AE Domain

Adverse Events
Sponsor Dataset
Dataset Name Variable Name
ae
STUDY
ae
ae
PID
ae
ae
AEVERB
ae
AESTRDT, AESTTM
ae
AEENDDT
ae
ae
ae
ANYAE
ae
AECODE
ae
AESOC
ae
TEAEFLA_
ae
SEVERIT_
ae
SAEFLAG_
ae
ACTIONG_
ae
ACTIOND_
ae
RELATD_
ae
RELATG_
ae
AEOUTC_
ae
ae
ae
ae
ae
AECONT
ae
ae
ae
ae
ae
ae
ae
ae
ae
ae
ae
ae
TEAEFLA_
ae
ae

CDISC Domain
Type Label DOMAIN VARIABLE NAME
AE
STUDYID
AE
DOMAIN
AE
USUBJID
AE
AESEQ
AE
AETERM
AE
AESTDTC
AE
AEENDTC
AE
AESTDY
AE
AEENDY
AE
AEMODIFY
AE
AEDECOD
AE
AEBODSYS
AE
AETRTEM
AE
AESEV
AE
AESER
AE
AEACN
AE
AEACNOTH
AE
AEREL
AE
AERELOTH
AE
AEOUT
AE
AEDUR
AE
AEDURU
AE
AEELTM
AE
AETPTREF
AE
AEONGO
AE
AEDTM
AE
AEDTMP
AE
AESCAN
AE
AESCONG
AE
AESDISAB
AE
AESDTH
AE
AESHOSP
AE
AESLIFE
AE
AESOD
AE
AESOTH
AE
AESOTHC
AE
AECONTRT
AE
AETOXGR
AE
AECOM

VARIABLE LABEL
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Reported Term for the Adverse Event
Start Date/ Time of Event
End Date/Time of Event
Study Day of Start of Event
Study Day of End of Event
Modified Reported Term
Dictionary-Derived Text Description
Body System or Organ Class
Treatment Emergent
Severity / Intensity
Seriousness Criteria
Action Taken with Study Treatment
Other Action Taken
Causality
Relationship to Other (Non-Study) Treat
Outcome of Event
Duration of Event
Units of Time for AEDUR
Elapsed Time from Reference Point
Time Point Reference
Ongoing Adverse Event?
Date/Time of Collection
Precision of AEDTM
Involves Cancer
Congenital Anomaly or Birth Defect
Permanent/Serious/Disable/Incapacitating
Results in Death
Requires or Prolongs Hospitalization
Is Life Threatening
Occurred with Overdose
Other Medically Important Serious Event
Dscr of Other Med Impt Serious Events
Concomitant or Additional Trtmnt Given
Toxicity Grade
Comment

TYPE
CHAR
CHAR
CHAR
NUM
CHAR
CHAR
CHAR
NUM
NUM
CHAR
CHAR
CHAR
CHAR
CHAR
CHAR
CHAR
CHAR
CHAR
CHAR
CHAR
NUM
CHAR
NUM
CHAR
CHAR
NUM
NUM
CHAR
CHAR
CHAR
CHAR
CHAR
CHAR
CHAR
CHAR
CHAR
CHAR
CHAR
CHAR

CDISC MAPPING (Comments)
DOMAIN = "AE"

May be dropped.
may be dropped

may be dropped
may be dropped
may be dropped
may be dropped
may be dropped
may be dropped
may be dropped
may be dropped
may be dropped
may be dropped
may be dropped
may be dropped
may be dropped
may be dropped
may be dropped
may be dropped
may be dropped

PING (Comments)

MAIN = "AE"

be dropped.
be dropped

be dropped
be dropped
be dropped
be dropped

be dropped
be dropped
be dropped
be dropped
be dropped
be dropped
be dropped
be dropped
be dropped
be dropped
be dropped

be dropped
be dropped