Adverse Experience (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 3.3.6.1, Subject-level Analysis Dataset (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.

ae.xpt

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Row	STUDYID	DOMAIN	SPDEVID	USUBJID	AESEQ	AETERM	AEMODIFY	AEDECOD	AEBODSYS	AESEV	AESER	AEACN	AEACNDEV	AEREL	AERLDEV	AEOUT	AESHOSP	AESLIFE	AECONTRT	EPOCH	AESTDTC	AEENDTC	AESTDY	AEENDY
1	A123	AE		A2001	1	POUNDING HEADACHE	HEADACHE	Headache	Nervous system disorders	SEVERE	N	DOSE NOT CHANGED		DEFINITELY NOT RELATED		RECOVERED/RESOLVED			Y	PRODUCT EXPOSURE	2021-01-21	2021-01-21	16	16
2	A123	AE	VAPE-Z01	A2008	1	SKIN REDNESS	SKIN REDNESS	Skin Redness		MODERATE	N	DOSE NOT CHANGED	DEVICE REPLACED	PROBABLY RELATED	RELATED	RECOVERED/RESOLVED			N	PRODUCT EXPOSURE	2021-02-16	2021-02-21	8	13
3	A123	AE		A3009	1	INFLUENZA	INFLUENZA	Influenza	Infections and infestations	SEVERE	Y	PRODUCT DISCONTINUED		PROBABLY NOT RELATED		RECOVERING/RESOLVING	Y	Y	Y	PRODUCT EXPOSURE	2021-06-21	2021-06-26	13	18

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The example ADAE dataset and associated metadata serve as an example and are not intended to indicate that ADAE 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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adae.xpt

Row	STUDYID	USUBJID	AETERM	AEMODIFY	AEDECOD	AEBODSYS	ASTDT	AENDT	ASTDY	AENDY	TRTEMFL	FUPFL	AETRTEM	AOCCFL	AOCCPFL	AOCCSFL	AESER	AEREL	AERLDEV	RELGR1	AESEV	AEACN	AEACNDEV	AEOUT	TRTA	SAFFL	TRTSDT	TRTEDT	AESEQ	AESTDTC	AEENDTC	AESTDY	AEENDY
1	A123	A2001	POUNDING HEADACHE	HEADACHE	Headache	Nervous system disorders	21JAN2021	21JAN2021	14	14	Y						N	DEFINITELY NOT RELATED		NOT RELATED	SEVERE	DOSE NOT CHANGED		RECOVERED/RESOLVED	Placebo	Y	08JAN2021	28JAN2021	1	2021-01-21	2021-01-21	14	14
2	A123	A2008	SKIN REDNESS	SKIN REDNESS	Skin Redness		16FEB2021	21FEB2021	9	14	Y		Y	Y	Y	Y	N	PROBABLY RELATED	RELATED	RELATED	MODERATE	DOSE NOT CHANGED	DEVICE REPLACED	RECOVERED/RESOLVED	Placebo	Y	08FEB2021	01MAR2021	2	2021-02-16	2021-02-21	9	14
3	A123	A3009	INFLUENZA	INFLUENZA	Influenza	Infections and infestations	21JUN2021	26JUN2021	13	18	Y	Y	Y		Y	Y	Y	PROBABLY NOT RELATED		NOT RELATED	SEVERE	TRIAL INTERVENTION DISCONTINUED		RECOVERING/RESOLVING	Placebo	Y	09JUN2021	21JUN2021	3	2021-06-21	2021-06-26	13	18

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ADAE Dataset Metadata

Dataset	Description	Class	Structure	Purpose	Keys	Location	Documentation
ADAE	Adverse Events Analysis Dataset	OCCURRENCE DATA STRUCTURE	One record per subject per adverse event	Analysis	STUDYID, USUBJID, AEBODSYS, AEDECOD, AETERM	ADAE.xpt	ADAE.SAS/SAP

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
AETERM	Reported Term for the Adverse Experience	text		Req	AE.AETERM
AEMODIFY	Modified Reported Term	text		Perm	AE.MODIFY
AEBODSYS	Body System or Organ Class	text		Req	AE.AEBODSYS
AEDECOD	Dictionary-Derived Term	text		Req	AE.AEDECOD
ASTDT	Analysis Start Date	integer		Cond	Created from converting AE.AESTDTC from character ISO8601 format to numeric date format
AENDT	Analysis End Date	integer		Cond	Created from converting AE.AEENDTC from character ISO8601 format to numeric date 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-product Flag	text	Y	Cond	If ASTDT < ADSL.TRTSDT then PREFL=’Y’
TRTEMFL	Product TOBA-787 - Getting issue details... STATUS 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	Product 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 product 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 product 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 product emergent record for each body system for each subject.
AESER	Serious Experience TOBA-788 - Getting issue details... STATUS	text	(NY)	Req	AE.AESER
AEREL	Causality	text		Perm	AE.AEREL
AERLDEV	Relationship of Event to Device	text	*	Perm	AE.AERLDEV
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 Product	text	(TPACN)	Perm	AE.AEACN
AEACNDEV	Action Taken with Device	text		Perm	AE.AEACNDEV
AEOUT	Outcome of Adverse Experience	text	(OUT)	Perm	AE.AEOUT
TRTA	Actual Product	text		Cond	ADSL.TRT01A
SAFFL	Safety Population Flag	text		Cond	ADSL.SAFFL
TRTSDT	Date of First Exposure to Product	integer		Perm	ADSL.TRTSDT
TRTEDT	Date of Last Exposure to Product	integer		Perm	ADSL.TRTEDT
AEOUT	Outcome of Adverse experience	text		Perm	AE.AEOUT
AESEQ	Sequence Number	integer		Perm	AE.AESEQ
AESTDTC	Start Date/Time of Adverse Experience	text		Perm	AE.AESTDTC
AEENDTC	End Date/Time of Adverse Experience	text		Perm	AE.AEENDTC
AESTDY	Study Day of Start of Adverse Experience	text		Perm	AE.AESTDY
AEENDY	Study Day of End of Adverse Experience	text		Perm	AE.AEENDY
AEENRF	End Relative to Reference Period	text		Perm	AE.AEENRF

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Adverse Experience (ADAE)