What does the term "adverse event" mean in clinical trials?

The term "adverse event" in clinical trials refers specifically to any undesirable experience associated with the use of a medical product. This encompasses a wide range of negative effects that may occur during the course of a study, including symptoms, diseases, or any health deterioration linked to the intervention being tested. It is important for monitoring patient safety, assessing the risk-benefit balance of the study treatment, and complying with regulatory requirements.

Adverse events can vary in severity, from mild reactions to serious and life-threatening conditions, and they need to be meticulously documented and analyzed to ensure participant safety and the integrity of the data collected during the trial. This definition underscores the importance of vigilance in clinical research to recognize any potential impacts the treatment may have on participants' health, regardless of whether they are anticipated or unexpected.