CDISC-Gloss – A category of important medical events that may not be immediately life- threatening, result in death, or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the outcomes criteria events requiring assessment for potential regulatory reporting as a serious adverse event.
Note: These “Other serious” events require medical and scientific judgement in evaluating the need for reporting as a serious adverse event. Examples include allergic bronchospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events. [after FDA 310.305, ICH E2A] See also serious adverse event.