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8 de ago. de 2022 · Side effects, also known as adverse reactions, are unwanted undesirable effects that are possibly related to a drug. Side effects can vary from minor problems like a runny nose to life-threatening ...
Registries that collect information on specific drugs and medical devices need to anticipate the need for adverse event (AE) detection, processing, and reporting. This chapter addresses the identification, processing, and reporting of AEs detected in situations in which a registry has contact with individual patients. This document is not a formal regulatory or legal document; therefore, any ...
Adverse drug reaction (ADR, or adverse drug effect) is a broad term referring to unwanted, uncomfortable, or dangerous effects that drugs (including medications ) may have. Adverse drug reactions can be considered a form of toxicity; however, toxicity is most commonly applied to effects of overingestion (accidental or intentional) or to ...
adverse event. 原文. an unexpected medical problem that happens during treatment with a drug or other therapy. adverse events do not have to be caused by the drug or therapy, and they may be mild, moderate, or severe. also called adverse effect. 日本語訳. 薬物 や その他の 療法 による 治療 を受けて いる 間に 発生 ...
An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
Adverse reactions due to medicines administered in a clinical trial that are unexpected and serious. EudraVigilance: Unexpected events: Events that affect the benefit-risk balance of a clinical trial that were unforeseen, e.g. an unexpected increase in the incidence of expected serious adverse reactions that may be clinically important.
an adverse event but fails to do so because of chance or because it is intercepted. Also called potential adverse event. Adverse drug event: A medication-related adverse event. Hazard: Any threat to safety, e.g. unsafe practices, conduct, equipment, labels, names. System: A set of interdependent elements (people, processes, equipment) that inter-
