NCT02674685已完成不适用
VFEND SPECIAL INVESTIGATION FOR PROPHYLAXIS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 241
- 主要终点
- Number of Participants With Adverse Drug Reactions
研究概览
简要总结
Examine the safety and effectiveness of Vfend [voriconazole] for prophylaxix use under general clinical practices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).
排除标准
- •Patients who have been previously enrolled in this study.
结局指标
主要结局
Number of Participants With Adverse Drug Reactions
时间窗: Maximum 3 years
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to VFEND was assessed by the physician.
次要结局
- Number of Participants With Adverse Drug Reactions Not Expected From the Approved Local Product Document (Unknown Adverse Drug Reactions)(Maximum 3 years)
- Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate)(Maximum 3 years)
- Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate)(Maximum 3 years)
- Proportion of Participants With Adverse Drug Reactions by Age(Maximum 3 years)
- Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Age(Maximum 3 years)
- Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Age(Maximum 3 years)
- Proportion of Participants With Adverse Drug Reactions by Reason for Use(Maximum 3 years)
- Proportion of Participants With Adverse Drug Reactions by Long-term Use(Maximum 3 years)
- Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Reason for Use(Maximum 3 years)
- Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Reason for Use(Maximum 3 years)
研究者
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