GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients
Completed
- Conditions
- Magnetic Resonance ImagingMagnetic Resonance Angiography
- Interventions
- Registration Number
- NCT01095081
- Lead Sponsor
- Bayer
- Brief Summary
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
- Detailed Description
Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23775
Inclusion Criteria
- Patients undergoing contrast enhanced Magnetic Resonance Imaging with Gadobutrol (Gadovist).
Read More
Exclusion Criteria
- 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.
Read More
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Gadobutrol (Gadovist, BAY86-4875) -
- Primary Outcome Measures
Name Time Method Number of Adverse Event Collection / Calculation of Adverse Event rates in Study population and subgroups 1 day
- Secondary Outcome Measures
Name Time Method Analysis of Adverse Event Collection rates according to age, gender, concomitant diseases and risk factors, dose administered. 1 day