Publication details

Průběžná zpráva: Optimalizace léčby pacientů s nově diagnostikovanou Ph/BCR-ABL pozitivní chronickou myeloidní leukémií (CML) v chronické fázi srovnávající nilotinib versus nilonitib a interferon alfa v indukční léčbě a nilotinib versus interferon alfa v udržovací terapii

Title in English Interim Report: Patients treatment optimization with newly diagnosed Ph/BCR-ABL positive chronic myeloid eukemia (CML) in the chronic phase comparing nilotinib versus nilotinib and interferon alfa in induction therapy and nilotinib versus interferon alfa


Year of publication 2020
MU Faculty or unit

Faculty of Medicine

Attached files
Description EudraCT number: 2010-024262-22 The clinical trial interim report describes the clinical trial (CT) course in the monitored period and the current progress of CT. The report includes information on document updates, changes in examiners and evaluation sites in the Czech Republic, screening, number of newly enrolled patients, an overview of previously enrolled patients, number of prematurely discontinued patients in the Czech Republic, termination of recruitment, incidence of serious adverse events, identified protocol violations. newly-identified properties / new knowledge about the evaluated medicinal product in relation to its safety and efficacy, newly adopted measures (e.g., interventions of ethics committees, foreign control authorities, possible restrictive interventions of the sponsor), and information on performed internal audits or audits by the sponsor
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