Analysis Data Subject Level (ADSL)

This is an example of an ADSL dataset and is based on input from the SDTM DM and DS datasets. This is just an example and does not mean to indicate that ADSL must be used as the dataset name nor are the parameters described necessarily the ones that would be used in a particular study.

Example

These are example SDTM datasets used to create the ADSL dataset. Only variables needed for illustration are shown in the examples.

dm.xpt

Row	STUDYID	DOMAIN	USUBJID	SUBJID	RFSTDTC	RFENDTC	RFXSTDTC	RFXENDTC	RFICDTC	RFPENDTC	SITEID	INVNAM	BRTHDTC	AGE	AGEU	SEX	RACE	ETHNIC	ARMCD	ARM	ACTARMCD	ACTARM	COUNTRY
1	A123	DM	A2001	2001	2021-01-08	2021-01-28	2021-01-08	2021-01-28	2021-01-02	2021-02-04	01	JOHNSON, M	1948-12-13	72	YEARS	M	WHITE	NOT HISPANIC OR LATINO	Plac	Placebo	Plac	Placebo	USA
2	A123	DM	A2008	2008	2021-02-08	2021-03-01	2021-02-08	2021-03-01	2021-02-02	2021-03-10	02	JAMES, A	1955-03-22	65	YEARS	M	WHITE	NOT HISPANIC OR LATINO	A	Product A	A	Product A	USA
3	A123	DM	A3009	3009	2021-06-09	2021-06-21	2021-06-09	2021-06-21	2021-06-01	2021-06-30	03	ADAMS, J	1964-01-19	57	YEARS	F	BLACK OR AFRICAN AMERICAN	NOT HISPANIC OR LATINO	B	Product B	B	Product B	USA

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ds.xpt

Row	STUDYID	DOMAIN	USUBJID	DSSEQ	DSTERM	DSDECOD	DSCAT	DSSCAT	EPOCH	DSDTC	DSSTDTC
1	A123	DS	A2001	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE			2021-01-02	2021-01-02
2	A123	DS	A2001	2	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE			2021-01-08	2021-01-08
3	A123	DS	A2001	3	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2021-01-08	2021-01-08
4	A123	DS	A2001	4	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	PRODUCT EXPOSURE	2021-01-28	2021-01-28
5	A123	DS	A2001	5	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	FOLLOW-UP	2021-02-04	2021-02-04
6	A123	DS	A2008	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE			2021-02-02	2021-02-02
7	A123	DS	A2008	2	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE			2021-02-08	2021-02-08
3	A123	DS	A2008	3	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2021-02-08	2021-02-08
4	A123	DS	A2008	4	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	PRODUCT EXPOSURE	2021-03-01	2021-03-01
5	A123	DS	A2008	5	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	FOLLOW-UP	2021-03-10	2021-03-10
8	A123	DS	A3009	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE			2021-06-01	2021-06-01
9	A123	DS	A3009	2	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE			2021-06-09	2021-06-09
10	A123	DS	A3009	3	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2021-06-09	2003-06-09
10	A123	DS	A3009	4	FLU	ADVERSE EVENT	DISPOSITION EVENT	STUDY PARTICIPATION	PRODUCT EXPOSURE	2021-06-21	2021-06-21
11	A123	DS	A3009	5	LOST TO FOLLOW-UP	LOST TO FOLLOW-UP	DISPOSITION EVENT	STUDY PARTICIPATION	FOLLOW-UP	2021-06-30	2021-06-30

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This is an example of the ADSL dataset and associated metadata.

