NCT04089839已完成不适用
Prospective Assessment of Dasatinib Management Among CP-CML Patients With Dasatinib Initiation in a Real Life Setting: DasaREALISE.
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2016年4月21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
- 177
- 试验地点
- 1
- 主要终点
- Incidence of CP-CML patients remaining on dasatinib treatment
研究概览
简要总结
This is a prospective, non-interventional study conducted in CP-CML patients receiving dasatinib who are enrolled by a sample of hematologists in France.
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
- •Patients aged greater than or equal to 18 years
- •Patients diagnosed with CP-CML
- •Patients who started dasatinib within the last month before inclusion, or on the day of inclusion or within the month after inclusion
排除标准
- •Patients participating in an ongoing interventional trial
- •Patients diagnosed with AP-CML (accelerated phase) or BP-CML (blast phase)
结局指标
主要结局
Incidence of CP-CML patients remaining on dasatinib treatment
时间窗: 24 months
次要结局
- Distribution of sex ratio of CP-CML patients receiving dasatinib(24 months)
- Distribution of median age of CP-CML patients receiving dasatinib(24 months)
- Distribution of concomitant treatment of CP-CML patients receiving dasatinib(24 months)
- Distribution of cardiovascular risk factors of CP-CML patients receiving dasatinib(24 months)
- Distribution of disease characteristics duration between diagnosis and drug initiation in CP-CML patients receiving dasatinib(24 months)
- SOKAL distribution of disease characteristics of CP-CML patients receiving dasatinib(24 months)
- Distribution of prior treatment(s) of CP-CML patients receiving dasatinib(24 months)
- Distribution of body mass index (BMI) of CP-CML patients receiving dasatinib(24 months)
- Distribution of comorbidities of CP-CML patients receiving dasatinib(24 months)
- Distribution disease characteristics of last known molecular response in CP-CML patients receiving dasatinib(24 months)
- Incidence of initiating dasatinib due to failure(24 months)
- Incidence of initiating dasatinib due to suboptimal response(24 months)
- Incidence of initiating dasatinib due to convenience(24 months)
- Incidence of initiating dasatinib due to intolerance(24 months)
- Incidence of initiating dasatinib due to physician decision(24 months)
- Incidence of AE's(24 months)
- Incidence of SAE's(24 months)
- Utilization of dasatinib(24 months)
- Incidence of complete molecular response (CMR)(Up to 24 months)
- Incidence of major molecular response (MMR)(Up to 24 months)
研究者
研究点 (1)
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