试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 44,456
- 主要终点
- Frequency of Adverse Events
研究概览
简要总结
Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine). The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to gain additional insights into the diagnostic efficacy, reliability and safety of Dotarem in routine practice using the most up-to-date MRI techniques and application methods.
详细描述
Diagnostic efficacy was assessed by the following endpoints: diagnostic value ("yes"/"no") and imaging quality (5-step scale from "excellent" to "very poor"). Safety was evaluated on the basis of the frequency and seriousness of adverse events that occurred following Dotarem injection.
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
- — 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing routine MRI using the MRI contrast medium Dotarem
排除标准
- 未提供
结局指标
主要结局
Frequency of Adverse Events
时间窗: From the beginning of the MRI procedure to 30-60 min after
The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded.
次要结局
- Diagnostic Value(During MRI procedure)
- Image Quality(During MRI procedure)