Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 10:45 AM
Study NCT ID:
NCT00395460
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2006-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D013122', 'term': 'Spinal Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C090600', 'term': 'gadobutrol'}, {'id': 'D019786', 'term': 'Gadolinium DTPA'}], 'ancestors': [{'id': 'D004369', 'term': 'Pentetic Acid'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'otherDetails': "PIs shall provide sponsor with an advance copy of any proposed publication or oral presentation at least ninety (90) days prior to the date of the planned submission or presentation. Sponsor shall have sixty (60) days to recommend any changes it reasonably believes are necessary for scientific purposes or to preserve the confidentiality of sponsor's confidential information. PIs agree that the adoption of such recommended changes shall not be unreasonably refused.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)', 'otherNumAtRisk': 71, 'otherNumAffected': 2, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)', 'description': 'Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec', 'otherNumAtRisk': 75, 'otherNumAffected': 4, 'seriousNumAtRisk': 75, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 10.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 10.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 10.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 10.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 10.0'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 10.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 10.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)'}, {'id': 'OG001', 'title': 'GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)', 'description': 'Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec'}], 'classes': [{'categories': [{'measurements': [{'value': '50.41', 'spread': '38.448', 'groupId': 'OG000'}, {'value': '43.47', 'spread': '39.178', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '6.939', 'ciLowerLimit': '-3.897', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '38.83', 'statisticalMethod': 'non-inferiority', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The analysis was performed by means of a Confidence Interval (CI) approach: noninferiority of Gadavist was assumed if the one-sided 95% CI for pGadavist-pMagnevist was lying entirely to the right of the value -delta, where p is the estimated change in CNR and with pre-defined non-inferiority margin delta of 15% (=6.52 or 15% of 43.467).'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'CNR = (signal intensity \\[SI\\] lesion - SI normal tissue) / standard deviation (SD) background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.', 'unitOfMeasure': 'Contrast to Noise ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Two participants in each treatment group had missing values for signal intensity for central nervous system lesions at pre- and post-contrast and could thus not be considered for evaluation.'}, {'type': 'SECONDARY', 'title': 'Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)'}, {'id': 'OG001', 'title': 'GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)', 'description': 'Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec'}], 'classes': [{'title': 'Investigator', 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Reader 2', 'categories': [{'measurements': [{'value': '1.4', 'spread': '6.94', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.87', 'groupId': 'OG001'}]}]}, {'title': 'Reader 3', 'categories': [{'measurements': [{'value': '1.7', 'spread': '9.72', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': 'Reader 4', 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.72', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'The number of lesions in the magnetic resonance scans was recorded before and after injection of contrast agent for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases'}, {'type': 'SECONDARY', 'title': 'Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)'}, {'id': 'OG001', 'title': 'GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)', 'description': 'Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec'}], 'classes': [{'title': 'Investigator - improved', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Investigator - unchanged', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Investigator - worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reader 2 - improved', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Reader 2 - unchanged', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Reader 2 - worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reader 3 - improved', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Reader 3 - unchanged', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Reader 3 - worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reader 4 - improved', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Reader 4 - unchanged', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Reader 4 - worsened', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'The change in diagnostic confidence was assessed based on post-contrast compared to pre-contrast scans as "improved", "unchanged" or "worsened" for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases.'}, {'type': 'SECONDARY', 'title': 'Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)'}, {'id': 'OG001', 'title': 'GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)', 'description': 'Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec'}], 'classes': [{'title': 'Investigator', 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Reader 2', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.22', 'groupId': 'OG001'}]}]}, {'title': 'Reader 3', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Reader 4', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'The degree of contrast enhancement was recorded on a 4-point scale as follows: 1 = No: lesion is not enhanced. 2 = Moderate: lesion is weakly enhanced. 3 = Good: lesion is clearly enhanced. 