NCT00924248已完成不适用
Primovist Regulatory Post Marketing Surveillance
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
- Bayer
- 入组人数
- 4,358
- 主要终点
- Safety evaluation in real practice (SAE/AE/ADR collection)
研究概览
简要总结
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice
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
- 否
入选标准
- •Patient who take Primovist for liver MRI
排除标准
- •Patients who belong to the contraindication on the product label
研究组 & 干预措施
Group 1
干预措施: Gadoxetic acid disodium (Primovist, BAY86-4873) (Drug)
结局指标
主要结局
Safety evaluation in real practice (SAE/AE/ADR collection)
时间窗: After administration
次要结局
- Assessment of contrast effect by imaging after administration(Before administration)
- Overall contrast effects by combining individual assessment(Before administration)
- Assessment of contrast enhancement effect(After administration)
研究者
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