Intense Monitoring Study on Sintilimab Injection (Tyvyt®)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Occurrence of adverse drug reactions in special population
研究概览
简要总结
The study is a multi-center, prospective, non-interventional and observational study, and will collect data on the safety and efficacy of Tyvyt® in the treatment of Chinese patients with relapsed or refractory classical Hodgkin's lymphoma.
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
- •Patients must be able to understand and voluntarily sign the informed consent form (ICF).
- •Patients must provide reliable contact information, including home phone numbers or follow-up phone number, and be voluntary to be followed up.
- •Patients must have agreed to use Tyvyt® to treat the target indication.
排除标准
- •Patients refuse to be included in the study or refuse to cooperate.
- •Patients have participated in another interventional studies within 4 weeks prior to enrollment.
结局指标
主要结局
Occurrence of adverse drug reactions in special population
时间窗: During the actual Tyvyt treatment time.
Association, risk factors, severity and incidence of serious adverse drug reactions
时间窗: During the actual Tyvyt treatment time.
Occurrence of new adverse drug reactions
时间窗: During the actual Tyvyt treatment time.
Incidence of known adverse drug reactions
时间窗: During the actual Tyvyt treatment time.
Association, risk factors, severity and incidence of immune-related adverse drug reactions/events
时间窗: During the actual Tyvyt treatment time.
次要结局
- Overall survival (OS)(During the actual Tyvyt treatment time.)