4 = Excellent: lesion is clearly and brightly enhanced. In case of more than one lesion, the lesion with maximum enhancement was to be assessed. The change in lesion contrast enhancement was assessed based on post-contrast in comparison to pre-contrast scans for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).', 'unitOfMeasure': 'Contrast enhancement score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Lesion contrast enhancement of 1 participant in the Gadavist group was assessed by the investigator (but not the blinded readers) as 'not applicable'."}, {'type': 'SECONDARY', 'title': 'Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)'}, {'id': 'OG001', 'title': 'GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)', 'description': 'Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec'}], 'classes': [{'title': 'Investigator', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Reader 2', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'Reader 3', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Reader 4', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'Lesion delineation was recorded on a 4-point scale as follows: 1 = None: no or unclear delineation of the boundary between lesion and surrounding tissue; 2 = Moderate: some aspects of border delineation covered; 3 = Good: almost clear delineation, but not complete on relevant slices; 4 = Excellent: sharp and complete delineation. In case of more than one lesion, the lesion with maximum enhancement was assessed. Change in lesion delineation was assessed based on post-contrast in comparison to pre-contrast scans for investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).', 'unitOfMeasure': 'Lesion delineation score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Lesion contrast enhancement of 1 participant in the Gadavist group was assessed by the investigator (but not the blinded readers) as 'not applicable'."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)'}, {'id': 'OG001', 'title': 'GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)', 'description': 'Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec'}], 'classes': [{'categories': [{'measurements': [{'value': '54.95', 'spread': '42.405', 'groupId': 'OG000'}, {'value': '46.56', 'spread': '30.074', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'CNR = (SI lesion - SI normal tissue) / SD background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.', 'unitOfMeasure': 'Contrast to Noise ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): All valid case participants who received contrast injection. Subgroup: those with primary malignant brain tumor(s) / brain metastases. One participant in the Gadavist group had missing values for signal intensity for central nervous system lesions at pre- and post-contrast and could thus not be considered for evaluation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)'}, {'id': 'OG001', 'title': 'GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)', 'description': 'Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec'}], 'classes': [{'categories': [{'measurements': [{'value': '48.51', 'spread': '36.985', 'groupId': 'OG000'}, {'value': '41.86', 'spread': '43.379', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'CNR = (SI lesion - SI normal tissue) / SD background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.', 'unitOfMeasure': 'Contrast to Noise ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): All valid case participants who received contrast injection. Subgroup: those with CNS lesions other than primary malignant brain tumor(s) / brain metastases. 1 (Gadavist) and 2 participants (Magnevist) had missing values for signal intensity for CNS lesions pre- and post-contrast and could not be considered for evaluation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)'}, {'id': 'OG001', 'title': 'GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)', 'description': 'Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec'}], 'classes': [{'title': 'Investigator', 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Reader 2', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Reader 3', 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Reader 4', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'Investigators and blinded readers (reader 2, 3 and 4) were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Subgroup: participants with primary malignant brain tumor(s) / brain metastases'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)'}, {'id': 'OG001', 'title': 'GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)', 'description': 'Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec'}], 'classes': [{'title': 'Investigator', 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reader 2', 'categories': [{'measurements': [{'value': '1.8', 'spread': '8.20', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '2.26', 'groupId': 'OG001'}]}]}, {'title': 'Reader 3', 'categories': [{'measurements': [{'value': '2.2', 'spread': '11.53', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.70', 'groupId': 'OG001'}]}]}, {'title': 'Reader 4', 'categories': [{'measurements': [{'value': '0.7', 'spread': '3.24', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'Investigators and blinded readers (reader 2, 3 and 4= were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Subgroup: participants with CNS lesions other than primary malignant brain tumor(s) / brain metastases'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)'}, {'id': 'FG001', 'title': 'GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)', 'description': 'Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'Received Treatment', 'achievements': [{'comment': '1 participant withdrew consent prior to study drug injection and did not receive any study drug.', 'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited at specialized study centers if they satisfied the inclusion and exclusion criteria. All had known or suspected central nervous system lesions (including cranial and spinal lesions) with an indication for contrast enhanced magnetic resonance imaging for diagnosis and further treatment.', 'preAssignmentDetails': 'Of 150 screened participants, 3 were not randomized (2 due to withdrawal of consent, and 1 due to poor physical condition). 