Drug Use Investigation of EOB-Primovist Inj. Syringe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 2,030
- 主要终点
- Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist
研究概览
简要总结
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Primovist for contrast enhancement in MRI of liver. The objective of this study is to assess safety, especially in relation to renal dysfunction, and efficacy of using Primovist in clinical practice. A total 2,000 patients for diagnosis on detection and identify hepatic tumor will be recruited and followed 7 days after the injection.
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
- •Patients who received Primovist for liver MRI
排除标准
- •Patients who are contraindicated based 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
Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist
时间窗: After Primovist injection, up to 7 days
Incidence of adverse drug reactions in patients with renal impairment
时间窗: After Primovist injection, up to 7 days
次要结局
- Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease and dose of Primovist](After Primovist injection, up to 7 days)
- MRI image evaluation assessment by the five rank scales of 1 to 5: 1) much improved; 2) improved; 3) slightly improved; 4) not improved; and 5) impaired(After Primovist injection, up to 7 days)