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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transfusion dependent | Participants that received ≥2 units of red blood cell transfusion during the 8 weeks after initial myelodysplastic syndrome diagnosis date. |
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| Non-transfusion dependent | Participants that received 0 units or <2 units of red blood cell transfusion during the 8 weeks after initial myelodysplastic syndrome diagnosis date. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red blood cell transfusion | Procedure | ≥2 units of red blood cell transfusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Participant age | At date of diagnosis | |
| Participant sex | At date of diagnosis | |
| Participant weight | At date of diagnosis | |
| Participant height | At date of diagnosis | |
| Participant comorbidities calculated using the Charlson Comorbidity Index (CCI) method | From 30 days prior to diagnosis up to 7 days post to diagnosis | |
| Participant Eastern Cooperative Oncology Group (ECOG) score | From 30 days prior to diagnosis up to 7 days post to diagnosis | |
| Participant International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R) risk category | Date of diagnosis, 6-months and 12 months post-diagnosis | |
| Percentage of ring sideroblasts present in participants | Date of bone marrow test; from 30 days prior to diagnosis up to 7 days post to diagnosis | |
| Percentage of bone marrow blasts present in participants | From 30 days prior to diagnosis up to 7 days post to diagnosis | |
| Histopathology results | From 30 days prior to diagnosis up to 7 days post to diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that achieved red-blood cell transfusion independence during first-line of therapy treatment | From week 1-24 and week 1-48 post date of treatment initiation | |
| Mean hemoglobin change of participants during first-line of therapy | From week 1-24 and week 1-48 post date of treatment initiation |
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Inclusion Criteria:
Participants with at least one definitive myelodysplastic syndrome (MDS) diagnosis as per the 10th Revision of the International Statistical Classification of Diseases and Related Health Problems (MDS; ICD10: D46.X) between 01-May-2017 and 31-Jan-2022
Participants with confirmed low-risk MDS by International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R) during baseline as follows:
Participants with a record of a confirmed bone marrow procedure (bone marrow aspiration code D404-00 and/or bone marrow biopsy code D404-02) during baseline period
Exclusion Criteria:
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Adult participants with myelodysplastic syndrome in Japan
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mebix, Inc | Tokyo | Minato-ku | 107-0052 | Japan |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D017707 | Erythrocyte Transfusion |
| ID | Term |
|---|---|
| D016913 | Blood Component Transfusion |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Red blood cell transfusion |
| Procedure |
0 units or <2 units of red blood cell transfusion |
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| Number of red-blood cell transfusions received by participants | Up to 56 days post diagnosis |
| Treatment prescribed by line of therapy | From date of diagnosis, up to 5-years |
| Duration of treatment by line of therapy | From date of diagnosis, up to 5-years |
| Time between date of diagnosis and treatment | From date of diagnosis to treatment initiation |
| Time between date of treatment initiation to treatment discontinuation | Date of treatment initiation, up to 5-years |
| Time between date of diagnosis to date of first red-blood cell transfusion | Date of diagnosis, up to 5-years |
| 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 | Week 1-24 post treatment initiation |
| Number of non-transfusion dependant participants achieving red-blood cell transfusion independence during first-line therapy for ≥24, 48 and 72 weeks | Week 24, 48 and 72 post date of initiation of treatment |
| Time to red-blood call transfusion independence of ≥12 weeks for transfusion dependant participants receiving first line therapy | From week 1-24 and week 1-48 post date of treatment initiation |
| Hematologic Improvement - Erythroid (HI-E) response of transfusion dependant participants receiving first line therapy | From week 1-24 post date of treatment initiation |
| Modified Hematologic Improvement - Erythroid (mHI-E) of transfusion dependant participants receiving first line therapy | From week 1-24 post date of treatment initiation |
| Hematologic Improvement - Erythroid (HI-E) response of non-transfusion dependant participants receiving first line therapy | From week 1-24 and week 1-48 post date of treatment initiation |
| Modified Hematologic Improvement - Erythroid (mHI-E) of non-transfusion dependant participants receiving first line therapy | From week 1-24 and week 1-48 post date of treatment initiation |
| Time to Hematologic Improvement - Erythroid (HI-E) or Modified hematologic improvement - Erythroid (mHI-E) during first-line therapy | From week 1-24 and week 1-48 post date of treatment initiation |
| Duration of Hematologic Improvement - Erythroid (HI-E) or Modified hematologic improvement - Erythroid (mHI-E) during first-line therapy | From date of treatment initiation to date of treatment discontinuation, up 5-years |
| Duration of red-blood call transfusion independence of ≥12 weeks for transfusion dependant participants receiving first line therapy | From date of treatment initiation to date of treatment discontinuation, up 5-years |
| Number of participants diagnosed with Acute Myeloid Leukemia | Date of treatment initiation, up to 5-years |
| Time to Acute Myeloid Leukemia diagnosis | Date of treatment initiation, up to 5-years |
| Overall survival (OS) of participants | 1, 2, 3 and 5-years post treatment initiation |
| Number of red-blood cell transfusion days per participant | Date of treatment initiation, up to 5-years |
| Number of red-blood cell units used per transfusion | Date of treatment initiation, up to 5-years |
| Number of outpatient visits per month | Date of treatment initiation, up to 5-years |
| Number of hospital admissions | Date of treatment initiation, up to 5-years |
| Length of hospitalization | Date of treatment initiation, up to 5-years |
| Reason for hospitalization | Date of treatment initiation, up to 5-years |
| Number of emergency department visits | Date of treatment initiation, up to 5-years |
| Number of Intensive care unit admissions (ICU) | Date of treatment initiation, up to 5-years |
| Number of outpatient/inpatient medication claims | Date of treatment initiation, up to 5-years |
| Supplemental medication use: Iron chelation use | Date of treatment initiation, up to 5-years |
| Supplemental medication use: Granulocyte-colony stimulating factors (G-CSF) | Date of treatment initiation, up to 5-years |
| Number of hematology tests ordered | Date of treatment initiation, up to 5-years |
| Medical costs | Including: cost of red-blood cell transfusion, cost of red-blood cell transfusion administration, cost of erythropoiesis stimulating agents (ESA) medication, cost of ESA administration, cost of iron chelation therapy medications, cost of iron chelation therapy administration, other costs and total costs | Date of treatment initiation, up to 5-years |