Common Data Element: Adverse event relatedness scale
Listed below are the details for the data element.
FITBIR
1.9
Element Type
Common Data Element
Adverse event relatedness scale
AdvrsEvntRelatednessScale
Short Description
The scale of the causality between the treatment modality/intervention and the specific adverse event.
Definition
Scale of the causality between the treatment modality/intervention and the specific adverse event
Biomedical Terminologies and Standards
Notes
CDISC SDTM variables: AEREL
Creation Date
Historical Notes
Adverse event relatedness scale
References
No references available
Data Type
Alphanumeric
Input Restrictions
Single Pre-Defined Value Selected
Population
Adult and Pediatric
Guidelines/Instructions
EPILEPSY/GENERAL: Choose one. Record the investigator's assessment as to whether there is at least a reasonable possibility that the AE is related to (or caused by) use of the study intervention. Definitions for each of the relatedness responses should be supplied in the protocol.
Preferred Question Text
Investigator Assessment of Causality
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
Labels
