NCT01332396已完成不适用
Drug Use Investigation for TYKERB Tablet (All Case Investigation)
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
- Novartis
- 入组人数
- 4,054
- 主要终点
- The incidence of adverse events in Japanese patients treated with TYKERB based on prescribing information under the conditions of general clinical practice
研究概览
简要总结
Data on the safety and efficacy of TYKERB shall be collected from the patients in order to grasp the actual conditions of post-marketing use and assess background information on the patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HER2 overexpressing inoperable or recurrent breast cancer
排除标准
- •Patients with hypersensitivity to lapatinib or any components
- •Pregnant women and women suspected of being pregnant
研究组 & 干预措施
Patients prescribed TYKERB
Patients with HER2 overexpressing inoperable or recurrent breast cancer
干预措施: Lapatinib (Drug)
结局指标
主要结局
The incidence of adverse events in Japanese patients treated with TYKERB based on prescribing information under the conditions of general clinical practice
时间窗: 1 year
次要结局
未报告次要终点
研究者
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