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This is an example of the ADVS dataset and associated metadata. This is just an example and does not mean to indicate that ADVS must be used as the dataset name, nor are the parameters described necessarily those that would be used in a particular study.

Dataset wrap

Name	ADVS

Dataset2

STUDYID	USUBJID	TRTP	TRT01P	TRTA	TRT01A	ADT	ADTM	ADY	AVISIT	AVISITN	ATPT	ATPTN	APHASE	PARAM	PARAMCD	PARAMN	AVAL	BASE	CHG	PCHG	DTYPE	ABLFL	ANL01FL	SAFFL	RANDFL	TRTSDT	TRTEDT	VSSEQ	VSTESTCD	VSTEST	VSSTAT	VSREASND	VSLOC	VSLAT	VSLOBXFL	VISITNUM	VISIT	VSDTC	VSDY	VSTPT	VSTPTNUM
A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021	01JAN2021:08:45	-6	Baseline	1	Baseline 1	1	SCREENING	Systolic Blood Pressure (mmHg)	SYSBP	4	154						Y	Y	Y	2021-01-08	2021-01-28	1	SYSBP	Systolic Blood Pressure			ARM	LEFT		1	Baseline	2021-01-02T08:45	-6	BASELINE 1	1
A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021	01JAN2021:09:00	-6	Baseline	1	Baseline 2	2	SCREENING	Systolic Blood Pressure (mmHg)	SYSBP	4	152						Y	Y	Y	2021-01-08	2021-01-28	2	SYSBP	Systolic Blood Pressure			ARM	LEFT	Y	1	Baseline	2021-01-02-T09:00	-6	BASELINE 2	2
A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021		-6	Baseline	1			SCREENING	Systolic Blood Pressure (mmHg)	SYSBP	4	153	153	0		AVERAGE	Y	Y	Y	Y	2021-01-08	2021-01-28
A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021	01JAN2021:08:45	-6	Baseline	1	Baseline 1	1	SCREENING	Diastolic Blood Pressure (mmHg)	DIABP	1	44						Y	Y	Y	2021-01-08	2021-01-28	3	DIABP	Diastolic Blood Pressure			ARM	LEFT		1	Baseline	2021-01-02T08:45	-6	BASELINE 1	1
A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021	01JAN2021:09:00	-6	Baseline	1	Baseline 2	2	SCREENING	Diastolic Blood Pressure (mmHg)	DIABP	1	48						Y	Y	Y	2021-01-08	2021-01-28	4	DIABP	Diastolic Blood Pressure			ARM	LEFT	Y	1	Baseline	2021-01-02-T09:00	-6	BASELINE 2	2
A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021		-6	Baseline	1			SCREENING	Diastolic Blood Pressure (mmHg)	DIABP	1	46	46	0		AVERAGE	Y	Y	Y	Y	2021-01-08	2021-01-28
A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021		-6	Baseline	1			SCREENING	Pulse Rate (beats/min)	PULSE	3	72	72	0			Y	Y	Y	Y	2021-01-08	2021-01-28	5	PULSE	Pulse Rate			ARM	LEFT	Y	1	Baseline	2021-01-02T08:45	-6
A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021	01JAN2021:08:45	-6	Baseline	1	Baseline 1	1	SCREENING	Temperature (C)	TEMP	5	34.7						Y	Y	Y	2021-01-08	2021-01-28	6	TEMP	Temperature			SUBLINGUAL REGION			1	Baseline	2021-01-02T08:45	-6	BASELINE 1	1
A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021	01JAN2021:09:00	-6	Baseline	1	Baseline 2	2	SCREENING	Temperature (C)	TEMP	5	36.2						Y	Y	Y	2021-01-08	2021-01-28	7	TEMP	Temperature			SUBLINGUAL REGION		Y	1	Baseline	2021-01-02-T09:00	-6	BASELINE 2	2
A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021		-6	Baseline	1			SCREENING	Temperature (C)	TEMP	5	35.45	35.45	0		AVERAGE	Y	Y	Y	Y	2021-01-08	2021-01-28
A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021		-6	Baseline	1			SCREENING	Weight (kg)	WEIGHT	6	90.5	90.5	0			Y	Y	Y	Y	2021-01-08	2021-01-28	8	WEIGHT	Weight					Y	1	Baseline	2021-01-02	-6
A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021		-6	Baseline	1			SCREENING	Height (cm)	HEIGHT	2	157	157	0			Y	Y	Y	Y	2021-01-08	2021-01-28	9	HEIGHT	Height					Y	1	Baseline	2021-01-02	-6
A123	A2001	Placebo	Placebo	Placebo	Placebo	28JAN2021		21	Visit 2	2			PRODUCT	Systolic Blood Pressure (mmHg)	SYSBP	4	95	153	-58	-37.9085			Y	Y	Y	2021-01-08	2021-01-28	10	SYSBP	Systolic Blood Pressure			ARM	LEFT		2	Visit 2	2021-01-28	21
A123	A2001	Placebo	Placebo	Placebo	Placebo	28JAN2021		21	Visit 2	2			PRODUCT	Diastolic Blood Pressure (mmHg)	DIABP	1	44	46	-2	-4.3478			Y	Y	Y	2021-01-08	2021-01-28	11	DIABP	Diastolic Blood Pressure			ARM	LEFT		2	Visit 2	2021-01-28	21
A123	A2001	Placebo	Placebo	Placebo	Placebo	28JAN2021		21	Visit 2	2			PRODUCT	Temperature (C)	TEMP	5	36.2	35.45	.75	2.1157			Y	Y	Y	2021-01-08	2021-01-28	12	TEMP	Temperature			SUBLINGUAL REGION			2	Visit 2	2021-01-28	21
A123	A2001	Placebo	Placebo	Placebo	Placebo	28JAN2021		21	Visit 2	2			PRODUCT	Weight (kg)	WEIGHT	6							Y	Y		2021-01-08	2021-01-28	13	WEIGHT	Weight	NOT DONE	SUBJECT REFUSED				2	Visit 2	2021-01-28	21

Definexmltable

Level	Dataset
Purpose	Analysis
Name	ADVS

Dataset	Description	Class	Structure	Purpose	Keys	Location	Documentation
ADVS	Vital Signs Analysis Dataset	BASIC DATA STRUCTURE	One or more records per subject per analysis parameter per analysis visit per analysis timepoint	Analysis	STUDYID, USUBJID, PARAM, PARAMCD, AVISIT, ATPT	ADVS.xpt	ADVS.SAS/SAP

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 Product	Char		Cond	ADSL.TRT01P
TRT01P	Planned Product for Period 01	Char		Cond	ADSL.TRT01P
TRTA	Actual Product	Char		Cond	ADSL.TRT01A
TRT01A	Actual Product 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 PRODUCT, else if ADT gt TRTEDT then set to FOLLOW-UP
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.
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
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 Product	Num		Perm	ADSL.TRTSDT
TRTEDT	Date of Last Exposure to Product	Num		Perm	ADSL.TRTEDT
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	VS.VSTPTNUM

...

STUDYID

...

Num

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21JIL1999

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