Trial Outcomes & Findings for Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose (NCT NCT03602339)

NCT ID: NCT03602339

Last Updated: 2021-06-14

Results Overview

Degree of lesion contrast enhancement is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded Readers scored up to 5 lesions using image sequences and a 4-point scale (1 - No = Lesion not enhanced; 2 - Moderate = Lesion weakly enhanced; 3 - Good = Lesion clearly enhanced; 4 - Excellent = Lesion clearly and brightly enhanced).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 157 participants
• Primary outcome timeframe: Up to 20 days
• Results posted on: 2021-06-14

Participant Flow

Study was conducted at multiple centers in 7 countries between 14 November 2018 (first participant first visit) and 13 March 2020 (last participant last visit).

From 166 participants screened, 9 participants were screening failure and a total of 157 participants were enrolled, 157 received study drug for period 1 however 142 received study drug for period 2.

Participant milestones

Measure	Gadoterate 0.1 mmol/kg BW-Gadobutrol 0.075 mmol/kg BW Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight (BW) by single intravenous (IV) injection in Study Period 1 and gadobutrol at a dose of 0.075 mmol/kg BW by single IV injection in Study Period 2.
Overall Study STARTED	157
Overall Study Completed Period 1 (Gadoterate)	155
Overall Study Started Period 2 (Gadobutrol)	142
Overall Study COMPLETED	142
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	Gadoterate 0.1 mmol/kg BW-Gadobutrol 0.075 mmol/kg BW Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight (BW) by single intravenous (IV) injection in Study Period 1 and gadobutrol at a dose of 0.075 mmol/kg BW by single IV injection in Study Period 2.
Overall Study Withdrawal by Subject	9
Overall Study Physician Decision	2
Overall Study Other reason	4

Baseline Characteristics

Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose

Baseline characteristics by cohort

Measure	Gadoterate 0.1 mmol/kg BW-Gadobutrol 0.075 mmol/kg BW n=157 Participants Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight (BW) by single intravenous (IV) injection in Study Period 1 and gadobutrol at a dose of 0.075 mmol/kg BW by single IV injection in Study Period 2.
Age, Continuous	58.9 years STANDARD_DEVIATION 13.3 • n=5 Participants
Age, Customized In utero	0 Participants n=5 Participants
Age, Customized Preterm newborn infants (gestational age < 37 wks)	0 Participants n=5 Participants
Age, Customized Newborns (0-27 days)	0 Participants n=5 Participants
Age, Customized Infants and toddlers (28 days-23 months)	0 Participants n=5 Participants
Age, Customized Children (2-11 years)	0 Participants n=5 Participants
Age, Customized Adolescents (12-17 years)	0 Participants n=5 Participants
Age, Customized Adults (18-64 years)	94 Participants n=5 Participants
Age, Customized From 65-84 years	62 Participants n=5 Participants
Age, Customized 85 years and over	1 Participants n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants
Sex: Female, Male Male	86 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	27 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	109 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 20 days

Population: Full analysis set (FAS) was used for analysis, which is defined as All participants for whom electronic case report form (eCRF) entries and images are available for unenhanced MRI, combined unenhanced and gadobutrol enhanced MRI, and combined unenhanced and gadoterate enhanced MRI.

Degree of lesion contrast enhancement is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded Readers scored up to 5 lesions using image sequences and a 4-point scale (1 - No = Lesion not enhanced; 2 - Moderate = Lesion weakly enhanced; 3 - Good = Lesion clearly enhanced; 4 - Excellent = Lesion clearly and brightly enhanced).

