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A phase III randomized non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients

机译：一项非III期随机非劣效性研究比较了仿制药非格司亭和原发非司亭对乳腺癌患者化疗诱发的中性粒细胞减少症的疗效和安全性

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摘要

OBJECTIVES:To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the non-inferiority of the test drug relative to the originator.

机译：目的：比较两种非格司亭制剂对控制化疗引起的中性粒细胞减少症的疗效和安全性，并评估试验药物相对于原发药物的非劣效性。

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期刊名称 Clinics
作者
Roberto Hegg; André Mattar; João Nunes de Matos Neto; José Luiz Pedrini; Sabina Bandeira Aleixo; Roberto Odebrecht Rocha; Renato Peixoto Cramer Junior; Sylvie van-Eyll-Rocha;
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年(卷),期 2016(71),10
年度 2016
页码 586–592
总页数 7
原文格式 PDF
正文语种
中图分类基础医学;
关键词
Neutropenia Filgrastim Neutrophils Non-Inferiority Biosimilar Drugs Fiprima®;

机译：中性粒细胞减少症;非格司亭;中性粒细胞;非自卑症;生物仿制药;Fiprima®;

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专利

1. A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients [J] . Sylvie van-Eyll-Rocha, Jo?o Nunes de Matos-Neto, Roberto Hegg, Clinics . 2016,第10期

机译：一项III期随机，非劣效性研究，比较了仿生非格司亭和原发非司亭对乳腺癌患者化疗诱发的中性粒细胞减少症的疗效和安全性
2. Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: a phase III, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy [J] . KBlackwell, PGascon, AKrendyukov, Annals of oncology: official journal of the European Society for Medical Oncology . 2018,第1期

机译：与EP2006，菲格拉特灭蚊和参考菲拉特交替治疗的安全性和有效性：III期，随机，双盲临床研究预防乳腺癌患者患髓抑制化疗的乳腺癌患者
3. A phase III randomized equivalence study of biosimilar filgrastim versus Amgen filgrastim in patients receiving myelosuppressive chemotherapy for breast cancer. [J] . Waller CF, Semiglazov VF, Tjulandin S, Onkologie . 2010,第10期

机译：生物仿制药非格司亭与安进非司莫司汀在接受骨髓抑制性化疗的乳腺癌患者中的III期随机等效研究。
4. Efficacy Analysis of Preservative-Free Tafluprost and Timolol in Open-Angle Glaucoma and OHT Patients in a Phase-III Study [C] . GrundenJ., Lupinacci R. International Symposium on Ocular Pharmacology and Therapeutics . 2013

机译：在第三阶段研究中，在开放角度荧光眼和OHT患者中无防腐型TaFluprost和蒂莫尔的疗效分析
5. Hypotensive resuscitation versus standard fluid resuscitation for the management of trauma patients in hemorrhagic shock: The safety phase of a randomized controlled trial. [D] . Morrison, C. Anne. 2009

机译：低血压复苏与标准液体复苏在失血性休克中对创伤患者的处理：一项随机对照试验的安全性阶段。
6. Comparison of EP2006 a filgrastim biosimilar to the reference: a phase III randomized double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy [O] . K. Blackwell, V. Semiglazov, D. Krasnozhon, -1

机译：非格司亭生物仿制药EP2006与参考文献的比较：一项III期随机双盲临床研究用于预防接受骨髓抑制性化疗的乳腺癌患者的严重中性粒细胞减少
7. A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients [O] . Roberto Hegg, André Mattar, João Nunes de Matos-Neto, 100

机译：一项III期，随机，非劣效性研究，比较生物仿制药非格司亭与原发性非格司亭治疗乳腺癌患者化疗诱导的中性粒细胞减少症的疗效和安全性

A phase III randomized non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients

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