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| ID | Type | Description | Link |
|---|---|---|---|
| MAGNEVIST |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadopentetate dimeglumine (Magnevist, BAY86-4882) | Drug | Patients who will need to undergo contrast enhanced MR angiography with Magnevist (a dosage of more than 0.2 mg/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse drug reactions and serious adverse events in subjects who received Magnevist | 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 | After Magnevist administration, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After Magnevist injection, up to 3 years | |
| Incidence of adverse drug reactions in subpopulation with baseline data |
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Inclusion Criteria:
Exclusion Criteria:
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The target population of this study is patients who received Magnevist for MR angiography. The study is expected to collect data of 2,000 patients in approximately 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 |
|---|---|
| D019786 | Gadolinium DTPA |
| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| At baseline and after Magnevist administration, up to 3 years |
| D000085 |
| Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |