NCT02554656已完成不适用
VFEND SPECIAL INVESTIGATION- INVESTIGATION FOR TREATMENT OF INVASIVE FUNGAL INFECTIONS IN PEDIATRIC PATIENTS -
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
- 89
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Reactions
研究概览
简要总结
Examine the safety and effectiveness of Vfend [voriconazole] for pediatric 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 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who is under 15 years old and deep mycosis infection.
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 Reactions
时间窗: 16 weeks at maximum
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 LPD (Unknown Adverse Drug Reaction)(16 weeks at maximum)
- Clinical Response Rate by Diagnostic Name (Name of Infection)(16 weeks at maximum)
- Incidence of Aadverse Reactions by Diagnosis (Infection)(16 weeks at maximum)
- Overall Clinical Response(16 weeks at maximum)
研究者
研究点 (1)
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