Trial Outcomes & Findings for Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) (NCT NCT03986138)
NCT ID: NCT03986138
Last Updated: 2025-10-27
Results Overview
The lesion visualization at patient level was based on 3 co-primary criteria on marching lesions: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor \[internal morphology\] or none \[border delineation, contrast enhancement\], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each co-criterion was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between Paired \[unenhanced and contrast-enhanced\] images and Pre-contrast \[unenhanced\] images was calculated for each of the 3 co-primary criteria and for each reader.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
324 participants
Primary outcome timeframe
At first MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 1. At second MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 2, performed 2-14 days after gadobutrol-enhanced MRI.
Results posted on
2025-10-27
Participant Flow
Among the 324 screened patients,19 were screen failure, 1 received the first contrast agent but was not randomized. A total of 304 patients were randomized, of whom 300 (151 in Arm 1 and 149 in Arm 2) received the first contrast agent and underwent the first MRI (First MRI Period). After a washout period of 2-14 days, 277 patients (141 in the Arm 1 and 136 in the Arm 2) received the second contrast agent and underwent the second MRI (Second MRI Period). 275 patients completed the study.
Participant milestones
| Measure |
Arm 1: Gadopiclenol-enhanced MRI for First MRI and Gadobutrol-enhanced MRI for Second MRI
Cross-over study design
For each patient in this Arm, he (she) performed the first contrast-enhanced MRI with gadopiclenol as contrast agent (First MRI Period). After a washout period of 2-14 days (Washout Period), the patient performed the second contrast-enhanced MRI with gadobutrol as contrast agent (Second MRI Period).
For each patient, two sets of MR images per MRI examination were obtained: unenhanced and gadopiclenol-enhanced MR images obtained in the First MRI Examination Period, unenhanced and gadobutrol-enhanced MR images obtained in the Second MRI Examination Period.
Gadopiclenol: single intravenous (IV) bolus injection at a rate of 2ml/second
Gadobutrol 1Mmol/mL Solution for Injection Vial: single intravenous (IV) bolus injection at a rate of 2ml/second
|
Arm 2: Gadobutrol-enhanced MRI for First MRI and Gadopiclenol-enhanced MRI for Second MRI
Cross-over study design
For each patient in this Arm, he (she) performed the first contrast-enhanced MRI with gadobutrol as contrast agent (First MRI Period). After a washout period of 2-14 days (Washout Period), the patient performed the second contrast-enhanced MRI with gadopiclenol as contrast agent (Second MRI Period).
For each patient, two sets of MR images per MRI examination were obtained: unenhanced and gadobutrol-enhanced MR images obtained in the First MRI Examination Period, unenhanced and gadopiclenol-enhanced MR images obtained in the second MRI Examination Period.
Gadobutrol 1Mmol/mL Solution for Injection Vial: single intravenous (IV) bolus injection at a rate of 2ml/second
Gadopiclenol: single intravenous (IV) bolus injection at a rate of 2ml/second
|
|---|---|---|
|
First MRI Examination
STARTED
|
152
|
152
|
|
First MRI Examination
COMPLETED
|
151
|
149
|
|
First MRI Examination
NOT COMPLETED
|
1
|
3
|
|
Washout
STARTED
|
151
|
149
|
|
Washout
COMPLETED
|
141
|
136
|
|
Washout
NOT COMPLETED
|
10
|
13
|
|
Second MRI Examination
STARTED
|
141
|
136
|
|
Second MRI Examination
COMPLETED
|
141
|
134
|
|
Second MRI Examination
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Arm 1: Gadopiclenol-enhanced MRI for First MRI and Gadobutrol-enhanced MRI for Second MRI
Cross-over study design
For each patient in this Arm, he (she) performed the first contrast-enhanced MRI with gadopiclenol as contrast agent (First MRI Period). After a washout period of 2-14 days (Washout Period), the patient performed the second contrast-enhanced MRI with gadobutrol as contrast agent (Second MRI Period).
