A Post-marketing Observational Study of Tazemetostat on Safety in Patients With Relapsed or Refractory Follicular Lymphoma With EZH2 Gene Mutation in Japan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 145
- 试验地点
- 135
- 主要终点
- Number of Participants With Adverse Drug Reactions (ADRs)
研究概览
简要总结
The primary purpose of the study is to investigate the safety of tazemetostat in participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation under daily clinical practice.
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
- •Participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation
- •Participants treated with tazemetostat
排除标准
- •1. Participants with a history of hypersensitivity to any ingredient of Tazverik
研究组 & 干预措施
Tazemetostat
Participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation will receive Tazemetostat 800 milligram (mg), tablet, orally, twice daily or as per physicians discretion in routine clinical practice. All the participants will be observed for up to Week 52 prospectively.
干预措施: Tazemetostat (Drug)
结局指标
主要结局
Number of Participants With Adverse Drug Reactions (ADRs)
时间窗: Up to Week 52
An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. Adverse events (AEs) with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
Number of Participants With Serious ADRs
时间窗: Up to Week 52
Serious ADRs are defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition.
次要结局
- Percentage of Participants with Overall Response(Up to Week 52)
- Number of Participants With ADRs Based on Participant Background Factors(Up to Week 52)