Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-01 @ 5:54 AM
Study NCT ID:
NCT01890434
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2013-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gadobutrol / Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C090600', 'term': 'gadobutrol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'phone': '(+) 1-888-8422937', 'title': 'Therapeutic Area Head', 'organization': 'Bayer'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the time of gadobutrol injection until 24 ± 6 hours follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 mmol/kg BW in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.', 'otherNumAtRisk': 478, 'deathsNumAtRisk': 478, 'otherNumAffected': 79, 'seriousNumAtRisk': 478, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tongue ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Application site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Limb discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Head discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 27, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pharyngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Throat tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 478, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Reader 1', 'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000', 'lowerLimit': '56.5', 'upperLimit': '72.3'}]}]}, {'title': 'Reader 2', 'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000', 'lowerLimit': '47.7', 'upperLimit': '64.1'}]}]}, {'title': 'Reader 3', 'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000', 'lowerLimit': '53.0', 'upperLimit': '69.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Blinded readers evaluated 6 myocardial regions based on regional perfusion score \\[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \\>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \\>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR, coronary angiography \\[CA\\] or computed tomography angiography \\[CTA, only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative).', 'unitOfMeasure': 'Sensitivity %', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS (full analysis set, included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \\>= 50%) as verified by SoR.'}, {'type': 'PRIMARY', 'title': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Reader 1', 'categories': [{'measurements': [{'value': '77.1', 'groupId': 'OG000', 'lowerLimit': '67.9', 'upperLimit': '84.8'}]}]}, {'title': 'Reader 2', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '61.8', 'upperLimit': '79.8'}]}]}, {'title': 'Reader 3', 'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000', 'lowerLimit': '66.9', 'upperLimit': '84.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Blinded readers evaluated 6 myocardial regions based on regional perfusion score \\[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \\>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of \\>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.', 'unitOfMeasure': 'Sensitivity %', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \\>= 70%) as verified by SoR.'}, {'type': 'PRIMARY', 'title': "Absence of Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Specificity Based on Blinded Readers' Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Reader 1', 'categories': [{'measurements': [{'value': '85.3', 'groupId': 'OG000', 'lowerLimit': '80.1', 'upperLimit': '89.5'}]}]}, {'title': 'Reader 2', 'categories': [{'measurements': [{'value': '88.7', 'groupId': 'OG000', 'lowerLimit': '83.9', 'upperLimit': '92.4'}]}]}, {'title': 'Reader 3', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000', 'lowerLimit': '84.9', 'upperLimit': '93.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Blinded readers evaluated 6 myocardial regions based on regional perfusion score \\[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \\>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of \\>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Specificity= true negative/ (true negative + false positive).', 'unitOfMeasure': 'Specificity %', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of \\>= 50%) as verified by SoR.'}, {'type': 'PRIMARY', 'title': "Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Reader 1', 'categories': [{'measurements': [{'value': '82.0', 'groupId': 'OG000', 'lowerLimit': '77.0', 'upperLimit': '86.3'}]}]}, {'title': 'Reader 2', 'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000', 'lowerLimit': '82.8', 'upperLimit': '90.9'}]}]}, {'title': 'Reader 3', 'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000', 'lowerLimit': '82.4', 'upperLimit': '90.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Blinded readers evaluated 6 myocardial regions based on regional perfusion score \\[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \\>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of \\>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was retrospective analysis.', 'unitOfMeasure': 'Specificity %', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of \\>= 70%) as verified by SoR.'}, {'type': 'PRIMARY', 'title': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Gadobutrol-enhanced CMRI - Reader 1', 'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000'}]}]}, {'title': 'Gadobutrol-enhanced CMRI - Reader 2', 'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000'}]}]}, {'title': 'Gadobutrol-enhanced CMRI - Reader 3', 'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000'}]}]}, {'title': 'Unenhanced CMRI - Reader 1', 'categories': [{'measurements': [{'value': '48.0', 'groupId': 'OG000'}]}]}, {'title': 'Unenhanced CMRI - Reader 2', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}]}]}, {'title': 'Unenhanced CMRI - Reader 3', 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.00009', 'groupIds': ['OG000'], 'paramType': 'Sensitivity Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '16.7', 'ciLowerLimit': '9.3', 'groupDescription': 'Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'McNemar one-sided test at alpha level of 5%'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Sensitivity Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '26.0', 'ciLowerLimit': '18.2', 'groupDescription': 'Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'McNemar one-sided test at alpha level of 5%'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Sensitivity Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '32.0', 'ciLowerLimit': '24.5', 'groupDescription': 'Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'McNemar one-sided test at alpha level of 5%'}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': "Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as QCA stenosis of \\>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative).", 'unitOfMeasure': 'Sensitivity %', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \\>= 50%) as verified by SoR.'