definiens: or means an Adverse Event that at any dose ( i ) results in death, ( ii ) is life - threatening, ( iii ) requires inpatient hospitalization or prolongation of existing hospitalization, ( iv ) results in persistent orsignificant disability / incapacity, or ( v ) is a congenital anomaly / birth defect . The term in this definitionrefers to an event in which the patient was at risk of death at the time of the event ; it does not refer to an event whichhypothetically might have caused death if it had been more severe . Important medical events that may not be immediatelylife - threatening or result in death or hospitalization but may jeopardizeCONFIDENTIAL TREATMENT REQUESTEDWITH RESPECT TO CERTAIN PORTIONS HEREOFDENOTED WITH the patient or require intervention to prevent one of the other outcomes listed above should also be included in this definitionto the extent reasonable medical and scientific judgement indicates that expedited reporting is appropriate under ApplicableLaws