Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-02-20 @ 4:47 PM
Study NCT ID:
NCT00862459
Status:
COMPLETED
Last Update Posted:
2014-01-13
First Post:
2008-11-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C090600', 'term': 'gadobutrol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'otherDetails': 'Publication of results will be a group publication. Sites with recruitment of \\>= 6 valid patients will contribute. There will be one author from each site having contributed \\>= 6 valid patients. Authorship listed according to recruitment. Sponsor will appoint up to 3 persons as co-authors. Main author of publication may be announced by site with most valid patients enrolled. In case more than 1 center reaches maximum patient No., main author will be from the center with fastest recruitment', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'OptiMARK was used as a standard of reference in this study. A formal comparison of the efficacy of gadobutrol and OptiMARK was not specified prospectively in the statistical analysis plan. For completeness, the safety data of OptiMARK is presented.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Reporting Group 1 (RG1): Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.', 'otherNumAtRisk': 67, 'otherNumAffected': 19, 'seriousNumAtRisk': 67, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Reporting group 2 (RG2): Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.', 'otherNumAtRisk': 90, 'otherNumAffected': 30, 'seriousNumAtRisk': 90, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Reporting group 3 (RG3): Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.', 'otherNumAtRisk': 68, 'otherNumAffected': 22, 'seriousNumAtRisk': 68, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Optimark~0.1mmol/kg BW', 'description': 'Reporting group 4 (RG4): Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.', 'otherNumAtRisk': 227, 'otherNumAffected': 23, 'seriousNumAtRisk': 227, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Injection site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Electrocardiogram ST segment depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Cerebellar syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Paraparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Petit mal epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Claustrophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Bladder discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Galactorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}], 'seriousEvents': [{'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Intracranial pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Neurological symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v9.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Categorical Visualization Score (CVS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.43', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '2.02', 'spread': '1.04', 'groupId': 'OG001'}, {'value': '1.98', 'spread': '1.20', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.59', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.49', 'groupDescription': '2 sample t-test between the dose groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.844', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.04', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.59', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The primary visualization variables (number \\[no.\\] of lesions detected, border delineation, contrast enhancement, internal morphology) were condensed to a composite score (CVS). Each variable was considered a category; the CVS was calculated as: CVS=(No. of categories with increase over precontrast)-(No. of categories with decrease over precontrast). The possible outcomes of the CVS for a participant and each reader were in the range of - 3 to +4. The CVS was averaged across the 3 blinded readers, producing 1 mean CVS per participant. The higher the CVS, the more effective the treatment.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The per protocol set (PPS), which included all participants with valid images who received +/-10% of the intended dose of study drug and had no major protocol or Magnetic Resonance Imaging (MRI) procedure deviations (excluding one participant with insufficient images)'}, {'type': 'PRIMARY', 'title': 'Difference in Number of Lesions Detected in Pre-contrast and Combined Pre-/Post-contrast MRI.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '2.28', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '2.22', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.069', 'ciLowerLimit': '-0.825', 'ciUpperLimit': '0.69', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.92', 'statisticalMethod': 'confidence interval using t-distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '0.79', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.18', 'statisticalMethod': 'confidence interval using t-distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'Three blinded readers evaluated the unenhanced MRI sets and the combined unenhanced/gadobutrol-enhanced MRI sets to evaluate the number of lesions, which was then averaged to produce an average reader value.', 'unitOfMeasure': 'Lesions per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding one participant with insufficient images)'}, {'type': 'PRIMARY', 'title': 'Assessment of Lesion Contrast Enhancement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.98', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '1.78', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '1.79', 'spread': '1.15', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-1.17', 'ciUpperLimit': '-0.42', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.42', 'statisticalMethod': 'confidence interval using t-distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.41', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.57', 'statisticalMethod': 'confidence interval using t-distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded readers assessed the degree of contrast enhancement for each lesion on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement, which was then averaged to produce an average reader score.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding subjects with no lesion detected)'}, {'type': 'PRIMARY', 'title': 'Assessment of Border Delineation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.28', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '0.70', 'spread': '0.60', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.619', 'ciUpperLimit': '-0.17', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.86', 'statisticalMethod': 'confidence interval using t-distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.01', 'statisticalMethod': 'confidence interval using t-distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded readers assessed the delineation for each lesion on a 4-point scale where 1 = none and 4 = excellent, which was then averaged to produce an average reader score.