Vital Signs Analysis Dataset (ADVS)

This is an example of an ADVS dataset and is based on input from the SDTM VS dataset. Other administrative data about the subjects are based on the ADSL dataset provided in Section x.x, Analysis Data Subject Level (ADSL).

Example

This is an example SDTM datasets used to create the ADVS dataset. Only variables needed for illustration are shown in the examples.

vs.xpt

xx.xpt

Row	STUDYID	DOMAIN	USUBJID	VSSEQ	VSTESTCD	VSTEST	VSPOS	VSORRES	VSORRESU	VSSTRESC	VSSTRESN	VSSTRESU	VSSTAT	VSREASND	VSLOC	VSLAT	VSLOBXFL	VISITNUM	VISIT	VSDTC	VSTPT	VSTPTNUM
1	A123	VS	A2001	1	SYSBP	Systolic Blood Pressure	SITTING	154	mmHg	154	154	mmHg			ARM	LEFT		1	Baseline	2021-01-02T08:45	BASELINE 1	1
2	A123	VS	A2001	2	SYSBP	Systolic Blood Pressure	SITTING	152	mmHg	152	152	mmHg			ARM	LEFT	Y	1	Baseline	2021-01-02T09:00	BASELINE 2	2
3	A123	VS	A2001	3	DIABP	Diastolic Blood Pressure	SITTING	44	mmHg	44	44	mmHg			ARM	LEFT		1	Baseline	2021-01-02T08:45	BASELINE 1	1
4	A123	VS	A2001	4	DIABP	Diastolic Blood Pressure	SITTING	48	mmHg	48	48	mmHg			ARM	LEFT	Y	1	Baseline	2021-01-02T09:00	BASELINE 2	2
5	A123	VS	A2001	5	PULSE	Pulse Rate	SITTING	72	beats/min	72	72	beats/min			ARM	LEFT	Y	1	Baseline	2021-01-02T08:45
6	A123	VS	A2001	6	TEMP	Temperature		34.7	C	34.7	34.7	C			SUBLINGUAL REGION			1	Baseline	2021-01-02T08:45	BASELINE 1	1
7	A123	VS	A2001	7	TEMP	Temperature		36.2	C	36.2	36.2	C			SUBLINGUAL REGION		Y	1	Baseline	2021-01-02T09:00	BASELINE 2	2
8	A123	VS	A2001	8	WEIGHT	Weight		90.5	kg	90.5	90.5	kg					Y	1	Baseline	2021-01-02
9	A123	VS	A2001	9	HEIGHT	Height		157	cm	157	157	cm					Y	1	Baseline	2021-01-02
10	A123	VS	A2001	10	SYSBP	Systolic Blood Pressure	SITTING	95	mmHg	95	95	mmHg			ARM	LEFT		2	Visit 4	2021-01-28
11	A123	VS	A2001	11	DIABP	Diastolic Blood Pressure	SITTING	44	mmHg	44	44	mmHg			ARM	LEFT		2	Visit 4	2021-01-28
12	A123	VS	A2001	12	TEMP	Temperature		97.16	F	36.2	36.2	C			SUBLINGUAL REGION			2	Visit 4	2021-01-28
13	A123	VS	A2001	13	WEIGHT	Weight							NOT DONE	SUBJECT REFUSED				2	Visit 4	2021-01-28

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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.

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advs.xpt

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

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ADVS Dataset Metadata

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

ADVS Variable Metadata

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

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Vital Signs Analysis Dataset (ADVS)