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