NCT04066335Unknown不适用
An Observational Study to Evaluate the Safety of Nanoxel M (Docetaxel-PM) Inj.
Samyang Biopharmaceuticals Corporation1 个研究点 分布在 1 个国家目标入组 1,498 人开始时间: 2019年9月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,498
- 试验地点
- 1
- 主要终点
- Safety of Nanoxel M inj.
研究概览
简要总结
Study to evaluate the safety of Nanoxel M inj. administration in patients.
详细描述
This is a multi-center, prospective observational study to observe the incidence of adverse events under actual clinical settings to test the safety of Nanoxel-M inj. administration in patients with breast cancer, non-small cell lung cancer, prostate cancer, ovarian cancer, head & neck cancer, gastric cancer or esophageal cancer.
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
- •Adults ≥18 years old
- •Patients who have signed written consent form prior to participating in the clinical trial
- •Patients who are assessed as adequate to administer Nanoxel M injection.
排除标准
- •Patients who have shown severe hypersensitivity to Docetaxel and concomitant drugs
结局指标
主要结局
Safety of Nanoxel M inj.
时间窗: through study completion, an average of 6cycles(each cycle is 3weeks)
The incidence of Treatment-Emergent Adverse Event
次要结局
未报告次要终点
研究者
研究点 (1)
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