Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 379
- 主要终点
- Number of Participants With Any Serious Adverse Event
研究概览
简要总结
The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of valaciclovir in pediatric patients with chickenpox
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients with chickenpox (aged less than 15 years old).
排除标准
- •Patients with a history of hypersensitivity to the ingredients of valaciclovir or acyclovir.
研究组 & 干预措施
Pediatric patients prescribed valaciclovir
Pediatric patients with chickenpox prescribed valaciclovir during study period.
干预措施: Valaciclovir (Drug)
结局指标
主要结局
Number of Participants With Any Serious Adverse Event
时间窗: 1 month
A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.
次要结局
- Number of Participants With the Indicated Adverse Drug Reactions(1 month)
- Number of Participants Classified as Effective and Not Effective(1 month)
- Number of Participants With Any Unexpected Adverse Drug Reactions(1 month)