ADaM Example.ADVS Vital Signs

This is an example of an ADaM dataset designed to describe the main variables needed to evaulate vital signs. The dataset decribed below is called ADVS and is based on the SDTM VS dataset shown here SDTM Example.Vital Signs.

The ADaM ADSL associated with this study are not shown. An example on the creation of an ADLS for another study is provided here ADaM Example.ADSL Analysis Data Subject Level New

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
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		Cond	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.
AVALC	Analysis Value (C)	Char		Cond	VS.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
COUNTRY	Country	Char		Perm	ADSL.COUNTRY
AGE	Age	Num		Perm	ADSL.AGE
SEX	Sex	Char		Perm	ADSL.SEX
RACE	Race	Char		Perm	ADSL.RACE
ETHNIC	Ethnicity	Char		Perm	ADSL.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	VS.VSTPTNUM

STUDYID	USUBJID	TRTP	TRT01P	TRTA	TRT01A	ADT	ADTM	ADY	AVISIT	AVISTN	ATPT	ATPTN	APHASE	PARAM	PARAMCD	PARAMN	AVAL	BASE	CHG	PCHG	DTYPE	ABLFL	VSSEQ	VSTESTCD	VSTEST	VSPOS	VSORRES	VSORRESU	VSSTRESC	VSSTRESN	VSSTRESU	VSSTAT	VSREASND	VSLOC	VSLAT	VSLOBXFL	VISITNUM	VISIT	VSDTC	VSDY	VSTPT	VSTPTNUM
ABC	ABC-001-001	Product A	Product A	Product A	Product A	19JUN1999	19JUN1999:08:45	1	Baseline	1	Baseline 1	1	SCREENING	Systolic Blood Pressure (mmHg)	SYSBP	4	154						1	SYSBP	Systolic Blood Pressure	SITTING	154	mmHg	154	154	mmHg			ARM	LEFT		1	Baseline	1999-06-19T08:45	1	BASELINE 1	1
ABC	ABC-001-001	Product A	Product A	Product A	Product A	19JUN1999	19JUN1999:09:00	1	Baseline	1	Baseline 2	2	SCREENING	Systolic Blood Pressure (mmHg)	SYSBP	4	152						2	SYSBP	Systolic Blood Pressure	SITTING	152	mmHg	152	152	mmHg			ARM	LEFT	Y	1	Baseline	1999-06-19T09:00	1	BASELINE 2	2
ABC	ABC-001-001	Product A	Product A	Product A	Product A	19JUN1999		1	Baseline	1			SCREENING	Systolic Blood Pressure (mmHg)	SYSBP	4	153	153	0		AVERAGE	Y																Baseline
ABC	ABC-001-001	Product A	Product A	Product A	Product A	19JUN1999	19JUN1999:08:45	1	Baseline	1	Baseline 1	1	SCREENING	Diastolic Blood Pressure (mmHg)	DIABP	1	44						3	DIABP	Diastolic Blood Pressure	SITTING	44	mmHg	44	44	mmHg			ARM	LEFT		1	Baseline	1999-06-19T08:45	1	BASELINE 1	1
ABC	ABC-001-001	Product A	Product A	Product A	Product A	19JUN1999	19JUN1999:09:00	1	Baseline	1	Baseline 2	2	SCREENING	Diastolic Blood Pressure (mmHg)	DIABP	1	48						4	DIABP	Diastolic Blood Pressure	SITTING	48	mmHg	48	48	mmHg			ARM	LEFT	Y	1	Baseline	1999-06-19T09:00	1	BASELINE 2	2
ABC	ABC-001-001	Product A	Product A	Product A	Product A	19JUN1999		1	Baseline	1			SCREENING	Diastolic Blood Pressure (mmHg)	DIABP	1	46	46	0		AVERAGE	Y																Baseline
ABC	ABC-001-001	Product A	Product A	Product A	Product A	19JUN1999		1	Baseline	1			SCREENING	Pulse Rate (beats/min)	PULSE	3	72	72	0			Y	5	PULSE	Pulse Rate	SITTING	72	beats/min	72	72	beats/min			ARM	LEFT	Y	1	Baseline	1999-06-19	1
ABC	ABC-001-001	Product A	Product A	Product A	Product A	19JUN1999	19JUN1999:08:45	1	Baseline	1	Baseline 1	1	SCREENING	Temperature (C)	TEMP	5	34.7						6	TEMP	Temperature		34.7	C	34.7	34.7	C			SUBLINGUAL REGION			1	Baseline	1999-06-19T08:45	1	BASELINE 1	1
ABC	ABC-001-001	Product A	Product A	Product A	Product A	19JUN1999	19JUN1999:09:00	1	Baseline	1	Baseline 2	2	SCREENING	Temperature (C)	TEMP	5	36.2						7	TEMP	Temperature		36.2	C	36.2	36.2	C			SUBLINGUAL REGION		Y	1	Baseline	1999-06-19T09:00	1	BASELINE 2	2
ABC	ABC-001-001	Product A	Product A	Product A	Product A	19JUN1999		1	Baseline	1			SCREENING	Temperature (C)	TEMP	5	35.45	35.45	0		AVERAGE	Y																Baseline
ABC	ABC-001-001	Product A	Product A	Product A	Product A	19JUN1999		1	Baseline	1			SCREENING	Weight (kg)	WEIGHT	6	90.5	90.5	0			Y	8	WEIGHT	Weight	STANDING	90.5	kg	90.5	90.5	kg					Y	1	Baseline	1999-06-19	1
ABC	ABC-001-001	Product A	Product A	Product A	Product A	19JUN1999		1	Baseline	1			SCREENING	Height (cm)	HEIGHT	2	157	157	0			Y	9	HEIGHT	Height	STANDING	157	cm	157	157	cm					Y	1	Baseline	1999-06-19	1
ABC	ABC-001-001	Product A	Product A	Product A	Product A	21JIL1999		33	Visit 2	2			TREATMENT	Systolic Blood Pressure (mmHg)	SYSBP	4	95	153	-58	-37.9085			10	SYSBP	Systolic Blood Pressure	SITTING	95	mmHg	95	95	mmHg			ARM	LEFT		2	Visit 2	1999-07-21	33
ABC	ABC-001-001	Product A	Product A	Product A	Product A	21JIL1999		33	Visit 2	2			TREATMENT	Diastolic Blood Pressure (mmHg)	DIABP	1	44	46	-2	-4.3478			11	DIABP	Diastolic Blood Pressure	SITTING	44	mmHg	44	44	mmHg			ARM	LEFT		2	Visit 2	1999-07-21	33
ABC	ABC-001-001	Product A	Product A	Product A	Product A	21JIL1999		33	Visit 2	2			TREATMENT	Temperature (C)	TEMP	5	36.2	35.45	.75	2.1157			12	TEMP	Temperature		97.16	F	36.2	36.2	C			SUBLINGUAL REGION			2	Visit 2	1999-07-21	33
ABC	ABC-001-001	Product A	Product A	Product A	Product A	21JIL1999		33	Visit 2	2			TREATMENT	Weight (kg)	WEIGHT	6		90.5					13	WEIGHT	Weight							NOT DONE	SUBJECT REFUSED				2	Visit 2

Visit 2

Page tree

ADaM Example.ADVS Vital Signs