Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Adverse events (AEs) reported to the registry with suspected relation to turoctocog alfa pegol, Adverse Drug Reactions (ADRs), in patients with haemophilia A for renal, hepatic and neurological events.
研究概览
简要总结
This non-interventional study concerns a safety data collection based on adverse event data from a third-party registry (European Haemophilia Safety Surveillance System, EUHASS) that includes information about adverse events from patients with haemophilia A treated with turoctocog alfa pegol. There is no extra burden to the patients by participating in this registry-based data collection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the European Haemophilia Safety Surveillance System (EUHASS).
排除标准
- 未提供
研究组 & 干预措施
Haemophilia A patients
All patients with haemophilia A treated with turoctocog alfa pegol and reporting adverse events to EUHASS.
干预措施: Turoctocog alfa pegol (Drug)
结局指标
主要结局
Adverse events (AEs) reported to the registry with suspected relation to turoctocog alfa pegol, Adverse Drug Reactions (ADRs), in patients with haemophilia A for renal, hepatic and neurological events.
时间窗: From start to end of data collection (December 2019 to January 2025)
Count
次要结局
- Other AEs reported to the registry during the study period with suspected relation to turoctocog alfa pegol in patients with haemophilia A(From start to end of data collection (December 2019 to January 2025))