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Trial record 4 of 12 for:    gadoteridol

Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00709852
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : March 6, 2012
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions Diagnostic Imaging
Central Nervous System Diseases
Interventions Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Drug: Gadoteridol (ProHance)
Enrollment 402
Recruitment Details The date of the first participant's first visit was 11 JUN 2008. The date of the last participant's last visit was 03 APR 2009.
Pre-assignment Details A total of 419 participants (part.) were screened; 17 prematurely discontinued prior to receiving any study drug. A total of 402 part. received study drug; 228 in gadobutrol : gadoteridol treatment sequence, 174 in gadoteridol : gadobutrol treatment sequence. Safety analysis set=402; gadobutrol=399, gadoteridol=393. Full analysis set (FAS)=336.
Arm/Group Title Gadobutrol (Gadavist, BAY86-4875) : Gadoteridol (ProHance) Gadoteridol (ProHance) : Gadobutrol (Gadavist, BAY86-4875)
Hide Arm/Group Description Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) in Period 1 and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 2. Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 1 and a single dose of gadobutrol 0.1 mmol/kg bw via i.v. in Period 2.
Period Title: Period 1
Started 228 174
Completed 220 171
Not Completed 8 3
Reason Not Completed
Adverse Event             2             0
Withdrawal by Subject             4             2
Protocol Violation             1             0
Defective scanner             0             1
Lost to Follow-up             1             0
Period Title: Period 2
Started 220 171
Completed 211 169
Not Completed 9 2
Reason Not Completed
Protocol Violation             4             1
Adverse Event             1             1
Lost to Follow-up             1             0
No 72-hour follow-up             3             0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes participants who received either treatment
Overall Number of Baseline Participants 402
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 402 participants
< 45 years 144
45-64 years 164
≥ 65 years 94
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 402 participants
Female
227
  56.5%
Male
175
  43.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 402 participants
Caucasian 235
Black 23
Hispanic 31
Asian 112
Other 1
1.Primary Outcome
Title Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)
Hide Description BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS); which used data from all participants for whom data and images were available for the unenhanced MRI, combined unenhanced and gadobutrol-enhanced MRI, and combined unenhanced and gadoteridol-enhanced MRI, excluding the sample participants (the first participant from each study site).
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 314 314
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement 0.94  (0.14) 2.21  (0.57)
border delineation 2.03  (0.37) 2.70  (0.53)
internal morphology 1.16  (0.26) 1.78  (0.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for contrast enhancement
Method paired t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.26
Parameter Dispersion
Type: Standard Deviation
Value: 0.61
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.67
Parameter Dispersion
Type: Standard Deviation
Value: 0.66
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.62
Parameter Dispersion
Type: Standard Deviation
Value: 0.47
Estimation Comments [Not Specified]
2.Primary Outcome
Title Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)
Hide Description BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 314 314
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement 1.01  (0.28) 2.60  (0.70)
border delineation 2.19  (0.49) 2.91  (0.60)
internal morphology 1.46  (0.37) 2.28  (0.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for contrast enhancement
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.59
Parameter Dispersion
Type: Standard Deviation
Value: 0.77
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.72
Parameter Dispersion
Type: Standard Deviation
Value: 0.78
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.82
Parameter Dispersion
Type: Standard Deviation
Value: 0.61
Estimation Comments [Not Specified]
3.Primary Outcome
Title Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)
Hide Description BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 312 312
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement 0.96  (0.16) 2.02  (0.46)
border delineation 1.73  (0.32) 2.16  (0.35)
internal morphology 1.34  (0.32) 1.76  (0.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for contrast enhancement
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.06
Parameter Dispersion
Type: Standard Deviation
Value: 0.51
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.43
Parameter Dispersion
Type: Standard Deviation
Value: 0.50
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.41
Parameter Dispersion
Type: Standard Deviation
Value: 0.52
Estimation Comments [Not Specified]
4.Primary Outcome
Title Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)
Hide Description The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 316 316
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement 0.97  (0.15) 2.26  (0.52)
border delineation 1.98  (0.30) 2.58  (0.43)
internal morphology 1.32  (0.24) 1.93  (0.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for contrast enhancement
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.29
Parameter Dispersion
Type: Standard Deviation
Value: 0.56
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.60
Parameter Dispersion
Type: Standard Deviation
Value: 0.53
