nctId: NCT06298643 id: CA056-1094 briefTitle: Real-World Practice Patterns and Outcomes of Lower-Risk Myelodysplastic Syndrome Patients in Japan overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-07 date: 2024-03-07 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: The purpose of this study is to describe the treatment patterns, clinical outcomes, healthcare resource utilization (HCRU) and medical costs of lower-risk myelodysplastic syndromes patients in Japan. conditions: Lower-risk Myelodysplastic Syndromes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300 type: ACTUAL name: Red blood cell transfusion name: Red blood cell transfusion measure: Participant age measure: Participant sex measure: Participant weight measure: Participant height measure: Participant comorbidities calculated using the Charlson Comorbidity Index (CCI) method measure: Participant Eastern Cooperative Oncology Group (ECOG) score measure: Participant International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R) risk category measure: Percentage of ring sideroblasts present in participants measure: Percentage of bone marrow blasts present in participants measure: Histopathology results measure: Number of red-blood cell transfusions received by participants measure: Treatment prescribed by line of therapy measure: Duration of treatment by line of therapy measure: Time between date of diagnosis and treatment measure: Time between date of treatment initiation to treatment discontinuation measure: Time between date of diagnosis to date of first red-blood cell transfusion measure: Number of participants that achieved red-blood cell transfusion independence during first-line of therapy treatment measure: Mean hemoglobin change of participants during first-line of therapy measure: Number of transfusion dependant participants achieving re-blood cell transfusion independence for ≥12 weeks with associated concurrent mean hemoglobin increase of ≥1.5 g/dL during first-line of therapy measure: Number of non-transfusion dependant participants achieving red-blood cell transfusion independence during first-line therapy for ≥24, 48 and 72 weeks measure: Time to red-blood call transfusion independence of ≥12 weeks for transfusion dependant participants receiving first line therapy measure: Hematologic Improvement - Erythroid (HI-E) response of transfusion dependant participants receiving first line therapy measure: Modified Hematologic Improvement - Erythroid (mHI-E) of transfusion dependant participants receiving first line therapy measure: Hematologic Improvement - Erythroid (HI-E) response of non-transfusion dependant participants receiving first line therapy measure: Modified Hematologic Improvement - Erythroid (mHI-E) of non-transfusion dependant participants receiving first line therapy measure: Time to Hematologic Improvement - Erythroid (HI-E) or Modified hematologic improvement - Erythroid (mHI-E) during first-line therapy measure: Duration of Hematologic Improvement - Erythroid (HI-E) or Modified hematologic improvement - Erythroid (mHI-E) during first-line therapy measure: Duration of red-blood call transfusion independence of ≥12 weeks for transfusion dependant participants receiving first line therapy measure: Number of participants diagnosed with Acute Myeloid Leukemia measure: Time to Acute Myeloid Leukemia diagnosis measure: Overall survival (OS) of participants measure: Number of red-blood cell transfusion days per participant measure: Number of red-blood cell units used per transfusion measure: Number of outpatient visits per month measure: Number of hospital admissions measure: Length of hospitalization measure: Reason for hospitalization measure: Number of emergency department visits measure: Number of Intensive care unit admissions (ICU) measure: Number of outpatient/inpatient medication claims measure: Supplemental medication use: Iron chelation use measure: Supplemental medication use: Granulocyte-colony stimulating factors (G-CSF) measure: Number of hematology tests ordered measure: Medical costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mebix, Inc city: Tokyo state: Minato-ku zip: 107-0052 country: Japan lat: 35.6895 lon: 139.69171 hasResults: False