ADaM Examples: ADSL

This is an example of an ADSL dataset and is based on the SDTM DM and DS domains. 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.

Below are example SDTM datasets used to create the ADSL dataset.

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	A0001	0001	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	UB	Usual Brand	UB	Usual Brand	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	2006-03-19	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

Dataset Debug Message

There is a leading, trailing, or non-breaking space in the dataset.

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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			2021-01-07	2021-01-07
3	A123	DS	A2001	3	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2021-01-07	20021-01-07
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	COMPLETED	LOST TO FOLLOW-UP	DISPOSITION EVENT	STUDY PARTICIPATION	PRODUCT EXPOSURE	2021-06-30	2021-06-30

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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, PARQUAL, PARAMCD, AVISIT,	ADSL.xpt	ADSL.SAS/SAP

ADSL Variable Metadata

Variable Name	Variable Label	Type	Codelist/Controlled Terms	Core	Notes
STUDYID	Study Identifier	text		Req	AE.STUDYID
USUBJID	Unique Subject Identifier	text		Req	AE.USUBJID
ASTDT	Analysis Start Date	integer		Cond	Created from converting AE.AESTDTC from character ISO8601 format to numeric date format
ASTDTM	Analysis Start Date/Time	integer		Cond	Created from converting AE.AESTDTC from character ISO8601 format to numeric datetime format
AENDT	Analysis End Date	integer		Cond	Created from converting AE.AEENDTC from character ISO8601 format to numeric date format
AENDTM	Analysis End Date/Time	integer		Cond	Created from converting AE.AEENDTC from character ISO8601 format to numeric datetime format
ASTDY	Analysis Start Relative Day	integer		Cond	ASTDT – ADSL.TRTSDT + 1 if ASTDT ≥ TRTSDT, else ASTDT – ADSL.TRTSDT if ASTDT< TRTSDT
AENDY	Analysis End Relative Day	integer		Cond	AENDT – ADSL.TRTSDT + 1 if AENDT ≥ TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT
PREFL	Pre-treatment Flag	text	Y	Cond	If ASTDT < ADSL.TRTSDT then PREFL=’Y’
TRTEMFL	Treatment Emergent Analysis Flag	text	Y	Cond	If ADSL.TRTSDT≤ASTDT then TRTEMFL=’Y’
FUPFL	Follow-up Flag	text	Y	Cond	If ASTDT > ADSL.TRTEDT then FUPFL=’Y’
AETRTEM	Treatment Emergent Flag	text	(NY)	Perm	SUPPAE.QVAL where QNAM=’AETRTEM’.
AOCCFL	1st Occurrence within Subject Flag	text	Y	Perm	Sort the data in the required order and flag the first treatment emergent record for each subject.
AOCCPFL	1st Occurrence of Preferred Term Flag	text	Y	Perm	Sort the data in the required order and flag the first treatment emergent record for each AEDECOD for each subject.
AOCCSFL	1st Occurrence of SOC Flag	text	Y	Perm	Sort the data in the required order and flag the first treatment emergent record for each body system for each subject.
AESER	Serious Event	text	(NY)	Req	AE.AESER
AEREL	Causality	text		Perm	AE.AEREL
RELGR1	Pooled Causality Group y	text		Perm	set to RELATED if AE.AEREL in (DEFINITELY,PROBABLY,POSSIBLY), set to NOT RELATED if AEREL in (PROBABLY NOT, DEFINITELY NOT)
AEACN	Action Taken with Study Treatment	text	(ACN)	Perm	AE.AEACN
TRTP	Planned Treatment	text		Cond	ADSL.TRT01P
TRTA	Actual Treatment	text		Cond	ADSL.TRT01A
SAFFL	Safety Population Flag	text		Cond	ADSL.SAFFL
TRTSDT	Date of First Exposure to Treatment	integer		Perm	ADSL.TRTSDT
TRTEDT	Date of Last Exposure to Treatment	integer		Perm	ADSL.TRTEDT
AETERM	Reported Term for the Adverse Event	text		Req	AE.AETERM
AEBODSYS	Body System or Organ Class	text		Req	AE.AEBODSYS
AEDECOD	Dictionary-Derived Term	text		Req	AE.AEDECOD
AEOUT	Outcome of Adverse Event	text		Perm	AE.AEOUT
AESEQ	Sequence Number	integer		Perm	AE.AESEQ
AESTDTC	Start Date/Time of Adverse Event	text		Perm	AE.AESTDTC
AEENDTC	End Date/Time of Adverse Event	text		Perm	AE.AEENDTC
AESTDY	Study Day of Start of Adverse Event	text		Perm	AE.AESTDY
AEENDY	Study Day of End of Adverse Event	text		Perm	AE.AEENDY
AEENRF	End Relative to Reference Period	text		Perm	AE.AEENRF

This is an example of the ADSL dataset.

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adsl.xpt

STUDYID	USUBJID	SUBJID	SITEID	AGE	AGEU	AGEGR1	SEX	RACE	ETHNIC	SAFFL	RANDFL	ARM	ACTARM	TRT01P	TRT01PN	TRT01A	TRT01AN	TRTSDT	TRTEDT	EOSSTT	DCSREAS
A123	A2001	0001	01	72	YEARS	<65	M	WHITE	NOT HISPANIC OR LATINO	Y	Y	Usual Brand	Usual Brand	Product A	1	Usual Brand	1	2021-01-08	2021-01-28	COMPLETED
A123	A2008	2008	02	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	ADVERSE EVENT
A123	A3009	3009	03	57	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	DISCONTINUED

Dataset Debug Message

There are three leading, trailing, or non-breaking spaces in the dataset.

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ADaM Examples: ADSL