GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 23,775
- 主要终点
- Number of Adverse Event Collection / Calculation of Adverse Event rates in Study population and subgroups
研究概览
简要总结
Prospective, non-interventional, multi-center study. The observation period for each subject covers the treatment period with Gadovist®. For each patient, the treating physician or nurse documents demographics, medical data, safety parameters and treatment signs and symptoms at the visit. Patients with severe renal impairment will be followed-up after 3 month by phone call from the investigator if in line with routine practice. Data audit/monitoring by source data verification will be done in a subset of sites and patients
详细描述
Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.
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
- •Patients undergoing contrast enhanced Magnetic Resonance Imaging with Gadobutrol (Gadovist).
排除标准
- •There are no other exclusion criteria beyond the contraindications contained in the Summary of Product Characteristics (hypersensitivity to the active substance or to any of the excipients) and the warnings.
研究组 & 干预措施
Group 1
干预措施: Gadobutrol (Gadovist, BAY86-4875) (Drug)
结局指标
主要结局
Number of Adverse Event Collection / Calculation of Adverse Event rates in Study population and subgroups
时间窗: 1 day
次要结局
- Analysis of Adverse Event Collection rates according to age, gender, concomitant diseases and risk factors, dose administered.(1 day)