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.61
Parameter Dispersion
Type: Standard Deviation
Value: 0.42
Estimation Comments [Not Specified]
5.Primary Outcome
Title Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers
Hide Description The blinded readers evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 336 336
Mean (Standard Deviation)
Unit of Measure: lesions
BR1 7.41  (13.05) 7.80  (12.92)
BR2 10.07  (16.60) 9.63  (15.04)
BR3 6.75  (8.97) 7.31  (9.13)
AR 8.08  (12.39) 8.25  (11.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments BR 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval for paired means
Comments lower limit of interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
-0.199 to 0.984
Parameter Dispersion
Type: Standard Deviation
Value: 5.51
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments BR 2
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval for paired means
Comments lower limit of confidence interval (CI) is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-1.772 to 0.885
Parameter Dispersion
Type: Standard Deviation
Value: 12.38
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments BR 3
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
0.125 to 1.000
Parameter Dispersion
Type: Standard Deviation
Value: 4.07
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments AR
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-0.439 to 0.780
Parameter Dispersion
Type: Standard Deviation
Value: 5.68
Estimation Comments [Not Specified]
6.Primary Outcome
Title Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)
Hide Description BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 310 310
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement 1.00  (0.04) 2.62  (0.30)
border delineation 2.14  (0.21) 2.95  (0.31)
internal morphology 1.26  (0.22) 2.03  (0.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for contrast enhancement
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.62
Parameter Dispersion
Type: Standard Deviation
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.81
Parameter Dispersion
Type: Standard Deviation
Value: 0.37
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.77
Parameter Dispersion
Type: Standard Deviation
Value: 0.38
Estimation Comments [Not Specified]
7.Primary Outcome
Title Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)
Hide Description BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 310 310
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement 1.15  (0.45) 3.28  (0.40)
border delineation 2.36  (0.33) 3.22  (0.37)
internal morphology 1.44  (0.31) 2.54  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for contrast enhancement
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.13
Parameter Dispersion
Type: Standard Deviation
Value: 0.62
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.86
Parameter Dispersion
Type: Standard Deviation
Value: 0.46
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.10
Parameter Dispersion
Type: Standard Deviation
Value: 0.39
Estimation Comments [Not Specified]
8.Primary Outcome
Title Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)
Hide Description BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 310 310
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement 1.04  (0.14) 2.39  (0.29)
border delineation 1.75  (0.20) 2.25  (0.28)
internal morphology 1.42  (0.21) 1.85  (0.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for contrast enhancement
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.36
Parameter Dispersion
Type: Standard Deviation
Value: 0.33
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.50
Parameter Dispersion
Type: Standard Deviation
Value: 0.33
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.43
Parameter Dispersion
Type: Standard Deviation
Value: 0.32
Estimation Comments [Not Specified]
9.Primary Outcome
Title Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)
Hide Description The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 310 310
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement 1.06  (0.16) 2.76  (0.23)
border delineation 2.09  (0.17) 2.81  (0.21)
internal morphology 1.38  (0.16) 2.14  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for contrast enhancement
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.70
Parameter Dispersion
Type: Standard Deviation
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.72
Parameter Dispersion
Type: Standard Deviation
Value: 0.23
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.76
Parameter Dispersion
Type: Standard Deviation
Value: 0.22
Estimation Comments [Not Specified]
10.Primary Outcome
Title Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)
Hide Description BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 267 267
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement 0.86  (0.30) 1.69  (1.04)
border delineation 1.89  (0.74) 2.40  (0.94)
internal morphology 1.04  (0.47) 1.48  (0.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for contrast enhancement
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.83
Parameter Dispersion
Type: Standard Deviation
Value: 1.16
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.52
Parameter Dispersion
Type: Standard Deviation
Value: 1.26
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.44
Parameter Dispersion
Type: Standard Deviation
Value: 0.82
Estimation Comments [Not Specified]
11.Primary Outcome
Title Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)
Hide Description BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 274 274
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement 0.87  (0.31) 1.75  (1.17)
border delineation 1.97  (0.83) 2.51  (1.06)
internal morphology 1.47  (0.67) 1.95  (0.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for contrast enhancement
