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Definexmltable
Level Dataset Purpose Analysis Name ADVS
Dataset Description Class Structure Purpose Keys Location Documentation ADVS VS Analysis Data Basic Data Structure Analysis STUDYID, USUBJID, PARQUAL, PARAMCD, AVISIT, ADVS.xpt ADVS.SAS/SAP

Cond

Definexmltable
Dataset ADVS Level Variable Purpose Analysis
Variable Name Variable Label Type Codelist/Controlled Terms Core Notes STUDYID Study Identifier text Req VS.STUDYID USUBJID Unique Subject Identifier text Req VS.USUBJID TRTP Planned Treatment Char Cond ADSL.TRT01P TRT01P Planned Treatment for Period 01 Char Cond ADSL.TRT01P TRTA Actual Treatment Char Cond ADSL.TRT01A TRT01A Actual Treatment for Period 01 Char Cond ADSL.TRT01A ADT Analysis Date Num Perm VS.VSDTC captured as a date in numeric format. ADTM Analysis Datetime integer Perm VS.VSDTC captured as a datetime in numeric format. ADY Analysis Relative Day Num Perm VS.VSDY AVISIT Analysis Visit Char Cond VS.VISIT AVISITN Analysis Visit (N) Num Perm VS.VISITNUM ATPT Analysis Timepoint Char Cond VS.VSTPT ATPTN Analysis Timepoint (N) Num Cond VS.VSTPTNUM APHASE Phase Char Perm if ADT lt ADSL,TRTSDT then set to SCREENING, else if TRTSDT le ADT le TRTEDT then set to TREATMENT, else if ADT gt TRTEDT then set to FOLLOW-UP	APERIOD	Period	Num

set to 1 if TRTSDT le ADT le TRTEDT and there is only one treatment period

PARAM	Parameter	Char		Req	set to VS.VSTEST concatenated with VS.VSTRESU
PARAMCD	Parameter Code	text		Req	set to VS.VSTESTCD
PARAMN	Parameter (N)	Num		Perm	Numeric representation of PARAM. sort by VSTESTCD and increment by 1 for each unique value of VSTESTCD
AVAL	Analysis Value	Num		Cond	VS.VSSTRESN for records taken from VS, Average of values taken on same datedataset.

AVALCAnalysis Value (C)CharCondVS.VSSTRESC where VS.vSTRESN is null

BASE	Baseline Value	Num		Cond	AVAL where ABLFL=Y
CHG	Change from Baseline	Num		Perm	AVAL-BASE
PCHG	Percent Change from Baseline	Num		Perm	((AVAL-BASE)/BASE)*100
DTYPE	Derivation Type	Char	AVERAGE	Cond	set to AVERAGE for rows added to capture average value for parameters with multiple assessments done at a VISIT
ABLFL	Baseline Record Flag	Char	Y	Cond	set to Y on the record that captures the baseline value
ANL01FL	Analysis Flag 01	Char	Y	Cond	set to Y on record chosen to represent AVISIT for analysis

COUNTRYCountryCharPermADSL.COUNTRYAGEAgeNumPermADSL.AGESEXSexCharPermADSL.SEXRACERaceCharPermADSL.RACEETHNICEthnicityCharPermADSL.ETHNIC

SAFFL	Safety Population Flag	Char	Y;N	Cond	ADSL.SAFFL
RANDFL	Randomized Population Flag	Char	Y;N	Cond	ADSL.RANDFL
TRTSDT	Date of First Exposure to Treatment	Num		Perm	ADSL.TRTSDT
TRTSDTM	Datetime of First Exposure to Treatment	Num		Perm	ADSL.TRTSDTM
TRTEDT	Date of Last Exposure to Treatment	Num		Perm	ADSL.TRTEDT
TRTEDTM	Datetime of Last Exposure to Treatment	integer		Perm	ADSL.TRTEDTM
VSSEQ	Sequence Number	Num		Perm	VS.VSSEQ
VISIT	Visit Name	Char		Perm	VS.VISIT
VISITNUM	Visit Number	Num		Perm	VS.VISITNUM
VSTPT	Planned Time

Point Name	Char		Perm	VS.VSTPT
VSTPTNUM	Planned Time

Point Number

Char

Perm

c

VS.VSTPTNUM