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
- 107
- 主要终点
- Number of Participants With Adverse Drug Reaction (ADR)
研究概览
简要总结
Secondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical practice
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have not used metronidazole (injection) in the past, and have been given this drug for treatment of anaerobic infection, infectious enterocolitis, or amebic dysentery. Patients who have used metronidazole (oral agent and vaginal tablet) in the past are eligible, and should not be excluded from this study.
排除标准
- •No exclusion criteria are set out in this study.
结局指标
主要结局
Number of Participants With Adverse Drug Reaction (ADR)
时间窗: Maximum 8 weeks
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to ANAEMETRO Intravenous infusion in a participant who received ANAEMETRO Intravenous infusion. 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 ANAEMETRO Intravenous infusion was assessed by the physician.
次要结局
- Clinical Response Rate(Maximum 8 weeks)
- Clinical Response Rates by Target Diseases(Maximum 8 weeks)
研究者
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