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The objectives of this study are to investigate the safety and effectiveness of Gadovist.
This is a prospective, non-interventional, continuous submission safety study that includes patients who planned Gadolinium (Gd) contrast enhanced Magnetic Resonance Imaging (MRI) in accordance with approved label. The investigator will have made the choice of Gd enhanced MRI (the decision to use Gadovist according the Japanese Package Insert prior to enrolling the patient in this study).
The study period is 3 years. Data analysis period is 1 year. In total, 3300 patients will be recruited.
For each patient, data are collected as defined in the case report form (CRF) at the visit for MRI examination (as per investigators routine practice).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY86-4875 | Gadovist administration goup |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadobutrol (Gadavist/Gadovist, BAY86-4875) | Drug | Gadovist dosage following summary of product characteristics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of episodes of adverse events as a measure of safety and tolerability | Up to 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of episodes of adverse drug reactions and adverse events | In subpopulations | Up to 3 days |
| Contrast enhancement | Investigator Discretion as very improved , improved, not changed, degraded, not evaluable. MRI- Magnetic Resonance Imaging |
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Inclusion Criteria:
Exclusion Criteria:
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Female and male patients who planned Gd contrast enhanced MRI in accordance with approved label. Eligible patients who receive Gadovist will be enrolled and documented in the eCRF
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30232584 | Result | Tsushima Y, Awai K, Shinoda G, Miyoshi H, Chosa M, Sunaya T, Endrikat J. Post-marketing surveillance of gadobutrol for contrast-enhanced magnetic resonance imaging in Japan. Jpn J Radiol. 2018 Nov;36(11):676-685. doi: 10.1007/s11604-018-0778-4. Epub 2018 Sep 19. |
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| ID | Term |
|---|---|
| C090600 | gadobutrol |
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| At the time of MRI |