Real-World Practice Patterns and Outcomes of Lower-Risk Myelodysplastic Syndrome Patients in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Participant comorbidities calculated using the Charlson Comorbidity Index (CCI) method
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Record of low (0 points) or intermediate-1 (>0 to 1 point) MDS according to IPSS scoring; or
- •Record of very low (≤1.5), low (>1.5-3), or intermediate (>3-4.5) MDS according to IPSS-R scoring; or
- •Mention of very low, low, intermediate, intermediate-1, or lower risk MDS in the Electronic Medical Records (EMR)
- •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
排除标准
- •Participants not meeting the inclusion criteria
- •Participants <18 years of age at index date
- •Participants who have a look back period <30 days from initial myelodysplastic syndrome diagnosis date
结局指标
主要结局
Participant comorbidities calculated using the Charlson Comorbidity Index (CCI) method
时间窗: From 30 days prior to diagnosis up to 7 days post to diagnosis
Percentage of bone marrow blasts present in participants
时间窗: From 30 days prior to diagnosis up to 7 days post to diagnosis
Histopathology results
时间窗: From 30 days prior to diagnosis up to 7 days post to diagnosis
Participant weight
时间窗: At date of diagnosis
Participant height
时间窗: At date of diagnosis
Treatment prescribed by line of therapy
时间窗: From date of diagnosis, up to 5-years
Time between date of treatment initiation to treatment discontinuation
时间窗: Date of treatment initiation, up to 5-years
Participant age
时间窗: At date of diagnosis
Participant International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R) risk category
时间窗: Date of diagnosis, 6-months and 12 months post-diagnosis
Participant sex
时间窗: At date of diagnosis
Participant Eastern Cooperative Oncology Group (ECOG) score
时间窗: From 30 days prior to diagnosis up to 7 days post to diagnosis
Percentage of ring sideroblasts present in participants
时间窗: Date of bone marrow test; from 30 days prior to diagnosis up to 7 days post to diagnosis
Time between date of diagnosis to date of first red-blood cell transfusion
时间窗: Date of diagnosis, up to 5-years
Number of red-blood cell transfusions received by participants
时间窗: Up to 56 days post diagnosis
Time between date of diagnosis and treatment
时间窗: From date of diagnosis to treatment initiation
Duration of treatment by line of therapy
时间窗: From date of diagnosis, up to 5-years
次要结局
- 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)
- 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)
- 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)
- Number of hospital admissions(Date of treatment initiation, up to 5-years)
- Length of hospitalization(Date of treatment initiation, up to 5-years)
- 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)
- 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)
- Number of participants diagnosed with Acute Myeloid Leukemia(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)
- Reason for hospitalization(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)
- 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)
- Overall survival (OS) of participants(1, 2, 3 and 5-years post treatment initiation)
- Number of emergency department visits(Date of treatment initiation, up to 5-years)
- Medical costs(Date of treatment initiation, 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)
- 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 outpatient visits per month(Date of treatment initiation, up to 5-years)
- Supplemental medication use: Iron chelation use(Date of treatment initiation, up to 5-years)
- Mean hemoglobin change of participants during first-line of 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 Acute Myeloid Leukemia diagnosis(Date of treatment initiation, up to 5-years)
- Number of red-blood cell transfusion days per participant(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)