This is an example of an ADAE dataset and is based primarily on the SDTM AE domains Other adminstrative data about the subjects are based on the ADSL datset provided ... > add the link.
Below is is an example AE SDTM datasets used to create the ADAE
Need to Determine Codes to be used TRIAL INTERVENTION DISCONTINUED or PRODUCT DISCONTINUED
Need to look Up code for MEDDRA SKIN REDNESS
ae.xpt
xx.xpt
Row
STUDYID
DOMAIN
SPDEVID
USUBJID
AESEQ
AETERM
AEMODIFY
AEDECOD
AEBODSYS
AESEV
AESER
AEACN
AEACNDEV
AEREL
AERLDEV
AEOUT
AESCONG
AESDISAB
AESDTH
AESHOSP
AESLIFE
AESMIE
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
A2001
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
A2008
1
INFLUENZA
INFLUENZA
Influenza
Infections and infestations
SEVERE
Y
TRIAL INTERVENTION DISCONTINUED
PROBABLY NOT RELATED
RECOVERING/RESOLVING
Y
Y
Y
PRODUCT EXPOSURE
2021-06-21
2021-06-26
13
18
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Below is the example ADAE dataset and associated metadata.
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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 Dataset Metadata
Dataset
Description
Class
Structure
Purpose
Keys
Location
Documentation
ADAE
One record per subject
Analysis
STUDYID, USUBJID, PARQUAL, PARAMCD, AVISIT,
ADSL.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
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)