}, {'type': 'PRIMARY', 'title': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Gadobutrol-enhanced CMRI - Reader 1', 'categories': [{'measurements': [{'value': '77.1', 'groupId': 'OG000'}]}]}, {'title': 'Gadobutrol-enhanced CMRI - Reader 2', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}]}]}, {'title': 'Gadobutrol-enhanced CMRI - Reader 3', 'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000'}]}]}, {'title': 'Unenhanced CMRI - Reader 1', 'categories': [{'measurements': [{'value': '56.2', 'groupId': 'OG000'}]}]}, {'title': 'Unenhanced CMRI - Reader 2', 'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000'}]}]}, {'title': 'Unenhanced CMRI - Reader 3', 'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.00005', 'groupIds': ['OG000'], 'paramType': 'Sensitivity Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '21.0', 'ciLowerLimit': '12.1', 'groupDescription': 'Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'McNemar one-sided test at alpha level of 2.5%'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Sensitivity Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '36.2', 'ciLowerLimit': '26.3', 'groupDescription': 'Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'McNemar one-sided test at alpha level of 2.5%'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Sensitivity Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '41.0', 'ciLowerLimit': '31.8', 'groupDescription': 'Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'McNemar one-sided test at alpha level of 2.5%'}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': "Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as QCA stenosis of \\>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.", 'unitOfMeasure': 'Sensitivity %', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \\>= 70%) as verified by SoR.'}, {'type': 'SECONDARY', 'title': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000', 'lowerLimit': '64.1', 'upperLimit': '79.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'The investigator evaluated 6 myocardial regions based on regional perfusion score \\[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \\>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of \\>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative).', 'unitOfMeasure': 'Sensitivity %', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \\>= 50%) as verified by SoR.'}, {'type': 'SECONDARY', 'title': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '77.5', 'upperLimit': '91.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'The investigator evaluated 6 myocardial regions based on regional perfusion score \\[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \\>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of \\>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.', 'unitOfMeasure': 'Sensitivity %', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \\>= 70%) as verified by SoR.'}, {'type': 'SECONDARY', 'title': "Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000', 'lowerLimit': '80.7', 'upperLimit': '89.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'The investigator evaluated 6 myocardial regions based on regional perfusion score \\[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \\>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of \\>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Specificity= true negative/ (true negative + false positive).', 'unitOfMeasure': 'Specificity %', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of \\>= 50%) as verified by SoR.'}, {'type': 'SECONDARY', 'title': "Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.7', 'groupId': 'OG000', 'lowerLimit': '76.7', 'upperLimit': '86.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'The investigator evaluated 6 myocardial regions based on regional perfusion score \\[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \\>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of \\>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was retrospective analysis.', 'unitOfMeasure': 'Specificity %', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of \\>= 70%) as verified by SoR.'}, {'type': 'SECONDARY', 'title': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Secondary Analysis of Sensitivity Comparison Based on the Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Gadobutrol-enhanced CMRI', 'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000'}]}]}, {'title': 'Unenhanced CMRI', 'categories': [{'measurements': [{'value': '50.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Sensitivity Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.3', 'ciLowerLimit': '12.9', 'ciUpperLimit': '28.4', 'groupDescription': 'Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'McNemar 2-sided test at alpha level of 5%'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Sensitivity Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '21.3', 'ciLowerLimit': '14.2', 'ciUpperLimit': '27.2', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'McNemar 2-sided test at alpha level of 10%'}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': "Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was defined as QCA stenosis of \\>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative).", 'unitOfMeasure': 'Sensitivity %', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \\>= 50%) as verified by SoR.'}, {'type': 'SECONDARY', 'title': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Gadobutrol-enhanced CMRI', 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000'}]}]}, {'title': 'Unenhanced CMRI', 'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': "Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was defined as QCA stenosis of \\>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.", 'unitOfMeasure': 'Sensitivity %', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \\>= 70%) as verified by SoR.'}, {'type': 'SECONDARY', 'title': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT - Secondary Analysis of Sensitivity Comparison Based on Majority Blinded Reader's and Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Gadobutrol-enhanced CMRI - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}]}]}, {'title': 'Gadobutrol-enhanced CMRI - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.3', 'groupId': 'OG000'}]}]}, {'title': 'GSPECT - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.3', 'groupId': 'OG000'}]}]}, {'title': 'GSPECT - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.2733', 'groupIds': ['OG000'], 'paramType': 'Sensitivity Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.7', 'ciLowerLimit': '-5.4', 'ciUpperLimit': '14.9', 'groupDescription': 'Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of GSPECT evaluated by majority BR.