2. Is life-threatening – defined as an event in which the subject was, in the judgment of the safety review team, at ris k of death at the time of the event; it does not refer to an event that hypothetically might have caused death had it been more severe. 3. Requires inpatient hospitalization or results in prolongation of an existing hospitalization – inpatient hospitalization refers to any inpatient admission, regardless of length of stay. 4. Results in persistent or significant disability/incapacity (i.e., a substantial disruption of a person’s ability to conduct normal life functions). 5.