Zpráva o průběhu klinického hodnocení PNET Annual Report Sledované období: 1. prosinec 2021 – 31. květen 2022
| Title in English | Clinical trial progress report PNET Annual Report Period covered: December 1, 2021 - May 31, 2022 |
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| Authors | |
| Year of publication | 2022 |
| MU Faculty or unit | |
| Web | PNET |
| Description | PNET EudraCT number: 2011-004868-30 PNET: AN INTERNATIONAL PROSPECTIVE TRIAL MEDULLOBLASTOMA (MB) IN CHILDREN OLDER THAN 3 TO 5 YEARS WITH WNT BIOLOGICAL PROFILE (PNET 5 MB - LR and PNET 5 MB - WNT-HR), AVERAGE-RISK BIOLOGICAL PROFILE (PNET 5 MB -SR), OR TP53 MUTATION AND REGISTRY FOR MB OCCURING IN THE CONTEXT OF GENETIC PREDISPOSITION. 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. These reports include information on document updates, screening, termination of recruitment, 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 findings on investigational medicinal product in relation to its 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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