Adverse Event (AE)
Any adverse event, unintended illness or damage, or any unexpected sign or symptom (whether or not considered medically significant) in patients, volunteers, or others who receive the investigational product, whether or not associated with the use of the investigational product. This includes events occurring during administration of the investigational product and events occurring up to 30 days after the last dose of the investigational product has been administered. Events occurring within 14 days following the last dose of the comparator drug may be included if they meet the criteria for inclusion under “Adverse Event.”
An anticipated serious adverse device effect (ASADE) is one which, by its natural occurrence, incidence, seriousness, or outcome, was already identified in the risk assessment report.
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