Dose Finding Study of Gadavist in Central Nervous System... | NCT00862459

ID	Type	Description	Link
308200	Other Identifier	company internal

Label	Type	Description	Intervention Names
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)	Experimental	Participant received one dose of 0.03 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg body weight (BW) of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.	Drug: Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) Drug: OptiMARK~0.1 mmol/kg BW
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)	Experimental	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.	Drug: Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) Drug: OptiMARK~0.1 mmol/kg BW
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)	Experimental	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.	Drug: Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) Drug: OptiMARK~0.1 mmol/kg BW

Name	Type	Description	Arm Group Labels	Other Names
Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)	Drug	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.

Measure	Description	Time Frame
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.	up to 2 hours after the injection of study medication
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.	up to 2 hours after the injection of study medication
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.	up to 2 hours after the injection of study medication
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.	up to 2 hours after the injection of study medication
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.

Measure	Description	Time Frame
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.

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of California Davis Medical Center		Sacramento	California	95817	United States
University of California-San Diego Medical Center

PubMed Identifier	Type	Citation	Retractions
23681501	Derived	Breuer J, Gutierrez J, Latchaw R, Lehr R, Sorensen AG. Gadobutrol in the central nervous system at three doses: results from a phase II, randomized, multicenter trial. J Magn Reson Imaging. 2014 Feb;39(2):410-8. doi: 10.1002/jmri.24180. Epub 2013 May 16.

ID	Title	Description
FG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)	Participant received one dose of 0.03 mmol/kg body weight (BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

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)

Posted

Mean

Standard Deviation

Scores on a scale

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

Units	Counts
Participants	OG00061 OG00155 OG00256

Title

Denominators

Categories

Title	Measurements
	OG0001.43± 1.07 OG0012.02± 1.04 OG0021.98± 1.20

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	2 sample t-test between the dose groups	t-test, 2 sided		0.003		Mean Difference (Final Values)	0.59	Standard Deviation	1.49								No	Superiority or Other
OG001 OG002		t-test, 2 sided

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.

PPS (excluding one participant with insufficient images)

Posted

Mean

Standard Deviation

Lesions per participant

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS (excluding subjects with no lesion detected)

Posted

Mean

Standard Deviation

scores on a scale

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS (excluding subjects with no lesion detected)

Posted

Mean

Standard Deviation

scores on a scale

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS (excluding subjects with no lesion detected)

Posted

Mean

Standard Deviation

scores on a scale

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS (excluding participants with insufficient images)

Posted

Mean

Standard Deviation

CNR

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS (excluding subjects with no lesion detected)

Posted

Number

percentage of lesions

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

Secondary

Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 2

PPS (excluding subjects with no lesion detected)

Posted

Number

percentage of lesions

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

Secondary

Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 3

PPS (excluding subjects with no lesion detected)

Posted

Number

percentage of lesions

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

Secondary

Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 1

PPS (excluding subjects with no enhanced lesion detected)

Posted

Number

percentage of lesions

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

Secondary

Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 2

PPS (excluding subjects with no enhanced lesion detected)

Posted

Number

percentage of lesions

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

Secondary

Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 3

PPS(excluding subjects with no enhanced lesion detected)

Posted

Number

percentage of lesions

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS

Posted

Number

percentage of exact matches

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS. Due to rounding, the sum of percentages may range from 99.9 to 100.1.

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS (excluding subjects whose parameter map value was not determined)

Posted

Mean

Standard Deviation

mL / 100 g tissue

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS (excluding subjects whose parameter map value was not determined)

Posted

Mean

Standard Deviation

mL / 100 g tissue

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS (excluding subjects whose parameter map value was not determined)

Posted

Mean

Standard Deviation

mL / 100 g tissue / min.

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS (excluding subjects whose parameter map value was not determined)

Posted

Mean

Standard Deviation

seconds

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS (excluding subjects whose parameter map value was not determined)

Posted

Mean

Standard Deviation

seconds

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

Secondary

Evaluation of Perfusion Map Parameter Value (Permeability Factor (PF)) - Independent Radiologist

The independent radiologist determined the PF for each lesion

PPS (excluding subjects whose parameter map value was not determined)

Posted

Mean

Standard Deviation

seconds

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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

PPS

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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

PPS

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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

PPS

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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

PPS

Posted

Number

percentage of participants

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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

PPS participants with tumors

Posted

Number

Percentage of accuracy

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

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.