147 participants were randomized to either Gadobutrol 0.1 mmol/kg body weight (BW) (72 participants) or Gadopentetate dimeglumine 0.1 mmol/kg BW (75 participants).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)', 'description': 'Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)'}, {'id': 'BG001', 'title': 'GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)', 'description': 'Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.8', 'spread': '12.24', 'groupId': 'BG000'}, {'value': '43.9', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '43.4', 'spread': '11.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-13', 'studyFirstSubmitDate': '2006-11-02', 'resultsFirstSubmitDate': '2011-07-04', 'studyFirstSubmitQcDate': '2006-11-02', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-21', 'studyFirstPostDateStruct': {'date': '2006-11-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'CNR = (SI lesion - SI normal tissue) / SD background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.'}, {'measure': 'Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'CNR = (SI lesion - SI normal tissue) / SD background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.'}, {'measure': 'Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'Investigators and blinded readers (reader 2, 3 and 4) were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.'}, {'measure': 'Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'Investigators and blinded readers (reader 2, 3 and 4= were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.'}], 'primaryOutcomes': [{'measure': 'Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'CNR = (signal intensity \\[SI\\] lesion - SI normal tissue) / standard deviation (SD) background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.'}], 'secondaryOutcomes': [{'measure': 'Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'The number of lesions in the magnetic resonance scans was recorded before and after injection of contrast agent for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).'}, {'measure': 'Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'The change in diagnostic confidence was assessed based on post-contrast compared to pre-contrast scans as "improved", "unchanged" or "worsened" for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).'}, {'measure': 'Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'The degree of contrast enhancement was recorded on a 4-point scale as follows: 1 = No: lesion is not enhanced. 2 = Moderate: lesion is weakly enhanced. 3 = Good: lesion is clearly enhanced. 4 = Excellent: lesion is clearly and brightly enhanced. In case of more than one lesion, the lesion with maximum enhancement was to be assessed. The change in lesion contrast enhancement was assessed based on post-contrast in comparison to pre-contrast scans for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).'}, {'measure': 'Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions', 'timeFrame': 'Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)', 'description': 'Lesion delineation was recorded on a 4-point scale as follows: 1 = None: no or unclear delineation of the boundary between lesion and surrounding tissue; 2 = Moderate: some aspects of border delineation covered; 3 = Good: almost clear delineation, but not complete on relevant slices; 4 = Excellent: sharp and complete delineation. In case of more than one lesion, the lesion with maximum enhancement was assessed. Change in lesion delineation was assessed based on post-contrast in comparison to pre-contrast scans for investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gadovist', 'Gadavist', 'Contrast agent', 'Brain', 'Spine disease', 'Magnetic Resonance Imaging'], 'conditions': ['Central Nervous System Diseases']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Liang Z; Ma L; Wang D; Huan Y; Li P; Yu J; Yao Z; Chen S; He H; Feng X and Breuer J. Efficacy and Safety of Gadobutrol (1.0 M) versus Gadopentetate Dimeglumine (0.5 M) for Enhanced MRI of CNS Lesions: A Phase III, Multicenter, SingleBlind, Randomized Study in Chinese Patients. Magnetic Resonance Insights 2012; 5:17-28'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.', 'detailedDescription': 'The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chinese origin, with known or suspected brain or spine diseases\n\nExclusion Criteria:\n\n* Pregnancy\n* Lactation\n* Conditions interfering with MRI\n* Allergy to any contrast agent or any drugs\n* Participation in other trial\n* Require emergency treatment\n* Severely impaired liver and kidney functions'}, 'identificationModule': {'nctId': 'NCT00395460', 'briefTitle': 'Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Single-blind, Multicenter, Randomized, Phase III Study of the Efficacy and Safety of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent for Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions in Chinese Patients', 'orgStudyIdInfo': {'id': '91536'}, 'secondaryIdInfos': [{'id': 'Project DE 00562', 'type': 'OTHER', 'domain': 'Company internal'}, {'id': '309761', 'type': 'OTHER', 'domain': 'Company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gadobutrol 0.1 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875)', 'description': 'Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)', 'interventionNames': ['Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)', 'description': 'Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec', 'interventionNames': ['Drug: Magnevist']}], 'interventions': [{'name': 'Gadobutrol (Gadavist, Gadovist, BAY86-4875)', 'type': 'DRUG', 'description': '1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW)', 'armGroupLabels': ['Gadobutrol 0.1 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875)']}, {'name': 'Magnevist', 'type': 'DRUG', 'description': '0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)', 'armGroupLabels': ['GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'The 1st Affiliated Hosp of the 4th Military Med Uni', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '100853', 'city': 'Beijing', 'country': 'China', 'facility': 'Chinese PLA General Hosp.', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200040', 'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}