Adverse Events
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Reference ID
Sponsor-Defined Identifier
Link Group ID
Reported Term for the Adverse Event
Lowest Level Term
Lowest Level Term Code
Dictionary-Derived Term
Preferred Term Code
High Level Term
High Level Term Code
High Level Group Term
High Level Group Term Code
Category for Adverse Event
Subcategory for Adverse Event
Pre-Specified Adverse Event
Body System or Organ Class
Body System or Organ Class Code
Primary System Organ Class
Primary System Organ Class Code
Location of Event
Laterality
Severity/Intensity
Serious Event
Action Taken with Study Treatment
Causality
Relationship to Non-Study Treatment
Outcome of Adverse Event
Congenital Anomaly or Birth Defect
Persist or Signif Disability/Incapacity
Results in Death
Requires or Prolongs Hospitalization
Is Life Threatening
Other Medically Important Serious Event
Concomitant or Additional Trtmnt Given
Standard Toxicity Grade
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
Duration of Adverse Event
Planned Elapsed Time from Time Point Ref
Time Point Reference
Date/Time of Reference Time Point
End Relative to Reference Time Point
End Reference Time Point