Common Data Element: Adverse event outcome status
Listed below are the details for the data element.
FITBIR
1.11
Element Type
Common Data Element
Adverse event outcome status
AdvrsEvntOutcomStatus
Short Description
Final status of the participant/subject related to the adverse event
Definition
Final status of the participant/subject related to the adverse event
Notes
CDISC SDTM variables: AEOUT
Creation Date
Historical Notes
Adverse event outcome status
References
No references available
Data Type
Alphanumeric
Input Restrictions
Single Pre-Defined Value Selected
Population
Adult and Pediatric
Guidelines/Instructions
Choose one outcome. The outcome of an AE may not be captured at the visit during which it was first reported, but must eventually be captured to provide a complete picture of the event. Entering the outcome of an AE may be deferred until the AE is resolved, or the participant/subject completes the study. For AEs that have not resolved at the time of a study visit, the outcome should be marked as Not recovered/not resolved on the AE case report form.
Preferred Question Text
Outcome
Category Groups and Classifications
| Disease | Domain | Sub-Domain |
|---|---|---|
| Epilepsy | Safety Data | Adverse Events |
| Parkinson's Disease | Treatment/Intervention Data | Surgeries and Other Procedures |
| General (For all diseases) | Safety Data | Adverse Events |
Classification
General (For all diseases):
Supplemental
Epilepsy:
Supplemental
Parkinson's Disease:
Supplemental
Keywords
AE_Mapped
Adverse_Event
See_also
Knowledge_graph
Labels
