Unexpected Adverse Event

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Unexpected Adverse Event Definition

Any adverse event associated with a medical product or procedure that has not been previously observed, whether or not the event was anticipated because of the pharmacologic properties of the study agent or the nature of the medical procedure. This includes events that are more serious than expected or occur more frequently than expected, particularly, any adverse experience, the nature, severity or frequency of which is not consistent with the product label, or with the current investigator brochure for investigational agent; or with the risk information described in the investigational plan or protocol or consent form.

Unexpected Adverse Event Synonyms

Unexpected Adverse Event, UAE, unexpected adverse drug reaction

Unexpected Adverse Event

Unexpected Adverse Event Definition

Unexpected Adverse Event Synonyms

Terms in Unexpected Adverse Event category