Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT01344460
Status:
COMPLETED
Last Update Posted:
2015-08-26
First Post:
2011-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gadobutrol Enhanced MRA of the Renal Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012078', 'term': 'Renal Artery Obstruction'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C090600', 'term': 'gadobutrol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were assessed from the time the consent was signed until 72 (±6) hours follow-up after the study MRA and continued until the end of the study (either the 72 hour follow-up or the CTA, if performed after the MRA as part of the study).', 'eventGroups': [{'id': 'EG000', 'title': 'Gadobutrol (Gadavist, BAY 86-4875)', 'description': 'Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.', 'otherNumAtRisk': 315, 'otherNumAffected': 14, 'seriousNumAtRisk': 315, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}, {'units': 'segments', 'counts': [{'value': '1764', 'groupId': 'OG000'}, {'value': '1764', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Majority reader (n=292/1752)', 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000'}, {'value': '77.6', 'groupId': 'OG001'}]}]}, {'title': 'Blinded reader 1 (n=292/1746)', 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000'}, {'value': '81.7', 'groupId': 'OG001'}]}]}, {'title': 'Blinded reader 2 (n=292/1752)', 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000'}, {'value': '71.5', 'groupId': 'OG001'}]}]}, {'title': 'Blinded reader 3 (n=292/1734)', 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000'}, {'value': '78.1', 'groupId': 'OG001'}]}]}, {'title': 'Clinical investigators (n=292/1764)', 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000'}, {'value': '68.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.3', 'ciLowerLimit': '15.2', 'groupDescription': 'Majority reader; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cluster adjusted McNemar', 'ciUpperLimitComment': 'Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.', 'testedNonInferiority': False}, {'pValue': '<0.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.4', 'ciLowerLimit': '13.2', 'groupDescription': 'Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cluster adjusted McNemar', 'ciUpperLimitComment': 'Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.', 'testedNonInferiority': False}, {'pValue': '<0.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.0', 'ciLowerLimit': '20.5', 'groupDescription': 'Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cluster adjusted McNemar', 'ciUpperLimitComment': 'Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.', 'testedNonInferiority': False}, {'pValue': '<0.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.4', 'ciLowerLimit': '14.3', 'groupDescription': 'Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'ciUpperLimitComment': 'Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.', 'testedNonInferiority': False}, {'pValue': '<0.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.6', 'ciLowerLimit': '21.9', 'groupDescription': 'Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'ciUpperLimitComment': 'Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (reader 1, 2 and 3) and majority readers (the outcome determined by at least two of the blinded readers). The segments were predefined to standardize the blinded reader evaluations. A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 6 segments assessed per participant (3 segments in the right renal artery and 3 segments in the left renal artery) and up to 9 segments in participants with renal transplant.', 'unitOfMeasure': 'Percentage of segments', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'segments', 'denomUnitsSelected': 'Participants', 'populationDescription': 'FAS; in below table, "n/n" signifies the number of participants/segments that were evaluable in specified category for both groups.'}, {'type': 'PRIMARY', 'title': 'Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}, {'units': 'segments', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Majority reader', 'categories': [{'measurements': [{'value': '53.4', 'groupId': 'OG000'}, {'value': '46.6', 'groupId': 'OG001'}]}]}, {'title': 'Blinded reader 1 (n=93/133)', 'categories': [{'measurements': [{'value': '51.9', 'groupId': 'OG000'}, {'value': '51.1', 'groupId': 'OG001'}]}]}, {'title': 'Blinded reader 2 (n=93/133)', 'categories': [{'measurements': [{'value': '54.1', 'groupId': 'OG000'}, {'value': '39.1', 'groupId': 'OG001'}]}]}, {'title': 'Blinded reader 3 (n=93/133)', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000'}, {'value': '50.4', 'groupId': 'OG001'}]}]}, {'title': 'Clinical investigators (n=113/140)', 'categories': [{'measurements': [{'value': '69.3', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.8', 'ciLowerLimit': '-2.2', 'groupDescription': 'Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.', 'statisticalMethod': 'The cluster-adjusted two-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'ciUpperLimitComment': 'Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.', 'testedNonInferiority': True, 'nonInferiorityComment': 'using a -7.5% non-inferiority margin'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-9.7', 'groupDescription': 'Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.', 'statisticalMethod': 'The cluster-adjusted two-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'ciUpperLimitComment': 'Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.', 'testedNonInferiority': True, 'nonInferiorityComment': 'using a -7.5% non-inferiority margin'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.3', 'ciLowerLimit': '5.1', 'groupDescription': 'Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.', 'statisticalMethod': 'The