Common Data Element: Adverse event study intervention action taken type
Listed below are the details for the data element.
1.9
Element Type
Common Data Element
Adverse event study intervention action taken type
AdvEvntStdyIntrvntActTakenTyp
Short Description
The type of action taken for adverse event in relation to study intervention.
Definition
Type of action taken for adverse event in relation to study intervention
Biomedical Terminologies and Standards
Notes
CDISC SDTM variables: AEACN
Creation Date
Historical Notes
Adverse event study intervention action taken type
References
No references available
Data Type
Alphanumeric
Input Restrictions
Single Pre-Defined Value Selected
Pre-Defined Values
Population
Adult and Pediatric
Guidelines/Instructions
GENERAL: Choose one. This CDE is only appropriate for clinical trials and should be removed from the CRF if a study does not have an intervention.
EPILEPSY: Choose one. If treatment was required, then the corresponding treatment needs to be recorded on the Prior and Concomitant Medications CRF.
Preferred Question Text
Action Taken with Study Intervention
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
Effective Date
Until Date
Last Change Date
Wed Apr 24 16:43:00 EDT 2024
See Also
AdvrsEvntDuringStudyInd;AdvrsEvntSeverScale;AdvrsEvntStartDateTime;AdverseEvntEndDateTime;AdvrsEvntVerbatimTermText;SeriousAdvrsEvntInd;AdvEvntMedDRALowerLvlTermCode;AdvrsEvntCTCAELowLvlTermName;InjElapsedTime;s0:AdvEvntOthrActionTakenTyp
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
