[ Adverse Event, AE ]
Any unfavourable and unintended sign, symptom, or disease associated with the use of a medicinal product in clinical trials or regular medical practise.
In most countries, AEs must be reported to applicable medical regulatory bodies such as Medicines and Healthcare products Regulatory Agency (HPRA, United Kingdom), the Food and Drug Administration (FDA, United States) or the Health Products and Food Branch (HPFB) of Health Canada.
The US National Cancer Institute publishes a grading system for AEs:
- Grade 1 – Mild
- Grade 2 – Moderate
- Grade 3 – Severe
- Grade 4 – Life-threatening or disabling
- Grade 5 – Death
An event is considered an AE whether or not it is directly attributable to the product attributable to the product. So, if a clinical trial subject or medical patient unexpectedly dies during the clinical trial of a heart-rate monitoring bracelet, that death would be considered an AE, whether or not a causal relationship between the bracelet and the death can be determined.