ADVEXIN

Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use

Any noxious and unintended response(s) to a medical product or procedure, for which a causal relationship with this product or procedure is…

An indication of whether an adverse event has occurred.

The verbatim description of the adverse event.

A coded value specifying the representation of the criteria for determining whether an adverse event (experience or reaction) is considered unanticipated. …

The toxicity grade value of the adverse event.