This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Magnevist at a dose of more than 0.2 ml/kg for MR angiography of peripheral vasculature with continuous imaging from the abdomen to the lower extremities. The objective of this study is to assess safety, especially in relation to renal dysfunction, and efficacy of using Magnevist in clinical practice. A total 2,000 patients will be recruited.
Study Type
OBSERVATIONAL
Enrollment
2,051
Patients who will need to undergo contrast enhanced MR angiography with Magnevist (a dosage of more than 0.2 mg/kg)
Unnamed facility
Many Locations, Japan
Incidence of adverse drug reactions and serious adverse events in subjects who received Magnevist
Time frame: After Magnevist administration, up to 3 years
Incidence of adverse drug reactions, especially Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy (NSF/NFD) in patients with reduced renal functions
Time frame: After Magnevist administration, up to 3 years
MRI image evaluation assessment by the four rank scales of 1 to 4: 1) sufficient extraction; 2) almost sufficient extraction; 3) not sufficient extraction; and 4) insufficient extraction
Time frame: After Magnevist injection, up to 3 years
Incidence of adverse drug reactions in subpopulation with baseline data
Time frame: At baseline and after Magnevist administration, up to 3 years
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