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Zpráva o průběhu klinického hodnocení Annual Report MEMMAT Sledované období: 27. květen - 27. listopad 2022
Title in English | Report on the progress of the clinical evaluation Annual Report MEMMAT Monitored period: May 27 - November 27, 2022 |
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Year of publication | 2022 |
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Description | Annotation: The aim of the study is to extend therapy options for children with recurrent or progressive medulloblastoma, ependymoma and atypical teratoid rhabdoid tumor (ATRT), for whom no known curative therapy exists, by prolonging survival while maintaining good quality of life. Semi-Annual reports on the progress of clinical trials describe the course of clinical trial in the observed period and the current status of trial. The reports include information on document updates, screening, number of newly enrolled patients, general overview of patients enrolled so far, number of prematurely discontinued patients in the Czech Republic, incidence of serious adverse events, identified protocol violations, information on newly identified characteristics on investigational medicinal product 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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