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Definexmltable
DatasetADSL
LevelVariable
PurposeAnalysis
NameVariable
Variable NameVariable LabelTypeCodelist/Controlled Terms/FormatSourceDerivation/Comment
STUDYIDStudy IdentifierChar

DM.STUDYID


USUBJIDUnique Subject IdentifierChar

DM.USUBJID


BRTHDTDate of BirthNumdate9.


Date portion of DM.BRTHDTC converted to numeric and displayed in a format such as date9.from ISO 8601 format to numeric date.9 9
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTAUGDMDCIS-5
 
AAGEAnalysis AgeNum


Age as screening, computed by DM.RFICDTC - BRTHDTC as continuous variable. Note that some countries do not allow capturing date of birth, so this could be computed by capturing age in years and months on a CRF.
AGEAgeNum

DM.AGE


AGEUAge UnitsCharYEARS

DM.AGEU


SEX

SexChar(SEX)

DM.SEX


RACE

RaceNum(RACE)

DM.RACE


TRTSDTDate of First Exposure to TreatmentNumdate9.
Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as date9.
RFICDT

Date of Informed Consent

Numdate9.
Date portion of DM.RFICDTC converted to numeric and displayed in a format such as date9.
DTHDT

Date of Death

Numdate9.
Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as date9.
DTHFL

Subject Death
Flag

CharYDM.DTHFL
TRT01P

Planned Treatment for Period 01

CharDrug A, Drug B

Predecessor: DM.ARM.

May be changed to lower case or more descriptive term for use in tables and listings.

TRT01A

Actual Treatment for Period 01

CharDrug A, Drug B

Predecessor: DM.ACTARM.

Note: Actual treatment matches planned treatment unless there is a reason subject does not take planned drug.

ITTFL

Intent-To-Treat Population Flag

Char

Y; N


Derive the intent-to-treat population as per the protocol and SAP.

ACEINHFL

ACE Inhibitor Medications Flag

Char

Y; N


Select a list of ACE inhibitor medications from concomitant medications (CM) domain as per SAP or protocol. Set to "Y" if these medications were taken during the study, and "N" if they are absent. Can be used to subset or to exclude the population who took ACE inhibitors.

HEIGHTSC

Height (cm) at Screening

Num



Set to VS.VSSTRESN where VS.VSTESTCD = "HEIGHT" and VISITNUM= 1 (or screening visit).

WEIGHTSC

Weight (kg) at Screening

Num



Set to VS.VSSTRESN where VS.VSTESTCD = "WEIGHT" and VISITNUM = 1 (or screening visit).

BSASC

Body Surface Area at Screening

Num



Select where VISITNUM = 1 (or screening visit). Compute from HEIGHT and WEIGHT, using the Du Bois method. BSA = 0.007184 × W0.425 × H0.725

There are multiple methods for calculating BSA (e.g., Du Bois, Mosteller, Haycock, Gehan & George, Boyd, Fujimoto, Takahira, Schlich); the study protocol should describe which to use.

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