NCT03509896已完成不适用
Treatment Pattern, Clinical Outcome and Healthcare Resource Utilization Associated With Chinese Newly Diagnosed Patients With Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP): A Retrospective Observational Study
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 463 人开始时间: 2017年11月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 463
- 试验地点
- 1
- 主要终点
- Number of participants receiving each first-line treatment option
研究概览
简要总结
Observational medical record review of newly diagnosed CML-CP participants in China
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
- •Ph+ CML-CP patients who were diagnosed between August 1, 2014 to August 1, 2016
- •18 years or older at time of diagnosis
排除标准
- •Participants once enrolled in any interventional clinical trial for CML
- •Participants whose records are not available
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Number of participants receiving each first-line treatment option
时间窗: 2 years
Starting dose of each first-line agent
时间窗: 2 years
Number of participants with complete cytogenetic response
时间窗: 2 years
Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow (BM)
Number of participants of each initial dose schema
时间窗: 2 years
Number of participants with major molecular response (MMR)
时间窗: 2 years
Major molecular response (MMR) is defined as 3-log reduction in International Scale of BCR-ABL mRNA
次要结局
- Distribution of clinical characteristics(2 years)
- Distribution of demographic characteristics(2 years)
研究者
研究点 (1)
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