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Listed below are the details for the data element.

FITBIR
1.7
Element Type
Common Data Element
Serious adverse event indicator
SeriousAdvrsEvntInd
Short Description
The indicator of whether the adverse event is serious.
Definition
The indicator of whether the adverse event is serious.
 

Biomedical Terminologies and Standards

Notes
CDISC CDASH: AESER. There is no relevant SDTM CDISC variable
Creation Date
2014-04-01
Historical Notes
Serious adverse event indicator
References
No references available

Data Type
Alphanumeric
Input Restrictions
Single Pre-Defined Value Selected
Population
Adult and Pediatric
Guidelines/Instructions
GENERAL: Choose either Yes or No. This question should only be answered YES if the outcome of the AE results in at least one of the following: death; a life-threatening adverse drug experience; results in inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacity; or a congenital anomaly/birth defect. If an AE is serious, this provides a trigger that additional information must be provided by the site investigator. The site investigator then completes a Serious Adverse Event (SAE) form. Additionally, the site institution and/or IRB may also have an SAE form and procedures for reporting SAEs. If an AE is serious, this provides a trigger that additional information must be provided by the site investigator. The site investigator then completes a Serious Adverse Event (SAE) form. Additionally, the site institution and/or IRB may also have an SAE form and procedures for reporting SAEs.
Preferred Question Text
Serious Adverse Event?
Category Groups and Classifications
DiseaseDomainSub-Domain
Epilepsy Safety Data Adverse Events
General (For all diseases) Safety Data Adverse Events

Classification

Epilepsy :
Supplemental
General (For all diseases) :
Supplemental
Keywords
AE_Mapped , Adverse_Event , See_also , Knowledge_graph , COVID19
Labels

Admin Information


Effective Date
Until Date
Last Change Date
2020-05-18
See Also
AdvrsEvntDuringStudyInd;AdvrsEvntSeverScale;AdvrsEvntStartDateTime;AdverseEvntEndDateTime;AdvrsEvntVerbatimTermText;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