For each patient, two sets of MR images per MRI examination were obtained: unenhanced and gadopiclenol-enhanced MR images obtained in the First MRI Examination Period, unenhanced and gadobutrol-enhanced MR images obtained in the Second MRI Examination Period.
Gadopiclenol: single intravenous (IV) bolus injection at a rate of 2ml/second
Gadobutrol 1Mmol/mL Solution for Injection Vial: single intravenous (IV) bolus injection at a rate of 2ml/second
|
Arm 2: Gadobutrol-enhanced MRI for First MRI and Gadopiclenol-enhanced MRI for Second MRI
Cross-over study design
For each patient in this Arm, he (she) performed the first contrast-enhanced MRI with gadobutrol as contrast agent (First MRI Period). After a washout period of 2-14 days (Washout Period), the patient performed the second contrast-enhanced MRI with gadopiclenol as contrast agent (Second MRI Period).
For each patient, two sets of MR images per MRI examination were obtained: unenhanced and gadobutrol-enhanced MR images obtained in the First MRI Examination Period, unenhanced and gadopiclenol-enhanced MR images obtained in the second MRI Examination Period.
Gadobutrol 1Mmol/mL Solution for Injection Vial: single intravenous (IV) bolus injection at a rate of 2ml/second
Gadopiclenol: single intravenous (IV) bolus injection at a rate of 2ml/second
|
|---|---|---|
|
First MRI Examination
Physician Decision
|
0
|
1
|
|
First MRI Examination
Other reason (mainly technical issues with MRI machine)
|
1
|
2
|
|
Washout
Withdrawal by Subject
|
4
|
5
|
|
Washout
Lost to Follow-up
|
0
|
2
|
|
Washout
Adverse Event
|
1
|
1
|
|
Washout
Other reason
|
5
|
5
|
|
Second MRI Examination
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
Baseline characteristics by cohort
| Measure |
Arm 1: Gadopiclenol-enhanced MRI for First MRI and Gadobutrol-enhanced MRI for Second MRI
n=145 Participants
Cross-over study design
For each patient in this Arm, he (she) performed the first contrast-enhanced MRI with gadopiclenol as contrast agent (First MRI Period). After a washout period of 2-14 days (Washout Period), the patient performed the second contrast-enhanced MRI with gadobutrol as contrast agent (Second MRI Period).
For each patient, two sets of MR images per MRI examination were obtained: unenhanced and gadopiclenol-enhanced MR images obtained in the First MRI Examination Period, unenhanced and gadobutrol-enhanced MR images obtained in the Second MRI Examination Period.
|
Arm 2: Gadobutrol-enhanced MRI for First MRI and Gadopiclenol-enhanced MRI for Second MRI
n=133 Participants
Cross-over study design
For each patient in this Arm, he (she) performed the first contrast-enhanced MRI with gadobutrol as contrast agent (First MRI Period). After a washout period of 2-14 days (Washout Period), the patient performed the second contrast-enhanced MRI with gadopiclenol as contrast agent (Second MRI Period).
For each patient, two sets of MR images per MRI examination were obtained: unenhanced and gadobutrol-enhanced MR images obtained in the First MRI Examination Period, unenhanced and gadopiclenol-enhanced MR images obtained in the second MRI Examination Period.
|
Total
n=278 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
102 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
28 participants
n=5 Participants
|
20 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
18 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
4 participants
n=5 Participants
|
9 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
32 participants
n=5 Participants
|
35 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
18 participants
n=5 Participants
|
12 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
France
|
8 participants
n=5 Participants
|
2 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
2 participants
n=5 Participants
|
9 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Weight
|
75.3 Kg
STANDARD_DEVIATION 17.1 • n=5 Participants
|
75.5 Kg
STANDARD_DEVIATION 17.1 • n=7 Participants
|
75.4 Kg
STANDARD_DEVIATION 17.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: At first MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 1. At second MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 2, performed 2-14 days after gadobutrol-enhanced MRI.Population: Full Analysis Set (FAS) included a total of 278 patients who had both Pre and Paired images with gadopiclenol assessable for primary criteria for at least one matching lesion for at least one off-site reader: 145 patients in the Arm 1 for whom gadopiclenol-enhanced MRI was performed as first MRI, and 133 patients in the Arm 2 for whom gadopiclenol-enhanced MRI was performed as second MRI. The analysis was based on participants (per patient).
