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.
Study Type
OBSERVATIONAL
Enrollment
2,030
Patients who will need to undergo contrast enhanced MRI with Primovist
Unnamed facility
Many Locations, Japan
Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist
Time frame: After Primovist injection, up to 7 days
Incidence of adverse drug reactions in patients with renal impairment
Time frame: After Primovist injection, up to 7 days
Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease and dose of Primovist]
Time frame: 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
Time frame: After Primovist injection, up to 7 days
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