Exposure (ADEX)

This is an example of an ADEX dataset and is based primarily on input from the SDTM EX 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 of the input SDTM EX dataset used to create the ADEX. Only variables needed for illustration are shown in the example.

ex.xpt

Row	STUDYID	DOMAIN	USUBJID	EXSEQ	SPTOBID	EXREFID	EXTRT	EXDOSE	EXDOSU	EXDOSFRM	EXROUTE	EXPSTRG	EXPSTRGU	EXSTDTC	EXENDTC
1	A123	EX	A2001	1	VAPE-Z27	CRT8754	e-nicotine liquid	6	mL	CARTRIDGE	RESPIRATORY (INHALATION)	0	mg/mL	2021-01-08	2021-01-14
2	A123	EX	A2001	2	VAPE-Z27	CRT8768	e-nicotine liquid	6.4	mL	CARTRIDGE	RESPIRATORY (INHALATION)	0	mg/mL	2021-01-15	2021-01-21
3	A123	EX	A2001	3	VAPE-Z27	CRT9756	e-nicotine liquid	7	mL	CARTRIDGE	RESPIRATORY (INHALATION)	0	mg/mL	2021-01-22	2021-01-28
4	A123	EX	A2008	1	VAPE-Z27	CRT8000	e-nicotine liquid	5	mL	CARTRIDGE	RESPIRATORY (INHALATION)	8	mg/mL	2021-02-08	2021-02-14
5	A123	EX	A2008	2	VAPE-Z27	CRT9006	e-nicotine liquid	7	mL	CARTRIDGE	RESPIRATORY (INHALATION)	8	mg/mL	2021-02-15	2021-02-21
6	A123	EX	A2008	3	VAPE-Z27	CRT9008	e-nicotine liquid	8	mL	CARTRIDGE	RESPIRATORY (INHALATION)	8	mg/mL	2021-02-22	2021-03-01
7	A123	EX	A3009	1	VAPE-Z27	CRT9128	e-nicotine liquid	8	mL	CARTRIDGE	RESPIRATORY (INHALATION)	4	mg/mL	2021-06-09	2021-06-15
8	A123	EX	A3009	2	VAPE-Z27	CRT6868	e-nicotine liquid	6.7	mL	CARTRIDGE	RESPIRATORY (INHALATION)	4	mg/mL	2021-06-16	2021-06-21

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

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adex.xpt

Row	STUDYID	USUBJID	ASTDT	ASTDY	AENDT	AENDY	EXTRT	DOSCUMA	EXSTDTC	EXENDTC	TRTA	EXDOSE	EXDOSU	SAFFL
1	A123	A2001	08JAN2021	1	14JAN2021	7	e-nicotine liquid	6	021-01-08	2021-01-14	Placebo	6	mL	Y
2	A123	A2001	15JAN2021	8	21JAN2021	14	e-nicotine liquid	12.4	2021-01-15	2021-01-21	Placebo	6.4	mL	Y
3	A123	A2001	22JAN2021	15	28JAN2021	21	e-nicotine liquid	19.4	2021-01-22	2021-01-28	Placebo	7	mL	Y
4	A123	A2008	08FEB2021	1	14FEB2021	7	e-nicotine liquid	5	2021-02-08	2021-02-14	Product A	5	mL	Y
5	A123	A2008	15FEB2021	8	21FEB2021	14	e-nicotine liquid	12	2021-02-15	2021-02-21	Product A	7	mL	Y
6	A123	A2008	22FEB2021	15	01MAR2021	22	e-nicotine liquid	20	2021-02-22	2021-03-01	Product A	8	mL	Y
7	A123	A3009	09JUN2021	1	15JUN2021	7	e-nicotine liquid	8	2021-06-09	2021-06-15	Product B	8	mL	Y
8	A123	A3009	16JUN2021	8	21JUN2021	13	e-nicotine liquid	14.7	2021-06-16	2021-06-21	Product B	6.7	mL	Y

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ADEX Dataset Metadata

Dataset	Description	Class	Structure	Purpose	Keys	Location	Documentation
ADEX	Exposure Analysis Dataset	OCCURRENCE DATA STRUCTURE	One record per subject per product (EXTRT) per start date	Analysis	STUDYID, USUBJID, EXTRT, ASTDT	ADEX.xpt	ADEX.SAS/SAP

ADEX Variable Metadata

Variable Name	Variable Label	Type	Core	CDISC Notes
STUDYID	Study Identifier	text	Req	EX.STUDYID
USUBJID	Unique Subject Identifier	text	Req	EX.USUBJID
ASTDT	Analysis Start Date	integer	Perm	EX.EXSTDTC cpatured as a numeric variable
ASTDY	Analysis Start Relative Day	integer	Perm	ASTDT-ADT.TRTSDT+1
AENDT	Analysis End Date	integer	Perm	EX.EXENDTC cpatured as a numeric variable
AENDY	Analysis End Relative Day	integer	Perm	AENDT-ADT.TRTSDT+1
EXTRT	Name of Product	text	Req	EX.EXTRT
DOSCUMA	Cumulative Actual Product Dose	float	Perm	Cumulative dose within USUBJID
EXSTDTC	Start Date/Time of Product	text	Perm	EX.EXSTDTC
EXENDTC	End Date/Time of Product	text	Perm	EX.EXENDTC
TRTA	Actual Product	text	Cond	ADSL.TRT01A
EXDOSE	Dose	float	Perm	EX.EXDOSE
EXDOSU	Dose Units	text	Perm	EX.EXDOSU
SAFFL	Safety Population Flag	text	Cond	ADSL.SAFFL

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adexsum.xpt

Row	STUDYID	USUBJID	TRTA	PARAM	PARAMCD	PARAMN	AVAL	SAFFL
1	A123	A2001	Placebo	Number of Days Exposed	NDAYS	1	21	Y
2	A123	A2001	Placebo	Average Daily Dose	ADD	2	0.92381	Y
3	A123	A2001	Placebo	Total Dose	TOTDOSE	3	19.4	Y
4	A123	A2008	Product A	Number of Days Exposed	NDAYS	1	22	Y
5	A123	A2008	Product A	Average Daily Dose	ADD	2	0.90909	Y
6	A123	A2008	Product A	Total Dose	TOTDOSE	3	20	Y
7	A123	A3009	Product B	Number of Days Exposed	NDAYS	1	13	Y
8	A123	A3009	Product B	Average Daily Dose	ADD	2	1.13077	Y
9	A123	A3009	Product B	Total Dose	TOTDOSE	3	14.7	Y

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ADEXSUM Dataset Metadata

Dataset	Description	Class	Structure	Purpose	Keys	Location	Documentation
ADEXSUM	Exposure Summary Analysis Dataset	BASIC DATA STRUCTURE	One or more records per subject per analysis parameter	Analysis	STUDYID, USUBJID, PARAM	ADEXSUM.xpt	ADEXSUM.SAS/SAP

ADEXSUM Variable Metadata

Variable Name	Variable Label	Type	Codelist/Controlled Terms	Core	CDISC Notes
STUDYID	Study Identifier	Char		Req	ADEX.STUDYID
USUBJID	Unique Subject Identifier	Char		Req	ADEX.USUBJID
TRTA	Actual Product	Char		Cond	ADEX.TRT01A
PARAM	Parameter	Char		Req	Assigned
PARAMCD	Parameter Code	text		Req	Assigned
PARAMN	Parameter (N)	Num		Perm	Assigned
AVAL	Analysis Value	Num		Cond	see parameter level metadata
SAFFL	Safety Population Flag	Char	Y;N	Cond	ADSL.SAFFL

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Exposure (ADEX)