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.89
Parameter Dispersion
Type: Standard Deviation
Value: 1.29
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.54
Parameter Dispersion
Type: Standard Deviation
Value: 1.44
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.48
Parameter Dispersion
Type: Standard Deviation
Value: 1.11
Estimation Comments [Not Specified]
12.Primary Outcome
Title Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)
Hide Description BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 277 277
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement 0.86  (0.30) 1.55  (0.83)
border delineation 1.72  (0.63) 2.05  (0.63)
internal morphology 1.26  (0.60) 1.64  (0.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for contrast enhancement
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.69
Parameter Dispersion
Type: Standard Deviation
Value: 0.95
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.33
Parameter Dispersion
Type: Standard Deviation
Value: 0.97
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.39
Parameter Dispersion
Type: Standard Deviation
Value: 0.96
Estimation Comments [Not Specified]
13.Primary Outcome
Title Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)
Hide Description The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 293 293
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement 0.85  (0.26) 1.62  (0.95)
border delineation 1.82  (0.62) 2.26  (0.81)
internal morphology 1.23  (0.47) 1.65  (0.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for contrast enhancement
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.78
Parameter Dispersion
Type: Standard Deviation
Value: 1.06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.44
Parameter Dispersion
Type: Standard Deviation
Value: 1.07
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.42
Parameter Dispersion
Type: Standard Deviation
Value: 0.83
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader
Hide Description The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadoteridol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Overall Number of Participants Analyzed 315 315
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement 0.98  (0.14) 2.22  (0.50)
border delineation 1.99  (0.28) 2.55  (0.41)
internal morphology 1.32  (0.22) 1.90  (0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for contrast enhancement
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.24
Parameter Dispersion
Type: Standard Deviation
Value: 0.53
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.56
Parameter Dispersion
Type: Standard Deviation
Value: 0.48
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.58
Parameter Dispersion
Type: Standard Deviation
Value: 0.41
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader
Hide Description The AR analysis used the mean of the values for the 3 blinded readers
Time Frame Up to 2 hours after injection of gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadoteridol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Overall Number of Participants Analyzed 336 336
Mean (Standard Deviation)
Unit of Measure: lesions
8.08  (12.39) 8.24  (11.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-0.532 to 0.851
Parameter Dispersion
Type: Standard Deviation
Value: 6.44
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
Hide Description The AR analysis used the mean of the values for the 3 blinded readers.
Time Frame Up to 2 hours after injection of gadobutrol or gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Combined Unenhanced/Gadobutrol-enhanced Combined Unenhanced/Gadoteridol-enhanced
Hide Arm/Group Description:
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Overall Number of Participants Analyzed 315 315
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement 2.28  (0.51) 2.24  (0.49)
border delineation 2.60  (0.39) 2.56  (0.39)
internal morphology 1.94  (0.34) 1.91  (0.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments analysis for contrast enhancement
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval 95%
0.0004 to 0.078
Parameter Dispersion
Type: Standard Deviation
Value: 0.33
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments analysis for border delineation
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval 95%
-0.009 to 0.082
Parameter Dispersion
Type: Standard Deviation
Value: 0.41
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments analysis for internal morphology
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval 95%
-0.006 to 0.059
Parameter Dispersion
Type: Standard Deviation
Value: 0.29
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
Hide Description The AR analysis used the mean of the values for the 3 blinded readers
Time Frame Up to 2 hours after injection of gadobutrol or gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Combined Unenhanced/Gadobutrol-enhanced Combined Unenhanced/Gadoteridol-enhanced
Hide Arm/Group Description:
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Overall Number of Participants Analyzed 336 336
Mean (Standard Deviation)
Unit of Measure: lesions
8.25  (11.40) 8.24  (11.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval 95%
-0.601 to 0.622
Parameter Dispersion
Type: Standard Deviation
Value: 5.70
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Unenhanced MRI by Blinded Readers
Hide Description The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another and determined the number of lesion from each.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Compared to Combined Unenhanced/Gadobutrol-enhanced Combined Unenhanced/Gadobutrol-enhanced Compared to Unenhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent. Lesions detected by Unenhanced MRI were compared to Combined Unenhanced/Gadobutrol-enhanced MRI.
