleep, i.e. more than 1/2 hour" • 2 = "Complains of nightly difficulty falling asleep."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD105" (HAMD1-Insomnia Middle - Middle Night)	HAMD-17 Question 5 Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 5 Standardized • 0 = "No difficulty." • 1 = "Patient complains of being restless and disturbed during the night." • 2 = "Waking during the night - any getting out of bed rates 2 (except for purposes of voiding)."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD106" (HAMD1-Insomnia Early Hours - Morning)	HAMD-17 Question 6 Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 6 Standardized • 0 = "No difficulty." • 1 = "Waking in early hours of the morning but goes back to sleep." • 2 = "Unable to fall asleep again if he/she gets out of bed."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD107" (HAMD1-Work and Activities)	HAMD-17 Question 7 Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 7 Standardized • 0 = "No difficulty." • 1 = "Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies." • 2 = "Loss of interest in activity, hobbies or work - either directly reported by the patient or indirect in listlessness, indecision and vacillation (feels he/she has to push self to work or activities)." • 3 = "Decrease in actual time spent in activities or decrease in productivity. Rate 3 if the patient does not spend at least three hours a day in activities (job or hobbies) excluding routine chores." • 4 = "Stopped working because of present illness. Rate 4 if patient engages in no activities except routine chores, or if patient fails to perform routine chores unassisted."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD108" (HAMD1-Retardation)	HAMD-17 Question 8 Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 8 Standardized • 0 = "Normal speech and thought." • 1 = "Slight retardation during the interview." • 2 = "Obvious retardation during the interview." • 3 = "Interview difficult." • 4 = "Complete stupor."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD109" (HAMD1-Agitation)	HAMD-17 Question 9 Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 9 Standardized • 0 = "None." • 1 = "Fidgetiness." • 2 = "Playing with hands, hair, etc." • 3 = "Moving about, cannot sit still." • 4 = "Hand wringing, nail biting, hair-pulling, biting of lips."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD110" (HAMD1-Anxiety Psychic)	HAMD-17 Question 10 Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 10 Standardized • 0 = "No difficulty." • 1 = "Subjective tension and irritability." • 2 = "Worrying about minor matters." • 3 = "Apprehensive attitude apparent in face or speech." • 4 = "Fears expressed without questioning."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD111" (HAMD1-Anxiety Somatic)	HAMD-17 Question 11 Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 11 Standardized • 0 = "Absent." • 1 = "Mild." • 2 = "Moderate." • 3 = "Severe." • 4 = "Incapacitating."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD112" (HAMD1-Somatic Symptoms GI)	HAMD-17 Question 12 Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 12 Standardized • 0 = "None." • 1 = "Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen." • 2 = "Difficulty eating without staff urging. Requests or requires laxatives or medication for bowels or medication for gastro-intestinal symptoms."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD113" (HAMD1-General Somatic Symptoms)	HAMD-17 Question 13 Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 13 Standardized • 0 = "None." • 1 = "Heaviness in limbs, back or head. Backaches, headaches, muscle aches. Loss of energy and fatigability." • 2 = "Any clear-cut symptom rates 2."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD114" (HAMD1-Genital Symptoms)	HAMD-17 Question 14 Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 14 Standardized • 0 = "Absent." • 1 = "Mild." • 2 = "Severe."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD115" (HAMD1-Hypochondriasis)	HAMD-17 Question 15 Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 15 Standardized • 0 = "Not present." • 1 = "Self-absorption (bodily)." • 2 = "Preoccupation with health." • 3 = "Frequent complaints, requests for help, etc." • 4 = "Hypochondriacal delusions."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD116A" (HAMD1-Loss of WT According to Patient)	HAMD-17 Question 16A Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 16A Standardized • 0 = "No weight loss." • 1 = "Probable weight loss associated with present illness." • 2 = "Definite (according to patient) weight loss." • 3 = "Not assessed."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD116B" (HAMD1-Loss of WT According to WK Meas)	HAMD-17 Question 16B Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 16B Standardized • 0 = "Less than 1 lb weight loss in week." • 1 = "Greater than 1 lb weight loss within week." • 2 = "Greater than 2 lb weight loss in week." • 3 = "Not assessed."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD117" (HAMD1-Insight)	HAMD-17 Question 17 Standardized	integer		8	Hamilton Depression Rating Scale - 17 Item - Question 17 Standardized • 0 = "Acknowledges being depressed and ill." • 1 = "Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc." • 2 = "Denies being ill at all."	[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
	RSTESTCD = "HAMD118" (HAMD1-Total Score)	HAMD-17 Question 18 Standardized	integer		8		[Origin] Collected (Source: Investigator) Annotated CRF [19 ]
RSSTRESN		Numeric Result/Finding in Standard Units	integer	Result Qualifier	8		[Origin] Derived (Source: Sponsor) [Method]If --STRESC represents a numeric value then --STRESN is the numeric version of --STRESC, else null. "--" represents the domain code.
RSLOBXFL		Last Observation Before Exposure Flag	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or null values • "Y" = "Yes"	[Origin] Derived (Source: Sponsor) [Method]Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise.
VISITNUM		Visit Number	float	Timing	8 [2]		[Origin] Assigned (Source: Sponsor)
VISIT		Visit Name	text	Timing	200		[Origin] Assigned (Source: Sponsor)
EPOCH		Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Derived (Source: Sponsor) [Method]EPOCH from SE where date >= SESTDTC and date < SEENDTC
RSDTC		Date/Time of Assessment	date	Timing		ISO 8601	[Origin] Assigned (Source: Sponsor)
RSDY		Study Day of Assessment	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.
RSEVLINT		Evaluation Interval	durationDatetime	Timing		ISO 8601	[Origin] Assigned (Source: Sponsor) Annotated CRF [19 ]

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Vital Signs (VS)

VS (Vital Signs) - [STDTMIG 3.3]Location: vs.xml
Variable	Where Condition	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN		Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Vital Signs • "VS" = "Vital Signs"	[Origin] Assigned (Source: Sponsor)
USUBJID		Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
VSSEQ		Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
VSTESTCD		Vital Signs Test Short Name	text	Topic	6	Vital Signs Test Code [6 Terms]	[Origin] Assigned (Source: Sponsor)
VSTEST		Vital Signs Test Name	text	Synonym Qualifier	24	Vital Signs Test Name [6 Terms]	[Origin] Assigned (Source: Sponsor)
VSPOS		Vital Signs Position of Subject	text	Record Qualifier	8	Position, subset to be used for VSPOS • "STANDING" = "Standing" • "SUPINE" = "Supine"	[Origin] Assigned (Source: Sponsor) Annotated CRF [8 9 10 11 12 13 ]
VSORRESVLM		Result or Finding in Original Units	text	Result Qualifier	8
	VSTESTCD IN ( "DIABP" (Diastolic Blood Pressure), "SYSBP" (Systolic Blood Pressure) )	Blood Pressure	integer		8		[Origin] Collected (Source: Investigator) Annotated CRF [8 9 10 11 12 13 14 ]
	VSTESTCD = "HEIGHT" (Height)	Height	float		8 [2]		[Origin] Collected (Source: Investigator) Annotated CRF [8 9 ]
	VSTESTCD = "PULSE" (Pulse Rate)	Pulse Rate	integer		8		[Origin] Collected (Source: Investigator) Annotated CRF [8 9 10 11 12 13 14 ]
	VSTESTCD = "TEMP" (Temperature)	Temperature	float		8 [2]		[Origin] Collected (Source: Investigator) Annotated CRF [8 9 10 11 12 13 14 ]
	VSTESTCD = "WEIGHT" (Weight)	Weight	float		8 [2]		[Origin] Collected (Source: Investigator) Annotated CRF [8 9 12 13 ]
VSORRESUVLM		Original Units	text	Variable Qualifier	9
	VSTESTCD IN ( "DIABP" (Diastolic Blood Pressure), "SYSBP" (Systolic Blood Pressure) )	Blood Pressure Units	text		4	Units for Vital Signs Results, subset for Blood Pressure • "mmHg" = "Millimeter of Mercury"	[Origin] Collected (Source: Investigator) Annotated CRF [8 9 10 11 12 13 14 ]
	VSTESTCD = "HEIGHT" (Height)	Height Units	text		2	Units for Vital Signs Results, subset for Height • "in" = "Inch"	[Origin] Collected (Source: Investigator) Annotated CRF [8 9 ]
	VSTESTCD = "PULSE" (Pulse Rate)	Pulse Rate Units	text		9	Units for Vital Signs Results, subset for Pulse • "beats/min" = "Beats per Minute"	[Origin] Collected (Source: Investigator) Annotated CRF [8 9 10 11 12 13 14 ]
	VSTESTCD = "TEMP" (Temperature)	Temperature Units	text		1	Units for Vital Signs Results, subset for Temperature • "F" = "Degree Fahrenheit"	[Origin] Collected (Source: Investigator) Annotated CRF [8 9 10 11 12 13 14 ]
	VSTESTCD = "WEIGHT" (Weight)	Weight Units	text		2	Units for Vital Signs Results, subset for Weight • "LB" = "Pound"	[Origin] Collected (Source: Investigator) Annotated CRF [8 9 12 13 ]
VSSTRESC		Character Result/Finding in Std Format	text	Result Qualifier	200		[Origin] Derived (Source: Sponsor) [Method]Data collected in conventional units (i.e. F, lbs, inches) is converted using standard conversion factors to standard units (C, kg, cm).
VSSTRESN		Numeric Result/Finding in Standard Units	float	Result Qualifier	8 [2]		[Origin] Derived (Source: Sponsor) [Method]If --STRESC represents a numeric value then --STRESN is the numeric version of --STRESC, else null. "--" represents the domain code.
VSSTRESUVLM		Standard Units	text	Variable Qualifier	9		[Origin] Assigned (Source: Sponsor)
	VSTESTCD IN ( "DIABP" (Diastolic Blood Pressure), "SYSBP" (Systolic Blood Pressure) )	Blood Pressure Units Std	text		4	Units for Vital Signs Results, subset for Blood Pressure Std • "mmHg" = "Millimeter of Mercury"
	VSTESTCD = "HEIGHT" (Height)	Height Units Std	text		2	Units for Vital Signs Results, subset for Height Std • "cm" = "Centimeter"
	VSTESTCD = "PULSE" (Pulse Rate)	Pulse Rate Units Std	text		9	Units for Vital Signs Results, subset for Pulse Std • "beats/min" = "Beats per Minute"
	VSTESTCD = "TEMP" (Temperature)	Temperature Units Std	text		1	Units for Vital Signs Results, subset for Temperature Std • "C" = "Degree Celsius"
	VSTESTCD = "WEIGHT" (Weight)	Weight Units Std	text		2	Units for Vital Signs Results, subset for Weight Std • "kg" = "Kilogram"
VSSTAT[No Data]		Completion Status	text	Record Qualifier	8	Not Done • "NOT DONE" = "Not Done"	[Origin] Collected (Source: Investigator) Annotated CRF [8 9 10 11 12 13 ] [Comment] All vital signs were performed as expected, so VSSTAT was never populated. The variable is included as it was possible to populate it in this study.
VSLOC		Location of Vital Signs Measurement	text	Record Qualifier	11	Anatomical Location • "EAR" = "Ear" • "ORAL CAVITY" = "Oral Cavity"	[Origin] Collected (Source: Investigator) Annotated CRF [8 9 10 11 12 13 ]
VSLOBXFL		Last Observation Before Exposure Flag	text	Record Qualifier	1	No Yes Response, subset for variables with only "Y" or null values • "Y" = "Yes"	[Origin] Derived (Source: Sponsor) [Method]Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise.
VSREPNUM		Repetition Number	integer	Record Qualifier	8		[Origin] Assigned (Source: Sponsor) Annotated CRF [8 10 12 ]
VISITNUM		Visit Number	float	Timing	8 [2]		[Origin] Assigned (Source: Sponsor)
VISIT		Visit Name	text	Timing	200		[Origin] Collected (Source: Investigator) Annotated CRF [8 9 10 11 12 13 ]
EPOCH		Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Derived (Source: Sponsor) [Method]EPOCH from SE where date >= SESTDTC and date < SEENDTC
VSDTC		Date/Time of Measurements	date	Timing		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [8 9 10 11 12 13 ]
VSDY		Study Day of Vital Signs	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.

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Findings About Events or Interventions (FA)

FA (Findings About Events or Interventions) - [STDTMIG 3.3]Location: fa.xml
Variable	Where Condition	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID		Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
DOMAIN		Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Findings About Events or Interventions • "FA" = "Findings About Events or Interventions"	[Origin] Assigned (Source: Sponsor)
USUBJID		Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
FASEQ		Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
FALNKGRP		Link Group ID	text	Identifier	200		[Origin] Collected (Source: Investigator) Annotated CRF [23 ]
FATESTCD		Findings About Test Short Name	text	Topic	5	Findings About Adverse Events Test Code • "OCCUR" = "Occurrence Indicator" • "SEV" = "Severity/Intensity"	[Origin] Assigned (Source: Sponsor)
FATEST		Findings About Test Name	text	Synonym Qualifier	20	Findings About Adverse Events Test Name • "Occurrence Indicator" • "Severity/Intensity"	[Origin] Assigned (Source: Sponsor)
FAOBJ		Object of the Observation	text	Record Qualifier	10	FA Object • "ERYTHEMA" = "Erythema" • "PAIN" = "Pain" • "INDURATION" = "Induration" • "PRURITUS" = "Pruritus" • "EDEMA" = "Edema"	[Origin] Assigned (Source: Sponsor) Annotated CRF [24 ]
FACAT		Category for Findings About	text	Grouping Qualifier	23	FA Category • "INJECTION SITE REACTION" = "Injection Site Reaction"	[Origin] Assigned (Source: Sponsor) Annotated CRF [24 ]
FAORRESVLM		Result or Finding in Original Units	text	Result Qualifier	8		[Origin] Collected (Source: Investigator) Annotated CRF [24 ]
	FATESTCD = "SEV" (Severity/Intensity)	Result or Finding in Original Units	text		8	Severity • "MILD" = "Mild" • "MODERATE" = "Moderate" • "SEVERE" = "Severe"
	FATESTCD = "OCCUR" (Occurrence Indicator)	Result or Finding in Original Units	text		1	Occurrence • "N" = "No" • "Y" = "Yes"
FASTRESCVLM		Character Result/Finding in Std Format	text	Result Qualifier	8		[Origin] Predecessor: FAORRES
	FATESTCD = "SEV" (Severity/Intensity)	Character Result/Finding in Std Format	text		8	Severity • "MILD" = "Mild" • "MODERATE" = "Moderate" • "SEVERE" = "Severe"
	FATESTCD = "OCCUR" (Occurrence Indicator)	Character Result/Finding in Std Format	text		1	Occurrence • "N" = "No" • "Y" = "Yes"
FALOC		Location of the Finding About	text	Record Qualifier	3	Location • "ARM"	[Origin] Assigned (Source: Sponsor)
VISITNUM		Visit Number	float	Timing	8 [2]		[Origin] Assigned (Source: Sponsor) [Comment] All values are null as the findings are not visit based. The variable is Expected and so is included.
EPOCH		Epoch	text	Timing	9	Epoch • "SCREENING" = "Screening" • "TREATMENT" = "Treatment"	[Origin] Assigned (Source: Sponsor)
FADTC		Date/Time of Collection	date	Timing		ISO 8601	[Origin] Collected (Source: Investigator) Annotated CRF [23 ]
FADY		Study Day of Collection	integer	Timing	8		[Origin] Derived (Source: Sponsor) [Method]Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.

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Related Records (RELREC)

RELREC (Related Records) - [STDTMIG 3.3]Location: relrec.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
RDOMAIN	Related Domain Abbreviation	text	Identifier	6	SDTM Domain Abbreviation, subset used for RELREC • "AE" = "Adverse Events" • "DS" = "Disposition" • "DD" = "Death Details" • "FA" = "Findings About Events or Interventions"	[Origin] Assigned (Source: Sponsor)
USUBJID	Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
IDVAR	Identifying Variable	text	Identifier	200		[Origin] Assigned (Source: Sponsor)
IDVARVAL	Identifying Variable Value	text	Identifier	200		[Origin] Assigned (Source: Sponsor)
RELTYPE	Relationship Type	text	Record Qualifier	4	Relationship Type • "MANY" = "Many" • "ONE" = "One"	[Origin] Assigned (Source: Sponsor)
RELID	Relationship Identifier	text	Record Qualifier	200		[Origin] Assigned (Source: Sponsor)

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Supplemental Qualifiers for DM (SUPPDM)

SUPPDM (Supplemental Qualifiers for DM, Demographics) - [STDTMIG 3.3]Location: suppdm.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: DM (Demographics)
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
RDOMAIN	Related Domain Abbreviation	text	Identifier	6	SDTM Domain Abbreviation, subset used for Demographics • "DM" = "Demographics"	[Origin] Assigned (Source: Sponsor)
USUBJID	Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
IDVAR	Identifying Variable	text	Identifier	200		[Origin] Assigned (Source: Sponsor)
IDVARVAL	Identifying Variable Value	text	Identifier	200		[Origin] Assigned (Source: Sponsor)
QNAM	Qualifier Variable Name	text	Topic	5		[Origin] Assigned (Source: Sponsor)
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		[Origin] Assigned (Source: Sponsor)
QVALVLM	Data Value	text	Result Qualifier	41
➤ QNAM = "RACE1"	Race 1	text	Result Qualifier	41	Race • "AMERICAN INDIAN OR ALASKA NATIVE" = "American Indian Or Alaska Native" • "ASIAN" = "Asian" • "BLACK OR AFRICAN AMERICAN" = "Black Or African American" • "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "Native Hawaiian Or Other Pacific Islander" • "WHITE" = "White"	[Origin] Collected (Source: Investigator) Annotated CRF [5 ]
➤ QNAM = "RACE2"	Race 2	text	Result Qualifier	41	Race • "AMERICAN INDIAN OR ALASKA NATIVE" = "American Indian Or Alaska Native" • "ASIAN" = "Asian" • "BLACK OR AFRICAN AMERICAN" = "Black Or African American" • "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "Native Hawaiian Or Other Pacific Islander" • "WHITE" = "White"	[Origin] Collected (Source: Investigator) Annotated CRF [5 ]
➤ QNAM = "RACE3"	Race 3	text	Result Qualifier	41	Race • "AMERICAN INDIAN OR ALASKA NATIVE" = "American Indian Or Alaska Native" • "ASIAN" = "Asian" • "BLACK OR AFRICAN AMERICAN" = "Black Or African American" • "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "Native Hawaiian Or Other Pacific Islander" • "WHITE" = "White"	[Origin] Collected (Source: Investigator) Annotated CRF [5 ]
➤ QNAM = "RACE4" [No Data]	Race 4	text	Result Qualifier	41	Race • "AMERICAN INDIAN OR ALASKA NATIVE" = "American Indian Or Alaska Native" • "ASIAN" = "Asian" • "BLACK OR AFRICAN AMERICAN" = "Black Or African American" • "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "Native Hawaiian Or Other Pacific Islander" • "WHITE" = "White"	[Origin] Collected (Source: Investigator) Annotated CRF [5 ] [Comment] Since no subjects had more than 3 Races, RACE4 was not used.
➤ QNAM = "RACE5" [No Data]	Race 5	text	Result Qualifier	41	Race • "AMERICAN INDIAN OR ALASKA NATIVE" = "American Indian Or Alaska Native" • "ASIAN" = "Asian" • "BLACK OR AFRICAN AMERICAN" = "Black Or African American" • "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "Native Hawaiian Or Other Pacific Islander" • "WHITE" = "White"	[Origin] Collected (Source: Investigator) Annotated CRF [5 ] [Comment] Since no subjects had more than 3 Races, RACE5 was not used.
QORIG	Origin	text	Record Qualifier	13		[Origin] Assigned (Source: Sponsor)
QEVAL	Evaluator	text	Record Qualifier	200		[Origin] Assigned (Source: Sponsor) [Comment] Since no collected data was subjective then QEVAL was not populated. It is an 'Expected' variable and so is included.

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Supplemental Qualifiers for EC (SUPPEC)

SUPPEC (Supplemental Qualifiers for EC, Exposure as Collected) - [STDTMIG 3.3]Location: suppec.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Origin / Source / Method / Comment
Related Parent Dataset: EC (Exposure as Collected)
STUDYID	Study Identifier	text	Identifier	12	[Origin] Protocol (Source: Sponsor)
RDOMAIN	Related Domain Abbreviation	text	Identifier	6	[Origin] Assigned (Source: Sponsor)
USUBJID	Unique Subject Identifier	text	Identifier	8	[Origin] Assigned (Source: Sponsor)
IDVAR	Identifying Variable	text	Identifier	200	[Origin] Assigned (Source: Sponsor)
IDVARVAL	Identifying Variable Value	text	Identifier	200	[Origin] Assigned (Source: Sponsor)
QNAM	Qualifier Variable Name	text	Topic	8	[Origin] Assigned (Source: Sponsor)
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40	[Origin] Assigned (Source: Sponsor)
QVALVLM	Data Value	text	Result Qualifier	200
➤ QNAM = "ECREASOC"	Reason for Occur Value	text	Variable Qualifier	200	[Origin] Collected (Source: Investigator) Annotated CRF [14 ]
QORIG	Origin	text	Record Qualifier	13	[Origin] Assigned (Source: Sponsor)
QEVAL	Evaluator	text	Record Qualifier	200	[Origin] Assigned (Source: Sponsor)

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Supplemental Qualifiers for NV (SUPPNV)

SUPPNV (Supplemental Qualifiers for NV, Nervous System Findings) - [STDTMIG 3.3][No Data]
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: NV (Nervous System Findings)
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
RDOMAIN	Related Domain Abbreviation	text	Identifier	6	SDTM Domain Abbreviation, subset used for Nervous System Findings • "NV" = "Nervous Sysytem Findings"	[Origin] Assigned (Source: Sponsor)
USUBJID	Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
IDVAR	Identifying Variable	text	Identifier	200		[Origin] Assigned (Source: Sponsor)
IDVARVAL	Identifying Variable Value	text	Identifier	200		[Origin] Assigned (Source: Sponsor)
QNAM	Qualifier Variable Name	text	Topic	7		[Origin] Assigned (Source: Sponsor)
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		[Origin] Assigned (Source: Sponsor)
QVALVLM	Data Value	text	Result Qualifier	1
➤ QNAM = "NVCLSIG"	Clinically Significant	text	Result Qualifier	1	No Yes Response, subset for variables with only "Y" or null values • "Y" = "Yes"	[Origin] Collected (Source: Investigator) Annotated CRF [20 ]
QORIG	Origin	text	Record Qualifier	13		[Origin] Assigned (Source: Sponsor)
QEVAL	Evaluator	text	Record Qualifier	200		[Origin] Assigned (Source: Sponsor)

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Supplemental Qualifiers for OE (SUPPOE)

SUPPOE (Supplemental Qualifiers for OE, Ophthalmic Examinations) - [STDTMIG 3.3][No Data]
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
Related Parent Dataset: OE (Ophthalmic Examinations)
STUDYID	Study Identifier	text	Identifier	12		[Origin] Protocol (Source: Sponsor)
RDOMAIN	Related Domain Abbreviation	text	Identifier	6	SDTM Domain Abbreviation, subset used for Ophthalmic Examinations • "OE" = "Ophthalmic Examinations"	[Origin] Assigned (Source: Sponsor)
USUBJID	Unique Subject Identifier	text	Identifier	8		[Origin] Assigned (Source: Sponsor)
IDVAR	Identifying Variable	text	Identifier	200		[Origin] Assigned (Source: Sponsor)
IDVARVAL	Identifying Variable Value	text	Identifier	200		[Origin] Assigned (Source: Sponsor)
QNAM	Qualifier Variable Name	text	Topic	7		[Origin] Assigned (Source: Sponsor)
QLABEL	Qualifier Variable Label	text	Synonym Qualifier	40		[Origin] Assigned (Source: Sponsor)
QVALVLM	Data Value	text	Result Qualifier	1
➤ QNAM = "OECLSIG"	Clinically Significant	text	Result Qualifier	1	No Yes Response, subset for variables with only "Y" or "N" val • "N" = "No" • "Y" = "Yes"	[Origin] Collected (Source: Investigator) Annotated CRF [21 ]
QORIG	Origin	text	Record Qualifier	13		[Origin] Assigned (Source: Sponsor)
QEVAL	Evaluator	text	Record Qualifier	200		[Origin] Assigned (Source: Sponsor)

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Device Identifiers (DI)

DI (Device Identifiers) - [STDTMIG 3.3]Location: di.xml
Variable	Label / Description	Type	Role	Length [SignificantDigits] : Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	Identifier	12		[Origin] Assigned (Source: Sponsor)
DOMAIN	Domain Abbreviation	text	Identifier	2	SDTM Domain Abbreviation, subset used for Device Identifiers • "DI" = "Device Identifiers"	[Origin] Assigned (Source: Sponsor)
SPDEVID	Sponsor Device Identifier	text	Identifier	200		[Origin] Assigned (Source: Sponsor)
DISEQ	Sequence Number	integer	Identifier	3		[Origin] Derived (Source: Sponsor) [Method]Starts at "1" for first device identifier and increments by one for each DIPARM
DIPARMCD	Device Identifier Element Short Name	text	Topic	7	Device Identifier Element Short Name • "DEVTYPE" = "Device Type" • "SERIAL" = "Serial Number"	[Origin] Assigned (Source: Sponsor)
DIPARM	Device Identifier Element Name	text	Synonym Qualifier	13	Device Identifier Element Name • "Device Type" • "Serial Number"	[Origin] Assigned (Source: Sponsor)
DIVAL	Device Identifier Element Value	text	Result Qualifier	200		[Origin] Assigned (Source: Sponsor)

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Action Taken with Study Treatment [C66767][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
DOSE INCREASED [C49503]	Dose Increased
DOSE NOT CHANGED [C49504]	Dose Not Changed
DOSE REDUCED [C49505]	Dose Reduced
DRUG INTERRUPTED [C49501]	Drug Interrupted
DRUG WITHDRAWN [C49502]	Drug Withdrawn
NOT APPLICABLE [C48660]	Not Applicable
UNKNOWN [C17998]	Unknown

Relationship[Non Standard]

Permitted Value (Code)	Display Value (Decode)
RELATED	Related
UNLIKELY RELATED	Unlikely Related
POSSIBLY RELATED	Possibly Related
NOT RELATED	Not Related

Severity/Intensity Scale for Adverse Events [C66769][CDISC/NCI SDTM 2020-12-18]

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

Age Unit in Years [C66781][CDISC/NCI SDTM 2020-12-18]

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

Arm[Non Standard]

Permitted Value (Code)
Placebo
Zanomaline Low Dose (54 mg)
Zanomaline High Dose (81 mg)

Arm Code[Non Standard]

Permitted Value (Code)	Display Value (Decode)
PLACEBO	Placebo
ZAN_LOW	Zanomaline Low Dose (54 mg)
ZAN_HIGH	Zanomaline High Dose (81 mg)

Arm Null Reason [C142179][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
SCREEN FAILURE [C49628]	Trial Screen Failure

Rey Auditory Verbal Learning Test Functional Test Code [C123655][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
AVL0201 [C123683]	AVLT-REY - List A Word 1
AVL0202 [C123684]	AVLT-REY - List A Word 2
AVL0203 [C123685]	AVLT-REY - List A Word 3
AVL0204 [C123686]	AVLT-REY - List A Word 4
AVL0205 [C123687]	AVLT-REY - List A Word 5
AVL0206 [C123688]	AVLT-REY - List A Word 6
AVL0207 [C123689]	AVLT-REY - List A Word 7
AVL0208 [C123690]	AVLT-REY - List A Word 8
AVL0209 [C123691]	AVLT-REY - List A Word 9
AVL0210 [C123692]	AVLT-REY - List A Word 10
AVL0211 [C123693]	AVLT-REY - List A Word 11
AVL0212 [C123694]	AVLT-REY - List A Word 12
AVL0213 [C123695]	AVLT-REY - List A Word 13
AVL0214 [C123696]	AVLT-REY - List A Word 14
AVL0215 [C123697]	AVLT-REY - List A Word 15
AVL0216 [C123698]	AVLT-REY - List A Total
AVL0217 [C123699]	AVLT-REY - List A Intrusions
AVL0218 [C123700]	AVLT-REY - List B Word 1
AVL0219 [C123701]	AVLT-REY - List B Word 2
AVL0220 [C123702]	AVLT-REY - List B Word 3
AVL0221 [C123703]	AVLT-REY - List B Word 4
AVL0222 [C123704]	AVLT-REY - List B Word 5
AVL0223 [C123705]	AVLT-REY - List B Word 6
AVL0224 [C123706]	AVLT-REY - List B Word 7
AVL0225 [C123707]	AVLT-REY - List B Word 8
AVL0226 [C123708]	AVLT-REY - List B Word 9
AVL0227 [C123709]	AVLT-REY - List B Word 10
AVL0228 [C123710]	AVLT-REY - List B Word 11
AVL0229 [C123711]	AVLT-REY - List B Word 12
AVL0230 [C123712]	AVLT-REY - List B Word 13
AVL0231 [C123713]	AVLT-REY - List B Word 14
AVL0232 [C123714]	AVLT-REY - List B Word 15
AVL0233 [C123715]	AVLT-REY - List B Total
AVL0234 [C123716]	AVLT-REY - List B Intrusions

Rey Auditory Verbal Learning Test Functional Test Response[Non Standard]

Permitted Value (Code)	Display Value (Decode)
RECALLED	Recalled
NOT RECALLED	Not Recalled

Rey Auditory Verbal Learning Test Functional Test Name [C123654][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)
AVL02- List B Total [C123715]
AVL02-List A Intrusions [C123699]
AVL02-List A Total [C123698]
AVL02-List A Word 1 [C123683]
AVL02-List A Word 10 [C123692]
AVL02-List A Word 11 [C123693]
AVL02-List A Word 12 [C123694]
AVL02-List A Word 13 [C123695]
AVL02-List A Word 14 [C123696]
AVL02-List A Word 15 [C123697]
AVL02-List A Word 2 [C123684]
AVL02-List A Word 3 [C123685]
AVL02-List A Word 4 [C123686]
AVL02-List A Word 5 [C123687]
AVL02-List A Word 6 [C123688]
AVL02-List A Word 7 [C123689]
AVL02-List A Word 8 [C123690]
AVL02-List A Word 9 [C123691]
AVL02-List B Intrusions [C123716]
AVL02-List B Word 1 [C123700]
AVL02-List B Word 10 [C123709]
AVL02-List B Word 11 [C123710]
AVL02-List B Word 12 [C123711]
AVL02-List B Word 13 [C123712]
AVL02-List B Word 14 [C123713]
AVL02-List B Word 15 [C123714]
AVL02-List B Word 2 [C123701]
AVL02-List B Word 3 [C123702]
AVL02-List B Word 4 [C123703]
AVL02-List B Word 5 [C123704]
AVL02-List B Word 6 [C123705]
AVL02-List B Word 7 [C123706]
AVL02-List B Word 8 [C123707]
AVL02-List B Word 9 [C123708]

Death Details Tests [C116107][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)
Primary Cause of Death [C99531]

Death Details Test Codes [C116108][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
PRCDTH [C99531]	Primary Cause of Death

Device Identifier Element Name [C106480][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)
Device Type [C53265]
Serial Number [C73518]

Device Identifier Element Short Name [C106481][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
DEVTYPE [C53265]	Device Type
SERIAL [C73518]	Serial Number

SDTM Domain Abbreviation, subset used for Adverse Events [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
AE [C49562]	Adverse Events

SDTM Domain Abbreviation, subset used for Concomitant Meds [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
CM [C49568]	Concomitant/Prior Medications

SDTM Domain Abbreviation, subset used for Death Diagnosis [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
DD [C95087]	Death Details

SDTM Domain Abbreviation, subset used for Device Identifiers [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
DI [C102618]	Device Identifiers

SDTM Domain Abbreviation, subset used for Demographics [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
DM [C49572]	Demographics

SDTM Domain Abbreviation, subset used for Disposition [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
DS [C49576]	Disposition

SDTM Domain Abbreviation, subset used for Exposure as Collected [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
EC [C117466]	Exposure as Collected

SDTM Domain Abbreviation, subset used for Exposure [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
EX [C49587]	Exposure

SDTM Domain Abbreviation, subset used for Findings About Events or Interventions [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
FA [C85442]	Findings About Events or Interventions

SDTM Domain Abbreviation, subset used for Functional Tests [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
FT [C117756]	Functional Tests

SDTM Domain Abbreviation, subset used for Inclusion/Exclusion [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
IE [C61536]	Inclusion/Exclusion Criteria Not Met

SDTM Domain Abbreviation, subset used for Laboratory Data [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
LB [C49592]	Laboratory Test Results

SDTM Domain Abbreviation, subset used for Medical History [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
MH [C49603]	Medical History

SDTM Domain Abbreviation, subset used for Nervous System Findings [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
NV [C49592]	Nervous Sysytem Findings

SDTM Domain Abbreviation, subset used for Ophthalmic Examinations [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
OE [C147180]	Ophthalmic Examinations

SDTM Domain Abbreviation, subset used for Questionnaires [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
QS [C49609]	Questionnaires

SDTM Domain Abbreviation, subset used for Disease Response and Clin Classification [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
RS [C107097]	Disease Response and Clin Classification

SDTM Domain Abbreviation, subset used for Subject Element [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
SE [C49616]	Subject Elements

SDTM Domain Abbreviation, subset used for Subject Visits [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
SV [C49617]	Subject Visits

SDTM Domain Abbreviation, subset used for Trial Arms [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
TA [C49618]	Trial Arms

SDTM Domain Abbreviation, subset used for Trial Elements [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
TE [C49619]	Trial Elements

SDTM Domain Abbreviation, subset used for Trial Inclusion/Exclusion Criteria [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
TI [C49620]	Trial Inclusion

SDTM Domain Abbreviation, subset used for Trial Summary [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
TS [C53483]	Trial Summary

SDTM Domain Abbreviation, subset used for Trial Visits [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
TV [C49621]	Trial Visits

SDTM Domain Abbreviation, subset used for Vital Signs [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
VS [C49622]	Vital Signs

Category for Disposition Event [C74558][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
DISPOSITION EVENT [C74590]	Disposition Event
PROTOCOL MILESTONE [C74588]	Protocol Milestone

Subcategory for Disposition Event[Non Standard]

Permitted Value (Code)	Display Value (Decode)
STUDY TREATMENT	Study Treatment
STUDY PARTICIPATION	Study Participation

Element[Non Standard]

Permitted Value (Code)
Screening
Placebo
Zanomaline 54 mg
Zanomaline 54 mg Titration
Zanomaline 81 mg

Relation to Reference Period, subset used for AE and CM. [C66728][CDISC/NCI SDTM 2020-12-18]

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

Epoch [C99079][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
SCREENING [C48262]	Screening
TREATMENT [C101526]	Treatment

Element Code[Non Standard]

Permitted Value (Code)	Display Value (Decode)
HIGH	Zanomaline 81 mg
LOW	Zanomaline 54 mg
PLACEBO	Placebo
SCREEN	Screening
TITRATE	Zanomaline 54 mg Titration

Ethnic Group Hispanic [C66790][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
HISPANIC OR LATINO [C17459]	Hispanic or Latino
NOT HISPANIC OR LATINO [C17459]	Not Hispanic or Latino

Study Treatment[Non Standard]

Permitted Value (Code)	Display Value (Decode)
PLACEBO	Placebo
ZANOMALINE	Zanomaline

FA Category[Non Standard]

Permitted Value (Code)	Display Value (Decode)
INJECTION SITE REACTION	Injection Site Reaction

FA Object[Non Standard]

Permitted Value (Code)	Display Value (Decode)
ERYTHEMA	Erythema
PAIN	Pain
INDURATION	Induration
PRURITUS	Pruritus
EDEMA	Edema

Occurrence [C66742][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
N [C49487]	No
Y [C49488]	Yes

Severity [C66769][CDISC/NCI SDTM 2020-12-18]

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

Findings About Adverse Events Test Name[Non Standard]

Permitted Value (Code)
Occurrence Indicator
Severity/Intensity

Findings About Adverse Events Test Code[Non Standard]

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

Frequency, subset used for CM [C71113][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
QD [C25473]	Daily
PRN [C64499]	As Needed
BID [C64496]	Twice Daily
Q4H [C64518]	Every Four Hours
QID [C64530]	Four Times Daily
Q6H [C64520]	Every Six Hours

Frequency, subset used for EC and EX [C71113][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
QD [C25473]	Daily

Dose Form, subset used for EC and EX [C66726][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
INJECTION [C42946]	Injectable Dosage Form

Category of Functional Test, subset used for FTCAT [C115304][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
AVLT-REY [C123668]	Rey Auditory Verbal Learning Functional Test

Hamilton Depression Rating Scale - 17 Item - Question 1[Non Standard]

Permitted Value (Code)
Absent.
These feeling states indicated only on questioning.
These feeling states spontaneously reported verbally.
Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and tendency to weep.
Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal communication.

Hamilton Depression Rating Scale - 17 Item - Question 1 Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	Absent.
1	These feeling states indicated only on questioning.
2	These feeling states spontaneously reported verbally.
3	Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and tendency to weep.
4	Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal communication.

Hamilton Depression Rating Scale - 17 Item - Question 2[Non Standard]

Permitted Value (Code)
Absent.
Self reproach, feels he/she has let people down.
Ideas of guilt or rumination over past errors or sinful deeds.
Present illness is a punishment. Delusions of guilt.
Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations.

Hamilton Depression Rating Scale - 17 Item - Question 2 Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	Absent.
1	Self reproach, feels he/she has let people down.
2	Ideas of guilt or rumination over past errors or sinful deeds.
3	Present illness is a punishment. Delusions of guilt.
4	Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations.

Hamilton Depression Rating Scale - 17 Item - Question 3[Non Standard]

Permitted Value (Code)
Absent.
Feels life is not worth living.
Wishes he/she were dead or any thoughts of possible death to self.
Ideas or gestures of suicide.
Attempts at suicide (any serious attempt rate 4).

Hamilton Depression Rating Scale - 17 Item - Question 3 Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	Absent.
1	Feels life is not worth living.
2	Wishes he/she were dead or any thoughts of possible death to self.
3	Ideas or gestures of suicide.
4	Attempts at suicide (any serious attempt rate 4).

Hamilton Depression Rating Scale - 17 Item - Question 4[Non Standard]

Permitted Value (Code)
No difficulty falling asleep.
Complains of occasional difficulty falling asleep, i.e. more than 1/2 hour
Complains of nightly difficulty falling asleep.

Hamilton Depression Rating Scale - 17 Item - Question 4 Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	No difficulty falling asleep.
1	Complains of occasional difficulty falling asleep, i.e. more than 1/2 hour
2	Complains of nightly difficulty falling asleep.

Hamilton Depression Rating Scale - 17 Item - Question 5[Non Standard]

Permitted Value (Code)
No difficulty.
Patient complains of being restless and disturbed during the night.
Waking during the night - any getting out of bed rates 2 (except for purposes of voiding).

Hamilton Depression Rating Scale - 17 Item - Question 5 Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	No difficulty.
1	Patient complains of being restless and disturbed during the night.
2	Waking during the night - any getting out of bed rates 2 (except for purposes of voiding).

Hamilton Depression Rating Scale - 17 Item - Question 6[Non Standard]

Permitted Value (Code)
No difficulty.
Waking in early hours of the morning but goes back to sleep.
Unable to fall asleep again if he/she gets out of bed.

Hamilton Depression Rating Scale - 17 Item - Question 6 Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	No difficulty.
1	Waking in early hours of the morning but goes back to sleep.
2	Unable to fall asleep again if he/she gets out of bed.

Hamilton Depression Rating Scale - 17 Item - Question 7[Non Standard]

Permitted Value (Code)
No difficulty.
Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies.
Loss of interest in activity, hobbies or work - either directly reported by the patient or indirect in listlessness, indecision and vacillation (feels he/she has to push self to work or activities).
Decrease in actual time spent in activities or decrease in productivity. Rate 3 if the patient does not spend at least three hours a day in activities (job or hobbies) excluding routine chores.
Stopped working because of present illness. Rate 4 if patient engages in no activities except routine chores, or if patient fails to perform routine chores unassisted.

Hamilton Depression Rating Scale - 17 Item - Question 7 Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	No difficulty.
1	Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies.
2	Loss of interest in activity, hobbies or work - either directly reported by the patient or indirect in listlessness, indecision and vacillation (feels he/she has to push self to work or activities).
3	Decrease in actual time spent in activities or decrease in productivity. Rate 3 if the patient does not spend at least three hours a day in activities (job or hobbies) excluding routine chores.
4	Stopped working because of present illness. Rate 4 if patient engages in no activities except routine chores, or if patient fails to perform routine chores unassisted.

Hamilton Depression Rating Scale - 17 Item - Question 8[Non Standard]

Permitted Value (Code)
Normal speech and thought.
Slight retardation during the interview.
Obvious retardation during the interview.
Interview difficult.
Complete stupor.

Hamilton Depression Rating Scale - 17 Item - Question 8 Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	Normal speech and thought.
1	Slight retardation during the interview.
2	Obvious retardation during the interview.
3	Interview difficult.
4	Complete stupor.

Hamilton Depression Rating Scale - 17 Item - Question 9[Non Standard]

Permitted Value (Code)
None.
Fidgetiness.
Playing with hands, hair, etc.
Moving about, cannot sit still.
Hand wringing, nail biting, hair-pulling, biting of lips.

Hamilton Depression Rating Scale - 17 Item - Question 9 Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	None.
1	Fidgetiness.
2	Playing with hands, hair, etc.
3	Moving about, cannot sit still.
4	Hand wringing, nail biting, hair-pulling, biting of lips.

Hamilton Depression Rating Scale - 17 Item - Question 10[Non Standard]

Permitted Value (Code)
No difficulty.
Subjective tension and irritability.
Worrying about minor matters.
Apprehensive attitude apparent in face or speech.
Fears expressed without questioning.

Hamilton Depression Rating Scale - 17 Item - Question 10 Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	No difficulty.
1	Subjective tension and irritability.
2	Worrying about minor matters.
3	Apprehensive attitude apparent in face or speech.
4	Fears expressed without questioning.

Hamilton Depression Rating Scale - 17 Item - Question 11[Non Standard]

Permitted Value (Code)
Absent.
Mild.
Moderate.
Severe.
Incapacitating.

Hamilton Depression Rating Scale - 17 Item - Question 11 Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	Absent.
1	Mild.
2	Moderate.
3	Severe.
4	Incapacitating.