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'McNemar 2-sided test at alpha level of 5%', 'nonInferiorityComment': 'A non-inferiority margin was set as 15%'}, {'pValue': '1.0000', 'groupIds': ['OG000'], 'paramType': 'Sensitivity Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-8.6', 'ciUpperLimit': '7.2', 'groupDescription': 'Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of GSPECT evaluated by investigator.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'McNemar 2-sided test at alpha level of 5%', 'nonInferiorityComment': 'A non-inferiority margin was set as 15%.'}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': "Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader (BR) and investigator's assessment. Significant CAD was defined as QCA stenosis of \\>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative). Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.", 'unitOfMeasure': 'Sensitivity %', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS (all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \\>= 50%) as verified by SoR and available GSPECT.'}, {'type': 'SECONDARY', 'title': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity Based on Majority Blinded Reader's and Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Gadobutrol-enhanced CMRI - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.8', 'groupId': 'OG000'}]}]}, {'title': 'Gadobutrol-enhanced CMRI - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000'}]}]}, {'title': 'GSPECT - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.9', 'groupId': 'OG000'}]}]}, {'title': 'GSPECT - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': "Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of \\>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.", 'unitOfMeasure': 'Sensitivity %', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS with significant CAD (defined as QCA stenosis of \\>= 70%) as verified by SoR, for assessment on gadobutrol-enhanced CMRI, and available GSPECT for assessment on GSPECT.'}, {'type': 'SECONDARY', 'title': "Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT -- Secondary Analysis of Specificity Comparison Based on Majority Blinded Reader's and Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Gadobutrol-enhanced CMRI - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.1', 'groupId': 'OG000'}]}]}, {'title': 'Gadobutrol-enhanced CMRI - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.3', 'groupId': 'OG000'}]}]}, {'title': 'GSPECT - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000'}]}]}, {'title': 'GSPECT - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0010', 'groupIds': ['OG000'], 'paramType': 'Specificity Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.1', 'ciLowerLimit': '4.1', 'ciUpperLimit': '17.0', 'groupDescription': 'Specificity of gadobutrol-enhanced CMRI was compared with specificity of GSPECT by majority BR.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'McNemar 2-sided test at alpha level of 5%', 'nonInferiorityComment': 'A non-inferiority margin was set as 15%.'}, {'pValue': '0.0094', 'groupIds': ['OG000'], 'paramType': 'Specificity Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.8', 'ciLowerLimit': '1.6', 'ciUpperLimit': '13.2', 'groupDescription': 'Specificity of gadobutrol-enhanced CMRI was compared with specificity of GSPECT by investigator.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'McNemar 2-sided test at alpha level of 5%', 'nonInferiorityComment': 'A non-inferiority margin was set as 15%.'}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': "Absence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of \\>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Specificity= true negative/(true negative + false positive). Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.", 'unitOfMeasure': 'Specificity %', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS (all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of \\>= 50%) as verified by SoR and available GSPECT.'}, {'type': 'SECONDARY', 'title': "Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Specificity Based on Majority Blinded Reader's and Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Gadobutrol-enhanced CMRI - Majority blinded reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.6', 'groupId': 'OG000'}]}]}, {'title': 'Gadobutrol-enhanced CMRI - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.7', 'groupId': 'OG000'}]}]}, {'title': 'GSPECT - Majority blinded reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000'}]}]}, {'title': 'GSPECT - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': "Absence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of \\>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Specificity= true negative/(true negative + false positive). This additional secondary analysis of specificity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.", 'unitOfMeasure': 'Specificity %', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS with significant CAD (defined as QCA stenosis of \\>= 70%) as verified by SoR, for assessment on gadobutrol-enhanced CMRI, and available GSPECT for assessment on GSPECT.'}, {'type': 'SECONDARY', 'title': "Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Localization to LAD territory - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.4', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.7', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.0', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.7', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.1', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.3', 'groupId': 'OG000'}]}]}, {'title': 'Localization to RCA territory - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000'}]}]}, {'title': 'Localization to RCA territory - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000'}]}]}, {'title': 'Localization to RCA territory - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}]}]}, {'title': 'Localization to RCA territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LCX territory - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.3', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LCX territory - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LCX territory - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.7', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LCX territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Sensitivity was calculated coronary territory based, a coronary territory (left anterior descending artery \\[LAD\\] / non-LAD / right coronary artery \\[RCA\\] / left circumflex artery \\[LCX\\]) was rated positive for significant CAD (significant CAD defined as QCA stenosis of\\>=50%), if \\>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \\>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers, majority blinded reader and the investigator.', 'unitOfMeasure': 'Sensitivity %', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS with significant CAD (defined as QCA stenosis of \\>= 50%) as verified by SoR in each coronary territory.'