Vfend Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,002
- 主要终点
- Number of Participants With the Frequency of Treatment Related Adverse Events.
研究概览
简要总结
To collect the efficacy and safety informations of voriconazole related to their appropriate use in daily practice.
详细描述
All the subjects whom an investigator prescribes the first voriconazole (VFEND) should be registered consecutively until the number of subjects reaches target number in order to extract subjects enrolled into the investigation at random.
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
- •Male or Female subjects intend to treat their deep mycosis who are prescribed voriconazole (VFEND) by their Physicians.
排除标准
- •Subject who heve been prescribed voriconazole (VFEND) before.
研究组 & 干预措施
Voriconazole
Subjects who are treated with voriconazole
干预措施: Voriconazole (Drug)
结局指标
主要结局
Number of Participants With the Frequency of Treatment Related Adverse Events.
时间窗: 16 weeks
Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.
Number of Participants That Responded to Voriconazole Treatment.
时间窗: 16 weeks
The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the subjects for efficacy analysis.
次要结局
- Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.(16 weeks)
- Risk Factors for the Frequency of Treatment Related Adverse Events -Gender.(16 weeks)
- Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections.(16 weeks)
- Risk Factors for the Frequency of Treatment Related Adverse Events -Past History.(16 weeks)
- Number of Participants That Responded to Voriconazole Treatment -Severity of Infections.(16 weeks)