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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib Group 1 | Patients diagnosed with intermediate-1 risk MF according to the Dynamic International Prognostic Scoring System Plus (DIPSS+) at the initial visit who were treated with ruxolitinib. | ||
| Ruxolitinib Group 2 | Patients diagnosed with intermediate-2 and High risk MF according to the DIPSS+ at the initial visit who were treated with ruxolitinib. |
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| Measure | Description | Time Frame |
|---|---|---|
| Age | Baseline | |
| Number of Patients by Gender | Baseline | |
| Number of Patients by Clinical Characteristic Category | Clinical characteristics included:
| Baseline |
| Time From Diagnosis to Initiation of Ruxolitinib | Baseline | |
| Number of Patients by DIPSS+ Risk Stratification | 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:
| Baseline, Month 12 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
None identified.
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This was a retrospective, non-interventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
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| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Spleen size was categorized as follows:
|
| Baseline, Month 3, 6, and 12 |
| Hemoglobin Levels | Baseline, Month 3, 6, and 12 |
| Hematocrit Levels | Baseline, Month 3, 6, and 12 |
| 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 |
| Percentage of Patients With Treatment Adjustments due to Anemia and Thrombocytopenia |
Treatment adjustments included dose modification, treatment interruption, and treatment discontinuation. |
| Month 3, 6, and 12 |