NCT01523873已完成不适用
Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 35,921
- 试验地点
- 10
- 主要终点
- Frequency of Adverse Events
研究概览
简要总结
The main purpose of this study is to prospectively assess the general safety profile of Dotarem
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patient scheduled for a Dotarem®-enhanced MRI
排除标准
- •patient with a contra-indication to MR examination
- •patient with a contra-indication to Dotarem® injection as per local SPC
结局指标
主要结局
Frequency of Adverse Events
时间窗: During the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination).
Adverse Events were notified and described.
次要结局
- Nephrogenic Systemic Fibrosis Incidence(Follow-up of at least 3 months after magnetic resonance examination)
- Image Quality(Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour))
- Diagnostic Quality(Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour))
研究者
研究点 (10)
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