Inrebic® (Fedratinib) Post-Marketing Surveillance in Korean Patients With Myelofibrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 137
- 试验地点
- 3
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The purpose of this study is to assess the real-world safety of fedratinib for the treatment of adult participants with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential thrombocythemia myelofibrosis (post-ET MF) who were previously treated with ruxolitinib. Participants will represent the overall patient population with PMF, post-PV MF or post-ET MF who lost adequate response to and/or are intolerant to ruxolitinib. Inadequate response definitions will follow Ministry of Food and Drug Safety-approved label and reimbursement criteria of the Health Insurance Review & Assessment Service.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants 19 years of age or older
- •Participants who will receive fedratinib according to the approved label
- •For the first 2 years after marketing authorization, all participants who have received or are receiving fedratinib will also be registered
- •Participants who signed the informed consent form
排除标准
- •Participants who have been prescribed fedratinib for an indication not approved in Korea
- •Participants who have been prescribed fedratinib at a dose not approved in Korea
- •Participants for whom fedratinib is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety
研究组 & 干预措施
Participants with myelofibrosis receiving fedratinib
干预措施: Fedratinib (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Up to 6 months
The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to Inrebic® (fedratinib)
次要结局
未报告次要终点