cluster-adjusted two-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'ciUpperLimitComment': 'Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.', 'testedNonInferiority': True, 'nonInferiorityComment': 'using a -7.5% non-inferiority margin'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.0', 'ciLowerLimit': '-5.8', 'groupDescription': 'Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.', 'statisticalMethod': 'The cluster-adjusted two-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'ciUpperLimitComment': 'Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.', 'testedNonInferiority': True, 'nonInferiorityComment': 'using a -7.5% non-inferiority margin'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.0', 'ciLowerLimit': '11.7', 'groupDescription': 'Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.', 'statisticalMethod': 'The cluster-adjusted two-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'ciUpperLimitComment': 'Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.', 'testedNonInferiority': True, 'nonInferiorityComment': 'using a -7.5% non-inferiority margin'}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Clinically significant disease was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease.', 'unitOfMeasure': 'percentage of sensitivity', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'segments', 'denomUnitsSelected': 'Participants', 'populationDescription': 'FAS; in below table, "n/n" signifies the number of participants/segments that were evaluable in specified category.'}, {'type': 'PRIMARY', 'title': 'Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}, {'units': 'segments', 'counts': [{'value': '1605', 'groupId': 'OG000'}, {'value': '1605', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Majority reader (n=292/1605)', 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000'}, {'value': '85.7', 'groupId': 'OG001'}]}]}, {'title': 'Blinded reader 1 (n=292/1605)', 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000'}, {'value': '83.1', 'groupId': 'OG001'}]}]}, {'title': 'Blinded reader 2 (n=292/1605)', 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000'}, {'value': '85.0', 'groupId': 'OG001'}]}]}, {'title': 'Blinded reader 3 (n=292/1605)', 'categories': [{'measurements': [{'value': '94.0', 'groupId': 'OG000'}, {'value': '80.7', 'groupId': 'OG001'}]}]}, {'title': 'Clinical investigators (n=292/1598)', 'categories': [{'measurements': [{'value': '96.5', 'groupId': 'OG000'}, {'value': '83.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.0', 'ciLowerLimit': '7.0', 'groupDescription': 'Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.', 'statisticalMethod': 'The cluster-adjusted two-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'ciUpperLimitComment': 'Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.', 'testedNonInferiority': True, 'nonInferiorityComment': 'using a -7.5% non-inferiority margin'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.3', 'ciLowerLimit': '9.1', 'groupDescription': 'Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.', 'statisticalMethod': 'The cluster-adjusted two-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'ciUpperLimitComment': 'Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.', 'testedNonInferiority': True, 'nonInferiorityComment': 'using a -7.5% non-inferiority margin'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.7', 'ciLowerLimit': '7.6', 'groupDescription': 'Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.', 'statisticalMethod': 'The cluster-adjusted two-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'ciUpperLimitComment': 'Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.', 'testedNonInferiority': True, 'nonInferiorityComment': 'using a -7.5% non-inferiority margin'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.4', 'ciLowerLimit': '11.2', 'groupDescription': 'Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.', 'statisticalMethod': 'The cluster-adjusted two-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'ciUpperLimitComment': 'Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.', 'testedNonInferiority': True, 'nonInferiorityComment': 'using a -7.5% non-inferiority margin'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.1', 'ciLowerLimit': '11.0', 'groupDescription': 'Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.', 'statisticalMethod': 'The cluster-adjusted two-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'ciUpperLimitComment': 'Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.', 'testedNonInferiority': True, 'nonInferiorityComment': 'using a -7.5% non-inferiority margin'}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Clinically significant disease (stenosis) was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Specificity = percentage of participants for which the imaging modalities (unenhanced or gadobutrol-enhanced) in the detection and exclusion of clinically significant stenosis.', 'unitOfMeasure': 'percentage of specificity', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'segments', 'denomUnitsSelected': 'Participants', 'populationDescription': 'FAS; in below table, "n/n" signifies the number of participants/segments that were evaluable in specified category.'}, {'type': 'PRIMARY', 'title': 'Minimum Gadobutrol Performance for Sensitivity: Sensitivity More Than (>) 50%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}, {'units': 'segments', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}], 'classes': [{'title': 'Majority reader (n=84/119)', 'categories': [{'measurements': [{'value': '54.6', 'groupId': 'OG000'}]}]}, {'title': 'Blinded reader 1 (n=91/128)', 'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000'}]}]}, {'title': 'Blinded reader 2 (n=82/114)', 'categories': [{'measurements': [{'value': '54.4', 'groupId': 'OG000'}]}]}, {'title': 'Blinded reader 3 (n=83/118)', 'categories': [{'measurements': [{'value': '53.4', 'groupId': 'OG000'}]}]}, {'title': 'Clinical investigators (n=108/129)', 'categories': [{'measurements': [{'value': '71.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '54.6', 'ciLowerLimit': '46.2', 'groupDescription': 'Majority reader', 'statisticalMethod': 'One sided 95% confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '51.6', 'ciLowerLimit': '43.6', 'groupDescription': 'Blinded Reader 1', 'statisticalMethod': 'One sided 95% confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '54.4', 'ciLowerLimit': '45.5', 'groupDescription': 'Blinded Reader 2', 'statisticalMethod': 'One sided 95% confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '53.4', 'ciLowerLimit': '44.8', 'groupDescription': 'Blinded Reader 3', 'statisticalMethod': 'One sided 95% confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '71.3', 'ciLowerLimit': '64.7', 'groupDescription': 'Clinical investigator', 'statisticalMethod': 'One sided 95% confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Clinically significant disease was defined as \\>50% stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.', 'unitOfMeasure': 'percentage of sensitivity', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'segments', 'denomUnitsSelected': 'Participants', 'populationDescription': 'FAS; in below table, "n/n" signifies the number of participants/segments that were evaluable in specified category.'}, {'type': 'PRIMARY', 'title': 'Minimum Gadobutrol Performance for Specificity: Specificity > 50%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}, {'units': 'segments', 'counts': [{'value': '1585', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}], 'classes': [{'title': 'Majority reader (n=291/1555)', 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000'}]}]}, {'title': 'Blinded reader 1 (n=292/1585)', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}]}]}, {'title': 'Blinded reader 2 (n=291/1554)', 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000'}]}]}, {'title': 'Blinded reader 3 (n=290/1544)', 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000'}]}]}, {'title': 'Clinical investigators (n=289/1535)', 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '95.9', 'ciLowerLimit': '94.9', 'groupDescription': 'Majority reader', 'statisticalMethod': 'One sided 95% confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '95.0', 'ciLowerLimit': '93.8', 'groupDescription': 'Blinded Reader 1', 'statisticalMethod': 'One sided 95% confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '96.2', 'ciLowerLimit': '95.2', 'groupDescription': 'Blinded Reader 2', 'statisticalMethod': 'One sided 95% confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '95.8', 'ciLowerLimit': '94.8', 'groupDescription': 'Blinded Reader 3', 'statisticalMethod': 'One sided 95% confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '98.4', 'ciLowerLimit': '97.8', 'groupDescription': 'Clinical investigator', 'statisticalMethod': 'One sided 95% confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Clinically significant disease (stenosis) was defined as \\>50% stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.', 'unitOfMeasure': 'percentage of specificity', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'segments', 'denomUnitsSelected': 'Participants', 'populationDescription': 'FAS; in below table, "n/n" signifies the number of participants/segments that were evaluable in specified category.'}, {'type': 'SECONDARY', 'title': 'Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Left renal artery- Blind reader 1', 'categories': [{'measurements': [{'value': '35.07', 'spread': '11.76', 'groupId': 'OG000'}, {'value': '32.25', 'spread': '11.32', 'groupId': 'OG001'}]}]}, {'title': 'Right renal artery - Blind reader 1', 'categories': [{'measurements': [{'value': '46.23', 'spread': '14.01', 'groupId': 'OG000'}, {'value': '43.05', 'spread': '14.34', 'groupId': 'OG001'}]}]}, {'title': 'Left renal artery- Blind reader 2', 'categories': [{'measurements': [{'value': '35.07', 'spread': '11.76', 'groupId': 'OG000'}, {'value': '32.15', 'spread': '11.35', 'groupId': 'OG001'}]}]}, {'title': 'Right renal artery - Blind reader 2', 'categories': [{'measurements': [{'value': '46.27', 'spread': '14.01', 'groupId': 'OG000'}, {'value': '42.95', 'spread': '14.42', 'groupId': 'OG001'}]}]}, {'title': 'Left renal artery- Blind reader 3', 'categories': [{'measurements': [{'value': '35.07', 'spread': '11.76', 'groupId': 'OG000'}, {'value': '32.64', 'spread': '12.74', 'groupId': 'OG001'}]}]}, {'title': 'Right renal artery - Blind reader 3', 'categories': [{'measurements': [{'value': '46.23', 'spread': '14.00', 'groupId': 'OG000'}, {'value': '43.05', 'spread': '14.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'The length of the left and right renal arteries were measured from the origin at the aorta to the bifurcation into the upper and lower pole arteries or the most distal point of the renal artery which could be visualized. This distal margin was the point where the diameter was still assessable. If there were more than 2 distal branches then the first large branch that was the dominant supply to a renal pole was used as the distal point.', 'unitOfMeasure': 'millimeter(s) (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants in FAS'}, {'type': 'SECONDARY', 'title': 'Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Computed Tomographic Angiography (CTA)'}], 'classes': [{'title': 'Left renal artery- CTA Blind reader 4', 'categories': [{'measurements': [{'value': '36.59', 'spread': '12.14', 'groupId': 'OG000'}]}]}, {'title': 'Right renal artery - CTA Blind reader 4', 'categories': [{'measurements': [{'value': '48.44', 'spread': '14.51', 'groupId': 'OG000'}]}]}, {'title': 'Left renal artery- CTA Blind reader 5', 'categories': [{'measurements': [{'value': '36.59', 'spread': '12.14', 'groupId': 'OG000'}]}]}, {'title': 'Right renal artery - CTA Blind reader 5', 'categories': [{'measurements': [{'value': '48.44', 'spread': '14.50', 'groupId': 'OG000'}]}]}, {'title': 'Left renal artery- CTA Blind reader 6', 'categories': [{'measurements': [{'value': '36.59', 'spread': '12.14', 'groupId': 'OG000'}]}]}, {'title': 'Right renal artery - CTA Blind reader 6', 'categories': [{'measurements': [{'value': '48.45', 'spread': '14.