| Health / Medical Topics |
Seriousness of Adverse Event
Definition 1
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. (NCI Thesaurus)
Definition 2
Specifies the degree or extent of the consequence suffered by the subject. (NCI Thesaurus/BRIDG)
YOU MAY ALSO LIKE
An indication or description of a critical circumstance.
A category of clinical events regarded as having similar characteristics considered crucial and consequential.
Terminology codelist containing values associated with the rationale for why the adverse event was reported as being serious.
The rationale for why the adverse event was reported as being serious.
Any expected or unexpected adverse event, related or unrelated to the intervention, occurring at any agent dose, any phase of product or…
Causing fear or anxiety by threatening great harm; of great consequence.