PPS (excluding subjects who had no lesion detected, and those who had no value determined)

Posted

Mean

Standard Deviation

CNR

up to 2 hours after the injection of study medication

ID	Title	Description
OG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, 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.
OG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, 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.
OG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, 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.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Conjunctivitis	Eye disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG0030 affected227 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected90 at risk EG0020 affected68 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected90 at risk EG0020 affected68 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0022 affected68 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Faeces discoloured	Gastrointestinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected90 at risk EG0020 affected68 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0013 affected90 at risk EG0021 affected68 at risk EG003
Stomach discomfort	Gastrointestinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected90 at risk EG0020 affected68 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0021 affected68 at risk EG003
Application site erythema	General disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Asthenia	General disorders	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Chest pain	General disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Chills	General disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Feeling hot	General disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0022 affected68 at risk EG003
Influenza like illness	General disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Injection site erythema	General disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Injection site irritation	General disorders	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected90 at risk EG0020 affected68 at risk EG003
Injection site pain	General disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0012 affected90 at risk EG0020 affected68 at risk EG003
Malaise	General disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Oedema peripheral	General disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Vessel puncture site bruise	General disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA v9.1	Non-systematic Assessment	EG0002 affected67 at risk EG0010 affected90 at risk EG0020 affected68 at risk EG003
Blood sodium decreased	Investigations	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Electrocardiogram ST segment depression	Investigations	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected90 at risk EG0020 affected68 at risk EG003
Heart rate increased	Investigations	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Protein urine present	Investigations	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected90 at risk EG0020 affected68 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Burning sensation	Nervous system disorders	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected90 at risk EG0020 affected68 at risk EG003
Cerebellar syndrome	Nervous system disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Convulsion	Nervous system disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Dizziness	Nervous system disorders	MedDRA v9.1	Non-systematic Assessment	EG0002 affected67 at risk EG0012 affected90 at risk EG0021 affected68 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0012 affected90 at risk EG0020 affected68 at risk EG003
Headache	Nervous system disorders	MedDRA v9.1	Non-systematic Assessment	EG0008 affected67 at risk EG0017 affected90 at risk EG0023 affected68 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0022 affected68 at risk EG003
Paraparesis	Nervous system disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Petit mal epilepsy	Nervous system disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Somnolence	Nervous system disorders	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0011 affected90 at risk EG0021 affected68 at risk EG003
Claustrophobia	Psychiatric disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Insomnia	Psychiatric disorders	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected90 at risk EG0020 affected68 at risk EG003
Bladder discomfort	Renal and urinary disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA v9.1	Non-systematic Assessment	EG0002 affected67 at risk EG0010 affected90 at risk EG0020 affected68 at risk EG003
Galactorrhoea	Reproductive system and breast disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0021 affected68 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0021 affected68 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected90 at risk EG0020 affected68 at risk EG003
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Hot flush	Vascular disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0021 affected68 at risk EG003
Hyperaemia	Vascular disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Hypertension	Vascular disorders	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected90 at risk EG0020 affected68 at risk EG003
Hypotension	Vascular disorders	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected90 at risk EG0020 affected68 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA v9.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected90 at risk EG0020 affected68 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003

ID	Term
D001927	Brain Diseases
D013118	Spinal Cord Diseases

ID	Term
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)	Reporting Group 1 (RG1): Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.	0	67	19	67
EG001	Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)	Reporting group 2 (RG2): Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.	1	90	30	90
EG002	Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)	Reporting group 3 (RG3): Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.	0	68	22	68
EG003	Optimark~0.1mmol/kg BW	Reporting group 4 (RG4): Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.	1	227	23	227

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Brain oedema	Nervous system disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG0030 affected227 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Neurological symptom	Nervous system disorders	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected90 at risk EG0020 affected68 at risk EG003
Hospitalisation	Surgical and medical procedures	MedDRA v9.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected90 at risk EG0020 affected68 at risk EG003