Laboratory Analysis Dataset (ADLB)

This is an example of an ADLB dataset and is based on input from the SDTM LB 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 ADLB dataset. Only variables needed for illustration are shown in the examples.

lb.xpt

ROW	STUDYID	DOMAIN	USUBJID	LBSEQ	LBTESTCD	LBTEST	LBCAT	LBORRES	LBORRESU	LBORNRLO	LBORNRHI	LBSTRESC	LBSTRESN	LBSTRESU	LBSTNRC	LBSTNRLO	LBSTNRHI	LBNRIND	LBLOINC	LBSPEC	LBLOBXFL	LBCLSIG	VISITNUM	LBDTC
1	A123	LB	A2001	1	WBC	Leukocytes	HEMATOLOGY	11.0	10^9/L	4.5	11.0	11.0	11.0	10^9/L		4.5	11.0		26464-8	BLOOD	Y		1	2021-1-02
2	A123	LB	A2001	2	RBC	RBC	HEMATOLOGY	5.4	10^12/L	4.7	6.1	5.4	5.4	10^12/L		4.7	6.1		33051-4	BLOOD	Y		1	2021-1-02
3	A123	LB	A2001	3	PLAT	Platelets	HEMATOLOGY	158	10^9/L	150	400	158	158	10^9/L		150	400		49497-1	BLOOD	Y		1	2021-1-02
4	A123	LB	A2001	4	HGB	Hemoglobin	HEMATOLOGY	14.5	g/dL	14	18	14.5	14.5	g/dL		14	18		718-7	BLOOD	Y		1	2021-1-02
5	A123	LB	A2001	5	CHOL	Cholesterol	CLINICAL CHEMISTRY	229	mg/dL	200		229	229	mg/dL		200			2093-3	BLOOD	Y		1	2021-1-02
6	A123	LB	A2001	6	ALB	Albumin	CLINICAL CHEMISTRY	40.0	g/L	34	54	4.0	4.0	g/dL		3.4	5.4		2862-1	BLOOD	Y		1	2021-1-02
7	A123	LB	A2001	7	CREAT	Creatinine	CLINICAL CHEMISTRY	0.8	mg/dL	0.7	1.3	0.8	0.8	mg/dl		0.7	1.3		2160-0	BLOOD	Y		1	2021-1-02
8	A123	LB	A2001	8	SPGRAV	Specific Gravity	URINALYSIS	1.002		1.005	1.030					1.005	1.030		2965-2	URINE	Y		1	2021-1-02
9	A123	LB	A2001	9	CANNAB	Cannabinoids	DRUG TOXICITY	POSITIVE				POSITIVE			NEGATIVE			ABNORMAL	18282-4	URINE	Y	Y	1	2021-1-02

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This is an example of the ADLB dataset and associated metadata. This is just an example and does not mean to indicate that ADLB 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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adlb.xpt

