definiens: means any untoward medical occurrence that at any dose : results in death ; is life - threatening ( defined as an event in which the subject or patient was at risk of death at the time of the event ; it does not refer to an event which hypothetically might have caused death if it were more severe ) ; requires inpatient hospitalization or causes prolongation of existing hospitalizations ; results in persistent or significant disabilitylincapacity ; results in a congenital anomalyibirth defect ; is an important medical event ( defined as a medical event(s ) that may not be immediately life - threatening or result in death or hospitalization, but based upon appropriate medical and scientific judgment, may jeopardize the patient / subject or may require intervention, e.g., medical surgical, to prevent one of the other serious outcomes listed in the definition above ) . Examples of such events include, but are not limited to, intensive treatment in an emergency room or at home for allergic bronchospasm ; blood dyscmsias or convulsions that do not result in hospitalization . For reporting purposes, Supplier also considers the occurrences of cancer, pregnancy, or overdose ( accidental or intentional and regardless of adverse outcome ) as event5 that must be expeditiously reported as important medical events