| Primary | Percentage of Participants With Overall Change in Additional Diagnostic Information Obtained When Comparing the Combined Precontrast/Postcontrast Images With the Precontrast Images. | Overall Change in additional diagnostic information was defined as a change in at least 1 of the 5 variables below obtained from the combined precontrast and postcontrast images as compared with the precontrast images: 1. Change in number of lesions: greater or fewer 2. Improved border delineation of the primary lesion 3. Increased contrast of primary lesion versus. background 4. Change in size of the primary lesion: larger or smaller 5. Change in information about lesion characterization (lesion type): improved, unchanged, worsened | Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51) | Posted | | Number | 95% Confidence Interval | Percentage of participants | | When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Primary | Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point | Laboratory parameters analyzed: Hematology: leukocytes, erythrocytes, hematocrit, platelets, hemoglobin, prothrombin time and differential counts (neutrophils total, neutrophils segmented and lymphocytes); Chemistry: lactate dehydrogenase (LDH), alkaline phosphatase (AKP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), sodium, potassium, blood urea nitrogen (BUN), glucose, creatinine, bilirubin:, direct bilirubin, indirect bilirubin, total protein, albumin, estimated glomerular filtration rate (eGFR), and α-fetoprotein levels. | The laboratory analyses were performed on participants in the Full Analysis Set (FAS) who had laboratory values collected | Posted | | Number | | Participants | | 14 days prior to Eovist/Primovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Primary | Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities 24 Hours Post-injection | The following parameters were analyzed: Hematology: leukocytes, erythrocytes, hematocrit, platelets, hemoglobin, prothrombin time and differential counts (neutrophils total, neutrophils segmented and lymphocytes) Clinical chemistry: lactate dehydrogenase (LDH), alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), sodium, potassium, blood urea nitrogen (BUN), glucose, creatinine, total bilirubin, direct bilirubin, indirect bilirubin, total protein, albumin, eGFR, and α-fetoprotein levels. | The laboratory analyses were performed on participants in the Full Analysis Set (FAS) who had laboratory values collected | Posted | | Number | | Participants | | Up to 24 hours post-Eovist/Primovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Primary | Vital Signs: Mean Change From Baseline in Heart Rate | | The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast | Posted | | Mean | Standard Deviation | beats/min | | 14 days prior to and up to 24 hours post-Eovist/Primovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Primary | Vital Signs: Mean Change From Baseline in Systolic Blood Pressure | | The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast | Posted | | Mean | Standard Deviation | mmHg | | 14 days prior to and up to 24 hours post-Eovist/Primovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Primary | Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure | | The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast | Posted | | Mean | Standard Deviation | mmHg | | 14 days prior to and up to 24 hours post-Eovist/Primovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Secondary | Change in Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | | Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51) | Posted | | Number | | Participants | | When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Secondary | Change in Confidence of Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | | Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51) | Posted | | Number | | Participants | | When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Secondary | Change in Number of Nonmalignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Change in number of nonmalignant lesions was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images | Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51) | Posted | | Number | | Participants | | When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Secondary | Change in Number of Malignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Change in number of malignant lesions was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images | Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51) | Posted | | Number | | Participants | | When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Secondary | Change in Recommended Next Course of Subject Management/Therapy Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | | Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51) | Posted | | Number | | Participants | | When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Secondary | Change in Recommended Next Course of Subject Management / Therapy - Comparison of Precontrast Versus Combined Precontrast/Postcontrast Images (Only Subjects for Whom a Change Was Documented) | | 45 subjects had a change from additional imaging with contrast-enhanced MRI based on the precontrast images to definitive therapy. | Posted | | Number | | Participants | | When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI | | | | ID | Title | Description |
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| OG000 | Precontrast | 45 subjects had a change based on the Precontrast image read | | OG001 | Combined Precontrast / Postcontrast | Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects |
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| Secondary | The Overall Image Quality for the Postcontrast Image Only | | Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51) | Posted | | Number | | Participants | | When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Secondary | Final Diagnosis (SoT) by Clinical Investigator | | Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51) | Posted | | Number | | Participants | | When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Secondary | Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis. | Sensitivity is the probability that a test indicates there is disease when there is disease. Specificity is the probability that a test indicates there is no disease when there is no disease. Accuracy is the probability that a test is correct: the test indicates there is no disease when there is no disease and it indicates there is disease when there is disease. | Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51) | Posted | | Number | | Percentage points | | When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI | | | | ID | Title | Description |
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| OG000 | Precontrast | 51 eligible for accuracy, 24 eligible for sensitivity, 27 eligible for specificity | | OG001 | Combined Precontrast / Postcontrast | 51 eligible for accuracy, 24 eligible for sensitivity, 27 eligible for specificity |
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| Other Pre-specified | Change in Number of Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | | Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51) | Posted | | Number | | Participants | | When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Other Pre-specified | Improved Border Delineation of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | | Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51) | Posted | | Number | | Participants | | When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Other Pre-specified | Increased Contrast of Primary Lesion vs Background Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | | Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51) | Posted | | Number | | Participants | | When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Other Pre-specified | Change in Size of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | | Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51) | Posted | | Number | | Participants | | When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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| Other Pre-specified | Change in Information About Lesion Characterization Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | | Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51) | Posted | | Number | | Participants | | When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI | | | | ID | Title | Description |
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| OG000 | Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records |
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