serious adverse event

Explanation

An adverse event (AE) is called serious if it: results in death, is life-threatening (at risk of death at the time of the adverse event, not an event which ‘could’ hypothetically have caused death if it were more severe), requires hospitalisation or extension of existing inpatients’ hospitalisation, results in a persistent or significate disability or incapacity, or is a congenital anomaly or birth defect.