Multicenter, Observational Study to Evaluate NeoRecormon Treatment in Anemic Patients Suffering From Non-myeloid Malignancy Receiving Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 主要终点
- Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8
研究概览
简要总结
This observational, prospective, multicenter study will evaluate the treatment response rate and the safety of NeoRecormon (epoetin beta) in anemic patients with non-myeloid malignancy. In addition to NeoRecormon, patients receive chemotherapy for their malignancy. Data will be collected for 16 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients, >/=18 years of age
- •Presence of solid-tumor or non-myeloid malignancy
- •Patients receiving chemotherapy
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- •Patients require NeoRecormon
排除标准
- •Hypersensitivity to the drug
- •Uncontrolled hypertension
- •Female patients if pregnant and/or lactating
结局指标
主要结局
Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8
时间窗: Baseline to Week 8
Therapeutic response was defined as an increase of greater than or equal to (\>=) 1 gram per decilitre (g/dL) in hemoglobin (Hb) level as compared to baseline, following 8 weeks of Epoetin beta treatment. The Therapeutic response rate was summarized as percentage of participants with an increase of \>= 1 g/dL in Hb level at Week 8 as compared to baseline.
次要结局
- Percentage of Red Blood Cell Transfusion-free Participants(Up to Week 16)
- Mean Change From Baseline in Hemoglobin Level up to Week 16(Baseline, Week 4, Week 8, Week 12, and Week 16)
- Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy(Up to Week 16)
- Number of Participants With Adverse Events and Serious Adverse Events(Up to Week 16)