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding subjects with no lesion detected)'}, {'type': 'PRIMARY', 'title': 'Assessment of Internal Morphology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '0.80', 'spread': '0.51', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '-0.18', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.76', 'statisticalMethod': 'confidence interval using t-distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.76', 'statisticalMethod': 'confidence interval using t-distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded readers assessed the degree of information available about internal morphology and structure for each lesion on a 3-point scale where 1 = poor and 3 = good, which was then averaged to produce an average reader score.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding subjects with no lesion detected)'}, {'type': 'PRIMARY', 'title': 'Contrast to Noise Ratio (CNR) Between White and Gray Matter With Gadobutrol Perfusion MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.42', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '27.0', 'spread': '75.6', 'groupId': 'OG001'}, {'value': '22.2', 'spread': '15.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-17.54', 'ciLowerLimit': '-37.11', 'ciUpperLimit': '2.02', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '76.45', 'groupDescription': 'difference in CNR between doses and confidence interval', 'statisticalMethod': 'confidence interval using t-distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '4.74', 'ciLowerLimit': '-15.86', 'ciUpperLimit': '25.35', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '77.11', 'statisticalMethod': 'confidence interval using t-distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'CNR between white and gray matter in the perfusion imaging was defined as the signal intensity (SI) difference between white and gray matter divided by the standard deviation of the SI of white matter. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.', 'unitOfMeasure': 'CNR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding participants with insufficient images)'}, {'type': 'SECONDARY', 'title': 'Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.58', 'groupId': 'OG000'}, {'value': '65.24', 'groupId': 'OG001'}, {'value': '54.49', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.80', 'groupIds': ['OG000', 'OG001'], 'paramType': 'accuracy difference', 'ciPctValue': '95', 'paramValue': '1.66', 'ciLowerLimit': '-10.93', 'ciUpperLimit': '14.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.29', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for clustering', 'testedNonInferiority': False}, {'pValue': '0.13', 'groupIds': ['OG001', 'OG002'], 'paramType': 'difference in accuracies', 'ciPctValue': '95', 'paramValue': '-10.75', 'ciLowerLimit': '-24.41', 'ciUpperLimit': '2.90', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.83', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for clustering', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for blinded reader (BR) 1.', 'unitOfMeasure': 'percentage of lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding subjects with no lesion detected)'}, {'type': 'SECONDARY', 'title': 'Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.62', 'groupId': 'OG000'}, {'value': '71.05', 'groupId': 'OG001'}, {'value': '57.47', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in accuracy', 'ciPctValue': '95', 'paramValue': '13.43', 'ciLowerLimit': '1.53', 'ciUpperLimit': '25.33', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for clustering', 'testedNonInferiority': False}, {'pValue': '0.02', 'groupIds': ['OG001', 'OG002'], 'paramType': 'difference in accuracies', 'ciPctValue': '95', 'paramValue': '-13.58', 'ciLowerLimit': '-25.07', 'ciUpperLimit': '-2.09', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for clustering', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 2', 'unitOfMeasure': 'percentage of lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding subjects with no lesion detected)'}, {'type': 'SECONDARY', 'title': 'Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.31', 'groupId': 'OG000'}, {'value': '57.18', 'groupId': 'OG001'}, {'value': '50.05', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in accuracy', 'ciPctValue': '95', 'paramValue': '-6.13', 'ciLowerLimit': '-13.73', 'ciUpperLimit': '1.48', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for clustering', 'testedNonInferiority': False}, {'pValue': '0.55', 'groupIds': ['OG001', 'OG002'], 'paramType': 'difference in accuracies', 'ciPctValue': '95', 'paramValue': '2.87', 'ciLowerLimit': '-6.59', 'ciUpperLimit': '12.32', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for clustering', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 3', 'unitOfMeasure': 'percentage of lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding subjects with no lesion detected)'}, {'type': 'SECONDARY', 'title': 'Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.10', 'groupId': 'OG000'}, {'value': '72.73', 'groupId': 'OG001'}, {'value': '55.21', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in accuracy', 'ciPctValue': '95', 'paramValue': '24.63', 'ciLowerLimit': '5.39', 'ciUpperLimit': '43.86', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for clustering', 'testedNonInferiority': False}, {'pValue': '0.13', 'groupIds': ['OG001', 'OG002'], 'paramType': 'difference in accuracy', 'ciPctValue': '95', 'paramValue': '-10.75', 'ciLowerLimit': '-24.41', 'ciUpperLimit': '2.90', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for clustering', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 1', 'unitOfMeasure': 'percentage of lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding subjects with no enhanced lesion detected)'}, {'type': 'SECONDARY', 'title': 'Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.23', 'groupId': 'OG000'}, {'value': '82.14', 'groupId': 'OG001'}, {'value': '63.77', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in accuracy', 'ciPctValue': '95', 'paramValue': '12.91', 'ciLowerLimit': '-1.44', 'ciUpperLimit': '27.26', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for clustering', 'testedNonInferiority': False}, {'pValue': '0.02', 'groupIds': ['OG001', 'OG002'], 'paramType': 'difference in accuracy', 'ciPctValue': '95', 'paramValue': '-18.37', 'ciLowerLimit': '-33.60', 'ciUpperLimit': '-1.35', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for clustering', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 2', 'unitOfMeasure': 'percentage of lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding subjects with no enhanced lesion detected)'}, {'type': 'SECONDARY', 'title': 'Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.07', 'groupId': 'OG000'}, {'value': '73.53', 'groupId': 'OG001'}, {'value': '68.24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in accuracy', 'ciPctValue': '95', 'paramValue': '18.46', 'ciLowerLimit': '3.15', 'ciUpperLimit': '33.77', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for clustering', 'testedNonInferiority': False}, {'pValue': '0.45', 'groupIds': ['OG001', 'OG002'], 'paramType': 'difference in accuracy', 'ciPctValue': '95', 'paramValue': '-5.29', 'ciLowerLimit': '-18.83', 'ciUpperLimit': '8.24', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for clustering', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 3', 'unitOfMeasure': 'percentage of lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS(excluding subjects with no enhanced lesion detected)'}, {'type': 'SECONDARY', 'title': 'Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'yes', 'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '54.2', 'groupId': 'OG002'}]}]}, {'title': 'no', 'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}, {'value': '45.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The gadobutrol-enhanced and unenhanced MRI diagnoses of the average reader were compared to the final diagnosis.', 'unitOfMeasure': 'percentage of exact matches', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'not confident', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}]}]}, {'title': 'somewhat confident', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '23.2', 'groupId': 'OG002'}]}]}, {'title': 'confident', 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000'}, {'value': '33.9', 'groupId': 'OG001'}, {'value': '39.3', 'groupId': 'OG002'}]}]}, {'title': 'very confident', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '33.9', 'groupId': 'OG001'}, {'value': '33.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The diagnostic confidence, the level of certainty in a diagnosis, was determined based on the average of the blinded readers.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Applicable (Appl.)', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '21.4', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '32.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 1 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '10.7', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '8.9', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}, {'value': '16.1', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}, {'value': '26.8', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 2 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS. Due to rounding, the sum of percentages may range from 99.9 to 100.1.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '16.1', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}, {'value': '19.6', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}, {'value': '16.1', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '10.7', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 3 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '10.7', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '8.9', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}, {'value': '30.4', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 1 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '7.1', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '7.1', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '32.1', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 2 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '23.2', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '10.7', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '10.7', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '23.2', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 3 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '23.2', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '30.4', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '30.4', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 1 evaluated the visibility of the lesion(s) on the CBF perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '8.9', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '19.6', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '8.9', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 2 evaluated the visibility of the lesion(s) on the CBF perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '16.1', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '10.7', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 3 evaluated the visibility of the lesion(s) on the CBF perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '34.4', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}, {'value': '26.8', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '21.4', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '10.7', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 1 evaluated the visibility of the lesion(s) on the TTP perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '8.9', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}, {'value': '30.4', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '33.9', 'groupId': 'OG001'}, {'value': '23.2', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 2 evaluated the visibility of the lesion(s) on the TTP perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21.4', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}, {'value': '16.1', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '10.7', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '8.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 3 evaluated the visibility of the lesion(s) on the TTP perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '19.6', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '19.6', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '26.8', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 1 evaluated the visibility of the lesion(s) on the MTT perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}, {'value': '30.4', 'groupId': 'OG001'}, {'value': '23.2', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '19.6', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 2 evaluated the visibility of the lesion(s) on the MTT perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '16.1', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21.4', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '16.1', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000'}, {'value': '30.4', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '16.