Tygacil Drug Use Investigation (Tigecycline Evaluation Study For Safety And Effectiveness In Patient Infected With Multi-Drug Resistance.)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 116
- 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 Tigecycline .under Japanese medical practice
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who are prescribed tigecycline (Tygacil).
排除标准
- •Subject who have not been prescribed tigecycline (Tygacil).
研究组 & 干预措施
Tigecycline (Tygacil)
Subjects who are treated with tigecycline
干预措施: Tigecycline (Tygacil) (Drug)
结局指标
主要结局
Number of Participants With Adverse Drug Reaction (ADR)
时间窗: Up until 14 days from the start date and 28 days from the end of the observation period
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Tygacil in a participant who received Tygacil. 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 Tygacil was assessed by the physician.
次要结局
- Clinical Response Rate(Within 14 days from the start date)
- Clinical Response Rate of Cure(Within 28 days post-treatment)