Outcome measures

Measure	Gadoterate 0.1 mmol/kg BW n=141 Participants Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight by single intravenous (IV) injection.	Gadobutrol 0.075 mmol/kg BW n=141 Participants Participants received gadobutrol at a dose of 0.075 mmol/kg body weight by single intravenous (IV) injection.
Degree of Lesion Contrast Enhancement Unenhanced	0.884 Scores on a scale Standard Deviation 0.252	0.863 Scores on a scale Standard Deviation 0.201
Degree of Lesion Contrast Enhancement Combined unenhanced/enhanced	3.007 Scores on a scale Standard Deviation 0.813	2.979 Scores on a scale Standard Deviation 0.837

PRIMARY outcome

Timeframe: Up to 20 days

Population: Full analysis set (FAS) was used for analysis, which is defined as All participants for whom electronic case report form (eCRF) entries and images are available for unenhanced MRI, combined unenhanced and gadobutrol enhanced MRI, and combined unenhanced and gadoterate enhanced MRI.

Lesion border delineation is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded readers scored the delineation of up to 5 lesions using image sequences and a 4-point scale (1 - None = No or unclear delineation; 2 - Moderate = Partial delineation; 3 - Good = Almost clear, but incomplete delineation; 4 - Excellent = Clear and complete delineation).

Outcome measures

Measure	Gadoterate 0.1 mmol/kg BW n=141 Participants Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight by single intravenous (IV) injection.	Gadobutrol 0.075 mmol/kg BW n=141 Participants Participants received gadobutrol at a dose of 0.075 mmol/kg body weight by single intravenous (IV) injection.
Lesion Border Delineation Unenhanced	2.279 Scores on a scale Standard Deviation 0.820	2.278 Scores on a scale Standard Deviation 0.864
Lesion Border Delineation Combined unenhanced/enhanced	3.096 Scores on a scale Standard Deviation 0.781	3.099 Scores on a scale Standard Deviation 0.828

PRIMARY outcome

Timeframe: Up to 20 days

Population: Full analysis set (FAS) was used for analysis, which is defined as All participants for whom electronic case report form (eCRF) entries and images are available for unenhanced MRI, combined unenhanced and gadobutrol enhanced MRI, and combined unenhanced and gadoterate enhanced MRI.

Lesion internal morphology is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded Readers scored the structure and internal morphology of up to 5 lesions using image sequences and a 3-point scale (1 - Poor = Poor visibility; 2 - Moderate = Partial visibility; 3 - Good = Sufficient visibility)

Outcome measures

Measure	Gadoterate 0.1 mmol/kg BW n=141 Participants Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight by single intravenous (IV) injection.	Gadobutrol 0.075 mmol/kg BW n=141 Participants Participants received gadobutrol at a dose of 0.075 mmol/kg body weight by single intravenous (IV) injection.
Lesion Internal Morphology Unenhanced	1.835 Scores on a scale Standard Deviation 0.620	1.823 Scores on a scale Standard Deviation 0.589
Lesion Internal Morphology Combined unenhanced/enhanced	2.503 Scores on a scale Standard Deviation 0.496	2.484 Scores on a scale Standard Deviation 0.545

SECONDARY outcome

Timeframe: Up to 20 days

Population: Full analysis set (FAS) was used for analysis, which is defined as All subjects for whom electronic case report form (eCRF) entries and images are available for unenhanced MRI, combined unenhanced and gadobutrol enhanced MRI, and combined unenhanced and gadoterate enhanced MRI.

Number of lesions identified (up to 10) detected by 3 blinded Readers. The mean (SD) number lesions in the Average Reader for gadobutrol and gadoterate in the Full Analysis Set was reported below.

Outcome measures

Measure	Gadoterate 0.1 mmol/kg BW n=141 Participants Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight by single intravenous (IV) injection.	Gadobutrol 0.075 mmol/kg BW n=141 Participants Participants received gadobutrol at a dose of 0.075 mmol/kg body weight by single intravenous (IV) injection.
Number of Lesions Identified	2.064 Number of lesions identified Standard Deviation 2.254	2.137 Number of lesions identified Standard Deviation 2.327

SECONDARY outcome

Timeframe: Up to 20 days

Population: Full analysis set (FAS) was used for analysis, which is defined as All subjects for whom electronic case report form (eCRF) entries and images are available for unenhanced MRI, combined unenhanced and gadobutrol enhanced MRI, and combined unenhanced and gadoterate enhanced MRI.

