Adverse event

An adverse event is any unwanted occurrence that happens after a participant begins treatment in a clinical trial, regardless of whether it’s caused by the study treatment. 

Adverse events can range from mild symptoms like fatigue to serious complications that require medical attention. Recording adverse events is a critical part of ensuring patient safety and evaluating the overall risk of a new treatment.

Want to understand how adverse events are classified and reported? Read the full breakdown in our blog post, “What Are Adverse Events in Clinical Trials?”