Special Drug Use Investigation (Survey) of Yervoy and Opdivo Combination Therapy in Patients With Unresectable Advanced/Recurrent Malignant Pleural Mesothelioma (MPM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Outcome of reported AEs
研究概览
简要总结
The purpose of this study is to observe the safety of the combination therapy with Yervoy and Opdivo in Japanese participants for the treatment of unresectable advanced/recurrent malignant pleural mesothelioma (MPM).
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
- •Initiated treatment with Yervoy and Opdivo in combination for the first time in accordance with the Japanese package insert
排除标准
- •Received combination therapy with Yervoy and Opdivo for indications other than Malignant Pleural Mesothelioma (MPM).
- •Received the Yervoy and Opdivo combination for MPM, but for an indication that is outside of the Japanese package insert.
结局指标
主要结局
Outcome of reported AEs
时间窗: Up to 6 Months
Time to onset of AEs
时间窗: Up to 6 Months
Time to resolution of AEs
时间窗: Up to 6 Months
Incidence of AEs leading to interruption of treatment
时间窗: Up to 6 Months
Incidence of SAEs leading to treatment discontinuation
时间窗: Up to 6 Months
Incidence of AEs leading to treatment discontinuation
时间窗: Up to 6 Months
Time to resolution of SAEs
时间窗: Up to 6 Months
Incidence of physician seriousness assessment measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade - Non-serious AE
时间窗: Up to 6 Months
Outcome of reported SAEs
时间窗: Up to 6 Months
Incidence of Adverse Events (AEs)
时间窗: Up to 6 Months
Time to onset of serious adverse events (SAEs)
时间窗: Up to 6 Months
Incidence of physician seriousness assessment measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade - SAE
时间窗: Up to 6 Months
Incidence of SAEs leading to interruption of treatment
时间窗: Up to 6 Months
Number of participants with Yervoy and Opdivo treatment related adverse events as assessed by physician causality
时间窗: Up to 6 Months
Number of participants with Yervoy and Opdivo treatment unrelated adverse events as assessed by physician causality
时间窗: Up to 6 Months
次要结局
未报告次要终点