![]() ![]() ![]() ![]() A sample size of 80 (40/arm) was required to show a superiority of olanzapine over metoclopramide with a power of 80% and an alpha of 5%. We assumed that the CR rates in the metoclopramide arm would be 40% and this would improve to 70% in the olanzapine arm. The primary end-point of the study was the proportion of patients who achieved a complete response (CR), defined as no vomiting or retching and no nausea during the 72-hours after the administration of the first dose of metoclopramide or olanzapine. Methods: Children aged 5-18 years who developed breakthrough CINV after receiving moderately or highly emetogenic chemotherapy, were randomly assigned to the metoclopramide or olanzapine arm. #Download wise registry cleaner pro 5.94 trialWe conducted an open-label, single-center, phase III randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CINV. Olanzapine and metoclopramide are two drugs recommended for the treatment of breakthrough CINV in children, without adequate evidence. It affects 30-50% of children receiving chemotherapy. Sagar 1ġCancer Institute, Chennai, India, Medical And Pediatric Oncology, Chennai, India 2Cancer Institute, Chennai, India, Biostatistics And Epidemiology, Chennai, Indiaīackground and Aims: Breakthrough chemotherapy-induced nausea and vomiting (CINV) is defined as CINV occurring after adequate anti-emetic prophylaxis. AWARD SESSION SIOP AWARD SESSION 10-15-2020 5:00 PM - 6:30 PM 0002 / #202 Olanzapine Versus Metoclopramide for the Treatment of Breakthrough Chemotherapy-Induced Vomiting in Children: An Open-Label, Randomized Phase 3 Trial ![]()
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