NCT03568929已完成不适用
Non-interventional Study to Assess the Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma (FL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 88
- 主要终点
- Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AE), Serious AEs, Special Situation Reports, Adverse Drug Reactions (ADR), and Serious ADRs
研究概览
简要总结
The primary objective of this study is to assess the overall safety profile of idelalisib monotherapy in patients with refractory follicular lymphoma (FL).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who were or are being treated for refractory Follicular Lymphoma (FL) according to the product information for idelalisib and treatment guidelines in routine clinical practice.
排除标准
- •Individuals included in clinical trials on idelalisib within the timeframe of this study.
研究组 & 干预措施
Idelalisib
Participants who have been or are currently being treated with 100 or 150 mg of idelalisib
干预措施: Idelalisib (Drug)
结局指标
主要结局
Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AE), Serious AEs, Special Situation Reports, Adverse Drug Reactions (ADR), and Serious ADRs
时间窗: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)
次要结局
- Duration of Response (DOR)(250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period))
- Time to Next Treatment (TTNT)(250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period))
- Overall Survival (OS)(250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period))
- Overall Response Rate (ORR)(250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period))
- Progression-free Survival (PFS)(250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period))
研究者
研究点 (88)
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