ae {pharmaversesdtm} | R Documentation |
Adverse Events
Description
An updated SDTM AE dataset that uses the CDISC pilot project
Usage
ae
Format
A data frame with 35 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- AESEQ
Sequence Number
- AESPID
Sponsor-Defined Identifier
- AETERM
Reported Term for the Adverse Event
- AELLT
Lowest Level Term
- AELLTCD
Lowest Level Term Code
- AEDECOD
Dictionary-Derived Term
- AEPTCD
Preferred Term Code
- AEHLT
High Level Term
- AEHLTCD
High Level Term Code
- AEHLGT
High Level Group Term
- AEHLGTCD
High Level Group Term Code
- AEBODSYS
Body System or Organ Class
- AEBDSYCD
Body System or Organ Class Code
- AESOC
Primary System Organ Class
- AESOCCD
Primary System Organ Class Code
- AESEV
Severity/Intensity
- AESER
Serious Event
- AEACN
Action Taken with Study Treatment
- AEREL
Causality
- AEOUT
Outcome of Adverse Event
- AESCAN
Involves Cancer
- AESCONG
Congenital Anomaly or Birth Defect
- AESDISAB
Persist or Signif Disability/Incapacity
- AESDTH
Results in Death
- AESHOSP
Requires or Prolongs Hospitalization
- AESLIFE
Is Life Threatening
- AESOD
Occurred with Overdose
- AEDTC
Date/Time of Collection
- AESTDTC
Start Date/Time of Adverse Event
- AEENDTC
End Date/Time of Adverse Event
- AESTDY
Study Day of Start of Adverse Event
- AEENDY
Study Day of End of Adverse Event
Details
Adverse Events
An updated SDTM AE dataset that uses the CDISC pilot project
Author(s)
Gopi Vegesna
Source
Access the source of the Adverse Events dataset.