What does SUSAR stand for and mean?

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SUSAR stands for Suspected Unexpected Serious Adverse Reaction. In clinical trials, this label is used for events that are believed to be related to the investigational product (suspected), are not already described in the current safety information (unexpected), and are serious in nature (serious). Suspected means there is at least a reasonable possibility the drug contributed, not proven causation. Unexpected means the event is not listed in the investigator brochure or labeling. Serious refers to outcomes like death, life-threatening events, hospitalization, disability, or other results that require important medical intervention. Because SUSARs can signal new safety concerns, they must be reported to regulators and ethics committees promptly within a defined timeframe. For context, other phrases in the options either replace key terms (for example, using Response instead of Reaction or Unspecified instead of Unexpected) or describe unrelated concepts (like a standard safety report for unblinded data), which is why they do not fit the established term.