}, {'type': 'SECONDARY', 'title': "Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Localization to LAD territory - Reader 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Reader 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Reader 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.1', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=50%), if \\>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \\>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers, majority blinded reader and the investigator. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.', 'unitOfMeasure': 'Sensitivity %', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS with significant CAD (defined as QCA stenosis of \\>= 50%) as verified by SoR and available GSPECT in each coronary territory, with either blinded reading or investigator reading performed.'}, {'type': 'SECONDARY', 'title': "Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Localization to LAD territory - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.6', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58.7', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.5', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.3', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.0', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000'}]}]}, {'title': 'Localization to RCA territory - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.5', 'groupId': 'OG000'}]}]}, {'title': 'Localization to RCA territory - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.2', 'groupId': 'OG000'}]}]}, {'title': 'Localization to RCA territory - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.2', 'groupId': 'OG000'}]}]}, {'title': 'Localization to RCA territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LCX territory - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LCX territory - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.8', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LCX territory - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LCX territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=70%), if \\>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \\>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of sensitivity was retrospective analysis.', 'unitOfMeasure': 'Sensitivity %', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS with significant CAD (defined as QCA stenosis of \\>= 70%) as verified by SoR in each coronary territory, with either blinded reading or investigator reading performed.'}, {'type': 'SECONDARY', 'title': "Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Localization to LAD territory - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.9', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.9', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Majority', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.8', 'groupId': 'OG000'}]}]}, {'title': 'Localization to RCA territory - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.1', 'groupId': 'OG000'}]}]}, {'title': 'Localization to RCA territory - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000'}]}]}, {'title': 'Localization to RCA territory - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.4', 'groupId': 'OG000'}]}]}, {'title': 'Localization to RCA territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.1', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LCX territory - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.3', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LCX territory - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LCX territory - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LCX territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=50%), if \\>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \\>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator.', 'unitOfMeasure': 'Specificity %', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS without significant CAD (defined as QCA stenosis of \\>= 50% by) as verified by SoR in each coronary territory, with either blinded reading or investigator reading performed.'}, {'type': 'SECONDARY', 'title': "Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Localization to LAD territory - Reader 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Reader 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Reader 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.8', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.1', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.6', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=50%), if \\>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \\>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers, majority blinded reader and the investigator. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.', 'unitOfMeasure': 'Specificity %', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS without significant CAD (defined as QCA stenosis of \\>= 50%) as verified by SoR and available GSPECT in each coronary territory, with either blinded reading or investigator reading,'}, {'type': 'SECONDARY', 'title': "Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Localization to LAD territory - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.8', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.8', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LAD territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.6', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.1', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.0', 'groupId': 'OG000'}]}]}, {'title': 'Localization to non-LAD territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000'}]}]}, {'title': 'Localization to RCA territory - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.0', 'groupId': 'OG000'}]}]}, {'title': 'Localization to RCA territory - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.0', 'groupId': 'OG000'}]}]}, {'title': 'Localization to RCA territory - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.5', 'groupId': 'OG000'}]}]}, {'title': 'Localization to RCA territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LCX territory - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.6', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LCX territory - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.2', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LCX territory - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.3', 'groupId': 'OG000'}]}]}, {'title': 'Localization to LCX territory - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=70%), if \\>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \\>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of specificity was retrospective analysis.', 'unitOfMeasure': 'Specificity %', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS without significant CAD (defined as QCA stenosis of \\>= 70%) as verified by SoR in each coronary territory, with either blinded reading or investigator reading.'}, {'type': 'SECONDARY', 'title': "Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Isolated - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Single vessel - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '2-vessel - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '3-vessel - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Isolated - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Single vessel - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '2-vessel - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '3-vessel - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Isolated - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Single vessel - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '2-vessel - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '3-vessel - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Isolated - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Single vessel - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '2-vessel - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '3-vessel - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Isolated - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Single vessel - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '2-vessel - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '3-vessel - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Number of participants with myocardial perfusion defects on gadobutrol-enhanced CMRI was calculated in participants with significant left main stem (LMS) stenosis and the myocardial perfusion defect pattern was described. If \\>=1 myocardial region showed a myocardial perfusion defect with a RPS of \\>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=50%).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS with significant LMS stenosis indicating significant CAD (defined as QCA stenosis of \\>= 50%) as verified by SoR.'}, {'type': 'SECONDARY', 'title': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single or Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Single-vessel - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000', 'lowerLimit': '32.7', 'upperLimit': '59.2'}]}]}, {'title': 'Single-vessel - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.2', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '45.6'}]}]}, {'title': 'Single-vessel - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '52.6'}]}]}, {'title': 'Single-vessel - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000', 'lowerLimit': '32.7', 'upperLimit': '59.2'}]}]}, {'title': 'Multi-vessel - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000', 'lowerLimit': '67.0', 'upperLimit': '85.8'}]}]}, {'title': 'Multi-vessel - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.6', 'groupId': 'OG000', 'lowerLimit': '61.8', 'upperLimit': '81.8'}]}]}, {'title': 'Multi-vessel - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000', 'lowerLimit': '67.0', 'upperLimit': '85.8'}]}]}, {'title': 'Multi-vessel - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.1', 'groupId': 'OG000', 'lowerLimit': '79.2', 'upperLimit': '94.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI in participants with single and multi-vessel diseases. If \\>=1 myocardial region showed a myocardial perfusion defect with a RPS of \\>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=50%). Sensitivity= true positive/ (true positive + false negative).', 'unitOfMeasure': 'Sensitivity %', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \\>= 50%) as verified by SoR.'}, {'type': 'SECONDARY', 'title': 'Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Gadobutrol-enhanced CMRI - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'Gadobutrol-enhanced CMRI - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.4', 'groupId': 'OG000'}]}]}, {'title': 'GSPECT - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}]}]}, {'title': 'GSPECT - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI and GSPECT in participants with single-vessel diseases. If \\>=1 myocardial region showed a myocardial perfusion defect with a RPS of \\>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.', 'unitOfMeasure': 'Sensitivity %', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS with single-vessel disease indicating significant CAD (defined as QCA stenosis of \\>= 70%) as verified by SoR.'}, {'type': 'SECONDARY', 'title': 'Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Gadobutrol-enhanced CMRI - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000'}]}]}, {'title': 'Gadobutrol-enhanced CMRI - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000'}]}]}, {'title': 'GSPECT - Majority BR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.6', 'groupId': 'OG000'}]}]}, {'title': 'GSPECT - Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI and GSPECT in participants with single-vessel diseases. If \\>=1 myocardial region showed a myocardial perfusion defect with a RPS of \\>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.', 'unitOfMeasure': 'Sensitivity %', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in FAS with multi-vessel disease indicating significant CAD (defined as QCA stenosis of \\>=70%) as verified by SoR.'}, {'type': 'SECONDARY', 'title': "Number of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'classes': [{'title': 'Gadobutrol-enhanced CMRI - Reader 1', 'categories': [{'title': 'Confident', 'measurements': [{'value': '310', 'groupId': 'OG000'}]}, {'title': 'Somewhat confident', 'measurements': [{'value': '74', 'groupId': 'OG000'}]}, {'title': 'Not confident', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Gadobutrol-enhanced CMRI - Reader 2', 'categories': [{'title': 'Confident', 'measurements': [{'value': '300', 'groupId': 'OG000'}]}, {'title': 'Somewhat confident', 'measurements': [{'value': '71', 'groupId': 'OG000'}]}, {'title': 'Not confident', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Gadobutrol-enhanced CMRI - Reader 3', 'categories': [{'title': 'Confident', 'measurements': [{'value': '186', 'groupId': 'OG000'}]}, {'title': 'Somewhat confident', 'measurements': [{'value': '155', 'groupId': 'OG000'}]}, {'title': 'Not confident', 'measurements': [{'value': '47', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Gadobutrol-enhanced CMRI - Investigator', 'categories': [{'title': 'Confident', 'measurements': [{'value': '274', 'groupId': 'OG000'}]}, {'title': 'Somewhat confident', 'measurements': [{'value': '98', 'groupId': 'OG000'}]}, {'title': 'Not confident', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unenhanced CMRI - Reader 1', 'categories': [{'title': 'Confident', 'measurements': [{'value': '315', 'groupId': 'OG000'}]}, {'title': 'Somewhat confident', 'measurements': [{'value': '72', 'groupId': 'OG000'}]}, {'title': 'Not confident', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Unenhanced CMRI - Reader 2', 'categories': [{'title': 'Confident', 'measurements': [{'value': '290', 'groupId': 'OG000'}]}, {'title': 'Somewhat confident', 'measurements': [{'value': '84', 'groupId': 'OG000'}]}, {'title': 'Not confident', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Unenhanced CMRI - Reader 3', 'categories': [{'title': 'Confident', 'measurements': [{'value': '329', 'groupId': 'OG000'}]}, {'title': 'Somewhat confident', 'measurements': [{'value': '44', 'groupId': 'OG000'}]}, {'title': 'Not confident', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Unenhanced CMRI - Investigator', 'categories': [{'title': 'Confident', 'measurements': [{'value': '341', 'groupId': 'OG000'}]}, {'title': 'Somewhat confident', 'measurements': [{'value': '46', 'groupId': 'OG000'}]}, {'title': 'Not confident', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Score for confidence in diagnosis (not confident, somewhat confident, and confident) was described descriptively for each of the 6 myocardial regions. The frequency over the worst confidence in diagnosis obtained within a participant was displayed. All these analyses were done separately for gadobutrol-enhanced CMRI and unenhanced wall motion CMRI.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Treated with gadobutrol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '478'}]}, {'type': 'Evaluated for Efficacy', 'achievements': [{'groupId': 'FG000', 'numSubjects': '389'}]}, {'type': 'COMPLETED', 'comment': 'Follow-up (FU) completed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '458'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'PCI at external hospital', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Assessment discrepancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': "CRC didn't contact participant for FU", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Could not get whole set of images', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Decline to return for GSPECT', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'GSPECT at rest was not done', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': "Participant didn't complete MRI", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Uncontactable by phone', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Moved out of position', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Unable to contact', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by PI for ICA not performed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The study was conducted at 24 centers across 4 countries, between 26 August 2013 (first patient first visit) and 06 August 2016 (last patient last visit).', 'preAssignmentDetails': 'Overall, 504 participants signed the informed consent, of which 14 did not finish their baseline visit (7 screening failures, 7 dropouts). A total of 490 participants entered the diagnostic imaging phase, of them 478 participants were treated and entered the follow-up phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Gadobutrol 0.1 mmol/kg Body Weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '58.6', 'spread': '10.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '177', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '301', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '448', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '322', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '356', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}, {'title': 'Singapore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '86.2', 'spread': '18.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '170.9', 'spread': '9.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29.4', 'spread': '5.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Childbearing potential', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '150', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number of female participants during baseline in SAF = 177'}, {'title': 'Estimated glomerular filtration rate (eGFR)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '82.0', 'spread': '18.73', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety analysis set (SAF)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 478}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'dispFirstSubmitDate': '2017-07-20', 'completionDateStruct': {'date': '2016-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-18', 'studyFirstSubmitDate': '2013-06-27', 'dispFirstSubmitQcDate': '2017-07-20', 'resultsFirstSubmitDate': '2018-03-07', 'studyFirstSubmitQcDate': '2013-06-27', 'dispFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-17', 'studyFirstPostDateStruct': {'date': '2013-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Blinded readers evaluated 6 myocardial regions based on regional perfusion score \\[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \\>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \\>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR, coronary angiography \\[CA\\] or computed tomography angiography \\[CTA, only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative).'}, {'measure': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Blinded readers evaluated 6 myocardial regions based on regional perfusion score \\[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \\>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of \\>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.'}, {'measure': "Absence of Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Specificity Based on Blinded Readers' Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Blinded readers evaluated 6 myocardial regions based on regional perfusion score \\[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \\>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of \\>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Specificity= true negative/ (true negative + false positive).'}, {'measure': "Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Blinded readers evaluated 6 myocardial regions based on regional perfusion score \\[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \\>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of \\>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was retrospective analysis.'}, {'measure': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': "Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as QCA stenosis of \\>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative)."}, {'measure': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': "Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as QCA stenosis of \\>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis."}], 'secondaryOutcomes': [{'measure': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'The investigator evaluated 6 myocardial regions based on regional perfusion score \\[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \\>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of \\>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative).'}, {'measure': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'The investigator evaluated 6 myocardial regions based on regional perfusion score \\[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \\>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of \\>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.'}, {'measure': "Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'The investigator evaluated 6 myocardial regions based on regional perfusion score \\[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \\>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of \\>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Specificity= true negative/ (true negative + false positive).'}, {'measure': "Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'The investigator evaluated 6 myocardial regions based on regional perfusion score \\[RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\\]. A myocardial region was rated to have a perfusion defect in case of a RPS of \\>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of \\>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was retrospective analysis.'}, {'measure': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Secondary Analysis of Sensitivity Comparison Based on the Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': "Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was defined as QCA stenosis of \\>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative)."}, {'measure': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': "Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was defined as QCA stenosis of \\>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis."}, {'measure': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT - Secondary Analysis of Sensitivity Comparison Based on Majority Blinded Reader's and Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': "Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader (BR) and investigator's assessment. Significant CAD was defined as QCA stenosis of \\>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative). Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers."}, {'measure': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity Based on Majority Blinded Reader's and Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': "Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of \\>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers."}, {'measure': "Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT -- Secondary Analysis of Specificity Comparison Based on Majority Blinded Reader's and Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': "Absence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of \\>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Specificity= true negative/(true negative + false positive). Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers."}, {'measure': "Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Specificity Based on Majority Blinded Reader's and Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': "Absence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of \\>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA \\[only if disease can be unequivocally rejected\\]). Specificity= true negative/(true negative + false positive). This additional secondary analysis of specificity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers."}, {'measure': "Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Sensitivity was calculated coronary territory based, a coronary territory (left anterior descending artery \\[LAD\\] / non-LAD / right coronary artery \\[RCA\\] / left circumflex artery \\[LCX\\]) was rated positive for significant CAD (significant CAD defined as QCA stenosis of\\>=50%), if \\>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \\>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers, majority blinded reader and the investigator.'}, {'measure': "Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=50%), if \\>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \\>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers, majority blinded reader and the investigator. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.'}, {'measure': "Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=70%), if \\>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \\>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of sensitivity was retrospective analysis.'}, {'measure': "Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=50%), if \\>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \\>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator.'}, {'measure': "Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=50%), if \\>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \\>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers, majority blinded reader and the investigator. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.'