Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 692
- 主要终点
- Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable
研究概览
简要总结
This is non-interventional study of voriconazole IV formulation in clinical use, which was mandated by the Korean government agency following the approval of Vfend in the Republic of Korea.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Invasive aspergillosis and other serious fungal infections.
排除标准
- 未提供
研究组 & 干预措施
A.
Patients who are indicated for VFEND according to drug package insert.
干预措施: voriconazole IV (Drug)
结局指标
主要结局
Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable
时间窗: Baseline (Day 1) up to 2 years
Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).
次要结局
- Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable(Baseline (Day 1) up to 2 years)