Serious adverse event
From Wikipedia, the free encyclopedia
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
- May have caused a congenital anomaly/birth defect
- Requires intervention to prevent permanent impairment or damage[1]
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.[2] 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.”[2]