1. Adverse Event (AE) versus Adverse Reaction (adverse drug reaction ADR) – the distinction
1.4. What is a serious adverse event or serious adverse reaction?
To note:
The terms "serious" and "severe," are not synonymous. To avoid confusion or misunderstanding of the difference between these terms the following clarification might help: The term "severe" is often used to describe the intensity (severity) of a specific event (such as in mild, moderate, or severe myocardial infarction); the event itself, however, may be of relatively minor medical significance (such as a severe headache). This is not the same as "serious," which is based on patient/event outcome or action criteria usually associated with events that pose a threat to a patient's life or physiological functioning. Seriousness (not severity) serves as a guide for defining regulatory reporting obligations.
A serious adverse event or an adverse reaction is one which:
- results in death;
- is life-threatening;
- requires in-patient hospitalisation or prolongation of existing hospitalisation;
- results in significant or persistent disability or incapacity;
- is a birth defect or congenital anomaly;
Life-threatening in this context refers to a reaction in which the patient was at risk of death at the time of the reaction; it does not refer to a reaction that hypothetically might have caused death if more severe (see GVP Annex IV, ICH-E2D Guideline).
Any suspected transmission via a medicinal product of an infectious agent is also considered a serious adverse reaction.