NCT01464047已完成不适用
Korean Post-marketing Surveillance for Sprycel®
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 670 人开始时间: 2011年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 670
- 试验地点
- 1
- 主要终点
- Adverse events occurrence
研究概览
简要总结
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Sprycel® so that the regulatory authority can manage the marketing approval properly.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
- •Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including Imatinib
- •Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) with resistance or intolerance to prior therapy
排除标准
- •According to Warning/Caution in local label
结局指标
主要结局
Adverse events occurrence
时间窗: 30 days after last dose of study drug
次要结局
- Improvement in cytogenetic response(12 weeks after registration)
- Improvement in hematologic response(4 weeks after registration)
- Overall efficacy assessment by investigator's discretion(4 weeks after registration)
研究者
研究点 (1)
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