" /> Seriousness of Adverse Event - CISMeF





Preferred Label : Seriousness of Adverse Event;

NCIt related terms : AdverseEventSeriousness; AESER;

NCIt definition : Clinical significance of adverse event defined based on the patient and event outcome or action criteria usually associated with events that pose a threat to a patient's life or functioning. Seriousness of adverse event serves as a primary guide for defining regulatory reporting obligations and changes in medicinal product development and usage.;

Alternative definition : BRIDG 3.0.3: Specifies the degree or extent of the consequence suffered by the subject.; BRIDG 5.3: Specifies the degree or extent of the consequence suffered by the subject. EXAMPLE(S): resulted in death, required hospitalization, was life threatening OTHER NAME(S): NOTE(S): While often not reported as a separate observation, seriousness codes are technically the result of assessing the subject and the adverse event they are experiencing. The association to the AdverseEvent should theoretically be derivable via the following path: AdverseEventSeriousness PerformedObservation [assess seriousness] AssessedResultRelationship AdverseEvent. However, since this information is often not available, AdverseEventSeriousness has been modeled as both a subclass of PerformedClinicalInterpretation and as having an association directly to the AdverseEvent class.;

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08/05/2024


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