Pharmacovigilance Glossary Terms

SUSAR (Suspected Unexpected Serious Adverse Reaction): This term is used in clinical trials to refers to a serious adverse reaction, i.e. any untoward medical occurrence that results in death, is life-threatening, causes persistent or significant disability, congenital anomaly, hospitalization, or prolonged an existing hospitalization, and that was reported as having a reasonable causal relationship with the experimental medicinal product and is not listed in the applicable product information.