Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Sponsor-Defined Identifier
Reported Term for the Adverse Event
Modified Reported Term
Dictionary-Derived Term
Body System or Organ Class
Severity/Intensity
Serious Event
Action Taken with Study Treatment
Causality
Start Date/Time of Adverse Event
End Date/Time of Adverse Event
Study Day of Start of Adverse Event
Study Day of End of Adverse Event
End Relative to Reference Period