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adsl.xpt

Row	STUDYID	USUBJID	SUBJID	SITEID	AGE	AGEU	AGEGR1	SEX	RACE	ETHNIC	SAFFL	RANDFL	ARM	ACTARM	TRT01P	TRT01PN	TRT01A	TRT01AN	TRTSDT	TRTEDT	EOSSTT	EOSDT	EOTSTT	DCTREAS	RANDDT
1	A123	A2008	2008	01	72	YEARS	>=65 Years	M	WHITE	NOT HISPANIC OR LATINO	Y	Y	Placebo	Placebo	Placebo	1	Placebo	1	2021-01-08	2021-01-28	COMPLETED	2021-02-04			2021-01-08
2	A123	A2008	2008	02	65	YEARS	>=65 Years	M	WHITE	NOT HISPANIC OR LATINO	Y	Y	Product A	Product A	Product A	2	Product A	2	2021-02-08	2021-03-01	COMPLETED	2021-03-10			2021-02-08
3	A123	A3008	3008	03	57	YEARS	<65 Years	F	BLACK OR AFRICAN AMERICAN	NOT HISPANIC OR LATINO	Y	Y	Product B	Product B	Product B	3	Product B	3	2021-06-09	2021-06-21	COMPLETED	2021-06-30	DISCONTINUED	ADVERSE EVENT	2021-06-09

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ADSL Dataset Metadata

Dataset	Description	Class	Structure	Purpose	Keys	Location	Documentation
ADSL	Subject-Level Analysis Dataset	SUBJECT LEVEL ANALYSIS DATASET	One record per subject	Analysis	STUDYID, USUBJID	ADSL.xpt	ADSL.SAS/SAP

ADSL Variable Metadata

Variable Name	Variable Label	Type	Codelist/Controlled Terms	Core	Notes
STUDYID	Study Identifier	Char		Req	DM.STUDYID
USUBJID	Unique Subject Identifier	Char		Req	DM.USUBJID
SUBJID	Subject Identifier for the Study	Char		Req	DM.SUBJID
SITEID	Study Site Identifier	Char		Req	DM.SITEID
AGE	Age	Num		Req	DM.AGE
AGEU	Age Units	Char	(AGEU)	Req	DM.AGEU
AGEGR1	Pooled Age Group 1	Char		Perm	Character description of a grouping or pooling of the subject's age for analysis purposes.
SEX	Sex	Char	(SEX)	Req	DM.SEX
RACE	Race	Char	(RACE)	Req	DM.RACE
ETHNIC	Ethnicity	Char		Perm	DM.ETHNIC
SAFFL	Safety Population Flag	Char	Y; N	Cond	Y if ADSL.TRTSDT is not null, otherwise N
RANDFL	Randomized Population Flag	Char	Y; N	Cond	Y if the subject was randomized, otherwise N
ARM	Description of Planned Arm	Char		Req	DM.ARM
ACTARM	Description of Actual Arm	Char		Perm	DM.ACTARM
TRT01P	Planned Product for Period 01	Char		Req	DM.ARM
TRT01PN	Planned Product for Period 01 (N)	Num		Perm	Assigned based on the ARM value
TRT01A	Actual Product for Period 01	Char		Cond	DM.ACTARM
TRT01AN	Actual Product for Period 01 (N)	Num		Perm	Assigned based on the ACTARM value
TRTSDT	Date of First Exposure to Product	Num		Cond	Numeric version of RFXSTDTC
TRTEDT	Date of Last Exposure to Product	Num		Cond	Numeric version of RFXENDTC
EOSSTT	End of Study Status	Char	(SBJTSTAT)	Perm	The subject's status as of the end of study or data cutoff. Examples: COMPLETED, DISCONTINUED, ONGOING.
EOSDT	End of Study Date	Num		Perm	Date subject ended the study - either date of completion or date of discontinuation or data cutoff date for interim analyses.
DCSREAS	Reason for Discontinuation from Study	Char		Perm	Reason for subject's discontinuation from study. The source would most likely be the SDTM DS dataset. Null for subjects who completed the study.
EOTSTT	End of Product Status	Char	(SBJTSTAT)	Perm	The subject's status as of the end of product or data cutoff. Examples: COMPLETED, DISCONTINUED, ONGOING.
DCTREAS	Reason for Discontinuation of Product	Char		Perm	If a subject discontinued product in the study, then this variable indicates the reason for discontinuation. This is for discontinuation of product in the overall study and not to be used for discontinuation reason within individual product periods.
RANDDT	Date of Randomization	Num		Cond	DS.DSSTDTC where DSDECOD=RANDOMIZED

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Analysis Data Subject Level (ADSL)