Trial Outcomes & Findings for P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) (NCT NCT02633501)

NCT ID: NCT02633501

Last Updated: 2021-10-25

Results Overview

The Contrast-to-Noise Ratio (CNR) was calculated from the signal intensity measurement of maximum 3 enhanced lesions by 3 independent blinded readers. Only lesions detected by both MRIs after lesion tracking were used. The difference in CNR was calculated as follow: CNR (P03277) - CNR (gadobenate dimeglumine).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 312 participants
• Primary outcome timeframe: 1 day procedure
• Results posted on: 2021-10-25

Participant Flow

Among the 312 screened subjects, 32 subjects were screening failure. 280 subjects were randomized: 28 in subset 1 and 252 in subset 2. Images from the subset 1 were used for training of off-site readers and validation of imaging protocol. Consequently, these subjects were not included in the efficacy analysis but only in the safety assessment.

Participant milestones

Measure	Subset 1 - P03277 0.05 mmol/kg/Gadobenate Dimeglumine P03277 (0.05 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second	Subset 1 - P03277 0.1 mmol/kg/Gadobenate Dimeglumine P03277 (0.1 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second	Subset 2 - P03277 0.025 mmol/kg/Gadobenate Dimeglumine P03277 (0.025 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second	Subset 2 - P03277 0.05 mmol/kg/Gadobenate Dimeglumine P03277 (0.05 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second	Subset 2 - P03277 0.1 mmol/kg/Gadobenate Dimeglumine P03277 (0.1 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second	Subset 2 - P03277 0.2 mmol/kg/Gadobenate Dimeglumine P03277 (0.2 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second
Overall Study STARTED	14	14	62	63	64	63
Overall Study COMPLETED	12	11	55	59	53	48
Overall Study NOT COMPLETED	2	3	7	4	11	15

Reasons for withdrawal

Measure	Subset 1 - P03277 0.05 mmol/kg/Gadobenate Dimeglumine P03277 (0.05 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second	Subset 1 - P03277 0.1 mmol/kg/Gadobenate Dimeglumine P03277 (0.1 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second	Subset 2 - P03277 0.025 mmol/kg/Gadobenate Dimeglumine P03277 (0.025 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second	Subset 2 - P03277 0.05 mmol/kg/Gadobenate Dimeglumine P03277 (0.05 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second	Subset 2 - P03277 0.1 mmol/kg/Gadobenate Dimeglumine P03277 (0.1 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second	Subset 2 - P03277 0.2 mmol/kg/Gadobenate Dimeglumine P03277 (0.2 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI or vice versa P03277: Single intravenous (IV) bolus injection at a rate of 2 mL/second Gadobenate dimeglumine: Single IV bolus injection at a rate of 2 mL/second
Overall Study Adverse Event	0	0	1	0	1	1
Overall Study Withdrawal by Subject	2	1	2	2	1	3
Overall Study Various other reasons	0	2	4	1	7	11
Overall Study Lost to Follow-up	0	0	0	1	2	0

Baseline Characteristics

P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Baseline characteristics by cohort

Measure	Subset 2 - P03277 0.025 mmol/kg/Gadobenate Dimeglumine n=57 Participants P03277 (0.025 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	Subset 2 - P03277 0.05 mmol/kg/Gadobenate Dimeglumine n=62 Participants P03277 (0.05 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	Subset 2 - P03277 0.1 mmol/kg/Gadobenate Dimeglumine n=61 Participants P03277 (0.1 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	Subset 2 - P03277 0.2 mmol/kg/Gadobenate Dimeglumine n=60 Participants P03277 (0.2 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	Subset 1 - P03277 0.05 mmol/kg/Gadobenate Dimeglumine n=14 Participants P03277 (0.05 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	Subset 1 - P03277 0.1 mmol/kg/Gadobenate Dimeglumine n=14 Participants P03277 (0.1 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	Total n=268 Participants Total of all reporting groups
Age, Continuous	54.8 years STANDARD_DEVIATION 10.9 • n=5 Participants	54.0 years STANDARD_DEVIATION 14.8 • n=7 Participants	54.2 years STANDARD_DEVIATION 14.4 • n=5 Participants	52.1 years STANDARD_DEVIATION 13.7 • n=4 Participants	54.9 years STANDARD_DEVIATION 13.3 • n=21 Participants	56.1 years STANDARD_DEVIATION 16 • n=8 Participants	53.8 years STANDARD_DEVIATION 13.5 • n=8 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	39 Participants n=7 Participants	30 Participants n=5 Participants	39 Participants n=4 Participants	10 Participants n=21 Participants	5 Participants n=8 Participants	157 Participants n=8 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	23 Participants n=7 Participants	31 Participants n=5 Participants	21 Participants n=4 Participants	4 Participants n=21 Participants	9 Participants n=8 Participants	111 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	28 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	12 Participants n=8 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants	55 Participants n=7 Participants	49 Participants n=5 Participants	54 Participants n=4 Participants	10 Participants n=21 Participants	11 Participants n=8 Participants	226 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: 1 day procedure

Population: The analysis was done for each of the 3 independent off-site readers using the Per Protocol Set that included all subjects without major protocol deviations. A subject was analyzed as soon as he had a matching evaluation of the CNR at both MRIs by at least 1 off-site reader. Therefore, the numbers of subjects analyzed by reader could be different.

