Post-marketing Database Survey: A Cohort Study to Evaluate the Safety of Cuvitru in Patients with Primary Immunodeficiency Using the PIDJ2 (Primary Immunodeficiency Database in Japan) Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 主要终点
- Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- No limit 至 No limit（—）
- 性别
- All
入选标准
- •Patients with primary immunodeficiency (PID) enrolled in the PID patient registry.
- •Participant for whom study drug is entered in the therapeutic drug field on the data set.
- •Participant who is entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
- •Participant for whom the presence or absence of adverse events has been entered in the column of adverse events.
排除标准
- •Participant for whom study drug has not been entered in the drug name in the medical history field during the period from January 24, 2024 to January 23,
- •Participant who is not entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
- •Participant for whom the presence or absence of adverse events has not been entered in the column of adverse events.
结局指标
主要结局
Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE)
时间窗: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience anaphylactic reaction as an AE will be reported.
Number of Participants Who Experience Thromboembolism as an AE
时间窗: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience thromboembolism as an AE will be reported.
Number of Participants Who Experience Aseptic Meningitis as an AE
时间窗: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience aseptic meningitis as an AE will be reported.
次要结局
未报告次要终点