Adverse Events (ADAE)

This is an example of an ADAE dataset and is based primarily on input from the SDTM AE dataset. Other administrative data about the subjects are based on the ADSL dataset provided in Section x.x, Analysis Data Subject Level (ADSL). Only variables needed for illustration are shown in the examples.

Example

This is an example of the input SDTM AE datasets used to create the ADAE.

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Below is the example ADAE dataset and associated metadata. This is just an example and does not mean to indicate that ADAE must be used as the dataset name nor are the parameters described necessarily the ones that would be used in a particular study.

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adae.xpt

STUDYID	USUBJID	ASTDT	ASTDTM	AENDT	AENDTM	ASTDY	AENDY	PREFL	TRTEMFL	FUPFL	AETRTEM	AOCCFL	AOCCPFL	AOCCSFL	AESER	AEREL	RELGR1	AESEV	AEACN	TRTA	SAFFL	TRTSDT
ABC123	123101	12OCT2005		12OCT2005		-1	-1	Y							N	DEFINITELY NOT RELATED	NOT RELATED	SEVERE	NOT APPLICABLE	Product A	Y	13OCT2005
ABC123	123101	13OCT2005	13OCT2005:13:05	13OCT2005	13OCT2005:19:00	1	1		Y		Y	Y	Y	Y	N	Product A	RELATED	MODERATE	DOSE REDUCED	Product A	Y	13OCT2005
ABC123	123101	21OCT2005				9			Y	Y	Y		Y	Y	Y	PROBABLY NOT RELATED	NOT RELATED	MODERATE	DOSE REDUCED	Product A	Y	13OCT2005

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ADAE 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

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Adverse Events (ADAE)