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Common Data Element:  Unexpected adverse event indicator

Listed below are the details for the data element.

1.6
Element Type
Common Data Element
Unexpected adverse event indicator
UnexpectAdvrsEvntInd
Short Description
The indicator of whether the adverse event is unexpected
Definition
The indicator of whether the adverse event is unexpected
 

Biomedical Terminologies and Standards

Notes
Creation Date
2014-04-01
Historical Notes
References
EPILEPSY: No references available ----- GENERAL: 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
GENERAL: Choose Yes or No. This question should be answered YES if the AE was not previously identified as an adverse event associated with use of the investigational drug or medical device, based on those described in the Investigator's Brochure. An event may also be identified as unexpected if the adverse event increased in frequency or severity than what is described by the Investigator's Brochure. ----- EPILEPSY: Choose Yes or No. This question should be answered YES if the AE was not previously identified as an adverse event associated with use of the investigational drug or medical device, based on those described in the Investigator's Brochure. An event may also be identified as unexpected if the adverse event increased in frequency or severity than what is described by the Investigator's Brochure.
Preferred Question Text
Unexpected adverse event?
Category Groups and Classifications
DiseaseDomainSub-Domain
Epilepsy Safety Data Adverse Events
General (For all diseases) Safety Data Adverse Events

Classification

General (For all diseases) :
Supplemental
Epilepsy :
Supplemental
Keywords
AE_Mapped , Adverse_Event , See_also , Knowledge_graph , COVID19
Labels
Effective Date
Until Date
Last Change Date
Mon May 18 10:35:02 EDT 2020
See Also
AdvrsEvntDuringStudyInd;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