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Table 1 Adverse event definitions and reporting requirements

From: Methods for safety and endpoint ascertainment: identification of adverse events through scrutiny of negatively adjudicated events

Event typeFDA definitionFDA reporting requirement
Adverse event (AE)Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug relatedNo specific reporting requirement
Serious adverse event (SAE)AE that results in one of the following outcomes: death, threat to life, hospitalization or prolongation of an existing hospitalization, persistent incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly, or important medical event (serious jeopardy of patient well-being requiring medical or surgical treatment in the judgment of the investigator)When aggregate analysis of specific events observed in a clinical trial indicates that those events occur more frequently in the drug treatment group than in a concurrent or historical control group
Suspected unexpected serious adverse reaction (SUSAR)SAEs that are unexpected prior to study conduct and likely to be caused by the investigational productEach SUSAR must be reported within 15 days of the sponsor discovering it, and within 7 days if the event was life-threatening or fatal