Primovist Post-marketing Surveillance in Japan
Completed
- Conditions
- Diagnostic Imaging
- Interventions
- Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873)
- Registration Number
- NCT01411449
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2030
Inclusion Criteria
- Patients who received Primovist for liver MRI
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Exclusion Criteria
- Patients who are contraindicated based on the product label
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Gadoxetic Acid Disodium (Primovist, BAY86-4873) -
- Primary Outcome Measures
Name Time Method Incidence of adverse drug reactions in patients with renal impairment After Primovist injection, up to 7 days Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist After Primovist injection, up to 7 days
- Secondary Outcome Measures
Name Time Method Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease and dose of Primovist] 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 After Primovist injection, up to 7 days