Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-08 @ 3:40 PM
Study NCT ID:
NCT00623467
Status:
COMPLETED
Last Update Posted:
2014-02-10
First Post:
2008-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging
Sponsor:
Organization:
Raw JSON
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The information regarding the study protocol is made publicly available on the internet at www.clinicaltrials.gov.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.', 'otherNumAtRisk': 343, 'otherNumAffected': 29, 'seriousNumAtRisk': 343, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Red blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'White blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. 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Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS); which used data from all participants for whom data and images were available for the unenhanced MRI and combined unenhanced and gadobutrol-enhanced MRI, excluding the sample participants (the first participant from each study site).'}, {'type': 'PRIMARY', 'title': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. 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Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. 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(intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'contrast enhancement', 'categories': [{'measurements': [{'value': '0.93', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '2.86', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'border delineation', 'categories': [{'measurements': [{'value': '1.92', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '2.94', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'internal morphology', 'categories': [{'measurements': [{'value': '1.57', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '2.35', 'spread': '0.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '1.94', 'pValueComment': 'for contrast enhancement', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.77', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '1.02', 'pValueComment': 'for border delineation', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.71', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.78', 'pValueComment': 'for internal morphology', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.53', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The AR analysis used the mean of the values for the 3 blinded readers. 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Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'BR1', 'categories': [{'measurements': [{'value': '2.26', 'spread': '7.61', 'groupId': 'OG000'}, {'value': '2.93', 'spread': '8.68', 'groupId': 'OG001'}]}]}, {'title': 'BR2', 'categories': [{'measurements': [{'value': '3.77', 'spread': '11.79', 'groupId': 'OG000'}, {'value': '3.60', 'spread': '10.40', 'groupId': 'OG001'}]}]}, {'title': 'BR3', 'categories': [{'measurements': [{'value': '1.92', 'spread': '7.19', 'groupId': 'OG000'}, {'value': '2.37', 'spread': '7.26', 'groupId': 'OG001'}]}]}, {'title': 'AR', 'categories': [{'measurements': [{'value': '2.65', 'spread': '6.30', 'groupId': 'OG000'}, {'value': '2.97', 'spread': '6.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.66', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.31', 'estimateComment': 'for BR1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.17', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '8.77', 'estimateComment': 'for BR2', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.45', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.20', 'estimateComment': 'for BR3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '-0.070', 'ciUpperLimit': '0.704', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.53', 'estimateComment': 'confidence interval provided for average reader, lower limit is compared to noninferiority margin', 'statisticalMethod': '95% confidence interval for paired means', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'noninferiority margin = -0.35'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The 3 blinded readers evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'contrast enhancement', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The data for "contrast enhancement - unenhanced" were not collected for the clinical investigators.', 'groupId': 'OG000'}, {'value': '2.97', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'border delineation', 'categories': [{'measurements': [{'value': '2.51', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '3.40', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'internal morphology', 'categories': [{'measurements': [{'value': '2.03', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '2.78', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.89', 'pValueComment': 'for border delineation', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.68', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.74', 'pValueComment': 'for internal morphology', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.65', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. 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(intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.53', 'spread': '4.60', 'groupId': 'OG000'}, {'value': '2.74', 'spread': '4.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '0.030', 'ciUpperLimit': '0.381', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.60', 'estimateComment': 'lower limit of the confidence interval is compared to the noninferiority margin', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'noninferiority margin = -0.35'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'contrast enhancement', 'categories': [{'measurements': [{'value': '0.84', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '2.42', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'border delineation', 'categories': [{'measurements': [{'value': '1.66', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '2.40', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'internal morphology', 'categories': [{'measurements': [{'value': '1.66', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '2.11', 'spread': '0.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '1.59', 'pValueComment': 'for contrast enhancement', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.47', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.75', 'pValueComment': 'for border delineation', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.34', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.45', 'pValueComment': 'for internal morphology', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.03', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'BR1 (reader 1 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'contrast enhancement', 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '2.28', 'spread': '1.26', 'groupId': 'OG001'}]}]}, {'title': 'border delineation', 'categories': [{'measurements': [{'value': '1.67', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '2.79', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': 'internal morphology', 'categories': [{'measurements': [{'value': '1.19', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '2.22', 'spread': '0.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '1.49', 'pValueComment': 'for contrast enhancement', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.38', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '1.12', 'pValueComment': 'for border delineation', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.60', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '1.02', 'pValueComment': 'for internal morphology', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.25', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'contrast enhancement', 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '2.48', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': 'border delineation', 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '2.34', 'spread': '1.22', 'groupId': 'OG001'}]}]}, {'title': 'internal morphology', 'categories': [{'measurements': [{'value': '1.10', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '1.67', 'pValueComment': 'for contrast enhancement', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.39', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '1.26', 'pValueComment': 'for border delineation', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.30', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.91', 'pValueComment': 'for internal morphology', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.02', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'contrast enhancement', 'categories': [{'measurements': [{'value': '0.79', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '2.29', 'spread': '1.23', 'groupId': 'OG001'}]}]}, {'title': 'border delineation', 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '2.42', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'internal morphology', 'categories': [{'measurements': [{'value': '1.27', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '2.04', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '1.51', 