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous). Lesions detected by Combined Unenhanced/Gadobutrol-enhanced MRI were compared to Unenhanced MRI.
Overall Number of Participants Analyzed 336 336
Measure Type: Number
Unit of Measure: percentage of participants
BR1 26.5 34.8
BR2 35.4 34.5
BR3 24.4 40.2
AR 35.1 44.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced Compared to Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadobutrol-enhanced Compared to Unenhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 8.3
Estimation Comments for BR1
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced Compared to Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadobutrol-enhanced Compared to Unenhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -0.9
Estimation Comments for BR2
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unenhanced Compared to Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadobutrol-enhanced Compared to Unenhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 15.8
Estimation Comments for BR3
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Unenhanced Compared to Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadobutrol-enhanced Compared to Unenhanced
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -10%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired percentages
Comments confidence interval is given for AR; lower limit is compared to the noninferiority margin
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 8.9
Confidence Interval (2-Sided) 95%
-0.5 to 18.4
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadoteridol-enhanced MRI or for Unenhanced MRI by Average Reader
Hide Description The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another and determined the number of lesion from each.
Time Frame Up to 2 hours after injection of gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Compared to Gadoteridol-enhanced Gadoteridol-enhanced Compared to Unenhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent. Lesions detected by Unenhanced MRI were compared to Combined Unenhanced/Gadoteridol-enhanced MRI.
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. Lesions detected by Combined Unenhanced/Gadoteridol-enhanced MRI were compared to Unenhanced MRI.
Overall Number of Participants Analyzed 336 336
Measure Type: Number
Unit of Measure: percentage of participants
37.8 41.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced Compared to Gadoteridol-enhanced, Gadoteridol-enhanced Compared to Unenhanced
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -10%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired percentages
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 3.6
Confidence Interval 95%
-5.9 to 13.1
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
Hide Description The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs in one session and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another and determined the number of lesion from each.
Time Frame Up to 2 hours after injection of gadobutrol or gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Gadobutrol-enhanced Compared to Gadoteridol-enhanced Gadoteridol-enhanced Compared to Gadobutrol-enhanced
Hide Arm/Group Description:
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. Lesions detected by Combined Unenhanced/Gadobutrol-enhanced MRI were compared to Combined Unenhanced/Gadoteridol-enhanced MRI.
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. Lesions detected by Combined Unenhanced/Gadoteridol-enhanced MRI were compared to Combined Unenhanced/Gadobutrol-enhanced MRI.
Overall Number of Participants Analyzed 336 336
Measure Type: Number
Unit of Measure: percentage of participants
41.7 33.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced Compared to Gadoteridol-enhanced, Gadoteridol-enhanced Compared to Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -10%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired percentages
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 8.3
Confidence Interval 95%
-0.9 to 17.6
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Hide Description The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 329 329
Mean (Standard Deviation)
Unit of Measure: scores on a scale
border delineation 2.16  (0.62) 2.90  (0.62)
internal morphology 1.77  (0.55) 2.38  (0.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.74
Parameter Dispersion
Type: Standard Deviation
Value: 0.78
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.61
Parameter Dispersion
Type: Standard Deviation
Value: 0.61
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Hide Description The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 336 336
Mean (Standard Deviation)
Unit of Measure: lesions
3.46  (7.99) 3.75  (8.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.29
Confidence Interval 95%
-0.053 to 0.636
Parameter Dispersion
Type: Standard Deviation
Value: 3.21
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Hide Description The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 310 310
Mean (Standard Deviation)
Unit of Measure: scores on a scale
border delineation 2.13  (0.55) 2.90  (0.54)
internal morphology 1.76  (0.48) 2.40  (0.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.77
Parameter Dispersion
Type: Standard Deviation
Value: 0.64
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.64
Parameter Dispersion
Type: Standard Deviation
Value: 0.50
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Hide Description The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 272 272
Mean (Standard Deviation)
Unit of Measure: scores on a scale
border delineation 2.20  (0.95) 2.94  (0.99)
internal morphology 1.80  (0.80) 2.36  (0.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.74
Parameter Dispersion
Type: Standard Deviation
Value: 1.26
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.56
Parameter Dispersion
Type: Standard Deviation
Value: 0.97
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Hide Description The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadoteridol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Overall Number of Participants Analyzed 329 329
Mean (Standard Deviation)
Unit of Measure: scores on a scale
border delineation 2.17  (0.61) 2.88  (0.60)
internal morphology 1.78  (0.55) 2.36  (0.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.71
Parameter Dispersion
Type: Standard Deviation
Value: 0.76
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.58
Parameter Dispersion
Type: Standard Deviation
Value: 0.63
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Hide Description The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another to determine the total number of lesions.
