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 ADAMIG Data Definitions
Metadata Description
Dataset metadata for CDISCPILOT01 ADAMIG datasets

Standards for Study CDISCPILOT01

Standards for Study CDISCPILOT01
Standard Type Status Documentation
ADAMIG 1.1 IG Final
CDISC/NCI ADAMIG 2023-12-15 CT Final

Datasets

Datasets
Dataset Description Class Structure Purpose Keys Documentation Location
ADSL[ADAMIG 1.1] Subject-Level Analysis Dataset SUBJECT LEVEL ANALYSIS DATASET One record per subject Analysis STUDYID, USUBJID
ADVS[ADAMIG 1.1] Analysis Dataset for Vital Signs BASIC DATA STRUCTURE One record per subject per parameter per analysis timepoint Analysis STUDYID, USUBJID, PARAMCD, VISITNUM
ADAE[ADAMIG 1.1] Adverse Event Analysis Dataset OCCURRENCE DATA STRUCTURE One record per subject per adverse event Analysis STUDYID, USUBJID, ASEQ
ADEX[ADAMIG 1.1] Exposure Analysis Dataset BASIC DATA STRUCTURE One record per subject per exposure record Analysis STUDYID, USUBJID, ASEQ

Go to the top of the Define-XML document


Subject-Level Analysis Dataset (ADSL)

ADSL (Subject-Level Analysis Dataset) - [ADAMIG 1.1]Location:
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 12
Assigned
USUBJID Unique Subject Identifier text 40
Derived
SUBJID Subject Identifier for the Study text 20
CRF
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
CRF
ETHNIC Ethnicity text 60
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
TRT01P Planned Treatment for Period 01 text 200
Protocol
TRT01A Actual Treatment for Period 01 text 200
Assigned
TRTSDT Date of First Exposure to Treatment date ISO 8601
Derived
TRTEDT Date of Last Exposure to Treatment date ISO 8601
Derived
RFSTDTC Subject Reference Start Date/Time datetime ISO 8601
CRF
RFENDTC Subject Reference End Date/Time datetime ISO 8601
CRF
RFICDTC Date/Time of Informed Consent datetime ISO 8601
CRF
DTHFL Subject Death Flag text 2
Derived
SAFFL Safety Population Flag text 2
Derived
ITTFL Intent-To-Treat Population Flag text 2
Derived

Go to the top of the Define-XML document


Analysis Dataset for Vital Signs (ADVS)

ADVS (Analysis Dataset for Vital Signs) - [ADAMIG 1.1]Location:
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 12
Assigned
USUBJID Unique Subject Identifier text 40
Derived
PARAMCD Parameter Code text 8
Derived
PARAM Parameter text 200
Derived
AVAL Analysis Value float
Derived

Numeric analysis value; cast from raw vsorres string
AVALU Analysis Value Units text 20
Derived
ADT Analysis Date date ISO 8601
Derived
ADY Analysis Relative Day integer
Derived
ABLFL Baseline Record Flag text 2
Derived
BASE Baseline Value float
Derived
CHG Change from Baseline float
Derived
PCHG Percent Change from Baseline float
Derived
VISITNUM Visit Number float
Protocol
VISIT Visit Name text 200
Protocol
DTYPE Derivation Type text 8 Derivation Type
  • • "LOCF" = "Last Observation Carried Forward"
  • • "WOCF" = "Worst Observation Carried Forward"
Derived
ANL01FL Analysis Flag 01 text 2 Analysis Flag ANL01
  • • "Y" = "Yes"
Derived
SUBJID Subject Identifier for the Study text 20
CRF
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
CRF
ETHNIC Ethnicity text 60
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
TRT01P Planned Treatment for Period 01 text 200
Protocol
TRT01A Actual Treatment for Period 01 text 200
Assigned
TRTSDT Date of First Exposure to Treatment date ISO 8601
Derived
TRTEDT Date of Last Exposure to Treatment date ISO 8601
Derived
RFSTDTC Subject Reference Start Date/Time datetime ISO 8601
CRF
RFENDTC Subject Reference End Date/Time datetime ISO 8601
CRF
RFICDTC Date/Time of Informed Consent datetime ISO 8601
CRF
DTHFL Subject Death Flag text 2
Derived
SAFFL Safety Population Flag text 2
Derived
ITTFL Intent-To-Treat Population Flag text 2
Derived

Go to the top of the Define-XML document


Adverse Event Analysis Dataset (ADAE)

ADAE (Adverse Event Analysis Dataset) - [ADAMIG 1.1]Location:
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 12
Assigned
USUBJID Unique Subject Identifier text 40
Derived
AETERM Reported Term for the Adverse Event text 200
CRF
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
AEREL Causality text 60
CRF
AEOUT Outcome of Adverse Event text 60
CRF
AEACN Action Taken with Study Treatment text 60
CRF
ASTDT Analysis Start Date date ISO 8601
Derived
AENDT Analysis End Date date ISO 8601
Derived
ADY Analysis Relative Day integer
Derived
TRTEMFL Treatment Emergent Analysis Flag text 2
Derived
ANL01FL Analysis Flag 01 (worst severity) text 2
Derived
ASEQ Analysis Sequence Number integer
Derived
TRTSDT Date of First Exposure to Treatment date ISO 8601
Derived
TRTEDT Date of Last Exposure to Treatment date ISO 8601
Derived
TRT01P Planned Treatment for Period 01 text 200
Protocol
AGE Age integer
CRF
SEX Sex text 2 Sex
  • • "M" = "MALE"
  • • "F" = "FEMALE"
CRF
SAFFL Safety Population Flag text 2
Derived

Go to the top of the Define-XML document


Exposure Analysis Dataset (ADEX)

ADEX (Exposure Analysis Dataset) - [ADAMIG 1.1]Location:
Variable Label / Description Type Length or Display Format Controlled Terms or ISO Format Origin / Source / Method / Comment
STUDYID Study Identifier text 12
Assigned
USUBJID Unique Subject Identifier text 40
Derived
EXTRT Name of Actual Treatment text 200
CRF
EXDOSE Dose per Administration float
CRF
EXDOSU Dose Units text 20
CRF
ASTDT Analysis Start Date date ISO 8601
Derived
AENDT Analysis End Date date ISO 8601
Derived
ASEQ Analysis Sequence Number integer
Derived
EXDURD Exposure Duration (days, inclusive) integer
Derived
TRTSDT Date of First Exposure to Treatment date ISO 8601
Derived
TRTEDT Date of Last Exposure to Treatment date ISO 8601
Derived
TRT01P Planned Treatment for Period 01 text 200
Protocol
AGE Age integer
CRF
SAFFL Safety Population Flag text 2
Derived

Go to the top of the Define-XML document


CodeLists

Sex
Permitted Value (Code) Display Value (Decode)
M MALE
F FEMALE
Derivation Type
Permitted Value (Code) Display Value (Decode)
LOCF Last Observation Carried Forward
WOCF Worst Observation Carried Forward
Analysis Flag ANL01
Permitted Value (Code) Display Value (Decode)
Y Yes

Go to the top of the Define-XML document