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Listed below are the details for the data element.

1.10
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
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

Parkinson's Disease :
Supplemental
General (For all diseases) :
Supplemental
Epilepsy :
Supplemental
Keywords
AE_Mapped , Adverse_Event , See_also , Knowledge_graph
Labels
Effective Date
Until Date
Last Change Date
2020-05-18
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