[ Adverse Event, AE ]
Any unfavourable and unintended sign, symptom, or [ Disease ] In a living thing, an abnormal condition that is not the direct result of physical injury. Diseases are structural or functional disorders. Medically, they may be classified as infectious (communicable and non-communicable), genetic, physiological deficiency-related. More associated with the use of a [ Medicine, Medical Treatment ] The therapeutic practise of diagnosing and treating injury or disease. A drug or nutrient preparation prescribed for the treatment, or prevention of injury or disease. More product in clinical trials or regular medical practise.
In most countries, AEs must be reported to applicable medical regulatory bodies such as [ Medicine, Medical Treatment ] The therapeutic practise of diagnosing and treating injury or disease. A drug or nutrient preparation prescribed for the treatment, or prevention of injury or disease. More and Healthcare products Regulatory Agency (HPRA, United Kingdom), the Food and [ Drug ] A substance that causes a physiological or psychological changes, usually by stimulating or suppressing specific chemical activities in an organism. Drugs are distinct from nutrients or supplements in that they are considered foreign and not a normal More 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.
Compare: [ Iatrogenetic, Iatrogenesis ] An unintended condition or effect on patient brought about by medical treatment or advice. Complications due to surgery, adverse drug affects and medical malpractice are iatrogenic. From the Greek ἰατρός (iatros, "healer") and γένεσις (genesis, "origin"). More