The 3 Blinded Readers had to evaluate if the diagnosis resulting from the combined images was malignant disease or not. Each blinded Reader provided a malignant yes/no response. This was compared to the final diagnosis provided by the Investigator. The majority of Readers (2 or 3 Readers agree) was used to calculate sensitivity, specificity, and accuracy - eg. Final Diagnosis - Malignant (Reader 1-yes, Reader 2-no, Reader 3-yes --- Majority Reader yes) - this would be a match for sensitivity.

The percentage of sensitivity, specificity, and accuracy of detection of malignant disease detected by 3 blinded Readers, gadobutrol versus gadoterate (Full Analysis Set) is reported below for Majority Readers.

Outcome measures

Measure	Gadoterate 0.1 mmol/kg BW n=141 Participants Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight by single intravenous (IV) injection.	Gadobutrol 0.075 mmol/kg BW n=141 Participants Participants received gadobutrol at a dose of 0.075 mmol/kg body weight by single intravenous (IV) injection.
Detection of Malignant Disease Accuracy	70.2 Percentage (%)	70.2 Percentage (%)
Detection of Malignant Disease Sensitivity	58.7 Percentage (%)	58.7 Percentage (%)
Detection of Malignant Disease Specificity	91.8 Percentage (%)	91.8 Percentage (%)

SECONDARY outcome

Timeframe: Up to 20 days

Population: Full analysis set (FAS) was used for analysis, which is defined as All subjects for whom electronic case report form (eCRF) entries and images are available for unenhanced MRI, combined unenhanced and gadobutrol enhanced MRI, and combined unenhanced and gadoterate enhanced MRI.

Diagnostic confidence detected by 3 blinded Readers, gadobutrol vs gadoterate (Full Analysis Set). Blinded Readers rated their confidence in diagnosis according to a 4-point scale (1 - Not confident; 2 - Somewhat confident; 3 - Confident; 4 - Very confident). Results for the Average Reader are reported below.

Outcome measures

Measure	Gadoterate 0.1 mmol/kg BW n=141 Participants Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight by single intravenous (IV) injection.	Gadobutrol 0.075 mmol/kg BW n=141 Participants Participants received gadobutrol at a dose of 0.075 mmol/kg body weight by single intravenous (IV) injection.
Confidence in Diagnosis	3.272 Scores on a scale Standard Deviation 0.567	3.348 Scores on a scale Standard Deviation 0.591

SECONDARY outcome

Timeframe: Up to 20 days

Population: Full analysis set (FAS) was used for analysis, which is defined as All participants for whom electronic case report form (eCRF) entries and images are available for unenhanced MRI, combined unenhanced and gadobutrol enhanced MRI, and combined unenhanced and gadoterate enhanced MRI.

Comparison of image quality between gadobutrol and gadoterate detected by 3 blinded Readers (Full Analysis Set). Blinded Readers assessed the image quality of gadobutrol- and gadoterate-enhanced images (randomly assigned as left [L] and right [R] image positions) according to a 5-point scale (1- Image R is worse; 2 - Image R is slightly worse; 3- Image R is similar; 4 - Image R is slightly better; 5 - Image R is better). After unblinding of data, the above codes were translated into the following scale: -2 = Gadobutrol image set is worse ; -1 = Gadobutrol image set is slightly worse ; 0 = Image sets are the same ; 1 = Gadobutrol image set is slightly better; 2 = Gadobutrol image set is better. Results for the Average Reader are reported below.

Outcome measures

Measure	Gadoterate 0.1 mmol/kg BW n=141 Participants Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight by single intravenous (IV) injection.	Gadobutrol 0.075 mmol/kg BW Participants received gadobutrol at a dose of 0.075 mmol/kg body weight by single intravenous (IV) injection.
Image Quality	0.00 Scores on a scale Standard Deviation 0.61	—

SECONDARY outcome

Timeframe: Up to 20 days

Population: Full analysis set (FAS) was used for analysis, which is defined as All participants for whom electronic case report form (eCRF) entries and images are available for unenhanced MRI, combined unenhanced and gadobutrol enhanced MRI, and combined unenhanced and gadoterate enhanced MRI.