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 3 evaluated the visibility of the lesion(s) on the MTT perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}, {'value': '19.6', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 1 evaluated the visibility of the lesion(s) on the PF perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '8.9', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '16.1', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '16.1', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '26.8', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '7.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 2 evaluated the visibility of the lesion(s) on the PF perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Not Appl.', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '19.6', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'not visible', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '26.8', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}]}]}, {'title': 'excellent', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '10.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 3 evaluated the visibility of the lesion(s) on the PF perfusion map.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Parameter Value (Uncorrected Cerebral Blood Volume (CBV)) - Independent Radiologist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '114.61', 'spread': '127.75', 'groupId': 'OG000'}, {'value': '346.81', 'spread': '313.49', 'groupId': 'OG001'}, {'value': '1209.89', 'spread': '1121.63', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The independent radiologist determined the uncorrected CBV for each lesion. CBV is the volume of blood in the tissue.', 'unitOfMeasure': 'mL / 100 g tissue', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding subjects whose parameter map value was not determined)'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Parameter Value (Corrected Cerebral Blood Volume (CBV)) - Independent Radiologist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '2728.71', 'spread': '2788.59', 'groupId': 'OG000'}, {'value': '2682.97', 'spread': '1493.95', 'groupId': 'OG001'}, {'value': '3382.20', 'spread': '1908.56', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The independent radiologist determined the corrected CBV for each lesion. CBV is the volume of blood in the tissue.', 'unitOfMeasure': 'mL / 100 g tissue', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding subjects whose parameter map value was not determined)'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Parameter Value (Cerebral Blood Flow (CBF)) - Independent Radiologist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.80', 'spread': '6.37', 'groupId': 'OG000'}, {'value': '5.15', 'spread': '4.30', 'groupId': 'OG001'}, {'value': '3.48', 'spread': '2.24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The independent radiologist determined the CBF for each lesion. CBF is the volume of blood passing through tissue per unit of time.', 'unitOfMeasure': 'mL / 100 g tissue / min.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding subjects whose parameter map value was not determined)'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Parameter Value (Time to Peak (TTP)) - Independent Radiologist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.39', 'spread': '25.43', 'groupId': 'OG000'}, {'value': '80.31', 'spread': '27.21', 'groupId': 'OG001'}, {'value': '86.52', 'spread': '28.70', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The independent radiologist determined the TTP for each lesion. TTP is the delay between the arrival of the contrast agent bolus arrival time and the peak of the concentration curve.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding subjects whose parameter map value was not determined)'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Parameter Value (Mean Transit Time (MTT)) - Independent Radiologist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.30', 'spread': '4.77', 'groupId': 'OG000'}, {'value': '6.02', 'spread': '3.71', 'groupId': 'OG001'}, {'value': '7.05', 'spread': '4.54', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The independent radiologist determined the MTT for each lesion. The MTT is the time (seconds) for contrast to pass through tissues.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding subjects whose parameter map value was not determined)'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Parameter Value (Permeability Factor (PF)) - Independent Radiologist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.04', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '1.88', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The independent radiologist determined the PF for each lesion', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding subjects whose parameter map value was not determined)'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Blinded Reader 1 - Missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - 0 none', 'categories': [{'measurements': [{'value': '72.1', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '69.6', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - EPI distortion', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}, {'value': '21.4', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - movement artifacts', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - other', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '7.1', 'groupId': 'OG002'}]}]}, {'title': 'Blinded reader 2 - Missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - 0 none', 'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000'}, {'value': '66.1', 'groupId': 'OG001'}, {'value': '89.3', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - EPI distortion', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - movement artifacts', 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - Missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - none', 'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000'}, {'value': '67.9', 'groupId': 'OG001'}, {'value': '78.6', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - EPI distortion', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '10.7', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - T2 artifacts', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - movement artifacts', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - other', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded reader evaluated if artifacts were present on the uncorrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Blinded Reader 1 - Missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - 0 none', 'categories': [{'measurements': [{'value': '75.4', 'groupId': 'OG000'}, {'value': '76.8', 'groupId': 'OG001'}, {'value': '66.1', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - EPI distortion', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - other', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - Missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - 0 