Adverse event

An Adverse Event (AE) is an unfavorable or unintended medical occurrence in a patient or clinical trial participant. These events may or may not be related to a medical intervention, such as drug administration or a medical procedure. Adverse events are monitored and documented in clinical research to assess their impact on safety and efficacy, ensuring the well-being of study participants.

Definitions

ICH E6

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product .