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Un evento adverso ( EA) es cualquier aparición inesperada y perjudicial en un paciente o un sujeto de ensayo clínico a quien se administró un producto farmacéutico que no tiene, necesariamente, una relación causal con el tratamiento.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
13 de ago. de 2023 · Adverse events that occur with medical treatment can include medication side effects, injury, psychological harm or trauma, or death. Adverse events can be either preventable or unpreventable and are often associated with medication errors. Adverse events can occur with any provision of care or treatment have a wide range of severity.
18 de may. de 2023 · An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the...
11 de sept. de 2023 · Common adverse events that may result in avoidable patient harm are medication errors, unsafe surgical procedures, health care-associated infections, diagnostic errors, patient falls, pressure ulcers, patient misidentification, unsafe blood transfusion and venous thromboembolism.
15 de dic. de 2020 · This chapter describes a comprehensive approach to adverse event investigation and risk assessment, as well as the characteristics of an integrated system for patient safety and clinical risk management.
RESUMEN. Informar correctamente de los eventos adversos (EA) es fun-damental para mejorar la seguridad del paciente, objetivo cada vez más relevante en los ensayos clínicos (EC).
