Expected Adverse Event
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Expected Adverse Event Definition
Any adverse event associated with a medical product or procedure, whose nature and severity have been previously observed, identified in nature, severity, or frequency, and documented in the investigator brochure, investigational plan, protocol, current consent form, scientific publication, or in other relevant and reliable document. The old term Side Effect is retired and should not be used.
Expected Adverse Event Synonyms
Expected Adverse Event, EAE
Terms in Expected Adverse Event category
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