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A phase III, randomized, non-inferiority study comparing the efficacy and safet...

Hegg, Roberto; Mattar, André; Matos-Neto, João Nunes de; Pedrini, José Luiz; Aleixo, Sabina Bandeira; Rocha, Roberto Odebrecht

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. METHODS: This phase III non-inferiority study had a randomized, multicenter, and open-label design. The patients were randomized at a ratio of 1:1 with a follow-up period of 6 weeks for each patient. In bot...

Date: 2016   |   Origin: Oasisbr


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