Adverse Event

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NHLBI: Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An adverse event (also referred to as an adverse experience) can also be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. An adverse event can arise from any use of a drug (e.g., off label use, use in combination with another drug) and from any route of administration, formulation or dose, including overdose.

PVAMU: An untoward or undesirable experience or any undesirable experience associated with the use of a medical product/test article in clinical research (See also: Serious Adverse Event and Unexpected Adverse Event).