Brentuximab Vedotin (ADCETRIS) IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 292
- 主要终点
- Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)
研究概览
简要总结
The purpose of this study is to evaluate the safety of brentuximab vedotin (recombinant) for intravenous (IV) infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting, as well as to collect efficacy information for reference.
详细描述
The present survey was designed to evaluate the safety of brentuximab vedotin (recombinant) for IV infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting.
The usual adult dosage is 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) infused intravenously once every three weeks. The dose should be adjusted depending on the participant's condition. See the "PRECAUTIONS" section of the package insert.
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
- •All patients treated with brentuximab vedotin IV Infusion
排除标准
- 未提供
研究组 & 干预措施
brentuximab vedotin (recombinant) Intravenous infusion
Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks
干预措施: Brentuximab vedotin (recombinant) (Drug)
结局指标
主要结局
Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)
时间窗: Up to Week 48 or until discontinuation of treatment
次要结局
- Overall Survival (OS)(Up to Week 48 or until discontinuation of treatment)
- Percentage of Participants Who Achieve or Maintain Any Best Response(Up to Week 48 or until discontinuation of treatment)