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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadoxetic Acid Disodium (Primovist, BAY86-4873) | Drug | Patients who will need to undergo contrast enhanced MRI with Primovist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist | After Primovist injection, up to 7 days | |
| Incidence of adverse drug reactions in patients with renal impairment | After Primovist injection, up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The target population of this study is patients who received Primovist for liver MRI. The study is expected to collect data of 2,000 patients in about 150 hospitals in Japan.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Japan |
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| ID | Term |
|---|---|
| C073590 | gadolinium ethoxybenzyl DTPA |
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| After Primovist injection, up to 7 days |