Hamilton Depression Rating Scale - 17 Item - Question 12[Non Standard]

Permitted Value (Code)
None.
Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen.
Difficulty eating without staff urging. Requests or requires laxatives or medication for bowels or medication for gastro-intestinal symptoms.

Hamilton Depression Rating Scale - 17 Item - Question 12 Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	None.
1	Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen.
2	Difficulty eating without staff urging. Requests or requires laxatives or medication for bowels or medication for gastro-intestinal symptoms.

Hamilton Depression Rating Scale - 17 Item - Question 13[Non Standard]

Permitted Value (Code)
None.
Heaviness in limbs, back or head. Backaches, headaches, muscle aches. Loss of energy and fatigability.
Any clear-cut symptom rates 2.

Hamilton Depression Rating Scale - 17 Item - Question 13 Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	None.
1	Heaviness in limbs, back or head. Backaches, headaches, muscle aches. Loss of energy and fatigability.
2	Any clear-cut symptom rates 2.

Hamilton Depression Rating Scale - 17 Item - Question 14[Non Standard]

Permitted Value (Code)
Absent.
Mild.
Severe.

Hamilton Depression Rating Scale - 17 Item - Question 14 Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	Absent.
1	Mild.
2	Severe.

Hamilton Depression Rating Scale - 17 Item - Question 15[Non Standard]

Permitted Value (Code)
Not present.
Self-absorption (bodily).
Preoccupation with health.
Frequent complaints, requests for help, etc.
Hypochondriacal delusions.

Hamilton Depression Rating Scale - 17 Item - Question 15 Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	Not present.
1	Self-absorption (bodily).
2	Preoccupation with health.
3	Frequent complaints, requests for help, etc.
4	Hypochondriacal delusions.

Hamilton Depression Rating Scale - 17 Item - Question 16A[Non Standard]

Permitted Value (Code)
No weight loss.
Probable weight loss associated with present illness.
Definite (according to patient) weight loss.
Not assessed.

Hamilton Depression Rating Scale - 17 Item - Question 16A Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	No weight loss.
1	Probable weight loss associated with present illness.
2	Definite (according to patient) weight loss.
3	Not assessed.

Hamilton Depression Rating Scale - 17 Item - Question 16B[Non Standard]

Permitted Value (Code)
Less than 1 lb weight loss in week.
Greater than 1 lb weight loss within week.
Greater than 2 lb weight loss in week.
Not assessed.

Hamilton Depression Rating Scale - 17 Item - Question 16B Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	Less than 1 lb weight loss in week.
1	Greater than 1 lb weight loss within week.
2	Greater than 2 lb weight loss in week.
3	Not assessed.

Hamilton Depression Rating Scale - 17 Item - Question 17[Non Standard]

Permitted Value (Code)
Acknowledges being depressed and ill.
Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc.
Denies being ill at all.

Hamilton Depression Rating Scale - 17 Item - Question 17 Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	Acknowledges being depressed and ill.
1	Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc.
2	Denies being ill at all.

Hamilton Depression Rating Scale - 17 Item Clinical Classification Test Code [C100138][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
HAMD101 [C100398]	HAMD1-Depressed Mood
HAMD102 [C100399]	HAMD1-Feelings of Guilt
HAMD103 [C100400]	HAMD1-Suicide
HAMD104 [C100401]	HAMD1-Insomnia Early - Early Night
HAMD105 [C100402]	HAMD1-Insomnia Middle - Middle Night
HAMD106 [C100403]	HAMD1-Insomnia Early Hours - Morning
HAMD107 [C100404]	HAMD1-Work and Activities
HAMD108 [C100405]	HAMD1-Retardation
HAMD109 [C100406]	HAMD1-Agitation
HAMD110 [C100407]	HAMD1-Anxiety Psychic
HAMD111 [C100408]	HAMD1-Anxiety Somatic
HAMD112 [C100409]	HAMD1-Somatic Symptoms GI
HAMD113 [C100410]	HAMD1-General Somatic Symptoms
HAMD114 [C100411]	HAMD1-Genital Symptoms
HAMD115 [C100412]	HAMD1-Hypochondriasis
HAMD116A [C100413]	HAMD1-Loss of WT According to Patient
HAMD116B [C100414]	HAMD1-Loss of WT According to WK Meas
HAMD117 [C100415]	HAMD1-Insight
HAMD118 [C100416]	HAMD1-Total Score

Hamilton Depression Rating Scale - 17 Item Clinical Classification Test Name [C100137][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)
HAMD1-Depressed Mood [C100398]
HAMD1-Feelings of Guilt [C100399]
HAMD1-Suicide [C100400]
HAMD1-Insomnia Early - Early Night [C100401]
HAMD1-Insomnia Middle - Middle Night [C100402]
HAMD1-Insomnia Early Hours - Morning [C100403]
HAMD1-Work and Activities [C100404]
HAMD1-Retardation [C100405]
HAMD1-Agitation [C100406]
HAMD1-Anxiety Psychic [C100407]
HAMD1-Anxiety Somatic [C100408]
HAMD1-Somatic Symptoms GI [C100409]
HAMD1-General Somatic Symptoms [C100410]
HAMD1-Genital Symptoms [C100411]
HAMD1-Hypochondriasis [C100412]
HAMD1-Loss of WT According to Patient [C100413]
HAMD1-Loss of WT According to WK Meas [C100414]
HAMD1-Insight [C100415]
HAMD1-Total Score [C100416]

Category for Inclusion/Exclusion [C66797][CDISC/NCI SDTM 2020-12-18]

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

Inclusion/Exclusion Criterion[Non Standard]

Permitted Value (Code)
Males and postmenopausal females at least 50 years of age.
Diagnosis of probable AD as defined by NINCDS and the ADRDA guidelines.
MMSE score of 10 to 23.
Modified Hachinski Ischemic Scale score of <= 4.
CNS imaging (CT scan or MRI of brain) compatible with AD within past 1 year. (See Protocol for incompatible findings.)
Investigator has obtained informed consent signed by the patient (and/or legal representative) and by the caregiver.
Geographic proximity to investigator's site that allows adequate follow-up.
Caregiver will monitor administration of prescribed medications, and will be responsible for the overall care of the patient at home.
Persons who have previously completed or withdrawn from this study or any other investigating xanomeline TTS or the oral formulation of Zanomaline.
Use of any investigational agent or approved Alzheimer's therapeutic medication within 30 days prior to enrollment into the study.
Serious illness which required hospitalization within 3 months of screening.
Diagnosis of serious neurological conditions (See Protocol)
Diagnosis of serious neurological conditions (See Amendment 1)
Episode of depression meeting DSM-IV criteria within 3 months of screening.
A history within the last 5 years of the following: a) Schizophrenia b) Bipolar Disease c) Ethanol or psychoactive drug abuse or dependence.
A history of syncope within the last 5 years.
Evidence from ECG recording at screening of any of the following conditions: a) Left bundle branch block b) Bradycardia <50 beats per minute c) Sinus pauses >2 seconds (See Protocol for Remainder)
A history within the last 5 years of a serious cardiovascular disorder, including a) Clinically significant arrhythmia (See Protocol for Remainder)
A history within the last 5 years of a serious gastrointestinal disorder, including a) Chronic peptic/duodenal/gastric/esophageal ulcer that are untreated or refractory to treatment(See Protocol)
A history within the last 5 years of a serious endocrine disorder, including a) Uncontrolled Insulin Dependent Diabetes Mellitus (IDDM) (See Protocol for other excluded disorders)
A history within the last 5 years of a serious respiratory disorder, including a) Asthma with bronchospasm refractory to treatment b) Decompensated chronic obstructive pulmonary disease.
A history within the last 5 years of a serious genitourinary disorder, including a) Renal failure b) Uncontrolled urinary retention
A history within the last 5 years of a serious rheumatologic disorder, including a) Lupus b) Temporal arteritis c) Severe rheumatoid arthritis
A known history of human immunodeficiency virus (HIV) within the last 5 years.
A history within the last 5 years of a serious infectious disease including a) Neurosyphilis b) Meningitis c) Encephalitis
A history within the last 5 years of a primary or recurrent malignant disease (See Exceptions in Protocol).
Visual, hearing, or communication disabilities impairing the ability to participate in the study; (for example, inability to speak or understand English, illiteracy).
Laboratory test values exceeding the Reference Range III for the patient's age in any of the following analytes: creatinine, total bilirubin, SGOT, SGPT, (See Protocol for Additional Analytes)
Central laboratory test values below reference range for folate, and vitamin B12, and outside reference range for thyroid function tests.
Positive syphilis screening with confirmatory testing.
Central laboratory test value above reference range for glycosylated hemoglobin (A1C) (insulin dependent diabetes mellitus patients only).
Treatment with medications within 1 month prior to enrollment (See Protocol)
Treatment with medications within 1 month prior to enrollment a) Anticonvulsants b) Alpha receptor blockers c) Calcium channel blockers that are CNS active (See Amendment 1)

Incl/Excl Criterion Short Name[Non Standard]

