Zpráva o průběhu klinického hodnocení TIGER za období: 3. červenec 2020 - 2. červenec 2021
| Title in English | TIGER Clinical trial progress report for the period: July 3, 2020 - July 2, 2021 |
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| Authors | |
| Year of publication | 2021 |
| MU Faculty or unit | |
| Web | TIGER |
| Description | EudraCT number: 2010-024262-22 The interim report describes the clinical trial (CT) TIGER - Treatment optimization of newly diagnosed Ph/BCR-ABL positive patients with chronic myeloid leukemia (CML) in chronic phase with nilotinib vs. nilotinib plus interferon-alpha induction and nilotinib or interferon-alpha maintenance therapy the course of a clinical trial in the observed period. The report includes information on document updates, number of prematurely discontinued patients and properly terminated patients in the Czech Republic, IMP (investigational medicinal product) and supply (addition of new release site), the incidence of serious adverse events, identified protocol violations, information on newly identified characteristics on IMP in relation to safety and efficacy, newly adopted measures (eg interventions of ethics committees, foreign control authorities, possible restrictive interventions of the contracting authority) and information on performed internal audits or audits by the contracting authority if applicable. |
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