none', 'categories': [{'measurements': [{'value': '78.7', 'groupId': 'OG000'}, {'value': '80.4', 'groupId': 'OG001'}, {'value': '83.9', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - EPI distortion', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - movement artifacts', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - Missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - 0 none', 'categories': [{'measurements': [{'value': '55.7', 'groupId': 'OG000'}, {'value': '69.6', 'groupId': 'OG001'}, {'value': '76.8', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - EPI distortion', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - T2 artifacts', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - movement artifacts', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - other', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded reader evaluated if artifacts were present on the corrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time. CBV is the fraction of the tissue volume occupied by the blood.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Blinded Reader 1 - Missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - 0 none', 'categories': [{'measurements': [{'value': '70.5', 'groupId': 'OG000'}, {'value': '85.7', 'groupId': 'OG001'}, {'value': '71.4', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - EPI distortion', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '23.2', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - T2 artifacts', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2- Missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2- 0 none', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '82.1', 'groupId': 'OG001'}, {'value': '80.4', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - EPI distortion', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '10.7', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2- movement artifacts', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '7.1', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2- other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - Missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - 0 none', 'categories': [{'measurements': [{'value': '68.9', 'groupId': 'OG000'}, {'value': '76.8', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - EPI distortion', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - T2 artifacts', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '8.9', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - movement artifacts', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - other', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded reader evaluated if artifacts were present on the CBF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Blinded Reader 1 - missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - 0 none', 'categories': [{'measurements': [{'value': '75.4', 'groupId': 'OG000'}, {'value': '76.8', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - EPI distortion', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}, {'value': '19.6', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1- movement artifacts', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - other', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - 0 none', 'categories': [{'measurements': [{'value': '34.4', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}, {'value': '71.4', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - EPI distortion', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '10.7', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - movement artifacts', 'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - other', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - 0 none', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '64.3', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - EPI distortions', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - T2 artifacts', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '8.9', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader3 - movement artifacts', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}, {'value': '7.1', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - other', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '7.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded reader evaluated if artifacts were present on the TTP perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Blinded Reader 1 - missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - 0 none', 'categories': [{'measurements': [{'value': '80.3', 'groupId': 'OG000'}, {'value': '67.9', 'groupId': 'OG001'}, {'value': '71.4', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - EPI distortion', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '30.4', 'groupId': 'OG001'}, {'value': '19.6', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - T2 artifacts', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - movement artifacts', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - other', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - none', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '73.2', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - EPI distortion', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}, {'value': '8.9', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - movement artifacts', 'categories': [{'measurements': [{'value': '52.5', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}, {'value': '16.1', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - other', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - missing', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - 0 none', 'categories': [{'measurements': [{'value': '50.8', 'groupId': 'OG000'}, {'value': '66.1', 'groupId': 'OG001'}, {'value': '69.6', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - EPI distortion', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '16.1', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - T2 artifacts', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - movement artifacts', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - other', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded reader evaluated if artifacts were present on the MTT perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Blinded Reader 1 - 0 none', 'categories': [{'measurements': [{'value': '73.8', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '71.4', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - EPI distortion', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}, {'value': '26.8', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - T2 artifacts', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - movement artifacts', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 1 - other', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - missing', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - 0 none', 'categories': [{'measurements': [{'value': '73.8', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73.2', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - EPI distortion', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - movement artifacts', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2 - other', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - missing', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - 0 none', 'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}, {'value': '51.8', 'groupId': 'OG001'}, {'value': '69.6', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - EPI distortion', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - T2 artifacts', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - movement artifacts', 'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '7.1', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3 - other', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded reader evaluated if artifacts were present on the PF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'Blinded Reader 1', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 2', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}]}]}, {'title': 'Blinded Reader 3', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '30.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded readers gave an estimation of the tumor grade of brain tumors (low grade \\[I or II\\] or high grade \\[III or IV\\]) in terms of malignancy using the information obtained by perfusion imaging, which was compared to the biopsy sample results', 'unitOfMeasure': 'Percentage of accuracy', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS participants with tumors'}, {'type': 'SECONDARY', 'title': 'Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'OG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'classes': [{'title': 'lesion gray', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '78.4', 'groupId': 'OG001'}, {'value': '5.38', 'spread': '25.0', 'groupId': 'OG002'}]}]}, {'title': 'lesion white', 'categories': [{'measurements': [{'value': '-10', 'spread': '12', 'groupId': 'OG000'}, {'value': '-17', 'spread': '19.9', 'groupId': 'OG001'}, {'value': '-17', 'spread': '20.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'CNR between lesion/gray matter and lesion/white matter in the perfusion imaging was defined as the signal intensity (SI) difference between lesion and gray or white matter divided by the standard deviation of background noise. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.', 'unitOfMeasure': 'CNR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (excluding subjects who had no lesion detected, and those who had no value determined)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg body weight (BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'FG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'FG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '72'}]}, {'type': 'Participants Received Treatment', 'achievements': [{'comment': 'Number reflects all treated participants of whom 67 received Gadobutrol and 70 received OptiMARK', 'groupId': 'FG000', 'numSubjects': '70'}, {'comment': 'Number reflects all treated participants of whom 90 received Gadobutrol and 88 received OptiMARK', 'groupId': 'FG001', 'numSubjects': '90'}, {'comment': 'Number reflects all treated participants of whom 68 received Gadobutrol and 69 received OptiMARK', 'groupId': 'FG002', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Personal reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Operation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Intravenous (IV) site problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Unable to hold still for imaging', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Inclusion/exclusion criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "The date of the first participant's first visit was 27 August 2005. The date of the last participant's last visit was 26 March 2007.", 'preAssignmentDetails': '242 participants were screened: 5 were screening failures (withdrew consent, did not meet study criteria, other). The remaining 237 were randomized to the 0.3, 0.1, or 0.03 millimole per kilogram (mmol/kg) group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '229', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 millimole per kilogram of body weight (mmol/kg BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'BG001', 'title': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'BG002', 'title': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<45 years', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}]}, {'title': '45-64 years', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 237}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-11', 'studyFirstSubmitDate': '2008-11-26', 'resultsFirstSubmitDate': '2011-09-14', 'studyFirstSubmitQcDate': '2009-03-16', 'lastUpdatePostDateStruct': {'date': '2014-01-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-12-20', 'studyFirstPostDateStruct': {'date': '2009-03-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Categorical Visualization Score (CVS)', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The primary visualization variables (number \\[no.\\] of lesions detected, border delineation, contrast enhancement, internal morphology) were condensed to a composite score (CVS). Each variable was considered a category; the CVS was calculated as: CVS=(No. of categories with increase over precontrast)-(No. of categories with decrease over precontrast). The possible outcomes of the CVS for a participant and each reader were in the range of - 3 to +4. The CVS was averaged across the 3 blinded readers, producing 1 mean CVS per participant. The higher the CVS, the more effective the treatment.'}, {'measure': 'Difference in Number of Lesions Detected in Pre-contrast and Combined Pre-/Post-contrast MRI.', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'Three blinded readers evaluated the unenhanced MRI sets and the combined unenhanced/gadobutrol-enhanced MRI sets to evaluate the number of lesions, which was then averaged to produce an average reader value.'}, {'measure': 'Assessment of Lesion Contrast Enhancement', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded readers assessed the degree of contrast enhancement for each lesion on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement, which was then averaged to produce an average reader score.'}, {'measure': 'Assessment of Border Delineation', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded readers assessed the delineation for each lesion on a 4-point scale where 1 = none and 4 = excellent, which was then averaged to produce an average reader score.'