Time Frame Up to 2 hours after injection of gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadoteridol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Overall Number of Participants Analyzed 336 336
Mean (Standard Deviation)
Unit of Measure: lesions
3.46  (7.99) 3.74  (8.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.28
Confidence Interval 95%
-0.087 to 0.641
Parameter Dispersion
Type: Standard Deviation
Value: 3.39
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Hide Description The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadoteridol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Overall Number of Participants Analyzed 310 310
Mean (Standard Deviation)
Unit of Measure: scores on a scale
border delineation 2.13  (0.55) 2.91  (0.52)
internal morphology 1.76  (0.48) 2.39  (0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.78
Parameter Dispersion
Type: Standard Deviation
Value: 0.61
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.63
Parameter Dispersion
Type: Standard Deviation
Value: 0.49
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Hide Description The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadoteridol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Overall Number of Participants Analyzed 270 270
Mean (Standard Deviation)
Unit of Measure: scores on a scale
border delineation 2.23  (0.94) 2.88  (0.97)
internal morphology 1.83  (0.79) 2.34  (0.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for border delineation
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.65
Parameter Dispersion
Type: Standard Deviation
Value: 1.27
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments for internal morphology
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.51
Parameter Dispersion
Type: Standard Deviation
Value: 1.01
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
Hide Description The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol or gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Combined Unenhanced/Gadobutrol-enhanced Combined Unenhanced/Gadoteridol-enhanced
Hide Arm/Group Description:
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Overall Number of Participants Analyzed 328 328
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement 2.67  (0.70) 2.60  (0.72)
border delineation 2.95  (0.55) 2.91  (0.56)
internal morphology 2.42  (0.45) 2.39  (0.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments analysis for contrast enhancement
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval 95%
0.030 to 0.096
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments analysis for border delineation
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval 95%
0.003 to 0.071
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments analysis for internal morphology
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval 95%
0.003 to 0.055
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
Hide Description The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the combined unenhanced and gadoteridol-enhanced MRIs in another to determine the total number of lesions.
