NCT03663946已完成不适用
Drug Use Investigation on Combination Therapy With Yervoy and Opdivo (Unresectable or Metastatic Renal Cell Carcinoma)
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2018年9月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Incidence of immune-related AE's
研究概览
简要总结
Patients with non-surgical or renal cell carcinoma that has spread who are starting treatment for the first time with Yervoy and Opdivo in the real world
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unresectable or metastatic renal cell carcinoma who are initiating treatment for the first time with Yervoy and Opdivo in accordance with the Japanese package insert will be included in this PMS
排除标准
- •Patients receiving combination therapy with Yervoy and Opdivo for non RCC indication will be excluded from this PMS
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Incidence of immune-related AE's
时间窗: Approximately 13 weeks
Incidence of immune related SAE's
时间窗: Approximately 13 weeks
次要结局
- Incidence of unknown AE's(Approximately 13 weeks)
- Incidence of unknown SAE's(Approximately 13 weeks)
- Incidence of treatment for immune-related adverse reactions(Approximately 13 weeks)
研究者
研究点 (1)
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