跳至主要内容
临床试验/NCT01073631
NCT01073631已完成不适用

Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet

Pfizer0 个研究点目标入组 543 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Pfizer
入组人数
543
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 a non-interventional study of voriconazole tablet in Korea which is mandated by the Korean government agency.

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

入选标准

  • Patients who are indicated for voriconazole table according to the drug package insert.

排除标准

  • 未提供

研究组 & 干预措施

1

Patients who are indicated for use of voriconazole tablet.

干预措施: voriconazole tablet (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 2.1 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 2.1 Years)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

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