definiens: means ( i ) any untoward medical occurrence in a patient or clinical investigation subjectadministered Product or any other product incorporating Supplied Compound that results in death, is life - threatening, requiresinpatient hospitalization or prolongation of existing hospitalization, persistent, results in persistent or significantdisability / incapacity, or is a congenital anomaly / birth defect, provided that the term refers to an event inwhich the patient or subject was at risk of death at the time of the event ( it does not refer to an event which hypotheticallymight have caused death if it were more severe ) or ( ii ) any event in a patient or clinical investigation subject administeredProduct or any other product incorporating Supplied Compound which may jeopardize the patient or subject or may requireintervention to prevent one of the outcomes listed above . Important medical events that may not be immediately life - threatening or result in death or hospitalization but, based on appropriate medical and scientific judgment, may jeopardize thepatient / subject or may require intervention ( e.g., medical, surgical ) to prevent one of the other outcomes listed above shouldalso constitute . Examples of such events include, but are not limited to, intensive treatment in anemergency room or at home for allergic bronchospasm ; blood dyscrasias or convulsions that do not result in hospitalization