Common Data Element: Unexpected adverse event indicator
Listed below are the details for the data element.
FITBIR
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
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GENERAL:
No references available
Data Type
Alphanumeric
Input Restrictions
Single Pre-Defined Value Selected
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.
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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
| Disease | Domain | Sub-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
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