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Common Data Element:  Adverse event outcome status

Listed below are the details for the data element.

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
 

Biomedical Terminologies and Standards

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
Pre-Defined Values
External Schema Permissible Value Mapping
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
DiseaseDomainSub-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

Epilepsy :
Supplemental
Parkinson's Disease :
Supplemental
General (For all diseases) :
Supplemental
Keywords
AE_Mapped , Adverse_Event , See_also , Knowledge_graph
Labels
Effective Date
Until Date
Last Change Date
Wed Apr 24 16:43:15 EDT 2024
See Also
AdvrsEvntDuringStudyInd;AdvrsEvntExpecStatus;AdvrsEvntSeverScale;AdvrsEvntStartDateTime;AdverseEvntEndDateTime;AdvrsEvntVerbatimTermText;SeriousAdvrsEvntInd;AdvEvntMedDRALowerLvlTermCode;AdvrsEvntCTCAELowLvlTermName;InjElapsedTime
Submitting Organization Name
NIH/NINDS
Submitting Contact Name
NINDSCDE
Submitting Contact Information
NINDSCDE@emmes.com
Steward Organization Name
NIH/NINDS
Steward Contact Name
NINDSCDE
Steward Contact Information
NINDSCDE@emmes.com
NINDS ID

Change History