'pValueComment': 'for contrast enhancement', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.32', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '1.00', 'pValueComment': 'for border delineation', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.27', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.77', 'pValueComment': 'for internal morphology', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.99', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'contrast enhancement', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '3.40', 'spread': '0.48', 'groupId': 'OG001'}]}]}, {'title': 'border delineation', 'categories': [{'measurements': [{'value': '2.57', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '3.51', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'internal morphology', 'categories': [{'measurements': [{'value': '2.03', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '2.40', 'pValueComment': 'for contrast enhancement', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.48', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.93', 'pValueComment': 'for border delineation', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.46', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.62', 'pValueComment': 'for internal morphology', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.32', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'BR1 (reader 1 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'contrast enhancement', 'categories': [{'measurements': [{'value': '1.01', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '3.36', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'border delineation', 'categories': [{'measurements': [{'value': '2.18', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '3.45', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'internal morphology', 'categories': [{'measurements': [{'value': '1.49', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '2.67', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '2.35', 'pValueComment': 'for contrast enhancement', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.40', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '1.27', 'pValueComment': 'for border delineation', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.38', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '1.17', 'pValueComment': 'for internal morphology', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.34', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'contrast enhancement', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '3.22', 'spread': '0.37', 'groupId': 'OG001'}]}]}, {'title': 'border delineation', 'categories': [{'measurements': [{'value': '2.07', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '3.15', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'internal morphology', 'categories': [{'measurements': [{'value': '1.79', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '2.50', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '2.21', 'pValueComment': 'for contrast enhancement', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.37', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '1.07', 'pValueComment': 'for border delineation', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.45', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.72', 'pValueComment': 'for internal morphology', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.30', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'contrast enhancement', 'categories': [{'measurements': [{'value': '1.01', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '3.33', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'border delineation', 'categories': [{'measurements': [{'value': '2.28', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '3.37', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'internal morphology', 'categories': [{'measurements': [{'value': '1.77', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '2.61', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '2.32', 'pValueComment': 'for contrast enhancement', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.34', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '1.09', 'pValueComment': 'for border delineation', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.30', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.84', 'pValueComment': 'for internal morphology', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.22', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Scores for Contrast Enhancement for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI by Clinical Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.84', 'spread': '1.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. The data for contrast enhancement - gadobutrol combined was shown below.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'border delineation', 'categories': [{'measurements': [{'value': '2.44', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '3.26', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'internal morphology', 'categories': [{'measurements': [{'value': '2.06', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '0.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.82', 'pValueComment': 'for border delineation', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.00', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.66', 'pValueComment': 'for internal morphology', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.90', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'contrast enhancement', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The data for "contrast enhancement - unenhanced" were not collected for the clinical investigators.', 'groupId': 'OG000'}, {'value': '3.47', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'border delineation', 'categories': [{'measurements': [{'value': '2.56', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '3.55', 'spread': '0.41', 'groupId': 'OG001'}]}]}, {'title': 'internal morphology', 'categories': [{'measurements': [{'value': '1.97', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '2.82', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.99', 'pValueComment': 'for border delineation', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.63', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.85', 'pValueComment': 'for internal morphology', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.64', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000'}, {'value': '61.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'paramValue': '9.4', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images was the percentage of the exact matches with the final clinical diagnosis.', 'unitOfMeasure': 'per. of the exact diagnostic matches', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'groupId': 'OG000'}, {'value': '74.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'paramValue': '7.3', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images was the percentage of the exact matches with the final clinical diagnosis.', 'unitOfMeasure': 'per. of the exact diagnostic matches', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.9', 'groupId': 'OG000'}, {'value': '79.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0285', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'paramValue': '5.0', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.4', 'groupId': 'OG000'}, {'value': '83.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'paramValue': '8.5', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0588', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'paramValue': '-12.5', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.4', 'groupId': 'OG000'}, {'value': '87.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0093', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'paramValue': '5.0', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '77.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'paramValue': '20.6', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000'}, {'value': '90.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'paramValue': '0.0', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000'}, {'value': '92.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'paramValue': '3.8', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '79.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0253', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'paramValue': '7.9', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000'}, {'value': '97.