Table 2

Adverse event definitions

Serious adverse event (SAE)An SAE is any untoward medical occurrence that:

  • Results in death

  • Is life-threatening

  • Requires inpatient hospitalisation or prolongation of existing hospitalisation

  • Results in persistent or significant disability/incapacity

  • Consists of a congenital anomaly or birth defect.


Other ‘important medical events’ may also be considered an SAE when, based on appropriate medical judgement, the event may jeopardise the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
Note the term ‘life-threatening’ in the definition of ‘serious’ refers to an event in which the participant 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.

  • NB: To avoid confusion or misunderstanding of the difference between the terms ‘serious’ and ‘severe’, the following note of clarification is provided: ‘Severe’ is often used to describe intensity of a specific event, which may be of relatively minor medical significance. ‘Seriousness’ is the regulatory definition supplied above.