CTRI/2020/09/028152已完成不适用
Retrospective, Prescription Event Monitoring (PEM) study of EMROK &/or EMROK – O (Levonadifloxacin)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Efficacy of EMROK &/or EMROK – O (Levonadifloxacin)
研究概览
简要总结
Wockhardt has designed this Retrospective, PrescriptionEvent Monitoring study of EMROK (LevonadifloxacinIntravenous Injection 800mg/100ml ) & EMROK – O (Levonadifloxacin Tablets 500mg) in real life setting. EMROK andEMROK - O are indicated in adults with ≥18 years of age. Study end points covered will be: Incidencerates of adverse events, Improvement rate, Failure rate, Overall Global Assessment forEfficacy, Overall Global Assessment forSafety, Patient Demographiccharacteristics and Usage of EMROK Treatment.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients who were prescribed with EMROK or EMROK – O by their treating physicians.
排除标准
- •Not applicable.
结局指标
主要结局
Efficacy of EMROK &/or EMROK – O (Levonadifloxacin)
时间窗: At the end of the study by Overall Global Assessment for Efficacy
次要结局
- Safety of EMROK &/or EMROK – O (Levonadifloxacin)(At the end of the study by Overall Global Assessment for Safety)
研究者
研究点 (1)
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