Pharmacovigilance Glossary Terms

SAE: The acronym SAE refers to a serious adverse event, which is defined as any noxious medical occurrence associated with the use of a pharmaceutical product that is life-threatening or is considered a medically important event or can cause persistent/significant disability, birth defect, hospitalisation, or prolong an existent hospitalisation, or ultimately results in death.

Please note that SAE does not necessarily need to be considered drug-related.