| Primary | Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images | Additional diagnostic information such as better delineation of the border of the lesion, better definition of the internal morphology of the lesion, better characterization of the lesion, better definition of the location of the lesion, better assessment of the communication of the lesion with respect to the biliary system obtained from the combined magnetic resonance (MR) images compared with pre-contrast MR images. Number of subjects with additional diagnostic information were recorded and analyzed. | | Posted | | Number | | participants | | Images were taken pre-injection and post-injection (within about 15 minutes) | | | | ID | Title | Description |
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| OG000 | Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually. |
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| Primary | Number of Subjects With Adverse Events | An adverse event (AE) was any untoward medical occurrence that is, any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease in a subject or clinical investigation subject after providing written informed consent for participation in the study. | | Posted | | Number | | participants | | From the signing of the informed consent form until the 6 month post MRI follow-up | | | | ID | Title | Description |
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| OG000 | Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually. |
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| Primary | Number of Subjects With Serious Adverse Events | An serious adverse events (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | | Posted | | Number | | participants | | From the signing of the informed consent form until the 6 month post MRI follow-up | | | | ID | Title | Description |
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| OG000 | Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually. |
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| Secondary | Number of Lesions Detected for the Pre-contrast Images | | | Posted | | Number | | number of lesions | | Images were taken pre-injection | | | | ID | Title | Description |
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| OG000 | Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually. |
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| Secondary | Number of Lesions Detected for the Combined Images | | | Posted | | Number | | number of lesions | | Images were taken pre-injection and post-injection (within about 15 minutes) | | | | ID | Title | Description |
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| OG000 | Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually. |
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| Secondary | Contrast Enhancement of the Liver for the Combined Images Assessed by Yes or no Question | | | Posted | | Number | | number of responses | | Images were taken pre-injection and post-injection (within about 15 minutes) | | | | ID | Title | Description |
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| OG000 | Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually. |
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| Secondary | Contrast Enhancement of the Biliary System for the Combined Images Assessed by Yes or no Question | Biliary system included
- Gall bladder
- Cystic duct
- Common bile duct
- Right main bile duct
- Left main bile duct
| | Posted | | Number | | number of responses | | Images were taken pre-injection and post-injection (within about 15 minutes) | | | | ID | Title | Description |
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| OG000 | Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually. |
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| Secondary | Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question | | | Posted | | Number | | participants | | Images were taken pre-injection and post-injection (within about 15 minutes) | | | | ID | Title | Description |
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| OG000 | Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually. |
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| Secondary | Change in Diagnosis for the Combined Images Compared With Precontrast Images | Diagnosis based on the pre-contrast images will be indicated. If there is a change in the diagnosis based on the combined images, then the combined images diagnosis will be recorded. | | Posted | | Number | | participants | | Images were taken pre-injection and post-injection (within about 15 minutes) | | | | ID | Title | Description |
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| OG000 | Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually. |
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| Secondary | Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question | Diagnostic confidence was classified as not confident (No), confident (Yes), very confident (Yes). | | Posted | | Number | | number of responses | | Images were taken pre-injection and post-injection (within about 15 minutes) | | | | ID | Title | Description |
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| OG000 | Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually. |
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