}, {'measure': "Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=70%), if \\>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \\>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of specificity was retrospective analysis.'}, {'measure': "Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Number of participants with myocardial perfusion defects on gadobutrol-enhanced CMRI was calculated in participants with significant left main stem (LMS) stenosis and the myocardial perfusion defect pattern was described. If \\>=1 myocardial region showed a myocardial perfusion defect with a RPS of \\>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=50%).'}, {'measure': "Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single or Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI in participants with single and multi-vessel diseases. If \\>=1 myocardial region showed a myocardial perfusion defect with a RPS of \\>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=50%). Sensitivity= true positive/ (true positive + false negative).'}, {'measure': 'Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI and GSPECT in participants with single-vessel diseases. If \\>=1 myocardial region showed a myocardial perfusion defect with a RPS of \\>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.'}, {'measure': 'Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator', 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI and GSPECT in participants with single-vessel diseases. If \\>=1 myocardial region showed a myocardial perfusion defect with a RPS of \\>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \\>=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.'}, {'measure': "Number of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessment", 'timeFrame': '0 to 30/40 min post-injection', 'description': 'Score for confidence in diagnosis (not confident, somewhat confident, and confident) was described descriptively for each of the 6 myocardial regions. The frequency over the worst confidence in diagnosis obtained within a participant was displayed. All these analyses were done separately for gadobutrol-enhanced CMRI and unenhanced wall motion CMRI.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myocardial Perfusion Imaging'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Subjects being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a subject in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required.\n\nThe primary objective of this study is to demonstrate that sensitivity and specificity of gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) exceed pre-specified minimum performance thresholds of 60% and 55%, respectively, and to show superior sensitivity over unenhanced wall motion CMRI at vasodilator rest/stress for the detection of significant CAD. The CMR images acquired with a uniform imaging acquisition software will be evaluated either against the results from routine clinical Coronary Angiography (CA) or Computed Tomography Angiography (CTA), which are the standard of reference.\n\nCMRI and CA/CTA images will be collected for an independent image 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* Subjects with suspected or known CAD based on signs and/or (typical or atypical) chest pain who have routine CA without intervention within plus/minus 4 weeks of gadobutrol-enhanced CMRI or subjects at low risk of CAD with / or scheduled to get a CTA for the purpose of exclusion of CAD within plus/minus 6 weeks of gadobutrol-enhanced CMRI\n* Willingness to undergo unenhanced wall motion and gadobutrol-enhanced CMRI at stress/rest and gated single photon emission computed tomography (GSPECT, if GSPECT will be a study procedure)\n* Women of childbearing potential (e.g. age \\< 60y, no history of surgical sterilization or hysterectomy): use of contraception and a negative pregnancy test\n* Subjects who are scheduled for / have undergone routine GSPECT or undergo GSPECT as a study procedure at stress and at rest within ± 4 weeks of gadobutrol-enhanced CMRI\n\nExclusion Criteria:\n\n* Suspected clinical instability or unpredictability of the clinical course during the study period\n* Contraindication to the cardiac MRI examination (e.g. inability to hold breath; severe claustrophobia, metallic devices such as pace makers)\n* History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents according to the investigator's assessment / judgment\n* Estimated glomerular filtration rate (eGFR) value \\<30 mL/min/1.73 m\\^2 derived from a serum / blood creatinine result within 2 weeks prior to gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from enrollment.\n* Acute renal insufficiency\n* Coronary artery bypass grafting (CABG)\n* Acute myocardial infarction (\\< 14 days prior to inclusion), unstable angina / acute coronary syndrome, severe congestive heart failure\n* Irregular heart rhythm\n* Condition that precludes the safe administration of pharmacological stressor according to the respective approved label such as sinus node disease, 2nd or 3rd degree atrioventricular block, obstructive lung disease"}, 'identificationModule': {'nctId': 'NCT01890434', 'acronym': 'GadaCAD 2', 'briefTitle': 'Gadobutrol / Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Multicenter Open-label Study to Evaluate Efficacy of Gadobutrol-enhanced Cardiac Magnetic Resonance Imaging (CMRI) for Detection of Significant Coronary Artery Disease (CAD) in Subjects With Known or Suspected CAD by a Blinded Image Analysis', 'orgStudyIdInfo': {'id': '15962'}, 'secondaryIdInfos': [{'id': '2013-000066-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gadobutrol 0.1 mmol/kg body weight', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.', 'interventionNames': ['Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)']}], 'interventions': [{'name': 'Gadobutrol (Gadavist, Gadovist, BAY86-4875)', 'type': 'DRUG', 'description': 'Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.', 'armGroupLabels': ['Gadobutrol 0.1 mmol/kg body weight']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90048-0750', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611-2908', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '5042', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '4032', 'city': 'Chermside', 'country': 'Australia', 'geoPoint': {'lat': -27.38472, 'lon': 153.03062}}, {'zip': '5006', 'city': 'North Adelaide', 'country': 'Australia', 'geoPoint': {'lat': -34.90733, 'lon': 138.59141}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '168752', 'city': 'Singapore', 'country': 'Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'country': 'Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}