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0253', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'paramValue': '2.5', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the FAS with assessments for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.70', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '3.13', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.44', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.70', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unenhanced', 'description': 'Participants had diagnostic imaging before receiving any contrast agent'}, {'id': 'OG001', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.61', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '3.45', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.84', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.81', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '343'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '336'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': "The date of the first participant's first visit was 17 DEC 2007. The date of the last participant's last visit was 12 DEC 2008.", 'preAssignmentDetails': 'A total of 347 participants were screened for inclusion into the study; 4 participants failed screening because they did not meet the inclusion criteria. Therefore, 343 participants were enrolled into the study and received study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 45 years', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}]}]}, {'title': '45 - 64 years', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}]}]}, {'title': '≥ 65 years', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '197', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '146', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 343}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-16', 'studyFirstSubmitDate': '2008-02-18', 'resultsFirstSubmitDate': '2011-06-20', 'studyFirstSubmitQcDate': '2008-02-25', 'lastUpdatePostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-01', 'studyFirstPostDateStruct': {'date': '2008-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'BR1 (reader 1 of 3) evaluated the images from the unenhanced magnetic resonance imaging (MRI) in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.'}, {'measure': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.'}, {'measure': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.'}, {'measure': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.'}, {'measure': 'Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The 3 blinded readers evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.'}], 'secondaryOutcomes': [{'measure': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible. The data for "contrast enhancement - unenhanced" were not collected for the clinical investigators.'}, {'measure': 'Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.'}, {'measure': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'BR1 (reader 1 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.'}, {'measure': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.'}, {'measure': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.'}, {'measure': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.'}, {'measure': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'BR1 (reader 1 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.'}, {'measure': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.'}, {'measure': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.'}, {'measure': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.'}, {'measure': 'Scores for Contrast Enhancement for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI by Clinical Investigator', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. The data for contrast enhancement - gadobutrol combined was shown below.'}, {'measure': 'Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.'}, {'measure': 'Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.'}, {'measure': 'Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images was the percentage of the exact matches with the final clinical diagnosis.'}, {'measure': 'Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images was the percentage of the exact matches with the final clinical diagnosis.'}, {'measure': 'Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.'}, {'measure': 'Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.'}, {'measure': 'Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee'}, {'measure': 'Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.'}, {'measure': 'Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.'}, {'measure': 'Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.'}, {'measure': 'Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.'}, {'measure': 'Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.'}, {'measure': 'Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.'}, {'measure': 'Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.'}, {'measure': 'Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator', 'timeFrame': 'Up to 2 hours after injection of gadobutrol', 'description': 'The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Central Nervous System Imaging', 'Diagnostic Imaging'], 'conditions': ['Central Nervous System Diseases']}, 'descriptionModule': {'briefSummary': 'This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Gadavist.', 'detailedDescription': 'Issues on safety will be addressed in Adverse Events section.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred for contrast enhanced MRI of the CNS based on symptoms or previous procedures.\n\nExclusion Criteria:\n\n* Patients with acute renal insufficiency\n* Patients with severe renal disease\n* Patients with any contraindication to magnetic resonance imaging.'}, 'identificationModule': {'nctId': 'NCT00623467', 'briefTitle': 'Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Multicenter, Open-label, Phase 3 Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients Referred for Contrast-enhanced MRI of the Central Nervous System (CNS).', 'orgStudyIdInfo': {'id': '91682'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gadobutrol (Gadavist, BAY86-4875)', 'description': 'Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.', 'interventionNames': ['Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)']}], 'interventions': [{'name': 'Gadobutrol (Gadavist, Gadovist, BAY86-4875)', 'type': 'DRUG', 'description': 'Gadobutrol single injection 0.1 mmol/kg BW via IV bolus administration at 2mL/sec.', 'armGroupLabels': ['Gadobutrol (Gadavist, BAY86-4875)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'HOPE Research Institute, LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Medical Imaging, Ltd.', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85711', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiology Ltd.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Landmark Imaging Medical Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars- Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Sharp & Children's MRI Center", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida - Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30513', 'city': 'Blue Ridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'River Birch Research Alliance, LLC', 'geoPoint': {'lat': 34.86397, 'lon': -84.32409}}, {'zip': '30905', 'city': 'Fort Gordon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Eisenhower Army Medical Center', 'geoPoint': {'lat': 33.42097, 'lon': -82.16206}}, {'zip': '48109-5302', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48071', 'city': 'Madison Heights', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bio-Magnetic Resonance, Inc.', 'geoPoint': {'lat': 42.48587, 'lon': -83.1052}}, {'zip': '11219', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Maimonides Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hahnemann University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'C1082A', 'city': 'Buenos Aires', 'state': 'Ciudad Auton. de Buenos Aires', 'country': 'Argentina', 'facility': 'Investigaciones Médicas', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1115AAB', 'city': 'Buenos Aires', 'state': 'Ciudad Auton. de Buenos Aires', 'country': 'Argentina', 'facility': 'Milbet Diagnostico por Imagenes', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1181ACH', 'city': 'Buenos Aires', 'state': 'Ciudad Auton. de Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1425BEE', 'city': 'Buenos Aires', 'state': 'Ciudad Auton. de Buenos Aires', 'country': 'Argentina', 'facility': 'Centro de Diagnóstico Dr. Enrique Rossi', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhongda Hosp. affiliated of Southeast Univ.', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'The 1st Affiliated Hosp of the 4th Military Med Uni', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '100853', 'city': 'Beijing', 'country': 'China', 'facility': 'Chinese PLA General Hosp.', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200025', 'city': 'Shanghai', 'country': 'China', 'facility': 'Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200040', 'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Fundación Instituto de Alta tecnología médica de Antioquia', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'city': 'Bogotá', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Fundación Santa Fe de Bogotá - Hospital Universitario'}, {'zip': '110-744', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'facility': "The Catholic University of Korea Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '110-799', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}