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'The length of the left and right renal arteries were measured from the origin at the aorta to the bifurcation into the upper and lower pole arteries or the most distal point of the renal artery which could be visualized. This distal margin was the point where the diameter was still assessable. If there were more than 2 distal branches then the first large branch that was the dominant supply to a renal pole was used as the distal point.', 'unitOfMeasure': 'millimeter(s) (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants in FAS'}, {'type': 'SECONDARY', 'title': 'Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}, {'units': 'segments', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}, {'value': '814', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-Enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}, {'id': 'OG002', 'title': 'Computed Tomographic Angiography'}], 'classes': [{'title': 'Vessel DIA at normal point: BRs', 'categories': [{'measurements': [{'value': '5.13', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '4.83', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '5.08', 'spread': '1.22', 'groupId': 'OG002'}]}]}, {'title': 'Vessel DIA at narrowest point: BRs', 'categories': [{'measurements': [{'value': '2.80', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '2.30', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '2.80', 'spread': '1.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Diameter difference', 'paramValue': '0.17', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.28', 'groupDescription': 'CTA Minus Unenhanced MRA for blinded Reader on vessel DIA at normal point', 'statisticalMethod': 'Mean Difference', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Diameter difference', 'paramValue': '-0.09', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.14', 'groupDescription': 'CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at normal point', 'statisticalMethod': 'Mean Difference', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference', 'paramValue': '0.41', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.15', 'groupDescription': 'CTA minus Unenhanced MRA for blinded reader on vessel DIA at narrowest point', 'statisticalMethod': 'Mean Difference', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Diameter difference', 'paramValue': '-0.15', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.01', 'groupDescription': 'CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at narrowest point', 'statisticalMethod': 'Mean Difference', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'The segment reduction in diameter (DIA) of greater than 10% was considered abnormal and measured. The diameter of each of these abnormal segments was measured using electronic calipers (perpendicular to the long axis of the vessel) at the point of most severe stenosis within each segment. Mean of vessel diameters was calculated by segment separately for CTA and MRA readers. For the ease of expression, the following abbreviations will be used: Diameter (DIA), Blinded Reader (BR).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'segments', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Evaluable participants in FAS'}, {'type': 'SECONDARY', 'title': 'The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Within 5 mm of the aorta BR 1 (n=110; 105)', 'categories': [{'measurements': [{'value': '26.4', 'groupId': 'OG000'}, {'value': '22.9', 'groupId': 'OG001'}]}]}, {'title': 'Within 5 mm of the aorta BR 2(n=83; 39)', 'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000'}, {'value': '71.8', 'groupId': 'OG001'}]}]}, {'title': 'Within 5 mm of the aorta BR 3 (n=83; 87)', 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000'}, {'value': '21.8', 'groupId': 'OG001'}]}]}, {'title': 'Beyond 5 mm from the aorta BR 1 (n=110; 105)', 'categories': [{'measurements': [{'value': '73.6', 'groupId': 'OG000'}, {'value': '77.1', 'groupId': 'OG001'}]}]}, {'title': 'Beyond 5 mm from the aorta BR 2 (n=83; 39)', 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000'}, {'value': '28.2', 'groupId': 'OG001'}]}]}, {'title': 'Beyond 5 mm from the aorta BR 3 (n=83; 87)', 'categories': [{'measurements': [{'value': '74.7', 'groupId': 'OG000'}, {'value': '78.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Location within the right and left proximal segment was based on the point of greatest stenosis and was recorded for stenosis \\>=50% as: - Within 5 mm of the aorta (or occlusion proximal to the origin of the segment); - Beyond 5 mm from the aorta.', 'unitOfMeasure': 'Percentage of location', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS that were evaluable; in below table, "n" signifies the number of segments that were evaluable in specified category.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Segments With Artifacts Presence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Blinded Reader 1', 'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000'}, {'value': '92.3', 'groupId': 'OG001'}]}]}, {'title': 'Blinded Reader 2', 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000'}, {'value': '80.4', 'groupId': 'OG001'}]}]}, {'title': 'Blinded Reader 3', 'categories': [{'measurements': [{'value': '41.5', 'groupId': 'OG000'}, {'value': '97.