Before revision: A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose results in death, is life-threatening requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or URL The term "life-threatening" in the definition of "serious" refers 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 which hypothetically might have caused death if it were more severe.
After revision: A serious adverse event (SAE) in human drug trials may have caused defined as any untoward medical occurrence that at any dose results in death, is life-threatening requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or URL The term "life-threatening" in the definition of "serious" refers 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 which hypothetically might have caused death if it were more severe.