A Non-Interventional, Post Authorisation Safety Study, to Continuously Monitor Safety and Pregnancy Outcomes in a Cohort of At-Risk Essential Thrombocythaemia (ET) Subjects Exposed to Xagrid Compared to Other Conventional Cytoreductive Treatments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 3,647
- 试验地点
- 157
- 主要终点
- Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies
研究概览
简要总结
This is an observational safety study being conducted in Europe comparing patients taking Xagrid to patients taking other cytoreductive treatments. The plan is to enrol at least 750 subjects taking Xagrid with up to 3000 subjects taking other cytoreductive therapies. The study will collect follow up data for 5 years for each patient enrolled that will focus on collecting data related to pre-defined events (PDEs) and Suspected Serious Adverse Reactions (SSARs).
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
- •High risk ET patients
- •Subjects who can give written informed consent.
- •Subjects taking cytoreductive therapy
排除标准
- •Contraindications listed by the product being used.
- •Patient cannot be participating in another clinical trial.
结局指标
主要结局
Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies
时间窗: Up to 5 years
Pre-defined events (PDEs) were evaluated whenever an event occurred and was defined by a panel of independent qualified physicians, blinded to cytoreductive therapy, validated all PDEs prior to analysis (Event Validation Panel). Non-PDE death only included deaths not recorded as outcome of another PDE.
Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events
时间窗: Up to 5 years
SSAR: serious adverse event (SAE) that was considered related to cytoreductive therapy. SAE: any untoward medical occurrence that at any dose resulted in death, life-threatening (at the time of the event), in-patient hospitalization/prolongation of existing hospitalization (elective hospitalizations/procedures for pre-existing conditions that had not worsened were excluded), resulted in persistent or significant disability/incapacity or congenital abnormality/birth defect. Relatedness (suspected/not suspected) to XAGRID or other cytoreductive theraphy was determined by the investigator. As for SSARs, it was important to consider whether the events were related to XAGRID or other cytoreductive therapy. A participant was included in Xagrid or other treatment group based on treatment exposure, participants received Xagrid + Other was counted both in Xagrid and other treatment group.
次要结局
- Event Rate of Thrombohaemorrhagic Events(Up to 5 years)
- Platelet Count(Baseline, Month 6,12,18, 24, 30, 36, 42, 48, 54, 60)
- Duration of Exposure for Each Essential Thrombocythemia (ET) Therapy(Up to 5 years)
- Cumulative Dose for Each Essential Thrombocythemia (ET) Therapy(Up to 5 years)