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Artifacts were collected for the MRA images on a segmental basis.', 'unitOfMeasure': 'percentage of segments', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants in FAS'}, {'type': 'SECONDARY', 'title': 'Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Motion artifact', 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000'}, {'value': '81.4', 'groupId': 'OG001'}]}]}, {'title': 'Venous opacification', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '15.1', 'groupId': 'OG001'}]}]}, {'title': 'Saturation artifact', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Susceptibility artifacts', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '7.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example \\[eg\\], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).', 'unitOfMeasure': 'percentage of segments', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS with artifact presence.'}, {'type': 'SECONDARY', 'title': 'Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Motion artifact', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}]}]}, {'title': 'Venous opacification', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Saturation artifact', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '24.4', 'groupId': 'OG001'}]}]}, {'title': 'Susceptibility artifacts', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'Ringing artifact', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Bolus timing error', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '6.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example \\[eg\\], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).', 'unitOfMeasure': 'percentage of segments', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS with artifacts presence.'}, {'type': 'SECONDARY', 'title': 'Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Motion artifact', 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000'}, {'value': '96.2', 'groupId': 'OG001'}]}]}, {'title': 'Venous opacification', 'categories': [{'measurements': [{'value': '14.2', 'groupId': 'OG000'}, {'value': '34.5', 'groupId': 'OG001'}]}]}, {'title': 'Saturation artifact', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '56.0', 'groupId': 'OG001'}]}]}, {'title': 'Susceptibility artifacts', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '7.0', 'groupId': 'OG001'}]}]}, {'title': 'Ringing artifact', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '76.7', 'groupId': 'OG001'}]}]}, {'title': 'Bolus timing error', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example \\[eg\\], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).', 'unitOfMeasure': 'percentage of segments', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS with artifacts presence.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Left side: Reader 1', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Right side: Reader 1', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Left side: Reader 2', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Right side: Reader 2', 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Left side: Reader 3', 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}]}]}, {'title': 'Right side: Reader 3', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'Left side: Clinical investigators', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000'}, {'value': '11.6', 'groupId': 'OG001'}]}]}, {'title': 'Right side: Clinical investigators', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000'}, {'value': '12.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'An accessory renal artery was defined as an additional, non-dominant, renal artery typically emanating from the aorta and anastomosing distal to the proximal third, segment of that renal artery. It was recorded only as present or absent on the right and left, regardless of how many accessory renal arteries were present.', 'unitOfMeasure': 'percentage of accessory', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Right : Proximal', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Right : Mid', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Right : Distal', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Left : Proximal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Left : Mid', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Left : Distal', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Any focal dilatation (aneurysmal dilatation) of a segment was recorded. The diameter at the widest point was measured with the electronic calipers if a dilatation was present in any segment. The number of participants with an aneurysmal dilatation in each segment (proximal, mid- and distal) in the right and the left renal arteries assessed by gadobutrol-enhanced MRA and unenhanced MRA were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Fibromuscular dysplasia : reader 1', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Arteriosclerotic : reader 1', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '12.0', 'groupId': 'OG001'}]}]}, {'title': 'Fibromuscular dysplasia : reader 2', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Arteriosclerotic : reader 2', 'categories': [{'measurements': [{'value': '38.4', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'Fibromuscular dysplasia : reader 3', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Arteriosclerotic : reader 3', 'categories': [{'measurements': [{'value': '41.1', 'groupId': 'OG000'}, {'value': '54.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Any focal dilatation (aneurysmal dilatation) of a segment was recorded. The diameter at the widest point was measured with the electronic calipers if a dilatation was present in any segment. The number of participants with an aneurysmal dilatation in each segment (proximal, mid- and distal) in the right and the left renal arteries assessed by gadobutrol-enhanced MRA and unenhanced MRA were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Blinded reader 1(n=1745; 1728)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Blinded reader 2 (n=1745; 1729)', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Blinded reader 3 (n=1749; 1737)', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Diagnostic confidence was evaluated to determine the level of certainty that the blinded readers assigned to a diagnosis for each segment. This was defined as the degree of confidence that the information on the MRA images represented the true and complete clinical picture of a particular segment. The degree of confidence was rated on a 4-point scale: 1=Not confident; 2=Somewhat confident; 3=Confident; 4=Very confident.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; In the below table, "n" signifies the number of segments that were evaluable in specified category.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Blinded reader 1', 'categories': [{'measurements': [{'value': '41.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '96.6', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Blinded reader 2', 'categories': [{'measurements': [{'value': '14.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '77.1', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Blinded reader 3', 'categories': [{'measurements': [{'value': '8.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '44.9', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Clinical investigators', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '43.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'A measure of diagnostic value was the reduction in the number of additional diagnostic imaging studies recommended/ordered. The clinical investigators and the blinded readers were asked if they had recommended an additional imaging study for each participant, and the data were recorded.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Non-contrast MRA', 'categories': [{'measurements': [{'value': '0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Contrast-enhanced MRA', 'categories': [{'measurements': [{'value': '1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'CTA', 'categories': [{'measurements': [{'value': '120', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '280', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Ultrasound', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'DSCA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nuclear medicine study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with participants who were recommended for additional imaging studies.'}, {'type': 'SECONDARY', 'title': 'Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Non-contrast MRA', 'categories': [{'measurements': [{'value': '0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Contrast-enhanced MRA', 'categories': [{'measurements': [{'value': '0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '114', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'CTA', 'categories': [{'measurements': [{'value': '39', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '110', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Ultrasound', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'DSCA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nuclear medicine study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with participants who were recommended for additional imaging studies.'}, {'type': 'SECONDARY', 'title': 'Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Non-contrast MRA', 'categories': [{'measurements': [{'value': '0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Contrast-enhanced MRA', 'categories': [{'measurements': [{'value': '1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '14', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'CTA', 'categories': [{'measurements': [{'value': '22', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '116', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Ultrasound', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'DSCA', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nuclear medicine study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with participants who were recommended for additional imaging studies.'}, {'type': 'SECONDARY', 'title': 'Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol-enhanced MRA'}, {'id': 'OG001', 'title': 'Unenhanced MRA'}], 'classes': [{'title': 'Non-contrast MRA', 'categories': [{'measurements': [{'value': '0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Contrast-enhanced MRA', 'categories': [{'measurements': [{'value': '2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '114', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'CTA', 'categories': [{'measurements': [{'value': '50', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '12', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Ultrasound', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'DSCA', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Nuclear medicine study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with participants who were recommended for additional imaging studies.