Myelofibrosis
Conditions
Keywords
Real life, Retrospective, Chart review
Brief summary
This was a non-interventional retrospective study. Data from patients who were diagnosed with myelofibrosis (MF) (primary MF, post-polycythemia vera MF & post-essential thrombocythemia MF) and treated with ruxolitinib for at least 3 months collectively were collected. The baseline visit was the visit that the patient started ruxolitinib treatment. Data was collected between January 01, 2015 and December 31, 2022. The main baseline clinical and laboratory data of the cohort with at least 3 months of ruxolitinib treatment was documented in order to identify real life patient data in Turkey. All the data was transferred to a clinical report form (CRF), then to the Statistical Package for the Social Sciences (SPSS) software in an anonymous fashion. The source documents were secured for quality control of the data. The quality control of the data was controlled by an unbiased data entry coordinator.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosed with MF * Treated with ruxolitinib for at least 3 months
Exclusion criteria
None identified.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| White Blood Cell (Leukocyte) Count | Baseline, Month 3, 6, and 12 | — |
| Platelet Count | Baseline, Month 3, 6, and 12 | — |
| Lactate Dehydrogenase (LDH) Levels | Baseline, Month 3, 6, and 12 | — |
| Age | Baseline | — |
| Number of Patients by Gender | Baseline | — |
| Number of Patients by Clinical Characteristic Category | Baseline | Clinical characteristics included: * Janus Kinase (JAK) mutation (yes/no) * MF-relevant type of mutation * MF Type * Cytogenic risk assessment (favorable/unfavorable karyotype) |
| Time From Diagnosis to Initiation of Ruxolitinib | Baseline | — |
| Number of Patients by DIPSS+ Risk Stratification | Baseline, Month 12 | DIPSS+ is a prognostic scoring system used to assign MF patients into 1 of 4 risk categories based on the 8 risk factors: age, hemoglobin level, leukocyte count, percentage of circulating blast cells, presence of constitutional symptoms, platelet count, need for red blood cell transfusion, and unfavorable karyotype. The 4 risk categories are as follows: * Low risk (0 points) * Intermediate-1 risk (1 point) * Intermediate-2 risk (2-3 points) * High risk (4-6 points) |
| Percentage of Patients With Blood Transfusions | Baseline, Month 3, 6, and 12 | — |
| Percentage of Patients With Splenomegaly | Baseline, Month 3, 6, and 12 | — |
| Change From Baseline in Percentage of Patients With Splenomegaly | Baseline, Month 12 | — |
| Percentage of Patients Categorized by Spleen Size | Baseline, Month 3, 6, and 12 | Spleen size was categorized as follows: * 20 centimeters (cm) or smaller * Bigger than 20 cm |
| Hemoglobin Levels | Baseline, Month 3, 6, and 12 | — |
| Hematocrit Levels | Baseline, Month 3, 6, and 12 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Treatment Adjustments due to Anemia and Thrombocytopenia | Month 3, 6, and 12 | Treatment adjustments included dose modification, treatment interruption, and treatment discontinuation. |
| Number of Patients With Hematological and Non-hematological Adverse Events | Up to 12 months | — |
| Percentage of Patients With Anemia and Thrombocytopenia | Baseline, Month 3, 6, and 12 | — |
Countries
United States
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed