NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 774
- 试验地点
- 1
- 主要终点
- Number of Participants Who Had One or More Adverse Drug Reactions (ADRs)
研究概览
简要总结
The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.
详细描述
The drug being tested in this study is called Ixazomib (NINLARO). Ixazomib is being tested to treat people who have relapsed/refractory multiple myeloma. This study will look at the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.
The study will enroll approximately 480 patients.
• Ixazomib 4 mg
This multi-center trial will be conducted in Japan.
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 who have been confirmed as administration of the drug.
排除标准
- 未提供
研究组 & 干预措施
Ixazomib 4 mg
The usual adult dosage for oral administration is 4 mg as ixazomib, in the fasting state, once a day, once a week for 3 weeks (Days 1, 8, and 15), with a 13-day washout period (Days 16 through 28). This 4-week cycle will be repeated for 6 cycles. The dose may be reduced appropriately according to the patient's condition. Participants will receive interventions as part of routine medical care.
干预措施: Ixazomib (Drug)
结局指标
主要结局
Number of Participants Who Had One or More Adverse Drug Reactions (ADRs)
时间窗: Up to 24 Week (From start of administration to the end of 6 cycles)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction (ADR) refers to AE related to administered drug.
Number of Participants Reporting One or More Adverse Events (AEs)
时间窗: Up to 24 Week (From start of administration to the end of 6 cycles)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
次要结局
未报告次要终点