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
