Serious and Unexpected Adverse Event

Serious and Unexpected Adverse Event. Any adverse reaction to a Study Drug (i) the nature or severity of which is not consistent with the investigator's brochure for a Study and (ii) that results in death, a life-threatening adverse experience, inpatient hospitalization or the prolonging of existing hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect