A<unk>  <unk>  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 #May have caused a congenital anomaly/birth defect #Requires intervention to prevent permanent impairment or damage The term "life-threatening" in the definition of<unk> " 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. Adverse events are further defined as “Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.”
Serious adverse event
Adverse event
Unwarranted variation
Therapeutic inertia
Adverse outcome pathway
Inclusion and exclusion criteria
Sentinel event
Clinical equipoise