Brain Diseases, Spinal Cord Diseases
Conditions
Keywords
Contrast Agents
Brief summary
The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI with Gadavist Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with OptiMARK.
Detailed description
Safety issues are addressed in the Adverse Events section
Interventions
DRUGGadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
DRUGGadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
DRUGGadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
DRUGOptiMARK~0.1 mmol/kg BW
Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with either known or highly suspected focal areas of disruption of the blood brain barrier (BBB) (eg, primary and secondary tumors, focal inflammatory or demyelinating disorders) and/or abnormal vascularity in the CNS, who are scheduled to undergo a routine contrast-enhanced MRI of the CNS. * Patients with untreated brain tumors should constitute a minimum of 50% of the study population and patients with treated brain tumors will be limited to a maximum of 20% of the study population
Exclusion criteria
* Is a female patient who is pregnant or nursing. * Is a female of childbearing potential and did not have a negative urine pregnancy test the same day as the administration of gadobutrol or comparator treatment. * Has received any investigational product within 30 days prior to enrolling in this study. * Has been previously enrolled in this study or any other study using gadobutrol. * Has any contraindication to the MRI examinations. * Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents. * Has received any contrast agent within 24 hours prior to gadobutrol contrast administration, or is scheduled to receive any contrast agent within 72 hours after the gadobutrol study. * Is considered to be clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure). * Has been treated with high dose (\>55 cobalt Gy equivalent) photon radiation or global radiotherapy for CNS lesions at any time before entering the study. * Is scheduled to receive chemotherapy or radiotherapy during the study period. * Is expected or scheduled to have a change in any treatment or procedure between the comparator and gadobutrol MRIs that may alter their interpretation. * Is scheduled or is likely to require a biopsy or surgery within the 72 hours after the gadobutrol MRI procedure, or is scheduled for or has undergone such interventions between the comparator and gadobutrol studies. * Has severe cardiovascular disease. * Has any contraindication to OptiMARK according to the package insert. * Has more than 30 brain lesions detected by any prior imaging examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Categorical Visualization Score (CVS) | up to 2 hours after the injection of study medication | The primary visualization variables (number \[no.\] of lesions detected, border delineation, contrast enhancement, internal morphology) were condensed to a composite score (CVS). Each variable was considered a category; the CVS was calculated as: CVS=(No. of categories with increase over precontrast)-(No. of categories with decrease over precontrast). The possible outcomes of the CVS for a participant and each reader were in the range of - 3 to +4. The CVS was averaged across the 3 blinded readers, producing 1 mean CVS per participant. The higher the CVS, the more effective the treatment. |
| Difference in Number of Lesions Detected in Pre-contrast and Combined Pre-/Post-contrast MRI. | up to 2 hours after the injection of study medication | Three blinded readers evaluated the unenhanced MRI sets and the combined unenhanced/gadobutrol-enhanced MRI sets to evaluate the number of lesions, which was then averaged to produce an average reader value. |
| Assessment of Lesion Contrast Enhancement | up to 2 hours after the injection of study medication | The blinded readers assessed the degree of contrast enhancement for each lesion on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement, which was then averaged to produce an average reader score. |
| Assessment of Border Delineation | up to 2 hours after the injection of study medication | The blinded readers assessed the delineation for each lesion on a 4-point scale where 1 = none and 4 = excellent, which was then averaged to produce an average reader score. |
| Assessment of Internal Morphology | up to 2 hours after the injection of study medication | The blinded readers assessed the degree of information available about internal morphology and structure for each lesion on a 3-point scale where 1 = poor and 3 = good, which was then averaged to produce an average reader score. |
| Contrast to Noise Ratio (CNR) Between White and Gray Matter With Gadobutrol Perfusion MRI | up to 2 hours after the injection of study medication | CNR between white and gray matter in the perfusion imaging was defined as the signal intensity (SI) difference between white and gray matter divided by the standard deviation of the SI of white matter. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI | up to 2 hours after the injection of study medication | The gadobutrol-enhanced and unenhanced MRI diagnoses of the average reader were compared to the final diagnosis. |
| Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI | up to 2 hours after the injection of study medication | The diagnostic confidence, the level of certainty in a diagnosis, was determined based on the average of the blinded readers. |
| Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | up to 2 hours after the injection of study medication | BR 1 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map. |
| Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | up to 2 hours after the injection of study medication | BR 2 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map. |
| Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | up to 2 hours after the injection of study medication | BR 3 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map. |
| Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | up to 2 hours after the injection of study medication | BR 1 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map. |
| Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | up to 2 hours after the injection of study medication | BR 2 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map. |
| Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | up to 2 hours after the injection of study medication | BR 3 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map. |
| Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | up to 2 hours after the injection of study medication | BR 1 evaluated the visibility of the lesion(s) on the CBF perfusion map. |
| Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | up to 2 hours after the injection of study medication | BR 2 evaluated the visibility of the lesion(s) on the CBF perfusion map. |
| Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | up to 2 hours after the injection of study medication | BR 3 evaluated the visibility of the lesion(s) on the CBF perfusion map. |
| Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | up to 2 hours after the injection of study medication | BR 1 evaluated the visibility of the lesion(s) on the TTP perfusion map. |
| Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | up to 2 hours after the injection of study medication | BR 2 evaluated the visibility of the lesion(s) on the TTP perfusion map. |
| Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | up to 2 hours after the injection of study medication | BR 3 evaluated the visibility of the lesion(s) on the TTP perfusion map. |
| Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | up to 2 hours after the injection of study medication | BR 1 evaluated the visibility of the lesion(s) on the MTT perfusion map. |
| Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | up to 2 hours after the injection of study medication | BR 2 evaluated the visibility of the lesion(s) on the MTT perfusion map. |
| Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | up to 2 hours after the injection of study medication | BR 3 evaluated the visibility of the lesion(s) on the MTT perfusion map. |
| Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | up to 2 hours after the injection of study medication | BR 1 evaluated the visibility of the lesion(s) on the PF perfusion map. |
| Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | up to 2 hours after the injection of study medication | BR 2 evaluated the visibility of the lesion(s) on the PF perfusion map. |
| Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | up to 2 hours after the injection of study medication | BR 3 evaluated the visibility of the lesion(s) on the PF perfusion map. |
| Evaluation of Perfusion Map Parameter Value (Uncorrected Cerebral Blood Volume (CBV)) - Independent Radiologist | up to 2 hours after the injection of study medication | The independent radiologist determined the uncorrected CBV for each lesion. CBV is the volume of blood in the tissue. |
| Evaluation of Perfusion Map Parameter Value (Corrected Cerebral Blood Volume (CBV)) - Independent Radiologist | up to 2 hours after the injection of study medication | The independent radiologist determined the corrected CBV for each lesion. CBV is the volume of blood in the tissue. |
| Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 1 | up to 2 hours after the injection of study medication | The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for blinded reader (BR) 1. |
| Evaluation of Perfusion Map Parameter Value (Time to Peak (TTP)) - Independent Radiologist | up to 2 hours after the injection of study medication | The independent radiologist determined the TTP for each lesion. TTP is the delay between the arrival of the contrast agent bolus arrival time and the peak of the concentration curve. |
| Evaluation of Perfusion Map Parameter Value (Mean Transit Time (MTT)) - Independent Radiologist | up to 2 hours after the injection of study medication | The independent radiologist determined the MTT for each lesion. The MTT is the time (seconds) for contrast to pass through tissues. |
| Evaluation of Perfusion Map Parameter Value (Permeability Factor (PF)) - Independent Radiologist | up to 2 hours after the injection of study medication | The independent radiologist determined the PF for each lesion |
| Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | up to 2 hours after the injection of study medication | The blinded reader evaluated if artifacts were present on the uncorrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time. |
| Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | up to 2 hours after the injection of study medication | The blinded reader evaluated if artifacts were present on the corrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time. CBV is the fraction of the tissue volume occupied by the blood. |
| Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | up to 2 hours after the injection of study medication | The blinded reader evaluated if artifacts were present on the CBF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time |
| Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | up to 2 hours after the injection of study medication | The blinded reader evaluated if artifacts were present on the TTP perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time |
| Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | up to 2 hours after the injection of study medication | The blinded reader evaluated if artifacts were present on the MTT perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time |
| Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | up to 2 hours after the injection of study medication | The blinded reader evaluated if artifacts were present on the PF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time |
| Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group | up to 2 hours after the injection of study medication | The blinded readers gave an estimation of the tumor grade of brain tumors (low grade \[I or II\] or high grade \[III or IV\]) in terms of malignancy using the information obtained by perfusion imaging, which was compared to the biopsy sample results |
| Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter | up to 2 hours after the injection of study medication | CNR between lesion/gray matter and lesion/white matter in the perfusion imaging was defined as the signal intensity (SI) difference between lesion and gray or white matter divided by the standard deviation of background noise. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity. |
| Evaluation of Perfusion Map Parameter Value (Cerebral Blood Flow (CBF)) - Independent Radiologist | up to 2 hours after the injection of study medication | The independent radiologist determined the CBF for each lesion. CBF is the volume of blood passing through tissue per unit of time. |
| Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 2 | up to 2 hours after the injection of study medication | The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 2 |
| Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 3 | up to 2 hours after the injection of study medication | The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 3 |
| Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 1 | up to 2 hours after the injection of study medication | The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 1 |
| Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 2 | up to 2 hours after the injection of study medication | The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 2 |
| Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 3 | up to 2 hours after the injection of study medication | The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 3 |
Countries
Argentina, Brazil, Colombia, United States
Participant flow
Recruitment details
The date of the first participant's first visit was 27 August 2005. The date of the last participant's last visit was 26 March 2007.
Pre-assignment details
242 participants were screened: 5 were screening failures (withdrew consent, did not meet study criteria, other). The remaining 237 were randomized to the 0.3, 0.1, or 0.03 millimole per kilogram (mmol/kg) group.
Participants by arm
| Arm | Count |
|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Participant received one dose of 0.03 millimole per kilogram of body weight (mmol/kg BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate. | 70 |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. | 90 |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. | 69 |
| Total | 229 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative problems | 0 | 1 | 0 |
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Inclusion/exclusion criteria not met | 0 | 1 | 0 |
| Overall Study | Intravenous (IV) site problems | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 | 2 |
| Overall Study | Operation | 1 | 1 | 0 |
| Overall Study | Personal reasons | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Unable to hold still for imaging | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 3 |
Baseline characteristics
| Characteristic | Total | Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) |
|---|---|---|---|---|
| Age, Customized 45-64 years | 91 Years | 24 Years | 39 Years | 28 Years |
| Age, Customized <45 years | 107 Years | 36 Years | 42 Years | 29 Years |
| Age, Customized >=65 years | 31 Years | 10 Years | 9 Years | 12 Years |
| Race/Ethnicity, Customized Asian | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 18 Participants | 7 Participants | 8 Participants | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 104 Participants | 30 Participants | 45 Participants | 29 Participants |
| Race/Ethnicity, Customized Hispanic | 12 Participants | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 93 Participants | 29 Participants | 30 Participants | 34 Participants |
| Sex: Female, Male Female | 129 Participants | 33 Participants | 58 Participants | 38 Participants |
| Sex: Female, Male Male | 100 Participants | 37 Participants | 32 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 19 / 67 | 30 / 90 | 22 / 68 | 23 / 227 |
| serious Total, serious adverse events | 0 / 67 | 1 / 90 | 0 / 68 | 1 / 227 |
Outcome results
Primary
Assessment of Border Delineation
The blinded readers assessed the delineation for each lesion on a 4-point scale where 1 = none and 4 = excellent, which was then averaged to produce an average reader score.
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding subjects with no lesion detected)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Border Delineation | 0.28 scores on a scale | Standard Deviation 0.6 |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Border Delineation | 0.68 scores on a scale | Standard Deviation 0.61 |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Border Delineation | 0.70 scores on a scale | Standard Deviation 0.6 |
95% CI: [-0.619, -0.17]confidence interval using t-distribution
95% CI: [-0.25, 0.22]confidence interval using t-distribution
Primary
Assessment of Internal Morphology
The blinded readers assessed the degree of information available about internal morphology and structure for each lesion on a 3-point scale where 1 = poor and 3 = good, which was then averaged to produce an average reader score.
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding subjects with no lesion detected)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Internal Morphology | 0.52 scores on a scale | Standard Deviation 0.5 |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Internal Morphology | 0.90 scores on a scale | Standard Deviation 0.57 |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Internal Morphology | 0.80 scores on a scale | Standard Deviation 0.51 |
95% CI: [-0.58, -0.18]confidence interval using t-distribution
95% CI: [-0.1, 0.31]confidence interval using t-distribution
Primary
Assessment of Lesion Contrast Enhancement
The blinded readers assessed the degree of contrast enhancement for each lesion on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement, which was then averaged to produce an average reader score.
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding subjects with no lesion detected)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Lesion Contrast Enhancement | 0.98 scores on a scale | Standard Deviation 0.93 |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Lesion Contrast Enhancement | 1.78 scores on a scale | Standard Deviation 1.07 |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Lesion Contrast Enhancement | 1.79 scores on a scale | Standard Deviation 1.15 |
95% CI: [-1.17, -0.42]confidence interval using t-distribution
95% CI: [-0.44, 0.41]confidence interval using t-distribution
Primary
Categorical Visualization Score (CVS)
The primary visualization variables (number \[no.\] of lesions detected, border delineation, contrast enhancement, internal morphology) were condensed to a composite score (CVS). Each variable was considered a category; the CVS was calculated as: CVS=(No. of categories with increase over precontrast)-(No. of categories with decrease over precontrast). The possible outcomes of the CVS for a participant and each reader were in the range of - 3 to +4. The CVS was averaged across the 3 blinded readers, producing 1 mean CVS per participant. The higher the CVS, the more effective the treatment.
Time frame: up to 2 hours after the injection of study medication
Population: The per protocol set (PPS), which included all participants with valid images who received +/-10% of the intended dose of study drug and had no major protocol or Magnetic Resonance Imaging (MRI) procedure deviations (excluding one participant with insufficient images)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Categorical Visualization Score (CVS) | 1.43 Scores on a scale | Standard Deviation 1.07 |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Categorical Visualization Score (CVS) | 2.02 Scores on a scale | Standard Deviation 1.04 |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Categorical Visualization Score (CVS) | 1.98 Scores on a scale | Standard Deviation 1.2 |
Comparison: 2 sample t-test between the dose groupsp-value: 0.003t-test, 2 sided
p-value: 0.844t-test, 2 sided
Primary
Contrast to Noise Ratio (CNR) Between White and Gray Matter With Gadobutrol Perfusion MRI
CNR between white and gray matter in the perfusion imaging was defined as the signal intensity (SI) difference between white and gray matter divided by the standard deviation of the SI of white matter. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding participants with insufficient images)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Contrast to Noise Ratio (CNR) Between White and Gray Matter With Gadobutrol Perfusion MRI | 9.42 CNR | Standard Deviation 11.4 |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Contrast to Noise Ratio (CNR) Between White and Gray Matter With Gadobutrol Perfusion MRI | 27.0 CNR | Standard Deviation 75.6 |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Contrast to Noise Ratio (CNR) Between White and Gray Matter With Gadobutrol Perfusion MRI | 22.2 CNR | Standard Deviation 15.2 |
Comparison: difference in CNR between doses and confidence interval95% CI: [-37.11, 2.02]confidence interval using t-distribution
95% CI: [-15.86, 25.35]confidence interval using t-distribution
Primary
Difference in Number of Lesions Detected in Pre-contrast and Combined Pre-/Post-contrast MRI.
Three blinded readers evaluated the unenhanced MRI sets and the combined unenhanced/gadobutrol-enhanced MRI sets to evaluate the number of lesions, which was then averaged to produce an average reader value.
