Publication details

Průběžná zpráva neintervenční observační studie: Ponderosa Observační studie k léčbě ponatinibem (Iclusig®) u pacientů s chronickou myeloidní leukémií (CML) ve všech fázích

Title in English Interim report


Year of publication 2020
MU Faculty or unit

Faculty of Medicine

Attached files
Description Ponderosa study Interim Report: The first report on the observational study describes the course of the approval process and subsequent activities in the period under review. The report includes information on the initial approval of the study by ethics committees in individual centers, as well as on the approval of documents that were subject to approval or acknowledgment by ethics committees in the period, an overview of activated centers in the Czech Republic (address, principal examiners the first patient to the ethics committee, the number of patients enrolled in each center, the incidence of serious adverse reactions and reports, identified protocol violations and information on newly identified properties / new findings on the investigational medicinal product in relation to its safety and efficacy.
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