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.
Study Type
OBSERVATIONAL
Enrollment
177
≥2 units of red blood cell transfusion
0 units or \<2 units of red blood cell transfusion
Mebix, Inc
Tokyo, Minato-ku, Japan
Participant age
Time frame: At date of diagnosis
Participant sex
Time frame: At date of diagnosis
Participant weight
Time frame: At date of diagnosis
Participant height
Time frame: At date of diagnosis
Participant comorbidities calculated using the Charlson Comorbidity Index (CCI) method
Time frame: From 30 days prior to diagnosis up to 7 days post to diagnosis
Participant Eastern Cooperative Oncology Group (ECOG) score
Time frame: 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
Time frame: Date of diagnosis, 6-months and 12 months post-diagnosis
Percentage of ring sideroblasts present in participants
Time frame: 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
Time frame: From 30 days prior to diagnosis up to 7 days post to diagnosis
Histopathology results
Time frame: From 30 days prior to diagnosis up to 7 days post to diagnosis
Number of red-blood cell transfusions received by participants
Time frame: Up to 56 days post diagnosis
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Treatment prescribed by line of therapy
Time frame: From date of diagnosis, up to 5-years
Duration of treatment by line of therapy
Time frame: From date of diagnosis, up to 5-years
Time between date of diagnosis and treatment
Time frame: From date of diagnosis to treatment initiation
Time between date of treatment initiation to treatment discontinuation
Time frame: Date of treatment initiation, up to 5-years
Time between date of diagnosis to date of first red-blood cell transfusion
Time frame: Date of diagnosis, up to 5-years
Number of participants that achieved red-blood cell transfusion independence during first-line of therapy treatment
Time frame: From week 1-24 and week 1-48 post date of treatment initiation
Mean hemoglobin change of participants during first-line of therapy
Time frame: From week 1-24 and week 1-48 post date of treatment initiation
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From week 1-24 post date of treatment initiation
Modified Hematologic Improvement - Erythroid (mHI-E) of transfusion dependant participants receiving first line therapy
Time frame: From week 1-24 post date of treatment initiation
Hematologic Improvement - Erythroid (HI-E) response of non-transfusion dependant participants receiving first line therapy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From date of treatment initiation to date of treatment discontinuation, up 5-years
Number of participants diagnosed with Acute Myeloid Leukemia
Time frame: Date of treatment initiation, up to 5-years
Time to Acute Myeloid Leukemia diagnosis
Time frame: Date of treatment initiation, up to 5-years
Overall survival (OS) of participants
Time frame: 1, 2, 3 and 5-years post treatment initiation
Number of red-blood cell transfusion days per participant
Time frame: Date of treatment initiation, up to 5-years
Number of red-blood cell units used per transfusion
Time frame: Date of treatment initiation, up to 5-years
Number of outpatient visits per month
Time frame: Date of treatment initiation, up to 5-years
Number of hospital admissions
Time frame: Date of treatment initiation, up to 5-years
Length of hospitalization
Time frame: Date of treatment initiation, up to 5-years
Reason for hospitalization
Time frame: Date of treatment initiation, up to 5-years
Number of emergency department visits
Time frame: Date of treatment initiation, up to 5-years
Number of Intensive care unit admissions (ICU)
Time frame: Date of treatment initiation, up to 5-years
Number of outpatient/inpatient medication claims
Time frame: Date of treatment initiation, up to 5-years
Supplemental medication use: Iron chelation use
Time frame: Date of treatment initiation, up to 5-years
Supplemental medication use: Granulocyte-colony stimulating factors (G-CSF)
Time frame: Date of treatment initiation, up to 5-years
Number of hematology tests ordered
Time frame: 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
Time frame: Date of treatment initiation, up to 5-years