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gadobutrol (Gadavist, BAY 86-4875)', 'description': 'Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants received study drug; Safety analysis set', 'groupId': 'FG000', 'numSubjects': '315'}]}, {'type': 'Fulfilled Requirements of FAS Population', 'achievements': [{'comment': 'Full analysis set (FAS)', 'groupId': 'FG000', 'numSubjects': '292'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '312'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The study was conducted at 55 study centers in 13 countries, between 16 May 2011 (first participant first visit) and 06 July 2012 (last participant last visit).', 'preAssignmentDetails': 'A total of 338 participants were screened, of which 317 were enrolled and 315 received the study drug. The 23 participants who did not receive the study drug included 9 screen failures and 12 premature discontinuations (10 participants withdrew consent and 2 participants for other reasons) and 2 participants never received the study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Gadobutrol (Gadavist, BAY 86-4875)', 'description': 'Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.9', 'spread': '16.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 45 years', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}]}]}, {'title': '45 - 64 years', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '145', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '170', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Weight', 'classes': [{'categories': [{'measurements': [{'value': '77.5', 'spread': '16.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram(s)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 317}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'dispFirstSubmitDate': '2013-06-20', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-29', 'studyFirstSubmitDate': '2011-04-05', 'dispFirstSubmitQcDate': '2013-06-20', 'resultsFirstSubmitDate': '2015-05-27', 'studyFirstSubmitQcDate': '2011-04-28', 'dispFirstPostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-29', 'studyFirstPostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (reader 1, 2 and 3) and majority readers (the outcome determined by at least two of the blinded readers). The segments were predefined to standardize the blinded reader evaluations. A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 6 segments assessed per participant (3 segments in the right renal artery and 3 segments in the left renal artery) and up to 9 segments in participants with renal transplant.'}, {'measure': 'Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Clinically significant disease was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease.'}, {'measure': 'Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Clinically significant disease (stenosis) was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Specificity = percentage of participants for which the imaging modalities (unenhanced or gadobutrol-enhanced) in the detection and exclusion of clinically significant stenosis.'}, {'measure': 'Minimum Gadobutrol Performance for Sensitivity: Sensitivity More Than (>) 50%', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Clinically significant disease was defined as \\>50% stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.'}, {'measure': 'Minimum Gadobutrol Performance for Specificity: Specificity > 50%', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Clinically significant disease (stenosis) was defined as \\>50% stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.'}], 'secondaryOutcomes': [{'measure': 'Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'The length of the left and right renal arteries were measured from the origin at the aorta to the bifurcation into the upper and lower pole arteries or the most distal point of the renal artery which could be visualized. This distal margin was the point where the diameter was still assessable. If there were more than 2 distal branches then the first large branch that was the dominant supply to a renal pole was used as the distal point.'}, {'measure': 'Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'The length of the left and right renal arteries were measured from the origin at the aorta to the bifurcation into the upper and lower pole arteries or the most distal point of the renal artery which could be visualized. This distal margin was the point where the diameter was still assessable. If there were more than 2 distal branches then the first large branch that was the dominant supply to a renal pole was used as the distal point.'}, {'measure': 'Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'The segment reduction in diameter (DIA) of greater than 10% was considered abnormal and measured. The diameter of each of these abnormal segments was measured using electronic calipers (perpendicular to the long axis of the vessel) at the point of most severe stenosis within each segment. Mean of vessel diameters was calculated by segment separately for CTA and MRA readers. For the ease of expression, the following abbreviations will be used: Diameter (DIA), Blinded Reader (BR).'}, {'measure': 'The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Location within the right and left proximal segment was based on the point of greatest stenosis and was recorded for stenosis \\>=50% as: - Within 5 mm of the aorta (or occlusion proximal to the origin of the segment); - Beyond 5 mm from the aorta.'}, {'measure': 'The Percentage of Segments With Artifacts Presence', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Artifacts were collected for the MRA images on a segmental basis.'}, {'measure': 'Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example \\[eg\\], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).'}, {'measure': 'Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example \\[eg\\], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).'}, {'measure': 'Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example \\[eg\\], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).'}, {'measure': 'The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'An accessory renal artery was defined as an additional, non-dominant, renal artery typically emanating from the aorta and anastomosing distal to the proximal third, segment of that renal artery. It was recorded only as present or absent on the right and left, regardless of how many accessory renal arteries were present.'