PegIntron Injection Surveillance Plan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,267
- 主要终点
- Number of Participants That Reported a Serious Adverse Event
研究概览
简要总结
Surveillance will be conducted at digestive departments of internal medicine in university or general hospitals where participants with chronic hepatitis C are generally treated. The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of PegIntron Injection under actual conditions of use and to examine adverse events, serious adverse events, and adverse drug reactions.
详细描述
The investigator will record continuously from the first patient since the day of contract to the numbers of patients of contract based on Pegintron approval.
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
- •Participants with chronic hepatitis C treated with peginterferon alfa-2b.
- •Signed written contract.
排除标准
- 未提供
结局指标
主要结局
Number of Participants That Reported a Serious Adverse Event
时间窗: 24 weeks after administration of PegIntron Injection
Serious adverse events (SAE's) were events that resulted in death, were life threatening, required hospitalization, caused disability, and congenital anomaly. All SAE's related or unrelated to the study drug and those SAE's that were determined by the investigator, using specific criteria defined in the protocol, were reported.
Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold
时间窗: 24 weeks after administration of PegIntron Injection.
Adverse events (AE's) were events that resulted in unintended signs, symptoms or illnesses. All non-serious adverse events related or unrelated to the study drug and those AE's determined by the investigator, using specific criteria defined in the protocol, were reported.
次要结局
未报告次要终点