Permitted Value (Code)	Display Value (Decode)
INCL01	Males and postmenopausal females at least 50 years of age.
INCL02	Diagnosis of probable AD as defined by NINCDS and the ADRDA guidelines.
INCL03	MMSE score of 10 to 23.
INCL04	Modified Hachinski Ischemic Scale score of <= 4.
INCL05	CNS imaging (CT scan or MRI of brain) compatible with AD within past 1 year. (See Protocol for incompatible findings.)
INCL06	Investigator has obtained informed consent signed by the patient (and/or legal representative) and by the caregiver.
INCL07	Geographic proximity to investigator's site that allows adequate follow-up.
INCL08	Caregiver will monitor administration of prescribed medications, and will be responsible for the overall care of the patient at home.
EXCL09	Persons who have previously completed or withdrawn from this study or any other investigating xanomeline TTS or the oral formulation of Zanomaline.
EXCL10	Use of any investigational agent or approved Alzheimer's therapeutic medication within 30 days prior to enrollment into the study.
EXCL11	Serious illness which required hospitalization within 3 months of screening.
EXCL12	Diagnosis of serious neurological conditions
EXCL13	Episode of depression meeting DSM-IV criteria within 3 months of screening.
EXCL14	A history within the last 5 years of the following: a) Schizophrenia b) Bipolar Disease c) Ethanol or psychoactive drug abuse or dependence.
EXCL15	A history of syncope within the last 5 years.
EXCL16	Evidence from ECG recording at screening of any of the following conditions: a) Left bundle branch block b) Bradycardia <50 beats per minute c) Sinus pauses >2 seconds (See Protocol for Remainder)
EXCL17	A history within the last 5 years of a serious cardiovascular disorder, including a) Clinically significant arrhythmia (See Protocol for Remainder)
EXCL18	A history within the last 5 years of a serious gastrointestinal disorder, including a) Chronic peptic/duodenal/gastric/esophageal ulcer that are untreated or refractory to treatment(See Protocol)
EXCL19	A history within the last 5 years of a serious endocrine disorder, including a) Uncontrolled Insulin Dependent Diabetes Mellitus (IDDM) (See Protocol for other excluded disorders)
EXCL20	A history within the last 5 years of a serious respiratory disorder, including a) Asthma with bronchospasm refractory to treatment b) Decompensated chronic obstructive pulmonary disease.
EXCL21	A history within the last 5 years of a serious genitourinary disorder, including a) Renal failure b) Uncontrolled urinary retention
EXCL22	A history within the last 5 years of a serious rheumatologic disorder, including a) Lupus b) Temporal arteritis c) Severe rheumatoid arthritis
EXCL23	A known history of human immunodeficiency virus (HIV) within the last 5 years.
EXCL24	A history within the last 5 years of a serious infectious disease including a) Neurosyphilis b) Meningitis c) Encephalitis
EXCL25	A history within the last 5 years of a primary or recurrent malignant disease (See Exceptions in Protocol).
EXCL26	Visual, hearing, or communication disabilities impairing the ability to participate in the study; (for example, inability to speak or understand English, illiteracy).
EXCL27	Laboratory test values exceeding the Reference Range III for the patient's age in any of the following analytes: creatinine, total bilirubin, SGOT, SGPT, (See Protocol for Additional Analytes)
EXCL28	Central laboratory test values below reference range for folate, and vitamin B12, and outside reference range for thyroid function tests.
EXCL29	Positive syphilis screening with confirmatory testing.
EXCL30	Central laboratory test value above reference range for glycosylated hemoglobin (A1C) (insulin dependent diabetes mellitus patients only).
EXCL31	Treatment with medications within 1 month prior to enrollment a) Anticonvulsants b) Alpha receptor blockers c) Calcium channel blockers that are CNS active
EXCL12A	Diagnosis of serious neurological conditions (Amend 1)
EXCL31A	Treatment with medications within 1 month prior to enrollment a) Anticonvulsants b) Alpha receptor blockers c) Calcium channel blockers that are CNS active (Amend 1)

Intervention Model Response [C99076][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
PARALLEL [C82639]	Parallel

Intervention Type Response [C99078][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
DRUG [C1909]	Drug

Laterality, subset to be used in OE [C99073][CDISC/NCI SDTM 2020-12-18]

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

Laboratory Test Category[Non Standard]

Permitted Value (Code)	Display Value (Decode)
CHEMISTRY	Chemistry
HEMATOLOGY	Hematology
URINALYSIS	Urinalysis
OTHER	Other

Laboratory Test Name [C67154][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)
Albumin [C64431]
Alkaline Phosphatase [C64432]
Alanine Aminotransferase [C64433]
Anisocytes; Anisocytosis [C74797]
Aspartate Aminotransferase [C64467]
Basophils [C64470]
Bilirubin [C38037]
Calcium [C64488]
Cholesterol [C105586]
Creatine Kinase [C64489]
Chloride [C64495]
Color [C64546]
Creatinine [C64547]
Eosinophils [C64550]
Gamma Glutamyl Transferase [C64847]
Glucose [C105585]
Hematocrit [C64796]
Hemoglobin [C64848]
Potassium [C64853]
Ketones [C64854]
Lymphocytes [C51949]
Macrocytes [C64821]
Ery. Mean Corpuscular Hemoglobin [C64797]
Ery. Mean Corpuscular HGB Concentration [C64798]
Ery. Mean Corpuscular Volume [C64799]
Monocytes [C64823]
pH [C45997]
Phosphate [C64857]
Platelets [C51951]
Poikilocytes [C79602]
Protein [C64858]
Erythrocytes [C51946]
Sodium [C64809]
Specific Gravity [C64832]
Thyrotropin [C64813]
Urate [C64814]
Urea Nitrogen [C125949]
Urobilinogen [C64816]
Vitamin B12 [C64817]
Leukocytes [C51948]

Laboratory Test Code [C65047][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
ALB [C64431]	Albumin Measurement
ALP [C64432]	Alkaline Phosphatase Measurement
ALT [C64433]	Alanine Aminotransferase Measurement
ANISO [C74797]	Anisocyte Measurement
AST [C64467]	Aspartate Aminotransferase Measurement
BASO [C64470]	Total Basophil Count
BILI [C38037]	Total Bilirubin Measurement
CA [C64488]	Calcium Measurement
CHOL [C105586]	Cholesterol Measurement
CK [C64489]	Creatine Kinase Measurement
CL [C64495]	Chloride Measurement
COLOR [C64546]	Color Assessment
CREAT [C64547]	Creatinine Measurement
EOS [C64550]	Eosinophil Count
GGT [C64847]	Gamma Glutamyl Transpeptidase Measurement
GLUC [C105585]	Glucose Measurement
HCT [C64796]	Hematocrit Measurement
HGB [C64848]	Hemoglobin Measurement
K [C64853]	Potassium Measurement
KETONES [C64854]	Ketone Measurement
LYM [C51949]	Lymphocyte Count
MACROCY [C64821]	Macrocyte Count
MCH [C64797]	Erythrocyte Mean Corpuscular Hemoglobin
MCHC [C64798]	Erythrocyte Mean Corpuscular Hemoglobin Concentration
MCV [C64799]	Erythrocyte Mean Corpuscular Volume
MONO [C64823]	Monocyte Count
PH [C45997]	pH
PHOS [C64857]	Phosphate Measurement
PLAT [C51951]	Platelet Count
POIKILO [C79602]	Poikilocyte Measurement
PROT [C64858]	Total Protein Measurement
RBC [C51946]	Erythrocyte Count
SODIUM [C64809]	Sodium Measurement
SPGRAV [C64832]	Specific Gravity
TSH [C64813]	Thyrotropin Measurement
URATE [C64814]	Urate Measurement
UREAN [C125949]	Urea Nitrogen Measurement
UROBIL [C64816]	Urobilinogen Measurement
VITB12 [C64817]	Vitamin B12 Measurement
WBC [C51948]	Leukocyte Count

Location [C74456][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)
ARM [C32141]

Anatomical Location, subset used for OELOC [C74456][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
CONJUNCTIVA [C12341]	Conjunctiva
EYE [C12401]	Eye
EYE, ANTERIOR CHAMBER [C12667]	Anterior Chamber of the Eye
IRIS [C12737]	Iris
CORNEA [C12342]	Cornea

Anatomical Location [C74456][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
EAR [C12394]	Ear
ORAL CAVITY [C12421]	Oral Cavity

Medical History Event Date Type, subset used for MHEVDTP [C124301][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
SYMPTOM ONSET [C124353]	Symptom Onset

Medical History Term[Non Standard]

Permitted Value (Code)	Display Value (Decode)
ALZHEIMER'S DISEASE	Alzheimer's Disease

Completion/Reason for Non-Completion [C66727][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
ADVERSE EVENT [C41331]	Adverse Event
COMPLETED [C25250]	Completed
DEATH [C28554]	Death
LACK OF EFFICACY [C48226]	Lack of Efficacy
LOST TO FOLLOW-UP [C48227]	Lost to Follow-Up
OTHER [C17649]	Other
PHYSICIAN DECISION [C48250]	Physician Decision
PREGNANCY [C25742]	Pregnancy
PROTOCOL DEVIATION [C48251]	Protocol Deviation
SCREEN FAILURE [C49628]	Screen Failure
STUDY TERMINATED BY SPONSOR [C49632]	Study Terminated By Sponsor
WITHDRAWAL BY PARENT/GUARDIAN [C102355]	Withdrawal By Parent/Guardian
WITHDRAWAL BY SUBJECT [C49634]	Withdrawal By Subject

Not Done [C66789][CDISC/NCI SDTM 2020-12-18]

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

Normal Abnormal Response, subset used in OE and NV. [C101834][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
ABNORMAL [C25401]	Abnormal
NORMAL [C14165]	Normal

Normal Range Indicator [C78736][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
ABNORMAL [C78802]	Abnormal
HIGH [C78800]	High
LOW [C78801]	Low
NORMAL [C78727]	Normal

Nervous System Test [C116103][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)
Interpretation [*]

* Extended Value

Nervous System Test Code [C116104][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
INTP [*]	Interpretation

* Extended Value

No Yes Response, subset for variables with only "Y" or "N" val [C66742][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
N [C49487]	No
Y [C49488]	Yes

No Yes Response, subset for variables with only "Y" or null values [C66742][CDISC/NCI SDTM 2020-12-18]

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

Ophthalmic Focus of Study Specific Interest [C119013][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
OD [C119333]	Right Eye
OS [C119334]	Left Eye

Method, subset used for OEMETHOD [C85492][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
SLIT LAMP [C75583]	Slit-lamp Examination

Ophthalmic Exam Test [C117742][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)
Abnormality Detail [*]
Interpretation [C41255]

* Extended Value

Ophthalmic Exam Test Code [C117743][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
ABDETAIL [*]	Abnormality Detail
INTP [C41255]	Interpretation

* Extended Value

Outcome of Event [C66768][CDISC/NCI SDTM 2020-12-18]

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

Patient Health Questionnaire - 9 Item Questionnaire Test Code [C103481][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
PHQ0101 [C103705]	PHQ01-Little Interest/Pleasure in Things
PHQ0102 [C103706]	PHQ01-Feeling Down Depressed or Hopeless
PHQ0103 [C103707]	PHQ01-Trouble Falling or Staying Asleep
PHQ0104 [C103708]	PHQ01-Feeling Tired or Little Energy
PHQ0105 [C103709]	PHQ01-Poor Appetite or Overeating
PHQ0106 [C103710]	PHQ01-Feeling Bad About Yourself
PHQ0107 [C103711]	PHQ01-Trouble Concentrating on Things
PHQ0108 [C103712]	PHQ01-Moving Slowly or Fidgety/Restless
PHQ0109 [C103713]	PHQ01-Thoughts You Be Better Off Dead
PHQ0110 [C103714]	PHQ01-Difficult to Work/Take Care Things
PHQ0111 [C113887]	PHQ01-Total Score

Patient Health Questionnaire Responses[Non Standard]

Permitted Value (Code)
Not at all
Several days
More than half the days
Nearly every day

Patient Health Questionnaire Responses-Question 10[Non Standard]

Permitted Value (Code)
Not difficult at all
Somewhat difficult
Very difficult
Extremely Difficult

Patient Health Questionnaire Responses Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
0	Not at all
1	Several days
2	More than half the days
3	Nearly every day

