Study design
reductions or interruptions, PPV-MF, PET-MF, Myeloproliferative Neoplasms
ADVERSE EVENT, MYELOPROLIFERATIVE NEOPLASM, CONCOMITANT DISEASE
JAKoMo is a two-arm, open-label, phase IV, non-interventional study of patients with MF who were either JAKi naïve or pretreated with JAKi. Patients ≥ 18 years with a diagnosis of PMF, according to the World Health Organization classification, or PPV-MF or PET-MF, according to the International Working Group for Myeloproliferative Neoplasms Research and Treatment criteria [Starting doses of RUX were based on platelet counts according to the SmPC. Dose reductions or interruptions were also recommended according to the SmPC. Patients were observed for up to 36 months after enrollment, unless discontinuation criteria according to the SmPC were met.Adverse events (AEs) and concomitant diseases were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 23.1.The study was sponsored by Novartis Pharma GmbH (Novartis) and designed by Novartis in collaboration with S. Koschmieder as the medical leading investigator. The study was approved by the institutional review boards of the respective institutions (leading ethics committee: Ethics Committee at the Faculty of Medicine, RWTH Aachen University, Aachen, Germany) before enrollment of patients and was conducted in accordance with the principles of the Declaration of Helsinki. The trial is registered with ClinicalTrials.gov (NCT05044026).All patients provided written informed consent.