}, {'measure': 'Assessment of Internal Morphology', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded readers assessed the degree of information available about internal morphology and structure for each lesion on a 3-point scale where 1 = poor and 3 = good, which was then averaged to produce an average reader score.'}, {'measure': 'Contrast to Noise Ratio (CNR) Between White and Gray Matter With Gadobutrol Perfusion MRI', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'CNR between white and gray matter in the perfusion imaging was defined as the signal intensity (SI) difference between white and gray matter divided by the standard deviation of the SI of white matter. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.'}], 'secondaryOutcomes': [{'measure': 'Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 1', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for blinded reader (BR) 1.'}, {'measure': 'Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 2', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 2'}, {'measure': 'Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 3', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 3'}, {'measure': 'Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 1', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 1'}, {'measure': 'Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 2', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 2'}, {'measure': 'Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 3', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 3'}, {'measure': 'Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The gadobutrol-enhanced and unenhanced MRI diagnoses of the average reader were compared to the final diagnosis.'}, {'measure': 'Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The diagnostic confidence, the level of certainty in a diagnosis, was determined based on the average of the blinded readers.'}, {'measure': 'Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 1 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 2 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 3 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 1 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 2 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 3 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 1 evaluated the visibility of the lesion(s) on the CBF perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 2 evaluated the visibility of the lesion(s) on the CBF perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 3 evaluated the visibility of the lesion(s) on the CBF perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 1 evaluated the visibility of the lesion(s) on the TTP perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 2 evaluated the visibility of the lesion(s) on the TTP perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 3 evaluated the visibility of the lesion(s) on the TTP perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 1 evaluated the visibility of the lesion(s) on the MTT perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 2 evaluated the visibility of the lesion(s) on the MTT perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 3 evaluated the visibility of the lesion(s) on the MTT perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 1 evaluated the visibility of the lesion(s) on the PF perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 2 evaluated the visibility of the lesion(s) on the PF perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'BR 3 evaluated the visibility of the lesion(s) on the PF perfusion map.'}, {'measure': 'Evaluation of Perfusion Map Parameter Value (Uncorrected Cerebral Blood Volume (CBV)) - Independent Radiologist', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The independent radiologist determined the uncorrected CBV for each lesion. CBV is the volume of blood in the tissue.'}, {'measure': 'Evaluation of Perfusion Map Parameter Value (Corrected Cerebral Blood Volume (CBV)) - Independent Radiologist', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The independent radiologist determined the corrected CBV for each lesion. CBV is the volume of blood in the tissue.'}, {'measure': 'Evaluation of Perfusion Map Parameter Value (Cerebral Blood Flow (CBF)) - Independent Radiologist', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The independent radiologist determined the CBF for each lesion. CBF is the volume of blood passing through tissue per unit of time.'}, {'measure': 'Evaluation of Perfusion Map Parameter Value (Time to Peak (TTP)) - Independent Radiologist', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The independent radiologist determined the TTP for each lesion. TTP is the delay between the arrival of the contrast agent bolus arrival time and the peak of the concentration curve.'}, {'measure': 'Evaluation of Perfusion Map Parameter Value (Mean Transit Time (MTT)) - Independent Radiologist', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The independent radiologist determined the MTT for each lesion. The MTT is the time (seconds) for contrast to pass through tissues.'}, {'measure': 'Evaluation of Perfusion Map Parameter Value (Permeability Factor (PF)) - Independent Radiologist', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The independent radiologist determined the PF for each lesion'}, {'measure': 'Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded reader evaluated if artifacts were present on the uncorrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time.'}, {'measure': 'Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded reader evaluated if artifacts were present on the corrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time. CBV is the fraction of the tissue volume occupied by the blood.'}, {'measure': 'Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded reader evaluated if artifacts were present on the CBF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time'}, {'measure': 'Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded reader evaluated if artifacts were present on the TTP perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time'}, {'measure': 'Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded reader evaluated if artifacts were present on the MTT perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time'}, {'measure': 'Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded reader evaluated if artifacts were present on the PF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time'}, {'measure': 'Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'The blinded readers gave an estimation of the tumor grade of brain tumors (low grade \\[I or II\\] or high grade \\[III or IV\\]) in terms of malignancy using the information obtained by perfusion imaging, which was compared to the biopsy sample results'}, {'measure': 'Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter', 'timeFrame': 'up to 2 hours after the injection of study medication', 'description': 'CNR between lesion/gray matter and lesion/white matter in the perfusion imaging was defined as the signal intensity (SI) difference between lesion and gray or white matter divided by the standard deviation of background noise. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contrast Agents'], 'conditions': ['Brain Diseases', 'Spinal Cord Diseases']}, 'referencesModule': {'references': [{'pmid': '23681501', 'type': 'DERIVED', 'citation': 'Breuer J, Gutierrez J, Latchaw R, Lehr R, Sorensen AG. Gadobutrol in the central nervous system at three doses: results from a phase II, randomized, multicenter trial. J Magn Reson Imaging. 2014 Feb;39(2):410-8. doi: 10.1002/jmri.24180. Epub 2013 May 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI with Gadavist Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with OptiMARK.', 'detailedDescription': 'Safety issues are addressed in the Adverse Events section'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with either known or highly suspected focal areas of disruption of the blood brain barrier (BBB) (eg, primary and secondary tumors, focal inflammatory or demyelinating disorders) and/or abnormal vascularity in the CNS, who are scheduled to undergo a routine contrast-enhanced MRI of the CNS.\n* Patients with untreated brain tumors should constitute a minimum of 50% of the study population and patients with treated brain tumors will be limited to a maximum of 20% of the study population\n\nExclusion Criteria:\n\n* Is a female patient who is pregnant or nursing.\n* Is a female of childbearing potential and did not have a negative urine pregnancy test the same day as the administration of gadobutrol or comparator treatment.\n* Has received any investigational product within 30 days prior to enrolling in this study.\n* Has been previously enrolled in this study or any other study using gadobutrol.\n* Has any contraindication to the MRI examinations.\n* Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents.\n* Has received any contrast agent within 24 hours prior to gadobutrol contrast administration, or is scheduled to receive any contrast agent within 72 hours after the gadobutrol study.\n* Is considered to be clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure).\n* Has been treated with high dose (\\>55 cobalt Gy equivalent) photon radiation or global radiotherapy for CNS lesions at any time before entering the study.\n* Is scheduled to receive chemotherapy or radiotherapy during the study period.\n* Is expected or scheduled to have a change in any treatment or procedure between the comparator and gadobutrol MRIs that may alter their interpretation.\n* Is scheduled or is likely to require a biopsy or surgery within the 72 hours after the gadobutrol MRI procedure, or is scheduled for or has undergone such interventions between the comparator and gadobutrol studies.\n* Has severe cardiovascular disease.\n* Has any contraindication to OptiMARK according to the package insert.\n* Has more than 30 brain lesions detected by any prior imaging examination.'}, 'identificationModule': {'nctId': 'NCT00862459', 'briefTitle': 'Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Multi-center, Double-blind, Randomized, Controlled, Parallel Group, Dose Comparison Study With Corresponding Blinded Image Evaluation Following a Single Intravenous Injection of Three Different Doses of Gadobutrol 1.0 Molar (Gadavist) in Patients With Known or Suspected Focal Blood Brain Barrier Disturbances and/or Abnormal Vascularity of the Central Nervous System', 'orgStudyIdInfo': {'id': '91400'}, 'secondaryIdInfos': [{'id': '308200', 'type': 'OTHER', 'domain': 'company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg body weight (BW) of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.', 'interventionNames': ['Drug: Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)', 'Drug: OptiMARK~0.1 mmol/kg BW']}, {'type': 'EXPERIMENTAL', 'label': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.', 'interventionNames': ['Drug: Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)', 'Drug: OptiMARK~0.1 mmol/kg BW']}, {'type': 'EXPERIMENTAL', 'label': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.', 'interventionNames': ['Drug: Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)', 'Drug: OptiMARK~0.1 mmol/kg BW']}], 'interventions': [{'name': 'Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)', 'type': 'DRUG', 'description': 'Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.', 'armGroupLabels': ['Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)']}, {'name': 'Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)', 'type': 'DRUG', 'description': 'Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.', 'armGroupLabels': ['Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)']}, {'name': 'Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)', 'type': 'DRUG', 'description': 'Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.', 'armGroupLabels': ['Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)']}, {'name': 'OptiMARK~0.1 mmol/kg BW', 'type': 'DRUG', 'description': 'Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.', 'armGroupLabels': ['Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)', 'Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California-San Diego Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Shands Jacksonville Medical Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Neuroscience Institute', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Methodist Hospital', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19146', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center Health System', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Methodist Le Bonheur Healthcare', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin - Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'city': 'Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'TCba Salguero'}, {'zip': 'B1832BQS', 'city': 'Lornas de Zamora', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Fundacion Cientifica del Sur'}, {'zip': '01323-001', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital da Beneficiência Portuguesa', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Centro de Diagnostico Medico', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Fundación Instituto de Alta tecnología médica de Antioquia', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'city': 'Cali', 'state': 'Valle del Cauca Department', 'country': 'Colombia', 'facility': 'DIME Clinica Neurocardiovascular S.A.', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'city': 'Cali', 'country': 'Colombia', 'facility': 'Fundación Clínica Valle del Lili', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}