NCT02441764已完成不适用
Post-Marketing Surveillance of Halaven Injection in Korean Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 主要终点
- Safety of Halaven as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions
研究概览
简要总结
This is a PMS to observe the safety profile of Halaven in normal clinical practice setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who meet all of the following criteria will be eligible for inclusion in the study:
- •Participants with following indication: Participants with locally advanced or metastatic breast cancer who have previously received at least two chemotherapeutic regimens which should have included an anthracycline and a taxane.
- •Participants who have verbal or written consent for use of personal and medical information.
- •Investigators will refer to indications regarding inclusion criteria.
排除标准
- •Hypersensitivity to the active substance or to any of the excipients
- •Breast feeding
- •Investigators will refer to indications and contraindications regarding exclusion criteria.
结局指标
主要结局
Safety of Halaven as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions
时间窗: Up to 1 year
次要结局
- Tumor response to Halaven treatment(Up to 12 weeks)
研究者
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