Row	STUDYID	USUBJID	TRTP	TRT01P	TRTA	TRT01A	ADT	ADY	AVISIT	AVISITN	PARAM	PARAMCD	PARAMN	PARCAT1	AVAL	AVALC	BASE	ABLFL	ANL01FL	LBSTNRC	ANRLO	ANRHI	ANRIND	LBLOINC	LBSPEC	RANDFL	SAFFL	TRTSDT	TRTEDT	LBCLSIG	LBSEQ	VISITNUM	LBDTC
1	A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021	-6	SCREENING	1	Leukocytes (10^9/L)	WBC	6	HEMATOLOGY	11.0		11.0	Y	Y		4.5	11.0		26464-8	BLOOD	Y	Y	2021-01-08	2021-01-28		1	1	2021-01-02
2	A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021	-6	SCREENING	1	RBC (10^12/L)	RBC	8	HEMATOLOGY	5.4		5.4	Y	Y		4.7	6.1		33051-4	BLOOD	Y	Y	2021-01-08	2021-01-28		2	1	2021-01-02
3	A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021	-6	SCREENING	1	Platelets (10^9/L)	PLAT	7	HEMATOLOGY	158		158	Y	Y		150	400		49497-1	BLOOD	Y	Y	2021-01-08	2021-01-28		3	1	2021-01-02
4	A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021	-6	SCREENING	1	Hemoglobin (g/dL)	HGB	5	HEMATOLOGY	14.5		14.5	Y	Y		14	18		718-7	BLOOD	Y	Y	2021-01-08	2021-01-28		4	1	2021-01-02
5	A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021	-6	SCREENING	1	Cholesterol (mg/dL)	CHOL	2	CLINICAL CHEMISTRY	229		229	Y	Y		200			2093-3	BLOOD	Y	Y	2021-01-08	2021-01-28		5	1	2021-01-02
6	A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021	-6	SCREENING	1	Albumin (g/L)	ALB	1	CLINICAL CHEMISTRY	4.0		4.0	Y	Y		3.4	5.4		2862-1	BLOOD	Y	Y	2021-01-08	2021-01-28		6	1	2021-01-02
7	A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021	-6	SCREENING	1	Creatinine (mg/dL)	CREAT	3	CLINICAL CHEMISTRY	0.8		0.8	Y	Y		0.7	1.3		2160-0	BLOOD	Y	Y	2021-01-08	2021-01-28		7	1	2021-01-02
8	A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021	-6	SCREENING	1	Urine Specific Gravity	USPGRAV	9	URINALYSIS				Y	Y		1.005	1.030		2965-2	URINE	Y	Y	2021-01-08	2021-01-28		8	1	2021-01-02
9	A123	A2001	Placebo	Placebo	Placebo	Placebo	02JAN2021	-6	SCREENING	1	Cannabinoids	CANNAB	4	DRUG TOXICITY		POSITIVE				NEGATIVE			ABNORMAL	18282-4	URINE	Y	Y	2021-01-08	2021-01-28	Y	9	1	2021-01-02

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ADLB Dataset Metadata

Dataset	Description	Class	Structure	Purpose	Keys	Location	Documentation
ADLB	Laboratory 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,	ADLB.xpt	ADLB.SAS/SAP

ADLB Variable Metadata

Variable Name	Variable Label	Type	Codelist/Controlled Terms	Core	CDISC Notes
STUDYID	Study Identifier	Char		Req	LB.STUDYID
USUBJID	Unique Subject Identifier	Char		Req	LB.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	LB.LBDTC captured in numeric format
ADY	Analysis Relative Day	Num		Perm	LB.LBDY
AVISIT	Analysis Visit	Char		Cond	LB.VISIT
AVISITN	Analysis Visit (N)	Num		Perm	LB.VISITNUM
PARAM	Parameter	Char		Req	LB.LBTEST concatenated with LB.LBSTRESU - if PARCAT1=URINALYSIS then preface with Urine
PARAMCD	Parameter Code	text		Req	LB.LBTESTCD - if PARCAT1=URINALYSIS then preface with U
PARAMN	Parameter (N)	Num		Perm	Numeric representation of PARAM. Sort by PARCAT! and PARAMCD and increment by 1 for each new LBTESTCD
PARCAT1	Parameter Category 1	Char		Perm	LB.LBCAT
AVAL	Analysis Value	Num		Cond	LB.LBSTRESN
AVALC	Analysis Value (C)	Char		Cond	LB.LBSTRESC where LB.LBSTRESN is null
BASE	Baseline Value	Num		Cond	AVAL where ABLFL=Y
CHG	Change from Baseline	Num		Perm	AVAL-BASE - populated on ABLFL=Y records and post-baseline records
PCHG	Percent Change from Baseline	Num		Perm	derived as ((AVAL-BASE)/BASE)*100
ABLFL	Baseline Record Flag	Char	Y	Cond	set to Y for last pre-product value within each PARAM
ANL01FL	Analysis Flag 01	Char	Y	Cond	set to Y for last value within PARAM and AVISIT
RANDFL	Randomized Population Flag	Char	Y;N	Cond	ADSL.RANDFL
SAFFL	Safety Population Flag	Char	Y;N	Cond	ADSL.SAFFL
TRTSDT	Date of First Exposure to Product TOBA-192 - Getting issue details... STATUS	Num		Perm	ADSL.TRTSDT
TRTEDT	Date of Last Exposure to Product TOBA-190 - Getting issue details... STATUS	Num		Perm	ADSL.TRTEDT
LBSEQ	Sequence Number	Num		Perm	LB.LBSEQ
VISITNUM	Visit Number	Num		Perm	LB.VISITNUM
LBDTC	Date/Time of Specimen Collection	Char		Perm	LB.LBDTC

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Laboratory Analysis Dataset (ADLB)