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