The Contrast-to-Noise Ratio (CNR) was calculated from the signal intensity measurement of maximum 3 enhanced lesions by 3 independent blinded readers. Only lesions detected by both MRIs after lesion tracking were used. The difference in CNR was calculated as follow: CNR (P03277) - CNR (gadobenate dimeglumine).

Outcome measures

Measure	P03277 0.025 mmol/kg - Gadobenate Dimeglumine - Reader 1 n=54 Participants P03277 (0.025 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	P03277 0.05 mmol/kg - Gadobenate Dimeglumine - Reader 1 n=56 Participants P03277 (0.05 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	P03277 0.1 mmol/kg - Gadobenate Dimeglumine - Reader 1 n=51 Participants P03277 (0.1 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	P03277 0.2 mmol/kg - Gadobenate Dimeglumine - Reader 1 n=44 Participants P03277 (0.2 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	P03277 0.025 mmol/kg - Gadobenate Dimeglumine - Reader 2 n=44 Participants P03277 (0.025 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	P03277 0.05 mmol/kg - Gadobenate Dimeglumine - Reader 2 n=47 Participants P03277 (0.05 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	P03277 0.1 mmol/kg - Gadobenate Dimeglumine - Reader 2 n=43 Participants P03277 (0.1 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	P03277 0.2 mmol/kg - Gadobenate Dimeglumine - Reader 2 n=41 Participants P03277 (0.2 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	P03277 0.025 mmol/kg - Gadobenate Dimeglumine - Reader 3 n=49 Participants P03277 (0.025 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	P03277 0.05 mmol/kg - Gadobenate Dimeglumine - Reader 3 n=51 Participants P03277 (0.05 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	P03277 0.1 mmol/kg - Gadobenate Dimeglumine - Reader 3 n=45 Participants P03277 (0.1 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI	P03277 0.2 mmol/kg - Gadobenate Dimeglumine - Reader 3 n=42 Participants P03277 (0.2 mmol/kg)-enhanced MRI and gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI
Contrast to Noise Ratio (CNR) Difference	-10.59 Ratio Interval -14.59 to -6.58	2.18 Ratio Interval -2.67 to 7.03	8.66 Ratio Interval 3.52 to 13.79	14.45 Ratio Interval 7.64 to 21.25	-14.14 Ratio Interval -23.33 to -4.95	1.91 Ratio Interval -7.28 to 11.1	19.38 Ratio Interval 11.42 to 27.34	38.37 Ratio Interval 18.62 to 58.12	-23.96 Ratio Interval -33.78 to -14.13	2.47 Ratio Interval -8.39 to 13.32	29.23 Ratio Interval 16.05 to 42.41	51.96 Ratio Interval 30.36 to 73.55

Adverse Events

P03277 0.025 mmol/kg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

P03277 0.05 mmol/kg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

P03277 0.1 mmol/kg

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

P03277 0.2 mmol/kg

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Gadobenate Dimeglumine

Serious events: 2 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Measure	P03277 0.025 mmol/kg n=56 participants at risk Patients who received one injection of P03277 0.025 mmol/kg regardless of injection order vs gadobenate dimeglumine (subset 2).	P03277 0.05 mmol/kg n=74 participants at risk Patients who received one injection of P03277 0.05 mmol/kg regardless of injection order vs gadobenate dimeglumine (subset 1 + subset 2).	P03277 0.1 mmol/kg n=70 participants at risk Patients who received one injection of P03277 0.1 mmol/kg regardless of injection order vs gadobenate dimeglumine (subset 1 + subset 2)	P03277 0.2 mmol/kg n=56 participants at risk Patients who received one injection of P03277 0.2 mmol/kg regardless of injection order vs gadobenate dimeglumine (subset 2)	Gadobenate Dimeglumine n=256 participants at risk Patients who received one injection of gadobenate dimeglumine regardless of injection order vs P03277 (subset 1 + subset 2).
Nervous system disorders Seizure	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Surgical and medical procedures Meningioma surgery	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Investigations Blood creatinine increased	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.

