Common Data Element: Serious adverse event resolution indicator
Listed below are the details for the data element.
1.0
Element Type
Common Data Element
Serious adverse event resolution indicator
SerAdvrsEvntResolInd
Short Description
Indicator to ask whether an adverse event ended after treatment with the study protocol drug or agent was stopped.
Definition
Indicator to ask whether an adverse event ended after treatment with the study protocol drug or agent was stopped.
Biomedical Terminologies and Standards
Notes
Was the seriousness of the event abated after discontinuation of the study intervention?
Creation Date
2015-05-22
Historical Notes
References
No references available
Data Type
Alphanumeric
Input Restrictions
Free-Form Entry
Maximum Character Quantity
4000
Pre-Defined Values
Population
Adult and Pediatric
Guidelines/Instructions
No instructions available
Preferred Question Text
Category Groups and Classifications
Disease | Domain | Sub-Domain |
---|---|---|
General (For all diseases) | Safety Data | Adverse Events |
Traumatic Brain Injury | Disease/Injury Related Events | Classification |
Classification
Acute Hospitalized
:
Supplemental
Moderate/Severe TBI: Rehabilitation
:
Supplemental
Concussion/Mild TBI
:
Supplemental
General (For all diseases)
:
Supplemental
Epidemiology
:
Supplemental
Keywords
AE_Mapped
,
Adverse_Event
Labels
Effective Date
Until Date
Last Change Date
Tue Apr 02 11:15:29 EDT 2024
See Also
AdvrsEvntDuringStudyInd;SeriousAdvrsEvntInd;SerAdvrsEvntAnticInd;SerAdvrsEvntCmntTxt;SerAdvrsEvntRslnInd
Submitting Organization Name
NIH/CIT/BRICS
Submitting Contact Name
Olga Vovk
Submitting Contact Information
olga.vovk@nih.gov
Steward Organization
Name
NIH/NINDS
Steward Contact Name
NINDSCDE
Steward Contact Information
NINDSCDE@emmes.com
NINDS ID