Patient Health Questionnaire - 9 Item Questionnaire Test Name [C103480][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)
PHQ01-Difficult to Work/Take Care Things [C103714]
PHQ01-Feeling Bad About Yourself [C103710]
PHQ01-Feeling Down Depressed or Hopeless [C103706]
PHQ01-Feeling Tired or Little Energy [C103708]
PHQ01-Little Interest/Pleasure in Things [C103705]
PHQ01-Moving Slowly or Fidgety/Restless [C103712]
PHQ01-Poor Appetite or Overeating [C103709]
PHQ01-Thoughts You Be Better Off Dead [C103713]
PHQ01-Total Score [C113887]
PHQ01-Trouble Concentrating on Things [C103711]
PHQ01-Trouble Falling or Staying Asleep [C103707]

Position, subset to be used for VSPOS [C71148][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
STANDING [C62166]	Standing
SUPINE [C62167]	Supine

Protocol Milestone [C114118][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
INFORMED CONSENT OBTAINED [C16735]	Informed Consent

Category of Questionnaire for PHQ-9 [C100129][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
PHQ-9 [C103526]	Patient Health Questionnaire - 9 Item

Category of Questionnaire for SWLS [C100129][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
SWLS [C115799]	Satisfaction With Life Scale Questionnaire

Race [C74457][CDISC/NCI SDTM 2020-12-18]

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
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER [C41219]	Native Hawaiian Or Other Pacific Islander
WHITE [C41261]	White

Race Multiple Selections[Non Standard]

Permitted Value (Code)	Display Value (Decode)
MULTIPLE	Multiple

SDTM Domain Abbreviation, subset used for RELREC [C66734][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
AE [C49562]	Adverse Events
DS [C49576]	Disposition
DD [C95087]	Death Details
FA [C85442]	Findings About Events or Interventions

Relationship Type [C78737][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
MANY [C78728]	Many
ONE [C66832]	One

Route of Administration, subset to be used for CM [C66729][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
ORAL [C38288]	Oral
TOPICAL [C38304]	Topical
INTRAVENOUS [C38276]	Intravenous
NASAL [C38284]	Nasal
RESPIRATORY (INHALATION) [C38216]	Inhalation Route of Administration
TRANSDERMAL [C38305]	Transdermal

Route of Administration, subset to be used for EC and EX [C66729][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
SUBCUTANEOUS [C38299]	Subcutaneous Route of Administration

Category of Clinical Classification, subset to be used for RSCAT [C118971][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
HAMD 17 [C100767]	Hamilton Depression Rating Scale 17 Item Clinical Classification

Sex Male Female [C66731][CDISC/NCI SDTM 2020-12-18]

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

Site Identifier[Non Standard]

Permitted Value (Code)
701
704
708
710
711
718

Study Type Response [C99077][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
INTERVENTIONAL [C98388]	Interventional

Satisfaction With Life Scale Questionnaire Test Code [C115408][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
SWLS0101 [C115895]	SWLS01-Have Gotten Important Things
SWLS0102 [C115896]	SWLS01-I Am Satisfied with My Life
SWLS0103 [C115897]	SWLS01-Live Life Over Change Nothing
SWLS0104 [C115898]	SWLS01-My Life Conditions are Excellent
SWLS0105 [C115899]	SWLS01-My Life is Close to Ideal

Satisfaction With Life Scale Questionnaire Test Name [C115407][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)
SWLS01-Have Gotten Important Things [C115898]
SWLS01-I Am Satisfied with My Life [C115897]
SWLS01-Live Life Over Change Nothing [C115899]
SWLS01-My Life Conditions are Excellent [C115896]
SWLS01-My Life is Close to Ideal [C115895]

SWLS-Responses[Non Standard]

Permitted Value (Code)
Strongly disagree
Disagree
Slightly disagree
Neither agree nor disagree
Slightly agree
Agree
Strongly agree

SWLS-Responses Standardized[Non Standard]

Permitted Value (Code)	Display Value (Decode)
1	Strongly disagree
2	Disagree
3	Slightly disagree
4	Neither agree nor disagree
5	Slightly agree
6	Agree
7	Strongly agree

Trial Blinding Schema Response [C66735][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
DOUBLE BLIND [C15228]	Double Blind

Control Type Response [C66785][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
PLACEBO [C49648]	Placebo

Trial Intent Type Response [C66736][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
TREATMENT [C49656]	Treatment

Trial Phase Response [C66737][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
PHASE II TRIAL [C15601]	Phase II Trial

Trial Summary Parameter Test Name [C67152][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)
Actual Number of Subjects [C98703]
Adaptive Design [C146995]
Added on to Existing Treatments [C49703]
Planned Maximum Age of Subjects [C49694]
Planned Minimum Age of Subjects [C49693]
Data Cutoff Description [C98718]
Data Cutoff Date [C98717]
Dose per Administration [C25488]
Dose Form [C42636]
Dosing Frequency [C89081]
Dose Units [C73558]
Planned Country of Investigational Sites [C98770]
Healthy Subject Indicator [C98737]
Trial Disease/Condition Indication [C112038]
Intervention Model [C98746]
Intervention Type [C98747]
Trial Length [C49697]
Planned Number of Arms [C98771]
Trial Primary Objective [C85826]
Trial Secondary Objective [C85827]
Primary Outcome Measure [C98772]
Secondary Outcome Measure [C98781]
Pharmacologic Class [C98768]
Planned Number of Subjects [C49692]
Trial is Randomized [C25196]
Randomization Quotient [C98775]
Registry Identifier [C98714]
Route of Administration [C38114]
SDTM IG Version [C156604]
SDTM Version [C156605]
Study End Date [C90462]
Sex of Participants [C49696]
Clinical Study Sponsor [C70793]
Study Start Date [C69208]
Study Stop Rules [C49698]
Study Type [C142175]
Trial Blinding Schema [C49658]
Control Type [C49647]
Diagnosis Group [C49650]
Trial Intent Type [C49652]
Trial Title [C49802]
Trial Phase Classification [C48281]
Investigational Therapy or Treatment [C41161]
Trial Type [C49660]

Trial Summary Parameter Test Code [C66738][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
ACTSUB [C98703]	Actual Subject Number
ADAPT [C146995]	Adaptive Study Design Indicator
ADDON [C49703]	Test Product Added to Existing Treatment
AGEMAX [C49694]	Planned Maximum Age of Subjects
AGEMIN [C49693]	Planned Minimum Age of Subjects
DCUTDESC [C98718]	Data Cutoff Date Description
DCUTDTC [C98717]	Data Cutoff Date
DOSE [C25488]	Dose
DOSFRM [C42636]	Pharmaceutical Dosage Form
DOSFRQ [C89081]	Dose Frequency
DOSU [C73558]	Dosage Form Unit
FCNTRY [C98770]	Planned Country of Investigational Site
HLTSUBJI [C98737]	Healthy Subject Indicator
INDIC [C112038]	Trial Indication
INTMODEL [C98746]	Intervention Model
INTTYPE [C98747]	Intervention Type
LENGTH [C49697]	Trial Length
NARMS [C98771]	Planned Number of Arms
OBJPRIM [C85826]	Trial Primary Objective
OBJSEC [C85827]	Trial Secondary Objective
OUTMSPRI [C98772]	Primary Outcome Measure
OUTMSSEC [C98781]	Secondary Outcome Measure
PCLAS [C98768]	Pharmacological Class of Investigational Therapy
PLANSUB [C49692]	Planned Subject Number
RANDOM [C25196]	Randomization
RANDQT [C98775]	Randomization Quotient
REGID [C98714]	Clinical Trial Registry Identifier
ROUTE [C38114]	Route of Administration
SDTIGVER [C156604]	Study Data Tabulation Model Implementation Guide Version
SDTMVER [C156605]	Study Data Tabulation Model Version
SENDTC [C90462]	Clinical Study End Date
SEXPOP [C49696]	Sex of Study Group
SPONSOR [C70793]	Clinical Study Sponsor
SSTDTC [C69208]	Study Start Date
STOPRULE [C49698]	Study Stop Rule
STYPE [C142175]	Study Type
TBLIND [C49658]	Trial Blinding Schema
TCNTRL [C49647]	Control Type
TDIGRP [C49650]	Diagnosis Group
TINDTP [C49652]	Clinical Study by Intent
TITLE [C49802]	Trial Title
TPHASE [C48281]	Trial Phase
TRT [C41161]	Protocol Agent
TTYPE [C49660]	Trial Type

Trial Type Response [C66739][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
EFFICACY [C49666]	Efficacy
PHARMACOKINETIC [C49663]	Pharmacokinetic
SAFETY [C49667]	Safety

Unit, subset to be used for CMDOSU [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
mg [C28253]	Milligram
ng [C48516]	Nanogram
TABLET [C42998]	Tablet

Unit, subset to be used for ECDOSU [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
mL [C25613]	Milliliter

Unit, subset to be used for ECPSTRGU [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
g/L [C42576]	Gram per Liter

Unit, subset to be used for EXDOSU [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
mg [C28253]	Milligram

Unit, subset to be used in VLM for tests with 10^12/L as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
10^12/L [C67308]	Million per Microliter

Unit, subset to be used in VLM for tests with 10^9/L as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
10^9/L [C67255]	Billion per Liter

Unit, subset to be used in VLM for tests with % as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
% [C25613]	Percentage

Unit, subset to be used in VLM for tests with U/L as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
U/L [C67456]	Unit per Liter

Unit, subset to be used in VLM for tests with fL as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
fL [C64780]	Femtoliter

Unit, subset to be used in VLM for tests with fmol as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
fmol [C42576]	Femtomole

Unit, subset to be used in VLM for tests with g/L as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
g/L [C68854]	Femtomole

Unit, subset to be used in VLM for tests with g/dL as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
g/dL [C64783]	Gram per Deciliter

Unit, subset to be used in VLM for tests with mEq/L as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
mEq/L [C67474]	Milliequivalent Per Liter

Unit, subset to be used in VLM for tests with mIU/L as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
mIU/L [C67405]	Microinternational Unit per Milliliter

Unit, subset to be used in VLM for tests with mU/L as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
mU/L [C48508]	Microunit per Milliliter

Unit, subset to be used in VLM for tests with mg/dL as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
mg/dL [C67015]	Milligram per Deciliter

Unit, subset to be used in VLM for tests with mmol/L as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
mmol/L [C64387]	Millimole per Liter

Unit, subset to be used in VLM for tests with ng/L as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
ng/L [C67327]	Nanogram per Liter

Unit, subset to be used in VLM for tests with pg as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
pg [C64551]	Picogram

Unit, subset to be used in VLM for tests with pmol/L as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
pmol/L [C67434]	Picomole per Liter

Unit, subset to be used in VLM for tests with umol/L as the unit [C71620][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
umol/L [C67408]	Micromole per Liter

Vital Signs Test Name [C67153][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)
Diastolic Blood Pressure [C25299]
Pulse Rate [C49676]
Height [C25347]
Systolic Blood Pressure [C25298]
Temperature [C25206]
Weight [C25208]

