NCT00683332已完成不适用
A Prospective, Observational Study To Monitor Safety In Patients Who Were Administered With Tigecycline (Tygacil) 50 mg By Intravenous Injection (An Observational Study for Safety - Monitored Release)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 621
- 试验地点
- 1
- 主要终点
- Number of Participants With Spontaneous Adverse Events
研究概览
简要总结
The purpose of this study is to collect post-marketing information on the safety of Tygacil in Filipino patients.
详细描述
Three-thousand or 10% of total number of patients given tigecycline will be included in the study
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients from the study center who received or will receive at least one dose of Tygacil according to the approved product indication.
排除标准
- •Previously discontinued Tygacil therapy due to significant safety concern.
研究组 & 干预措施
A
干预措施: Tigecycline (Tygacil) (Drug)
结局指标
主要结局
Number of Participants With Spontaneous Adverse Events
时间窗: 30 days post injection up to 3 years
Adverse events were based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participant. In addition to the information obtained from these sources, the participant was asked the following nonspecific question: "How have you been feeling since your last visit?"
次要结局
未报告次要终点
研究者
研究点 (1)
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