serious ae definition
A serious adverse event (SAE) in human drug trials are defined as any untoward medical occurrence that at any dose.1  results in death, 2  is life-threatening. 3  requires inpatient hospitalization or causes prolongation of existing hospitalization. 4  results in persistent or significant disability/incapacity, serious adverse event (SAE) in human drug trials are defined as any untoward medical occurrence that at any dose.