NCT02501330已完成不适用
DRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 702
- 主要终点
- Cytogenetic response
研究概览
简要总结
The objective of this surveillance is to collect information about
- adverse drug reaction not expected from the LPD (unknown adverse drug reaction)
- the incidence of adverse drug reactions in this surveillance
- factors considered to affect the safety and/or efficacy of this drug.
详细描述
The patients should be registered by central registration system.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic myelogenous leukemia patients resistant or intolerant to prior treatment there is no experience with this drug
- •Newly-diagnosed chronic phase Chronic myelogenous leukemia patients there is no experience with this drug
排除标准
- •Patients with a history of hypersensitivity
- •Women who may possibly be pregnant or become pregnant
研究组 & 干预措施
Bosutinib
干预措施: Bosutinib (Drug)
结局指标
主要结局
Cytogenetic response
时间窗: 24 weeks
The incidence of adverse drug reactions
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
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