Other adverse events

Measure	P03277 0.025 mmol/kg n=56 participants at risk Patients who received one injection of P03277 0.025 mmol/kg regardless of injection order vs gadobenate dimeglumine (subset 2).	P03277 0.05 mmol/kg n=74 participants at risk Patients who received one injection of P03277 0.05 mmol/kg regardless of injection order vs gadobenate dimeglumine (subset 1 + subset 2).	P03277 0.1 mmol/kg n=70 participants at risk Patients who received one injection of P03277 0.1 mmol/kg regardless of injection order vs gadobenate dimeglumine (subset 1 + subset 2)	P03277 0.2 mmol/kg n=56 participants at risk Patients who received one injection of P03277 0.2 mmol/kg regardless of injection order vs gadobenate dimeglumine (subset 2)	Gadobenate Dimeglumine n=256 participants at risk Patients who received one injection of gadobenate dimeglumine regardless of injection order vs P03277 (subset 1 + subset 2).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Vascular disorders Hypertension	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.78% 2/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Vascular disorders Peripheral coldness	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Vascular disorders Flushing	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Vascular disorders Hypotension	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Injection site pain	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	2.7% 2/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	7.1% 5/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	12.5% 7/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	3.5% 9/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Injection site coldness	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.6% 4/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Fatigue	3.6% 2/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	3.6% 2/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Injection site warmth	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.2% 3/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Feeling hot	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.78% 2/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Infusion site extravasation	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.78% 2/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Injection site oedema	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Chills	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Injection site bruising	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Injection site erythema	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Injection site haematoma	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	3.6% 2/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Injection site inflammation	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Injection site paraesthesia	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Injection site reaction	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Malaise	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Oedema peripheral	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Pain	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
General disorders Sensation of foreign body	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Psychiatric disorders Insomnia	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Investigations Blood pressure increased	3.6% 2/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.78% 2/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Investigations Blood creatinine increased	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.78% 2/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Investigations Hepatic enzyme increased	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.78% 2/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Investigations Blood urea increased	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Investigations Electrocardiogram QT interval abnormal	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Investigations Electrocardiogram QT prolonged	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	2.9% 2/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Investigations Urobilinogen urine	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Cardiac disorders Ventricular extrasystoles	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Cardiac disorders Palpitations	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Cardiac disorders Sinus arrhythmia	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Cardiac disorders Sinus tachycardia	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Cardiac disorders Tachycardia	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Blood and lymphatic system disorders Lymphocytosis	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Nervous system disorders Headache	7.1% 4/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	4.1% 3/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	2.7% 7/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Nervous system disorders Diziness	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	3.6% 2/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.6% 4/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Nervous system disorders Seizure	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Nervous system disorders Dysgeusia	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Eye disorders Eye irritation	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Eye disorders Periorbital oedema	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Ear and labyrinth disorders Tinnitus	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Ear and labyrinth disorders Ear pain	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Gastrointestinal disorders Nausea	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	3.5% 9/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Gastrointestinal disorders Diarrhoea	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Gastrointestinal disorders Vomiting	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Gastrointestinal disorders Abdominal pain	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Gastrointestinal disorders Constipation	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Gastrointestinal disorders Glossitis	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Renal and urinary disorders Leukocyturia	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Renal and urinary disorders Bilirubinuria	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	2.7% 2/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.6% 4/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Renal and urinary disorders Glycosuria	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.2% 3/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Renal and urinary disorders Haematuria	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.2% 3/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Renal and urinary disorders Haemoglobinuria	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	2.0% 5/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Renal and urinary disorders Proteinuria	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	2.7% 2/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.78% 2/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Renal and urinary disorders Ketonuria	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Renal and urinary disorders Nitrituria	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Skin and subcutaneous tissue disorders Rash	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.78% 2/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Metabolism and nutrition disorders Diabetes Mellitus	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Metabolism and nutrition disorders Hyperglycaemia	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Infections and infestations Urinary tract infection	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	4.3% 3/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.6% 4/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Infections and infestations Influenza	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Blood and lymphatic system disorders Anaemia	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Blood and lymphatic system disorders Neutrophilia	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Infections and infestations Asymptomatic bacteriuria	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.4% 1/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Investigations Haematocrit decreased	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Investigations Haemoglobin decreased	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Investigations White blood cell count increased	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Investigations Alanine aminotransferase increased	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	1.8% 1/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.
Renal and urinary disorders Renal impairment	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/74 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/70 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.00% 0/56 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.	0.39% 1/256 • Adverse events were recorded from informed consent signature up to one day after the second MRI, up to 22 days The Safety Set included all subjects (from both subsets 1 and 2) who had received at least one injection of contrast agent, regardless of the quantity.

Additional Information

Jing Hao, MD, Global Head of Medical Affairs & Clinical Development

Guerbet

Phone: +33 (0) 1 45 91 50 00

Email: jing.hao@guerbet.com

Results disclosure agreements

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

Restriction type: OTHER