Drug Use Investigation of Gadovist
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 3,357
- 试验地点
- 1
- 主要终点
- Number of episodes of adverse events as a measure of safety and tolerability
研究概览
简要总结
The objectives of this study are to investigate the safety and effectiveness of Gadovist.
详细描述
This is a prospective, non-interventional, continuous submission safety study that includes patients who planned Gadolinium (Gd) contrast enhanced Magnetic Resonance Imaging (MRI) in accordance with approved label. The investigator will have made the choice of Gd enhanced MRI (the decision to use Gadovist according the Japanese Package Insert prior to enrolling the patient in this study).
The study period is 3 years. Data analysis period is 1 year. In total, 3300 patients will be recruited.
For each patient, data are collected as defined in the case report form (CRF) at the visit for MRI examination (as per investigators routine practice).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 perform contrast enhanced Magnetic Resonance Imaging (MRI) with Gadovist.
排除标准
- •Patients who are contraindicated based on approved label.
研究组 & 干预措施
BAY86-4875
Gadovist administration goup
干预措施: Gadobutrol (Gadavist/Gadovist, BAY86-4875) (Drug)
结局指标
主要结局
Number of episodes of adverse events as a measure of safety and tolerability
时间窗: Up to 3 days
次要结局
- Number of episodes of adverse drug reactions and adverse events(Up to 3 days)
- Contrast enhancement(At the time of MRI)