Post Marketing Surveillance for General Drug Use to Assess the Safety and Efficacy Profile of NOXAFIL Oral Suspension in Usual Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 273
- 主要终点
- Number of participants with unexpected drug-related adverse experiences
研究概览
简要总结
This study will examine the safety and efficacy of posaconazole in general use in Korea.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated with posaconazole oral suspension within current local label
排除标准
- •Contraindication to posaconazole oral suspension according to current local label
研究组 & 干预措施
All Participants
All participants treated with posaconazole oral suspension during the pre-specified surveillance period.
干预措施: Posaconazole oral suspension 40 mg/mL (Drug)
结局指标
主要结局
Number of participants with unexpected drug-related adverse experiences
时间窗: During treatment and for 30 days following cessation of treatment
Number of Participants with Responses of Improved, Not Improved, and Worsened
时间窗: After at least 14 days of treatment
Number of participants with Serious Adverse Experiences
时间窗: During treatment and for 30 days following cessation of treatment
Number of participants with drug-related adverse experiences
时间窗: During treatment and for 30 days following cessation of treatment
Number of participants with Non-Serious Adverse Experiences
时间窗: During treatment and for 30 days following cessation of treatment
次要结局
未报告次要终点