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Adverse Event (AE): In the context of pharmacovigilance and outside a clinical trial: any untoward medical occurrence in a patient to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment (based on ICH-E2D Guideline, see GVP Annex IV).
Hace 1 día · Adverse drug events (ADEs) are a frequent cause of injury in patients. Our aim was to assess whether pharmacist interventions compared with no pharmacist intervention results in reduced ADEs and potential adverse drug events (PADEs). Methods.
Hace 2 días · Keywords: immune checkpoint inhibitors (ICIs), immune related adverse events (irAEs), rechallenge, neurological immune-related adverse events, myocarditis Citation: Eldani C, Kostine M, Faure M, Lazaro E, Rigothier C, Hiriart JB, Teulières B, Poullenot F, Haissaguerre M, Zysman M, Veillon R, Vergnenegre C, Issa N, Domblides C, Mary-Prey S, Beylot-Barry M, Pham-Ledard A, Dutriaux C, Sole G ...
Hace 1 día · Table 1 provides a summary of the most common (> 30%) treatment-emergent adverse events (TEAEs) in the safety analysis population (all randomized patients who received ≥ 1 dose of study ...
Hace 13 horas · Chemoradiotherapy (CRT) with concurrent high-dose cisplatin (CDDP) is the gold standard non-surgical treatment for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). 1-3 Although the prescribed CDDP dose is individually determined based on body surface area (BSA), its administration is commonly associated with adverse events (AEs), such as nausea, vomiting, renal ...
Hace 1 día · Secondary endpoints include progression free survival, overall survival, adverse events, patient reported outcomes and health economic analyses. The SOCRATES-HCC study will provide the first randomized, multicentre evaluation of the efficacy, safety and cost effectiveness of SABR versus other standard of care therapies in the first line treatment of unresectable, early-stage HCC.
Hace 4 días · This activity is intended for primary care clinicians, nurses, pharmacists, and other healthcare providers who treat patients. The goal of this activity is to learn how to report adverse drug events using the FDA’s MedWatch system.
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