Zpráva o průběhu neintervenční observační studie Ponderosa Annual Report Sledované období: 4. červenec 2021 – 4. červenec 2022

Title in English Report on the progress of the non-interventional observational study Ponderosa Annual Report Observed period: July 4, 2021 - July 4, 2022
Authors

DEMLOVÁ Regina MATYŠKOVÁ Šárka

Year of publication 2022
MU Faculty or unit

Faculty of Medicine

Web
Description Ponderosa study Interim Report: Observational study on CML patients in any phase treated with ponatinib (Iclusig®) at any dose.This study aims at giving a picture of real-life treatment with ponatinib in CML patients. The study will assess the incidence of adverse events (AEs) and response to treatment. The annual report of the observational study contains data about recruitment of subjects in individual clinical trial centers, the incidence of serious adverse reactions and their reporting, identified protocol violations and information on newly identified findings on the investigational medicinal product in relation to its safety and efficacy.
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