Time Frame Up to 2 hours after injection of gadobutrol or gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Combined Unenhanced/Gadobutrol-enhanced Combined Unenhanced/Gadoteridol-enhanced
Hide Arm/Group Description:
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Overall Number of Participants Analyzed 336 336
Mean (Standard Deviation)
Unit of Measure: lesions
3.75  (8.09) 3.74  (8.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval 95%
-0.049 to 0.078
Parameter Dispersion
Type: Standard Deviation
Value: 0.59
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
Hide Description The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol or gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Combined Unenhanced/Gadobutrol-enhanced Combined Unenhanced/Gadoteridol-enhanced
Hide Arm/Group Description:
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Overall Number of Participants Analyzed 310 310
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement – gadobutrol combined 2.88  (0.52) 2.85  (0.54)
border delineation – gadobutrol combined 2.90  (0.54) 2.91  (0.52)
internal morphology – gadobutrol combined 2.40  (0.44) 2.39  (0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments analysis for contrast enhancement
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval 95%
-0.009 to 0.065
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments analysis for border delineation
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval 95%
-0.040 to 0.020
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments analysis for internal morphology
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval 95%
-0.015 to 0.035
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
Hide Description The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame Up to 2 hours after injection of gadobutrol or gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Combined Unenhanced/Gadobutrol-enhanced Combined Unenhanced/Gadoteridol-enhanced
Hide Arm/Group Description:
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Overall Number of Participants Analyzed 263 263
Mean (Standard Deviation)
Unit of Measure: scores on a scale
contrast enhancement 2.44  (1.21) 2.34  (1.22)
border delineation 3.04  (0.88) 2.94  (0.84)
internal morphology 2.44  (0.63) 2.39  (0.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments analysis for contrast enhancement
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval 95%
0.042 to 0.153
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments analysis for border delineation
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval 95%
0.030 to 0.161
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments analysis for internal morphology
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -0.35
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired means
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval 95%
0.006 to 0.098
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
Hide Description The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 225 225
Measure Type: Number
Unit of Measure: per. of the exact diagnostic matches
58.2 64.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0082
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 6.2
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Hide Description The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 292 292
Measure Type: Number
Unit of Measure: per. of the exact diagnostic matches
69.2 79.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 9.9
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
Hide Description The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadoteridol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.
Time Frame Up to 2 hours after injection of gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadoteridol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Overall Number of Participants Analyzed 219 219
Measure Type: Number
Unit of Measure: per. of the exact diagnostic matches
58.9 65.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0039
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 6.8
Estimation Comments [Not Specified]
36.Secondary Outcome
Title Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Hide Description The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadoteridol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.
Time Frame Up to 2 hours after injection of gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadoteridol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Overall Number of Participants Analyzed 292 292
Measure Type: Number
Unit of Measure: per. of the exact diagnostic matches
69.2 78.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 9.2
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader
Hide Description The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the combined unenhanced/gadoteridol-enhanced MR images were evaluated for consistency with the final clinical diagnosis.
Time Frame Up to 2 hours after injection of gadobutrol or gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Combined Unenhanced/Gadobutrol-enhanced Combined Unenhanced/Gadoteridol-enhanced
Hide Arm/Group Description:
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Overall Number of Participants Analyzed 229 229
Measure Type: Number
Unit of Measure: per. of the exact diagnostic matches
65.1 65.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -10%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired percentages
Comments lower limit of confidence interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -0.4
Confidence Interval 95%
-3.8 to 2.9
Estimation Comments [Not Specified]
38.Secondary Outcome
Title Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
Hide Description The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the clinical investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the combined unenhanced/gadoteridol-enhanced MR images were evaluated for consistency with the final clinical diagnosis.
Time Frame Up to 2 hours after injection of gadobutrol or gadoteridol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Combined Unenhanced/Gadobutrol-enhanced Combined Unenhanced/Gadoteridol-enhanced
Hide Arm/Group Description:
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Overall Number of Participants Analyzed 292 292
Measure Type: Number
Unit of Measure: per. of the exact diagnostic matches
79.1 78.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Unenhanced/Gadobutrol-enhanced, Combined Unenhanced/Gadoteridol-enhanced
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments noninferiority margin = -10%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method CI for paired percentages
Comments lower limit of interval is compared to noninferiority margin
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 0.7
Confidence Interval 95%
-0.3 to 1.6
Estimation Comments [Not Specified]
39.Secondary Outcome
Title Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images
Hide Description The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.
Time Frame Up to 2 hours after injection of gadobutrol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS with assessments for this outcome measure.
Arm/Group Title Unenhanced Combined Unenhanced/Gadobutrol-enhanced
Hide Arm/Group Description:
Participants had diagnostic imaging before receiving any contrast agent
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
Overall Number of Participants Analyzed 267 267
Measure Type: Number
Unit of Measure: percentage of participants
66.7 77.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced, Combined Unenhanced/Gadobutrol-enhanced
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 10.5
Estimation Comments [Not Specified]
40.Secondary Outcome
Title Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images