Comparison of contrast enhancement utilizing an overall contrast enhancement estimation algorithm (Full Analysis Set). The exploratory algorithm analyzed the overall enhancement by comparing the axial T1w (longitudinal relaxation time-weighted) enhanced images to the T1w unenhanced images.

Outcome measures

Measure	Gadoterate 0.1 mmol/kg BW n=88 Participants Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight by single intravenous (IV) injection.	Gadobutrol 0.075 mmol/kg BW n=89 Participants Participants received gadobutrol at a dose of 0.075 mmol/kg body weight by single intravenous (IV) injection.
Contrast Enhancement Utilizing an Exploratory Overall Contrast Enhancement Estimation Algorithm Relative score	0.19894 Scores on a scale Standard Deviation 0.09905	0.18564 Scores on a scale Standard Deviation 0.09028
Contrast Enhancement Utilizing an Exploratory Overall Contrast Enhancement Estimation Algorithm Full image score	0.05604 Scores on a scale Standard Deviation 0.08581	0.05573 Scores on a scale Standard Deviation 0.08036
Contrast Enhancement Utilizing an Exploratory Overall Contrast Enhancement Estimation Algorithm Dice score	0.92984 Scores on a scale Standard Deviation 0.04293	0.92991 Scores on a scale Standard Deviation 0.05216

SECONDARY outcome

Timeframe: From the first study drug administration up to 24 hours post injection

Population: The Safety analysis set (SAF) included all enrolled participants who received at least 1 study treatment administration.

Number of subjects with treatment-emergent adverse events (TEAEs) (Safety Analysis Set). TEAEs are defined as any AEs that increase in intensity or that are newly developed during the TE period for Study Period 1 or Study Period 2, where TE period for Study Period 1 goes from the first study drug administration in Study Period 1 to 24 hours post-injection, and TE period for Study Period 2 from the first study drug administration in Study Period 2 to 24 hours post-injection.

Outcome measures

Measure	Gadoterate 0.1 mmol/kg BW n=156 Participants Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight by single intravenous (IV) injection.	Gadobutrol 0.075 mmol/kg BW n=143 Participants Participants received gadobutrol at a dose of 0.075 mmol/kg body weight by single intravenous (IV) injection.
Number of Participants With Treatment-emergent Adverse Events Any TESAE	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events Any TEAE	4 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events Any study drug-related TEAE	2 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events Any TEAE related to the protocol	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events Any TEAE leading to discontinuation	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE with outcome death	0 Participants	0 Participants

POST_HOC outcome

Timeframe: Up to 20 days

Population: Full analysis set (FAS) was used for analysis, which is defined as All participants for whom electronic case report form (eCRF) entries and images are available for unenhanced MRI, combined unenhanced and gadobutrol enhanced MRI, and combined unenhanced and gadoterate enhanced MRI.

Comparison of degree of lesion contrast enhancement detected by blinded Readers for combined image sets - Equivalence Test (Full Analysis Set). Results are presented as the Average Reader score.

Blinded Readers scored up to 5 lesions using image sequences and a 4-point scale (1 - No = Lesion not enhanced; 2 - Moderate = Lesion weakly enhanced; 3 - Good = Lesion clearly enhanced; 4 - Excellent = Lesion clearly and brightly enhanced).

Outcome measures

Measure	Gadoterate 0.1 mmol/kg BW n=141 Participants Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight by single intravenous (IV) injection.	Gadobutrol 0.075 mmol/kg BW n=141 Participants Participants received gadobutrol at a dose of 0.075 mmol/kg body weight by single intravenous (IV) injection.
Comparison of Degree of Lesion Contrast Enhancement Detected by Blinded Readers for Combined Image Sets - Equivalence Test	3.007 Scores on a scale Standard Deviation 0.813	2.979 Scores on a scale Standard Deviation 0.837

POST_HOC outcome

Timeframe: Up to 20 days

Population: Full analysis set (FAS) was used for analysis, which is defined as All participants for whom electronic case report form (eCRF) entries and images are available for unenhanced MRI, combined unenhanced and gadobutrol enhanced MRI, and combined unenhanced and gadoterate enhanced MRI.