Vital Signs Test Code [C66741][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
DIABP [C25299]	Diastolic Blood Pressure
PULSE [C49676]	Pulse Rate
HEIGHT [C25347]	Height
SYSBP [C25298]	Systolic Blood Pressure
TEMP [C25206]	Temperature
WEIGHT [C25208]	Weight

Units for Vital Signs Results, subset for Blood Pressure [C66770][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
mmHg [C49670]	Millimeter of Mercury

Units for Vital Signs Results, subset for Blood Pressure Std [C66770][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
mmHg [C49670]	Millimeter of Mercury

Units for Vital Signs Results, subset for Height [C66770][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
in [C48500]	Inch

Units for Vital Signs Results, subset for Height Std [C66770][CDISC/NCI SDTM 2020-12-18]

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

Units for Vital Signs Results, subset for Pulse [C66770][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
beats/min [C49673]	Beats per Minute

Units for Vital Signs Results, subset for Pulse Std [C66770][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
beats/min [C49673]	Beats per Minute

Units for Vital Signs Results, subset for Temperature [C66770][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
F [C44277]	Degree Fahrenheit

Units for Vital Signs Results, subset for Temperature Std [C66770][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
C [C42559]	Degree Celsius

Units for Vital Signs Results, subset for Weight [C66770][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
LB [C48531]	Pound

Units for Vital Signs Results, subset for Weight Std [C66770][CDISC/NCI SDTM 2020-12-18]

Permitted Value (Code)	Display Value (Decode)
kg [C28252]	Kilogram

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External Dictionaries

External Dictionaries
Reference Name	External Dictionary	Dictionary Version
Null Flavors	ISO 21090 NullFlavor	2017
Country Codes	ISO 3166-1 Alpha-3	2013-11-15
Adverse Events Dictionary	MedDRA	22.0
Trial Summary Medical Dictionary	SNOMED	2019-09-01

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Methods

Methods
Method	Type	Description
Algorithm to derive AEENTPT	Computation	If AEENRTPT is populated, AEENTPT is DM.RFPENDTC for the subject.
Algorithm to derive CMENTPT	Computation	If CMENRTPT is populated, CMENTPT is DM.RFPENDTC for the subject.
Algorithm to derive DAYCALC	Computation	Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.
Algorithm to derive DISEQ	Computation	Starts at "1" for first device identifier and increments by one for each DIPARM
Algorithm to derive DTHFL	Computation	If DTHDTC is populated then DTHFL='Y'
Algorithm to derive EPOCH	Computation	EPOCH from SE where date >= SESTDTC and date < SEENDTC
Algorithm to derive EXDOSE	Computation	EXDOSE = ECDOSE * ECPSTRG expressed in mg.
Algorithm to derive FTSTRESN	Computation	If FTSTRESC is numeric then FTSTRESN=FTSTRESC in numeric format, else null.
Algorithm to derive IEORRES	Computation	If IECAT=INCLUSION then IEORRES=N, else if IECAT=EXCLUSION then IEORRES=Y
Algorithm to derive LBSTRESC	Computation	LBSTRESC is equal to LBORRES or the value in standard units if a conversion is necessary.
Algorithm to derive LOBXFL	Computation	Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise.
Algorithm to derive QSSTRESC_PH	Computation	If QSORRES="Not at all" then 0 If QSORRES="Several days" then 1 If QSORRES="More than half the days" then 2 If QSORRES="Nearly every day" then 3
Algorithm to derive QSSTRESC_PH_10_11	Computation	QSSTRESC=QSORRES
Algorithm to derive QSSTRESC_SL	Computation	If QSORRES="Strongly disagree" then 1 If QSORRES="Disagree" then 2 If QSORRES="Slightly disagree" then 3 If QSORRES="Neither agree nor disagree" then 4 If QSORRES="Slightly agree" then 5 If QSORRES="Agree" then 6 If QSORRES="Strongly agree" then 7
Algorithm to derive QSSTRESN	Computation	If QSSTRESC is numeric then QSSTRESN=QSSTRESC in numeric format, else null.
Algorithm to derive RFENDTC	Computation	The Date of Study Completion or Early Termination. Null for screen failures.
Algorithm to derive RFPENDTC	Computation	The latest date of assessment for the subject as determined by the End of Study Form, any scheduled assessments, Adverse Events, or Concomitant Medications.
Algorithm to derive RFSTDTC	Computation	The first date/time of study drug. Null for screen failures.
Algorithm to derive RFXENDTC	Computation	The last date/time of study drug administration. Null for subjects with no treatment data.
Algorithm to derive RFXSTDTC	Computation	The first date/time of study drug administration. Null for subjects with no treatment data.
Algorithm to derive RSSTRESC	Computation	RSSTRESC is the corresponding numeric value of RSORRES according the values shown on the HAMD-17 CRF page.
Algorithm to derive SEENDTC	Computation	SEENDTC is set to the start of the next Element, or RFPENDTC for the last Element.
Algorithm to derive SEQ	Computation	Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.
Algorithm to derive SESTDTC	Computation	SESTDTC if set to the --DTC for that subject which exists in the data for the defined start of the Element, such as DSSTDTC when DSDECOD=INFORMED CONSENT OBTAINED for Screening Elements or min(EXSTDTC) for Dosing Elements.
Algorithm to derive STRESN	Computation	If --STRESC represents a numeric value then --STRESN is the numeric version of --STRESC, else null. "--" represents the domain code.
Algorithm to derive SVENDTC	Computation	For each scheduled visit, SVENDTC = the last (max) date associated with a subject for that visit. For unplanned visits, SVENDTC is the date of the visit.
Algorithm to derive SVSTDTC	Computation	For each scheduled visit, SVSTDTC = the first (min) date associated with a subject for that visit. For unplanned visits, SVSTDTC is the date of the visit.
Algorithm to derive TSSEQ	Computation	Unique sequence number within each TSPARM, restarting at 1 for per TSPARM, applied to sorted data.
Algorithm to derive VSSTRESC	Computation	Data collected in conventional units (i.e. F, lbs, inches) is converted using standard conversion factors to standard units (C, kg, cm).

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Comments

Comments
CommentOID	Description
COM.AE2	Even though the variable is 'Assigned' an annotation has been added to page 23 to clarify the assignment.
COM.AE3	Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.
COM.AEDECOD	Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required. Note CDISC Conformance Rule CG0014 would fire for this variable due to the decision not to populate coding variables.
COM.AESER	Subject CDISC003 had an AE of Epistaxis on 2013-09-30 with AESER set to 'Y' without any of the individual serious qualifiers set to 'Y' also. The site was queried several times but the data were not updated. Note Conformance Rule CG0041 would fire for this subject.
COM.CMINDC	If the CM is not taken for a 'Primary Study Condition' then CMINDC would be 'Prophylaxis or Non-therapeutic use'
COM.DM2	Since no collected data was subjective then QEVAL was not populated. It is an 'Expected' variable and so is included.
COM.DM3	Since no subjects had more than 3 Races, RACE4 was not used.
COM.DM4	Since no subjects had more than 3 Races, RACE5 was not used.
COM.DS1	Variable is Assigned but there are annotations to help understand the data and so references to the proper pages are included
COM.DTC1	DataType is 'partialDatetime' instead of 'datetime' since datetime values are planned to be collected without seconds for this study.
COM.FA1	All values are null as the findings are not visit based. The variable is Expected and so is included.
COM.FA2	The FA domain contains Findings About Injection Site Reaction Adverse Events
COM.IE1	IEDY is needed if IEDTC is included. Note RFSTDTC is not populated for not randomized subjects then IEDY could not be populated in those cases.
COM.IE2	Please see Appendix 1 of the cSDRG for complete versions of IETESTCD and IETEST.
COM.MDV	Standard's Conformance Notes: 1) The SDTM v1.7/SDTMIG v3.3 datasets were evaluated manually and programmatically by the CDISC SDS MSG Team. At the completion of the SDTM-MSG v2.0, the CDISC SDTM v1.7/SDTMIG v3.3 conformance rules were recently published, but not available by any validation tools to validate. 2) The Define-XML document was evaluated manually and programmatically by the CDISC SDS MSG Team. At the completion of the SDTM-MSG v2.0, the CDISC Define-XML v2.1 conformance rules were not published, nor available by any validation tools to validate. Please ensure that any official regulatory submission of an Define-XML v2.1 document and accompanying data is done in accordance to the respective regulatory health authorities requirements/guidance.
COM.NV1	Per protocol, electroencephalograms are only performed after such an event were to occur. No subjects within the trial had an occurrence of an electroencephalogram event. Therefore, no data exists for the NV dataset and as such was not submitted.
COM.NV2	Per protocol, electroencephalograms are only performed after such an event were to occur. No subjects within the trial had an occurrence of an electroencephalogram event. Therefore, no data exists for the NV dataset and as such SUPPNV was not submitted.
COM.OE1	No subjects within the trial had an ophthalmic examination of clinical significance to report. Therefore, no data exists for the SUPPOE dataset and as such was not submitted.
COM.QS1	QSPH contains the PATIENT HEALTH QUESTIONNAIRE-9 (PHQ-9) questionnaire data.
COM.QS2	QSSL contains the SATISFACTION WITH LIFE SURVEY (SWLS) questionnaire data.
COM.ST1	Study Data Tabulation Model Implementation Guide: Human Clinical Trials Version 3.3
COM.ST2	Study Data Tabulation Model Implementation Guide for Medical Devices Version 1.0
COM.ST3	This was the latest release of CDISC CT available when this sample submission was completed.
COM.ST4	This was the CDISC CT Package associated to the CDISC Define-XML Specification Version 2.1 when this sample submission was completed.
COM.VS1	All vital signs were performed as expected, so VSSTAT was never populated. The variable is included as it was possible to populate it in this study.

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Standards for Study CDISCPILOT01

Datasets

Trial Arms (TA)

Trial Elements (TE)

Trial Inclusion/Exclusion Criteria (TI)

Trial Summary (TS)

Trial Visits (TV)

Demographics (DM)

Subject Elements (SE)

Subject Visits (SV)

Concomitant Medications (CM)

Exposure as Collected (EC)

Exposure (EX)

Adverse Events (AE)

Disposition (DS)

Medical History (MH)

Death Details (DD)

Functional Tests (FT)

Inclusion/Exclusion Criteria Not Met (IE)

Laboratory Test Results (LB)

Nervous System Findings (NV)

Ophthalmic Examinations (OE)

Questionnaires (PHQ-9) (QSPH)

Questionnaires (SQLS) (QSSL)

Disease Response and Clin Classification (RS)

Vital Signs (VS)

Findings About Events or Interventions (FA)

Related Records (RELREC)

Supplemental Qualifiers for DM (SUPPDM)

Supplemental Qualifiers for EC (SUPPEC)

Supplemental Qualifiers for NV (SUPPNV)

Supplemental Qualifiers for OE (SUPPOE)

Device Identifiers (DI)

CodeLists

External Dictionaries

Methods

Comments