Estimating Risk of Selected Adverse Events in Patients With Von Willebrand Disease Treated With VEYVONDI® (Vonicog Alfa; Recombinant Von Willebrand Factor)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Hypersensitivity Reactions
研究概览
简要总结
The main aim of this study is to estimate the risks of certain adverse events in adults with Von Willebrand Disease treated with VEYVONDI. No study medicines will be provided to participants in this study.
Data from medical records of participants diagnosed with Von Willebrand Disease and treated with VEYVONDI will be evaluated during this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage of Participants With Hypersensitivity Reactions
时间窗: From 01 January 2019 up to one day before site activation at each site (up to approximately 4 years)
Hypersensitivity reactions are acute events and are considered an adverse events of special interest (AESI) in this study if they occur within 7 days of the infusion (including the day of the initial VEYVONDI infusion).
Percentage of Participants With Thromboembolic Events
时间窗: From 01 January 2019 up to one day before site activation at each site (up to approximately 4 years)
Thrombotic events considered as an AESIs if diagnosed during the 30 days after a VEYVONDI infusion. Thromboembolic events include venous thrombosis, arterial thrombosis, pulmonary embolism, and cerebral artery thrombosis.
Percentage of Participants With VWF or Factor VIII (FVIII) Inhibitor Formation
时间窗: From 01 January 2019 up to one day before site activation at each site (up to approximately 4 years)
Percentage of participants with VWF or FVIII inhibitor formation will be reported.
次要结局
未报告次要终点