Comparison of border delineation detected by blinded Readers for combined image sets - Equivalence Test (Full Analysis Set). Results are presented as the Average Reader score. Blinded Readers scored the delineation of up to 5 lesions using image sequences and a 4-point scale (1 - None = No or unclear delineation; 2 - Moderate = Partial delineation; 3 - Good = Almost clear, but incomplete delineation; 4 - Excellent = Clear and complete delineation).

Outcome measures

Measure	Gadoterate 0.1 mmol/kg BW n=141 Participants Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight by single intravenous (IV) injection.	Gadobutrol 0.075 mmol/kg BW n=141 Participants Participants received gadobutrol at a dose of 0.075 mmol/kg body weight by single intravenous (IV) injection.
Comparison of Border Delineation Detected by Blinded Readers for Combined Image Sets - Equivalence Test	3.096 Scores on a scale Standard Deviation 0.781	3.099 Scores on a scale Standard Deviation 0.828

POST_HOC outcome

Timeframe: Up to 20 days

Population: Full analysis set (FAS) was used for analysis, which is defined as All participants for whom electronic case report form (eCRF) entries and images are available for unenhanced MRI, combined unenhanced and gadobutrol enhanced MRI, and combined unenhanced and gadoterate enhanced MRI.

Comparison of internal morphology detected by blinded Readers for combined image sets - Equivalence Test (Full Analysis Set). Results are presented as the average Reader score. Blinded Readers scored the structure and internal morphology of up to 5 lesions using image sequences and a 3-point scale (1 - Poor = Poor visibility; 2 - Moderate = Partial visibility; 3 - Good = Sufficient visibility).

Outcome measures

Measure	Gadoterate 0.1 mmol/kg BW n=141 Participants Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight by single intravenous (IV) injection.	Gadobutrol 0.075 mmol/kg BW n=141 Participants Participants received gadobutrol at a dose of 0.075 mmol/kg body weight by single intravenous (IV) injection.
Comparison of Internal Morphology Detected by Blinded Readers for Combined Image Sets - Equivalence Test	2.503 Scores on a scale Standard Deviation 0.496	2.484 Scores on a scale Standard Deviation 0.545

