SAE

A Serious Adverse Event (SAE) is an adverse event associated with the use of a medical product that is of significant concern due to its severity. SAEs are characterized by one or more of the following criteria: the event results in death, is life-threatening, necessitates in-patient hospitalization or prolongation of an existing hospital stay, leads to persistent or significant disability or incapacity, or involves the occurrence of a congenital anomaly or birth defect. SAEs are closely monitored and reported as they represent critical safety issues requiring immediate attention and assessment within the healthcare and regulatory contexts.