What does SUSAR stand for?

• A. Serious Adverse Reaction
• B. Sudden Unanticipated Safety Adverse Reaction
• C. Suspected Unrelated Serious Adverse Response
• D. Suspected Unexpected Serious Adverse Reaction

Answer: (D)

Suspected Unexpected Serious Adverse Reaction is the term used to classify a certain safety signal in clinical trials. It describes an adverse event that is thought to be related to the investigational product (suspected), not already described in the known safety information (unexpected), and meets the criteria for seriousness (serious). In practice, it means a patient experiences a reaction that could be caused by the study drug, is not listed in the protocol or the product labeling/Investigator’s Brochure as a known adverse effect, and has outcomes such as death, life-threatening events, hospitalization, disability, or other important medical events. Because SUSARs may indicate new safety information, they require expedited reporting to sponsors and regulatory authorities and ongoing safety follow-up.