Adverse Events

Gadobutrol 0.075 mmol/kg BW

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Gadoterate 0.1 mmol/kg BW

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Gadobutrol 0.075 mmol/kg BW n=143 participants at risk Participants received gadobutrol at a dose of 0.075 mmol/kg body weight by single intravenous (IV) injection.	Gadoterate 0.1 mmol/kg BW n=156 participants at risk Participants received gadoterate at the standard dose of 0.1 mmol/kg body weight by single intravenous (IV) injection.
Gastrointestinal disorders Nausea	0.00% 0/143 • From the first study drug administration up to 24 hours post injection At study start 1 out of 157 participants received gadobutrol instead of gadoterate in study period 1. This participant dropped out and didn't receive gadoterate dose. That's why only 156 out of 157 participants received gadoterate. 156 participants received gadoterate and 143 participants received gadobutrol. 142 participants received both doses - of the 142 - 1 participant's dose extravasated and could not be adequately imaged and was removed from the efficacy population.	0.64% 1/156 • Number of events 1 • From the first study drug administration up to 24 hours post injection At study start 1 out of 157 participants received gadobutrol instead of gadoterate in study period 1. This participant dropped out and didn't receive gadoterate dose. That's why only 156 out of 157 participants received gadoterate. 156 participants received gadoterate and 143 participants received gadobutrol. 142 participants received both doses - of the 142 - 1 participant's dose extravasated and could not be adequately imaged and was removed from the efficacy population.
Nervous system disorders Paraesthesia	0.70% 1/143 • Number of events 1 • From the first study drug administration up to 24 hours post injection At study start 1 out of 157 participants received gadobutrol instead of gadoterate in study period 1. This participant dropped out and didn't receive gadoterate dose. That's why only 156 out of 157 participants received gadoterate. 156 participants received gadoterate and 143 participants received gadobutrol. 142 participants received both doses - of the 142 - 1 participant's dose extravasated and could not be adequately imaged and was removed from the efficacy population.	0.00% 0/156 • From the first study drug administration up to 24 hours post injection At study start 1 out of 157 participants received gadobutrol instead of gadoterate in study period 1. This participant dropped out and didn't receive gadoterate dose. That's why only 156 out of 157 participants received gadoterate. 156 participants received gadoterate and 143 participants received gadobutrol. 142 participants received both doses - of the 142 - 1 participant's dose extravasated and could not be adequately imaged and was removed from the efficacy population.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/143 • From the first study drug administration up to 24 hours post injection At study start 1 out of 157 participants received gadobutrol instead of gadoterate in study period 1. This participant dropped out and didn't receive gadoterate dose. That's why only 156 out of 157 participants received gadoterate. 156 participants received gadoterate and 143 participants received gadobutrol. 142 participants received both doses - of the 142 - 1 participant's dose extravasated and could not be adequately imaged and was removed from the efficacy population.	0.64% 1/156 • Number of events 1 • From the first study drug administration up to 24 hours post injection At study start 1 out of 157 participants received gadobutrol instead of gadoterate in study period 1. This participant dropped out and didn't receive gadoterate dose. That's why only 156 out of 157 participants received gadoterate. 156 participants received gadoterate and 143 participants received gadobutrol. 142 participants received both doses - of the 142 - 1 participant's dose extravasated and could not be adequately imaged and was removed from the efficacy population.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/143 • From the first study drug administration up to 24 hours post injection At study start 1 out of 157 participants received gadobutrol instead of gadoterate in study period 1. This participant dropped out and didn't receive gadoterate dose. That's why only 156 out of 157 participants received gadoterate. 156 participants received gadoterate and 143 participants received gadobutrol. 142 participants received both doses - of the 142 - 1 participant's dose extravasated and could not be adequately imaged and was removed from the efficacy population.	0.64% 1/156 • Number of events 1 • From the first study drug administration up to 24 hours post injection At study start 1 out of 157 participants received gadobutrol instead of gadoterate in study period 1. This participant dropped out and didn't receive gadoterate dose. That's why only 156 out of 157 participants received gadoterate. 156 participants received gadoterate and 143 participants received gadobutrol. 142 participants received both doses - of the 142 - 1 participant's dose extravasated and could not be adequately imaged and was removed from the efficacy population.
Eye disorders Visual impairment	0.00% 0/143 • From the first study drug administration up to 24 hours post injection At study start 1 out of 157 participants received gadobutrol instead of gadoterate in study period 1. This participant dropped out and didn't receive gadoterate dose. That's why only 156 out of 157 participants received gadoterate. 156 participants received gadoterate and 143 participants received gadobutrol. 142 participants received both doses - of the 142 - 1 participant's dose extravasated and could not be adequately imaged and was removed from the efficacy population.	0.64% 1/156 • Number of events 1 • From the first study drug administration up to 24 hours post injection At study start 1 out of 157 participants received gadobutrol instead of gadoterate in study period 1. This participant dropped out and didn't receive gadoterate dose. That's why only 156 out of 157 participants received gadoterate. 156 participants received gadoterate and 143 participants received gadobutrol. 142 participants received both doses - of the 142 - 1 participant's dose extravasated and could not be adequately imaged and was removed from the efficacy population.

Additional Information

Therapeutic Area Head

Bayer AG

Phone: (+) 1-888-8422937

Email: clinical-trials-contact@bayer.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60