what is an adverse event

3 hours ago 2
Nature

An adverse event (AE) is any untoward or undesirable medical occurrence in a patient after exposure to a medical treatment, such as a drug, device, or procedure. It does not necessarily mean that the treatment caused the event

. Adverse events can include any unexpected or harmful symptoms, signs, or conditions that arise during medical care or clinical trials, regardless of whether they are directly linked to the treatment

. Adverse events vary in severity and can be classified as serious or non- serious. Serious adverse events are those that result in death, are life- threatening, require hospitalization or prolong hospitalization, cause permanent disability, or lead to congenital anomalies

. Non-serious adverse events might be less severe but still unfavorable medical occurrences. In summary, an adverse event is any harmful or negative outcome experienced by a patient during or after medical treatment, which may or may not be caused by the treatment itself