Serious Adverse Events

Serious Adverse Events (SAEs) are significant health problems that occur during medical treatment or clinical trials, which can include hospitalization, disability, birth defects, or life-threatening conditions. They are important indicators of a treatment’s safety and require careful investigation to assess their causes and prevent future issues. Not all side effects are considered SAEs; only those that cause serious health consequences are classified as such. Monitoring SAEs helps ensure patient safety and informs healthcare providers and regulatory agencies about potential risks associated with medical interventions.