Common Data Element: Adverse event during study indicator
Listed below are the details for the data element.
FITBIR
1.12
Element Type
Common Data Element
Adverse event during study indicator
AdvrsEvntDuringStudyInd
Short Description
Indicator of whether the participant/subject experienced any adverse events during the study
Definition
Indicator of whether the participant/subject experienced any adverse events during the study
Notes
CDISC CDASH: AEYN. There is no relevant SDTM CDISC variable, the suggestion is to use AESTDY - Study Day of Start of Adverse Event and AEENDY Study Day of End of Adverse Event.
Creation Date
Historical Notes
Adverse event during study indicator
References
No references available
Data Type
Alphanumeric
Input Restrictions
Single Pre-Defined Value Selected
Population
Adult and Pediatric
Guidelines/Instructions
EPILEPSY/GENERAL: Choose one. If answered Yes, at least one AE must be recorded.
Preferred Question Text
Has the participant/subject had any adverse events during the study?
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
Labels
