Adverse Event Data Collection From External Registries on Nonacog Beta Pegol
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Adverse Drug Reactions (ADRs) reported to the registries with suspected relation to nonacog beta pegol in patients with haemophilia B
研究概览
简要总结
The purpose of this study is to collect data on adverse events from third party registries that include information about adverse events from patients with haemophilia B treated with nonacog beta pegol. The third party registries include PedNet Haemophilia Registry (PedNet) and the European Haemophilia Safety Surveillance System (EUHASS). Data from national and international registries in countries where nonacog beta pegol has been approved and marketed could be included in the 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 PedNet Registry and/or the European Haemophilia Safety Surveillance System (EUHASS), or other national and international registries
排除标准
- •Not applicable as this is a study collecting third-party data from registries
研究组 & 干预措施
Patients with haemophilia B
Patients with haemophilia B treated with nonacog beta pegol who report adverse events to the PedNet and EUHASS, and possibly other national or international registries.
干预措施: Nonacog beta pegol (Drug)
结局指标
主要结局
Adverse Drug Reactions (ADRs) reported to the registries with suspected relation to nonacog beta pegol in patients with haemophilia B
时间窗: From start of data collection (week 0) to end of data collection (after 9 years)
Number of events (renal, hepatic, neurodevelopmental, neurocognitive, neurologic or psychiatric events)
次要结局
- Other ADRs reported to the registries during the study period with suspected relation to nonacog beta pegol in patients with haemophilia B(From start of data collection (week 0) to end of data collection (after 9 years))