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The purpose of this study is to determine real-world patient-reported outcomes with fedratinib (FEDR) therapy for myelofibrosis (MF) in the real-world (RW) setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants that have discontinued RUX therapy and initiated FEDR prospectively |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF) | Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF) | |
| Absolute change in TSS assessed by MFSAF | At Baseline, 3 and 6 months post-FEDR initiation | |
| Proportion of participants reporting individual symptoms in TSS assessed by MFSAF | At Baseline, 3 and 6 months post-FEDR initiation | |
| Severity of each reported symptom in TSS assessed by MFSAF | At Baseline, 3 and 6 months post-FEDR initiation | |
| Frequency of report of domain assessed by Patients' Global Impression of Change (PGIC) | At Baseline, 3 and 6 months post-FEDR initiation | |
| Absolute reduction assessed by Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10) | At Baseline, 3 and 6 months post-FEDR initiation |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of participants who have discontinued RUX and will be initiating FEDR prospectively.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardinal Health Specialty Solutions | Dublin | Ohio | 43017 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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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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