Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR)

Any untoward medical occurrence that at any dose:
• results in death
• requires patient hospitalization
• results in persistent or significant disability or incapacity
• is life-threatening
• or is a congenital anomaly/birth defect.

In addition, medical judgment should be used to assess an AE as serious due to its medical importance: refer to MedDRA IME (important medical event) terms list. Remark: “severe” is not synonymous with “serious”:

“Severe” describes the intensity of an event (mild, moderate or severe), the event itself may be of minor medical significance (severe headache) and therefore not “serious”.

“Serious” describes the potential outcome for the patient and is used to define regulatory reporting obligations.