Date/Time of Define-XML document generation: 2026-03-16T09:14:09

Define-XML version: 2.1.0

Define-XML Context: Submission

Stylesheet version: 2019-02-11

Study Name: CDISCPILOT01
Study Description: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety, and Tolerability of Xanomeline in Patients with Mild to Moderate Alzheimer's Disease
Protocol Name: CDISCPILOT01
Metadata Name: CDISCPILOT01 SDTMIG Data Definitions
Metadata Description: Dataset metadata for CDISCPILOT01 SDTMIG datasets

Standards for Study CDISCPILOT01

Standards for Study CDISCPILOT01
Standard	Type	Status	Documentation
SDTMIG 3.4	IG	Final
CDISC/NCI SDTMIG 2023-12-15	CT	Final

Datasets

Datasets
Dataset	Description	Class	Structure	Purpose	Keys
DM[SDTMIG 3.4]	Demographics	SPECIAL PURPOSE	One record per subject	Tabulation	STUDYID, USUBJID
AE[SDTMIG 3.4]	Adverse Events	EVENTS	One record per adverse event per subject	Tabulation	STUDYID, USUBJID, AESEQ
VS[SDTMIG 3.4]	Vital Signs	FINDINGS	One record per vital sign measurement per subject per visit	Tabulation	STUDYID, USUBJID, VSTESTCD, VISITNUM
EX[SDTMIG 3.4]	Exposure	INTERVENTIONS	One record per protocol-specified study treatment per subject	Tabulation	STUDYID, USUBJID, EXSEQ

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DM (Demographics) - [SDTMIG 3.4]Location:
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	12		Assigned
DOMAIN	Domain Abbreviation	text	2		Assigned
USUBJID	Unique Subject Identifier	text	40		Derived Concatenation of STUDYID, SITEID, and SUBJID
SUBJID	Subject Identifier for the Study	text	20		CRF
RFSTDTC	Subject Reference Start Date/Time	datetime		ISO 8601	CRF
RFENDTC	Subject Reference End Date/Time	datetime		ISO 8601	CRF
RFXSTDTC	Date/Time of First Study Treatment	datetime		ISO 8601	Derived
RFXENDTC	Date/Time of Last Study Treatment	datetime		ISO 8601	Derived
SITEID	Study Site Identifier	text	20		CRF
AGE	Age	integer			CRF
AGEU	Age Units	text	10		Assigned
SEX	Sex	text	2	Sex • "M" = "MALE" • "F" = "FEMALE"	CRF
RACE	Race	text	60	Race • "WHITE" = "WHITE" • "BLACK OR AFRICAN AMERICAN" = "BLACK OR AFRICAN AMERICAN" • "ASIAN" = "ASIAN" • "AMERICAN INDIAN OR ALASKA NATIVE" = "AMERICAN INDIAN OR ALASKA NATIVE" • "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER"	CRF
ETHNIC	Ethnicity	text	60	Ethnicity • "HISPANIC OR LATINO" = "HISPANIC OR LATINO" • "NOT HISPANIC OR LATINO" = "NOT HISPANIC OR LATINO"	CRF
ARMCD	Planned Arm Code	text	20		Protocol
ARM	Description of Planned Arm	text	200		Protocol
ACTARMCD	Actual Arm Code	text	20		Assigned
ACTARM	Description of Actual Arm	text	200		Assigned
RFICDTC	Date/Time of Informed Consent	datetime		ISO 8601	CRF

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AE (Adverse Events) - [SDTMIG 3.4]Location:
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	12		Assigned
DOMAIN	Domain Abbreviation	text	2		Assigned
USUBJID	Unique Subject Identifier	text	40		Derived Concatenation of STUDYID, SITEID, and SUBJID
AESEQ	Sequence Number	integer			Assigned
AETERM	Reported Term for the Adverse Event	text	200		CRF
AEDECOD	Dictionary-Derived Term	text	200		Derived
AESTDTC	Start Date/Time of Adverse Event	datetime		ISO 8601	CRF
AEENDTC	End Date/Time of Adverse Event	datetime		ISO 8601	CRF
AESEV	Severity/Intensity	text	20		CRF
AESER	Serious Event	text	2		CRF
AEOUT	Outcome of Adverse Event	text	60		CRF
AEACN	Action Taken with Study Treatment	text	60		CRF
AEREL	Causality	text	60		CRF

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VS (Vital Signs) - [SDTMIG 3.4]Location:
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	12		Assigned
DOMAIN	Domain Abbreviation	text	2		Assigned
USUBJID	Unique Subject Identifier	text	40		Derived Concatenation of STUDYID, SITEID, and SUBJID
VSTESTCD	Vital Signs Test Short Name	text	8	Vital Signs Test Code [6 Terms]	CRF
VSTEST	Vital Signs Test Name	text	40		CRF
VSORRES	Result or Finding in Original Units	text	20		CRF
VSORRESU	Original Units	text	20		CRF
VSSTRESN	Numeric Result/Finding in Standard Units	float			Derived
VSSTRESU	Standard Units	text	20		Derived
VISITNUM	Visit Number	float			Protocol
VISIT	Visit Name	text	200		Protocol
VSDTC	Date/Time of Measurements	datetime		ISO 8601	CRF

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EX (Exposure) - [SDTMIG 3.4]Location:
Variable	Label / Description	Type	Length or Display Format	Controlled Terms or ISO Format	Origin / Source / Method / Comment
STUDYID	Study Identifier	text	12		Assigned
DOMAIN	Domain Abbreviation	text	2		Assigned
USUBJID	Unique Subject Identifier	text	40		Derived Concatenation of STUDYID, SITEID, and SUBJID
EXSEQ	Sequence Number	integer			Assigned
EXTRT	Name of Actual Treatment	text	200		Protocol
EXDOSE	Dose per Administration	float			CRF
EXDOSU	Dose Units	text	20		Protocol
EXSTDTC	Start Date/Time of Treatment	datetime		ISO 8601	CRF
EXENDTC	End Date/Time of Treatment	datetime		ISO 8601	CRF

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Sex

Permitted Value (Code)	Display Value (Decode)
M	MALE
F	FEMALE

Race

Permitted Value (Code)	Display Value (Decode)
WHITE	WHITE
BLACK OR AFRICAN AMERICAN	BLACK OR AFRICAN AMERICAN
ASIAN	ASIAN
AMERICAN INDIAN OR ALASKA NATIVE	AMERICAN INDIAN OR ALASKA NATIVE
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER

Ethnicity

Permitted Value (Code)	Display Value (Decode)
HISPANIC OR LATINO	HISPANIC OR LATINO
NOT HISPANIC OR LATINO	NOT HISPANIC OR LATINO

Vital Signs Test Code

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