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding one participant with insufficient images)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Difference in Number of Lesions Detected in Pre-contrast and Combined Pre-/Post-contrast MRI. | -0.03 Lesions per participant | Standard Deviation 1.82 |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Difference in Number of Lesions Detected in Pre-contrast and Combined Pre-/Post-contrast MRI. | 0.04 Lesions per participant | Standard Deviation 2.28 |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Difference in Number of Lesions Detected in Pre-contrast and Combined Pre-/Post-contrast MRI. | 0.09 Lesions per participant | Standard Deviation 2.22 |
95% CI: [-0.825, 0.69]confidence interval using t-distribution
95% CI: [-0.9, 0.79]confidence interval using t-distribution
Secondary
Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 1
The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 1
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding subjects with no enhanced lesion detected)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 1 | 48.10 percentage of lesions |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 1 | 72.73 percentage of lesions |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 1 | 55.21 percentage of lesions |
p-value: 0.0295% CI: [5.39, 43.86]Chi-squared
p-value: 0.1395% CI: [-24.41, 2.9]Chi-squared
Secondary
Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 2
The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 2
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding subjects with no enhanced lesion detected)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 2 | 69.23 percentage of lesions |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 2 | 82.14 percentage of lesions |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 2 | 63.77 percentage of lesions |
p-value: 0.0795% CI: [-1.44, 27.26]Chi-squared
p-value: 0.0295% CI: [-33.6, -1.35]Chi-squared
Secondary
Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 3
The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 3
Time frame: up to 2 hours after the injection of study medication
Population: PPS(excluding subjects with no enhanced lesion detected)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 3 | 55.07 percentage of lesions |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 3 | 73.53 percentage of lesions |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 3 | 68.24 percentage of lesions |
p-value: 0.0295% CI: [3.15, 33.77]Chi-squared
p-value: 0.4595% CI: [-18.83, 8.24]Chi-squared
Secondary
Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 1
The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for blinded reader (BR) 1.
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding subjects with no lesion detected)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 1 | 63.58 percentage of lesions |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 1 | 65.24 percentage of lesions |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 1 | 54.49 percentage of lesions |
p-value: 0.895% CI: [-10.93, 14.24]Chi-squared
p-value: 0.1395% CI: [-24.41, 2.9]Chi-squared
Secondary
Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 2
The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 2
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding subjects with no lesion detected)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 2 | 57.62 percentage of lesions |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 2 | 71.05 percentage of lesions |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 2 | 57.47 percentage of lesions |
p-value: 0.0395% CI: [1.53, 25.33]Chi-squared
p-value: 0.0295% CI: [-25.07, -2.09]Chi-squared
Secondary
Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 3
The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 3
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding subjects with no lesion detected)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 3 | 63.31 percentage of lesions |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 3 | 57.18 percentage of lesions |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 3 | 50.05 percentage of lesions |
p-value: 0.1195% CI: [-13.73, 1.48]Chi-squared
p-value: 0.5595% CI: [-6.59, 12.32]Chi-squared
Secondary
Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter
CNR between lesion/gray matter and lesion/white matter in the perfusion imaging was defined as the signal intensity (SI) difference between lesion and gray or white matter divided by the standard deviation of background noise. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding subjects who had no lesion detected, and those who had no value determined)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter | lesion gray | -0.03 CNR | Standard Deviation 13 |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter | lesion white | -10 CNR | Standard Deviation 12 |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter | lesion gray | 13.0 CNR | Standard Deviation 78.4 |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter | lesion white | -17 CNR | Standard Deviation 19.9 |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter | lesion gray | 5.38 CNR | Standard Deviation 25 |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter | lesion white | -17 CNR | Standard Deviation 20.4 |
Secondary
Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group
The blinded readers gave an estimation of the tumor grade of brain tumors (low grade \[I or II\] or high grade \[III or IV\]) in terms of malignancy using the information obtained by perfusion imaging, which was compared to the biopsy sample results
Time frame: up to 2 hours after the injection of study medication
Population: PPS participants with tumors
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group | Blinded Reader 2 | 40.0 Percentage of accuracy |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group | Blinded Reader 1 | 60.0 Percentage of accuracy |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group | Blinded Reader 3 | 60.0 Percentage of accuracy |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group | Blinded Reader 2 | 42.9 Percentage of accuracy |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group | Blinded Reader 1 | 57.1 Percentage of accuracy |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group | Blinded Reader 3 | 57.1 Percentage of accuracy |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group | Blinded Reader 1 | 40.0 Percentage of accuracy |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group | Blinded Reader 3 | 30.0 Percentage of accuracy |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group | Blinded Reader 2 | 40.0 Percentage of accuracy |
Secondary
Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
The blinded reader evaluated if artifacts were present on the CBF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time
Time frame: up to 2 hours after the injection of study medication
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - Missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 2- Missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 2- 0 none | 77 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 1 - Missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 2- other | 0 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 6.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 11.5 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 2- movement artifacts | 14.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 26.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - other | 8.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - EPI distortion | 6.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 1 - T2 artifacts | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - movement artifacts | 3.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - 0 none | 68.9 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 1 - other | 0 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 1 - 0 none | 70.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 1 - T2 artifacts | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 1 - Missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 1 - 0 none | 85.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 12.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 2- Missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 1 - other | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 2- 0 none | 82.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 7.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 2- movement artifacts | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 2- other | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - Missing | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - 0 none | 76.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - EPI distortion | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 8.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - movement artifacts | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - other | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - Missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 1 - T2 artifacts | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - other | 3.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - 0 none | 75 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 23.2 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - movement artifacts | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - EPI distortion | 12.5 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 1 - 0 none | 71.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 10.7 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 2- Missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 2- movement artifacts | 7.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 2- 0 none | 80.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 8.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 2- other | 1.8 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 1 - other | 5.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader | Blinded Reader 1 - Missing | 0 percentage of participants |
Secondary
Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
The blinded reader evaluated if artifacts were present on the corrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time. CBV is the fraction of the tissue volume occupied by the blood.
Time frame: up to 2 hours after the injection of study medication
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - 0 none | 78.7 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 21.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - 0 none | 55.7 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 6.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - 0 none | 75.4 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - Missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - movement artifacts | 13.1 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 6.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - other | 0 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - other | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - other | 8.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - Missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - Missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - movement artifacts | 23 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - EPI distortion | 4.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - EPI distortion | 12.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - Missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - 0 none | 76.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 23.2 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - other | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - Missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - 0 none | 80.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 8.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - movement artifacts | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - other | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - Missing | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - 0 none | 69.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - movement artifacts | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - other | 3.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - 0 none | 83.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - movement artifacts | 1.8 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - 0 none | 76.8 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - Missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - other | 5.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - EPI distortion | 12.5 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 28.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - Missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 3.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - movement artifacts | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - 0 none | 66.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - other | 1.8 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 14.3 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - other | 5.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - Missing | 0 percentage of participants |
Secondary
Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
The blinded reader evaluated if artifacts were present on the MTT perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time
Time frame: up to 2 hours after the injection of study medication
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 2 - missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - 0 none | 80.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 2 - none | 41 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 3.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 2 - other | 3.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - T2 artifacts | 0 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 2 - movement artifacts | 52.5 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - other | 9.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - EPI distortion | 8.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - movement artifacts | 0 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - movement artifacts | 26.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - 0 none | 50.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - other | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 16.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 2 - other | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - 0 none | 67.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 30.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - T2 artifacts | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - movement artifacts | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - other | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 2 - missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 2 - none | 71.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 5.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 2 - movement artifacts | 23.2 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - missing | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - 0 none | 66.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - EPI distortion | 7.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 5.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - movement artifacts | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - other | 8.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - 0 none | 71.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - movement artifacts | 1.8 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - other | 3.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - 0 none | 69.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - T2 artifacts | 1.8 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - movement artifacts | 5.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - EPI distortion | 16.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 19.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 8.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 5.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 2 - movement artifacts | 16.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 2 - none | 73.2 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 2 - missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 2 - other | 1.8 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader | Blinded Reader 1 - other | 5.4 percentage of participants |
Secondary
Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
The blinded reader evaluated if artifacts were present on the PF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time
Time frame: up to 2 hours after the injection of study medication
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 1 - other | 3.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 21.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 1 - T2 artifacts | 0 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 1 - movement artifacts | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 1 - 0 none | 73.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 2 - missing | 3.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 2 - 0 none | 73.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 4.9 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 2 - movement artifacts | 16.4 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 2 - other | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - missing | 4.9 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - 0 none | 37.7 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - EPI distortion | 8.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 4.9 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - movement artifacts | 36.1 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - other | 8.2 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 2 - missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 2 - 0 none | 75 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 8.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 2 - movement artifacts | 16.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 2 - other | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - other | 8.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - missing | 3.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 1 - 0 none | 75 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - movement artifacts | 14.3 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 23.2 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - 0 none | 51.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 1 - T2 artifacts | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 1 - movement artifacts | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 1 - other | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - EPI distortion | 10.7 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 2 - missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - EPI distortion | 12.5 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 1 - T2 artifacts | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 2 - 0 none | 73.2 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - other | 5.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 1 - 0 none | 71.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 12.5 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - 0 none | 69.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 1 - other | 1.8 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 2 - movement artifacts | 14.3 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 5.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 26.8 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 2 - other | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 1 - movement artifacts | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader | Blinded Reader 3 - movement artifacts | 7.1 percentage of participants |
Secondary
Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
The blinded reader evaluated if artifacts were present on the TTP perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time
Time frame: up to 2 hours after the injection of study medication
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 3 - missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 1- movement artifacts | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 3 - 0 none | 41 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 3 - EPI distortions | 4.9 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 1 - 0 none | 75.4 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 3.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 1 - other | 6.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader3 - movement artifacts | 26.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 2 - missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 2 - 0 none | 34.4 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 14.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 6.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 2 - movement artifacts | 37.7 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 1 - missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 2 - other | 19.7 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 3 - other | 23 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 21.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 2 - missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 1 - missing | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 3 - 0 none | 57.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 1- movement artifacts | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 3 - missing | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 3 - EPI distortions | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 2 - 0 none | 62.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 2 - movement artifacts | 19.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 8.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 2 - other | 8.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 8.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader3 - movement artifacts | 5.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 1 - other | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 3 - other | 16.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 1 - 0 none | 76.8 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 2 - other | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 1 - missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 1 - 0 none | 75 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 19.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 1- movement artifacts | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 1 - other | 5.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 2 - missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 2 - 0 none | 71.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 10.7 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 2 - movement artifacts | 17.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 3 - missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 3 - 0 none | 64.3 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 3 - EPI distortions | 12.5 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 8.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader3 - movement artifacts | 7.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader | Blinded Reader 3 - other | 7.1 percentage of participants |
Secondary
Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
The blinded reader evaluated if artifacts were present on the uncorrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time.
Time frame: up to 2 hours after the injection of study medication
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - other | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - 0 none | 72.1 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 24.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - movement artifacts | 0 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - Missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded reader 2 - Missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - 0 none | 62.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 3.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - movement artifacts | 32.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - other | 0 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - Missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - none | 62.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - EPI distortion | 6.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 3.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - movement artifacts | 14.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - other | 11.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded reader 2 - Missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - 0 none | 66.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - movement artifacts | 23.2 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - other | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - other | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - Missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - Missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - movement artifacts | 3.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - 0 none | 75 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - none | 67.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 23.2 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - movement artifacts | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - other | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - EPI distortion | 16.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - Missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded reader 2 - Missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - EPI distortion | 10.7 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - EPI distortion | 21.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - 0 none | 89.3 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - other | 3.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - Missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - EPI distortion | 5.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - none | 78.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - other | 7.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - movement artifacts | 3.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - T2 artifacts | 3.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - 0 none | 69.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 2 - other | 1.8 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 1 - movement artifacts | 1.8 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader | Blinded Reader 3 - movement artifacts | 3.6 percentage of participants |
Secondary
Evaluation of Perfusion Map Parameter Value (Cerebral Blood Flow (CBF)) - Independent Radiologist
The independent radiologist determined the CBF for each lesion. CBF is the volume of blood passing through tissue per unit of time.
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding subjects whose parameter map value was not determined)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Cerebral Blood Flow (CBF)) - Independent Radiologist | 4.80 mL / 100 g tissue / min. | Standard Deviation 6.37 |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Cerebral Blood Flow (CBF)) - Independent Radiologist | 5.15 mL / 100 g tissue / min. | Standard Deviation 4.3 |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Cerebral Blood Flow (CBF)) - Independent Radiologist | 3.48 mL / 100 g tissue / min. | Standard Deviation 2.24 |
Secondary
Evaluation of Perfusion Map Parameter Value (Corrected Cerebral Blood Volume (CBV)) - Independent Radiologist
The independent radiologist determined the corrected CBV for each lesion. CBV is the volume of blood in the tissue.
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding subjects whose parameter map value was not determined)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Corrected Cerebral Blood Volume (CBV)) - Independent Radiologist | 2728.71 mL / 100 g tissue | Standard Deviation 2788.59 |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Corrected Cerebral Blood Volume (CBV)) - Independent Radiologist | 2682.97 mL / 100 g tissue | Standard Deviation 1493.95 |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Corrected Cerebral Blood Volume (CBV)) - Independent Radiologist | 3382.20 mL / 100 g tissue | Standard Deviation 1908.56 |
Secondary
Evaluation of Perfusion Map Parameter Value (Mean Transit Time (MTT)) - Independent Radiologist
The independent radiologist determined the MTT for each lesion. The MTT is the time (seconds) for contrast to pass through tissues.
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding subjects whose parameter map value was not determined)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Mean Transit Time (MTT)) - Independent Radiologist | 6.30 seconds | Standard Deviation 4.77 |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Mean Transit Time (MTT)) - Independent Radiologist | 6.02 seconds | Standard Deviation 3.71 |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Mean Transit Time (MTT)) - Independent Radiologist | 7.05 seconds | Standard Deviation 4.54 |
Secondary
Evaluation of Perfusion Map Parameter Value (Permeability Factor (PF)) - Independent Radiologist
The independent radiologist determined the PF for each lesion
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding subjects whose parameter map value was not determined)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Permeability Factor (PF)) - Independent Radiologist | 4.04 seconds | Standard Deviation 3.35 |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Permeability Factor (PF)) - Independent Radiologist | 1.65 seconds | Standard Deviation 0.82 |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Permeability Factor (PF)) - Independent Radiologist | 0.99 seconds | Standard Deviation 1.88 |
Secondary
Evaluation of Perfusion Map Parameter Value (Time to Peak (TTP)) - Independent Radiologist
The independent radiologist determined the TTP for each lesion. TTP is the delay between the arrival of the contrast agent bolus arrival time and the peak of the concentration curve.
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding subjects whose parameter map value was not determined)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Time to Peak (TTP)) - Independent Radiologist | 79.39 seconds | Standard Deviation 25.43 |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Time to Peak (TTP)) - Independent Radiologist | 80.31 seconds | Standard Deviation 27.21 |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Time to Peak (TTP)) - Independent Radiologist | 86.52 seconds | Standard Deviation 28.7 |
Secondary
Evaluation of Perfusion Map Parameter Value (Uncorrected Cerebral Blood Volume (CBV)) - Independent Radiologist
The independent radiologist determined the uncorrected CBV for each lesion. CBV is the volume of blood in the tissue.
Time frame: up to 2 hours after the injection of study medication
Population: PPS (excluding subjects whose parameter map value was not determined)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Uncorrected Cerebral Blood Volume (CBV)) - Independent Radiologist | 114.61 mL / 100 g tissue | Standard Deviation 127.75 |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Uncorrected Cerebral Blood Volume (CBV)) - Independent Radiologist | 346.81 mL / 100 g tissue | Standard Deviation 313.49 |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Parameter Value (Uncorrected Cerebral Blood Volume (CBV)) - Independent Radiologist | 1209.89 mL / 100 g tissue | Standard Deviation 1121.63 |
Secondary
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1
BR 1 evaluated the visibility of the lesion(s) on the CBF perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | moderate | 14.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | poor | 31.1 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | Not Appl. | 6.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | excellent | 23 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | good | 9.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | not visible | 13.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | poor | 7.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | Not Appl. | 12.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | not visible | 14.3 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | moderate | 17.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | good | 17.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | excellent | 30.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | moderate | 12.5 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | excellent | 17.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | good | 30.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | poor | 14.3 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | not visible | 23.2 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1 | Not Appl. | 1.8 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2
BR 2 evaluated the visibility of the lesion(s) on the CBF perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | moderate | 23 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | poor | 21.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | Not Appl. | 8.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | excellent | 9.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | good | 24.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | not visible | 11.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | poor | 8.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | Not Appl. | 12.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | not visible | 12.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | moderate | 25 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | good | 16.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | excellent | 25 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | moderate | 25 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | excellent | 25 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | good | 8.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | poor | 19.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | not visible | 12.5 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2 | Not Appl. | 8.9 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3
BR 3 evaluated the visibility of the lesion(s) on the CBF perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | moderate | 31.1 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | poor | 14.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | Not Appl. | 13.1 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | excellent | 6.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | good | 18 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | not visible | 14.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | poor | 21.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | Not Appl. | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | missing | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | not visible | 17.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | moderate | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | good | 19.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | excellent | 17.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | moderate | 10.7 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | excellent | 17.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | good | 17.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | poor | 12.5 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | not visible | 25 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3 | Not Appl. | 16.1 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1
BR 1 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | moderate | 21.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | poor | 24.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | Not Appl. | 8.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | excellent | 18 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | good | 19.7 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | not visible | 6.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | poor | 19.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | Not Appl. | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | not visible | 14.3 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | moderate | 8.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | good | 21.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | excellent | 25 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | moderate | 8.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | excellent | 21.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | good | 30.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | poor | 10.7 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | not visible | 25 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1 | Not Appl. | 3.6 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
BR 2 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | moderate | 23 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | poor | 21.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | Not Appl. | 11.5 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | excellent | 9.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | good | 26.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | not visible | 6.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | poor | 14.3 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | Not Appl. | 16.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | not visible | 5.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | moderate | 21.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | good | 17.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | excellent | 25 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | moderate | 14.3 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | excellent | 25 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | good | 32.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | poor | 7.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | not visible | 14.3 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | Not Appl. | 7.1 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
BR 3 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | moderate | 19.7 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | poor | 24.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | Not Appl. | 11.5 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | excellent | 6.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | good | 21.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | not visible | 14.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | poor | 12.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | Not Appl. | 12.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | missing | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | not visible | 19.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | moderate | 17.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | good | 16.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | excellent | 19.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | moderate | 10.7 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | excellent | 14.3 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | good | 23.2 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | poor | 10.7 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | not visible | 23.2 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | Not Appl. | 17.9 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1
BR 1 evaluated the visibility of the lesion(s) on the MTT perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | moderate | 26.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | poor | 19.7 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | Not Appl. | 8.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | excellent | 8.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | good | 19.7 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | not visible | 16.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | poor | 19.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | Not Appl. | 7.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | not visible | 16.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | moderate | 12.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | good | 26.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | excellent | 17.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | moderate | 14.3 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | excellent | 17.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | good | 25 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | poor | 19.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | not visible | 19.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1 | Not Appl. | 3.6 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2
BR 2 evaluated the visibility of the lesion(s) on the MTT perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | moderate | 16.4 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | poor | 37.7 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | Not Appl. | 13.1 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | excellent | 3.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | good | 13.1 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | not visible | 14.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | poor | 30.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | Not Appl. | 16.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | not visible | 14.3 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | moderate | 16.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | good | 12.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | excellent | 10.7 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | moderate | 17.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | excellent | 12.5 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | good | 19.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | poor | 23.2 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | not visible | 14.3 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2 | Not Appl. | 12.5 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3
BR 3 evaluated the visibility of the lesion(s) on the MTT perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | moderate | 29.5 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | poor | 19.7 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | Not Appl. | 11.5 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | excellent | 4.9 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | good | 13.1 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | not visible | 19.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | poor | 12.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | Not Appl. | 12.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | missing | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | not visible | 25 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | moderate | 30.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | good | 7.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | excellent | 10.7 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | moderate | 12.5 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | excellent | 16.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | good | 17.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | poor | 16.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | not visible | 21.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3 | Not Appl. | 16.1 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1
BR 1 evaluated the visibility of the lesion(s) on the PF perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | Not Appl. | 13.1 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | not visible | 11.5 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | poor | 21.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | moderate | 13.1 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | good | 19.7 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | excellent | 21.3 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | excellent | 17.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | Not Appl. | 8.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | moderate | 7.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | good | 21.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | not visible | 21.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | poor | 23.2 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | not visible | 28.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | poor | 19.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | excellent | 14.3 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | moderate | 17.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | Not Appl. | 1.8 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1 | good | 17.9 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2
BR 2 evaluated the visibility of the lesion(s) on the PF perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | missing | 3.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | moderate | 26.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | poor | 21.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | Not Appl. | 14.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | excellent | 8.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | good | 19.7 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | not visible | 6.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | poor | 17.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | Not Appl. | 16.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | not visible | 14.3 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | moderate | 28.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | good | 16.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | excellent | 7.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | moderate | 25 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | excellent | 7.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | good | 26.8 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | poor | 16.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | not visible | 16.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2 | Not Appl. | 8.9 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3
BR 3 evaluated the visibility of the lesion(s) on the PF perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | good | 18 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | Not Appl. | 11.5 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | missing | 4.9 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | not visible | 13.1 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | poor | 24.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | moderate | 21.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | excellent | 6.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | moderate | 12.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | poor | 14.3 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | Not Appl. | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | not visible | 26.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | good | 21.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | missing | 3.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | excellent | 10.7 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | not visible | 25 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | excellent | 10.7 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | poor | 14.3 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | moderate | 12.5 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | Not Appl. | 19.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3 | good | 17.9 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1
BR 1 evaluated the visibility of the lesion(s) on the TTP perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | moderate | 9.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | poor | 29.5 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | Not Appl. | 6.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | excellent | 4.9 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | good | 13.1 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | not visible | 34.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | poor | 14.3 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | Not Appl. | 8.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | missing | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | not visible | 21.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | moderate | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | good | 17.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | excellent | 25 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | moderate | 10.7 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | excellent | 21.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | good | 14.3 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | poor | 21.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | not visible | 26.8 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1 | Not Appl. | 5.4 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2
BR 2 evaluated the visibility of the lesion(s) on the TTP perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | moderate | 11.5 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | poor | 26.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | Not Appl. | 24.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | excellent | 4.9 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | good | 13.1 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | not visible | 18 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | poor | 21.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | Not Appl. | 17.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | not visible | 5.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | moderate | 33.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | good | 17.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | excellent | 3.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | moderate | 23.2 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | excellent | 5.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | good | 17.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | poor | 30.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | not visible | 14.3 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2 | Not Appl. | 8.9 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3
BR 3 evaluated the visibility of the lesion(s) on the TTP perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | moderate | 18 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | poor | 23 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | Not Appl. | 11.5 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | excellent | 3.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | good | 9.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | not visible | 32.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | poor | 23.2 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | Not Appl. | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | missing | 1.8 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | not visible | 25 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | moderate | 19.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | good | 16.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | excellent | 3.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | moderate | 25 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | excellent | 8.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | good | 10.7 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | poor | 16.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | not visible | 21.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3 | Not Appl. | 17.9 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1
BR 1 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | moderate | 16.4 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | poor | 21.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | Not Applicable (Appl.) | 8.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | excellent | 13.1 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | good | 23 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | not visible | 16.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | poor | 17.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | Not Applicable (Appl.) | 7.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | not visible | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | moderate | 19.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | good | 19.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | excellent | 25 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | moderate | 12.5 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | excellent | 32.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | good | 17.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | poor | 12.5 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | not visible | 21.4 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1 | Not Applicable (Appl.) | 3.6 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
BR 2 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS. Due to rounding, the sum of percentages may range from 99.9 to 100.1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | moderate | 24.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | poor | 27.9 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | Not Appl. | 9.8 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | excellent | 8.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | good | 19.7 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | not visible | 8.2 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | poor | 12.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | Not Appl. | 10.7 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | not visible | 12.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | moderate | 21.4 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | good | 23.2 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | excellent | 19.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | moderate | 16.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | excellent | 25 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | good | 26.8 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | poor | 12.5 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | not visible | 8.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2 | Not Appl. | 10.7 percentage of participants |
Secondary
Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
BR 3 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.
Time frame: up to 2 hours after the injection of study medication
Population: PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | missing | 1.6 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | moderate | 26.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | poor | 23 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | Not Appl. | 11.5 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | excellent | 8.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | good | 16.4 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | not visible | 13.1 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | poor | 12.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | Not Appl. | 8.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | missing | 0 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | not visible | 23.2 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | moderate | 23.2 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | good | 12.5 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | excellent | 19.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | moderate | 16.1 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | missing | 0 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | excellent | 25 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | good | 10.7 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | poor | 12.5 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | not visible | 19.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3 | Not Appl. | 16.1 percentage of participants |
Secondary
Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI
The gadobutrol-enhanced and unenhanced MRI diagnoses of the average reader were compared to the final diagnosis.
Time frame: up to 2 hours after the injection of study medication
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI | yes | 62.3 percentage of exact matches |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI | no | 37.7 percentage of exact matches |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI | yes | 57.1 percentage of exact matches |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI | no | 42.9 percentage of exact matches |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI | yes | 54.2 percentage of exact matches |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI | no | 45.8 percentage of exact matches |
Secondary
Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI
The diagnostic confidence, the level of certainty in a diagnosis, was determined based on the average of the blinded readers.
Time frame: up to 2 hours after the injection of study medication
Population: PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI | not confident | 3.3 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI | somewhat confident | 23.0 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI | confident | 49.2 percentage of participants |
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI | very confident | 24.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI | very confident | 33.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI | not confident | 3.6 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI | confident | 33.9 percentage of participants |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI | somewhat confident | 28.6 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI | very confident | 33.9 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI | somewhat confident | 23.2 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI | confident | 39.3 percentage of participants |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI | not confident | 3.6 percentage of participants |