}, {'measure': 'The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Any focal dilatation (aneurysmal dilatation) of a segment was recorded. The diameter at the widest point was measured with the electronic calipers if a dilatation was present in any segment. The number of participants with an aneurysmal dilatation in each segment (proximal, mid- and distal) in the right and the left renal arteries assessed by gadobutrol-enhanced MRA and unenhanced MRA were reported.'}, {'measure': 'The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Any focal dilatation (aneurysmal dilatation) of a segment was recorded. The diameter at the widest point was measured with the electronic calipers if a dilatation was present in any segment. The number of participants with an aneurysmal dilatation in each segment (proximal, mid- and distal) in the right and the left renal arteries assessed by gadobutrol-enhanced MRA and unenhanced MRA were reported.'}, {'measure': 'Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'Diagnostic confidence was evaluated to determine the level of certainty that the blinded readers assigned to a diagnosis for each segment. This was defined as the degree of confidence that the information on the MRA images represented the true and complete clinical picture of a particular segment. The degree of confidence was rated on a 4-point scale: 1=Not confident; 2=Somewhat confident; 3=Confident; 4=Very confident.'}, {'measure': 'The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'A measure of diagnostic value was the reduction in the number of additional diagnostic imaging studies recommended/ordered. The clinical investigators and the blinded readers were asked if they had recommended an additional imaging study for each participant, and the data were recorded.'}, {'measure': 'Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 1', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.'}, {'measure': 'Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 2', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.'}, {'measure': 'Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 3', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.'}, {'measure': 'Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images', 'timeFrame': 'Images were taken pre-injection and post-injection', 'description': 'An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['magnetic resonance angiography (MRA) of the renal arteries'], 'conditions': ['Renal Artery Obstruction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe'}]}, 'descriptionModule': {'briefSummary': 'Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required.\n\nThis study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study.\n\nMRA and CTA images will be collected for an independent review (blinded read).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects, aged ≥ 18 years\n* Known or suspected renal artery disease based on any of the following:\n\n * Referred for evaluation of the renal arteries for clinically significant stenosis\n * Follow-up for a metallic stent in a renal artery\n * Prior imaging study (CTA) showing ≥ 50% renal artery stenosis (within 60 days prior to consent)\n* Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography (CE MRA) examinations with gadobutrol.\n* Willingness and ability to follow directions and complete all study procedures specified in the protocol.\n* Females of childbearing potential only: Negative pregnancy test on the day of the MRA prior to administration of study drug.\n* Written informed consent (IC), including information about the provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable.\n\nExclusion Criteria:\n\n* Pregnant or nursing (including pumping for storage and feeding)\n* Received any other investigational product or participation in any other clinical trial within 30 days before enrollment into this study\n* Previous enrolment into this study or into any other Bayer sponsored study using gadobutrol\n* Contraindication to the MRA examinations (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI)\n* Contraindication to the use of Gd-containing contrast agents (including subjects with suspicion for or known to have Nefrogenic Systemic Fibrosis (NSF)\n* History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents\n* Received any contrast agent within 72 hours before the study MRA, or scheduled receipt of any contrast agent within 24 hours after the study MRA (Note: This applies also to a CTA potentially scheduled during the course of the study.)\n* Estimated glomerular filtration rate (eGFR) value \\< 30 ml/min/1.73 m2 derived from a serum creatinine result within 2 weeks before the gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from participation. Use the value obtained prior to and closest to the time of the MRA, if there are multiple creatinine values. (Do not use the core lab value if not available prior to the MRA.)\n* Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period\n* Severe cardiovascular disease (e.g. acute myocardial infarction \\[\\< 14 days\\], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome'}, 'identificationModule': {'nctId': 'NCT01344460', 'acronym': 'GRAMS', 'briefTitle': 'Gadobutrol Enhanced MRA of the Renal Arteries', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Gadobutrol-enhanced Magnetic Resonance Angiography (MRA) After a Single Injection of 0.1 mmol/kg of Gadobutrol in Subjects With Known or Suspected Renal Artery Disease', 'orgStudyIdInfo': {'id': '91759'}, 'secondaryIdInfos': [{'id': '2010-023002-13', 'type': 'EUDRACT_NUMBER'}]}, 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