The lesion visualization at patient level was based on 3 co-primary criteria on marching lesions: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor \[internal morphology\] or none \[border delineation, contrast enhancement\], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each co-criterion was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between Paired \[unenhanced and contrast-enhanced\] images and Pre-contrast \[unenhanced\] images was calculated for each of the 3 co-primary criteria and for each reader.
Outcome measures
| Measure |
Patients With Gadopiclenol Paired Images
n=278 Participants
The analysis included a total of 278 patients on marching lesions who had both gadopiclenol Paired images and gadopiclonol Pre images:
145 patients of Arm 1 for whom gadopiclenol-enhanced MRI was performed as first MRI, and 133 patients of Arm 2 for whom gadopiclenol-enhanced MRI was performed as second MRI.
The analysis was based on participants (at patient level).
Therefore, the 278 patients with gadopiclenol Paired images are the same patients with gadopiclenol Pre images.
|
Patients With Gadopiclenol Pre Images
n=278 Participants
The analysis included a total of 278 patients on marching lesions who had both gadopiclenol Paired images and gadopiclonol Pre images:
145 patients of Arm 1 for whom gadopiclenol-enhanced MRI was performed as first MRI, and 133 patients of Arm 2 for whom gadopiclenol-enhanced MRI was performed as second MRI.
The analysis was based on participants (at patient level).
Therefore, the 278 patients with gadopiclenol Pre images are the same patients with gadopiclenol Paired images.
|
|---|---|---|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI
Border delineation - Reader 1
|
3.79 mean of a score (on a scale) per patient
Standard Error 0.03
|
2.26 mean of a score (on a scale) per patient
Standard Error 0.03
|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI
Border delineation - Reader 2
|
3.48 mean of a score (on a scale) per patient
Standard Error 0.06
|
3.01 mean of a score (on a scale) per patient
Standard Error 0.06
|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI
Border delineation - Reader 3
|
3.49 mean of a score (on a scale) per patient
Standard Error 0.03
|
1.78 mean of a score (on a scale) per patient
Standard Error 0.03
|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI
Internal morphology - Reader 1
|
3.80 mean of a score (on a scale) per patient
Standard Error 0.02
|
1.99 mean of a score (on a scale) per patient
Standard Error 0.02
|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI
Internal morphology - Reader 2
|
3.75 mean of a score (on a scale) per patient
Standard Error 0.05
|
3.22 mean of a score (on a scale) per patient
Standard Error 0.05
|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI
Internal morphology - Reader 3
|
3.72 mean of a score (on a scale) per patient
Standard Error 0.03
|
1.69 mean of a score (on a scale) per patient
Standard Error 0.03
|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI
Contrast enhancement - Reader 1
|
3.64 mean of a score (on a scale) per patient
Standard Error 0.03
|
1.00 mean of a score (on a scale) per patient
Standard Error 0.03
|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI
Contrast enhancement - Reader 2
|
2.82 mean of a score (on a scale) per patient
Standard Error 0.05
|
1.00 mean of a score (on a scale) per patient
Standard Error 0.05
|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI
Contrast enhancement - Reader 3
|
3.33 mean of a score (on a scale) per patient
Standard Error 0.03
|
1.00 mean of a score (on a scale) per patient
Standard Error 0.03
|
SECONDARY outcome
Timeframe: At each of two MRI examinations with an interval of 2-14 days between two MRI examinationsPopulation: Per-Protocol Set (PPS) analysis including 260 patients (135 patients in the Arm 1 and 125 patients in the Arm 2) with no major protocol deviation who have Paired (combined unenhanced and contrast-enhanced) images for both gadopiclenol and gadobutrol assessable for this secondary outcome mesure for at least one matching lesion for at least one off-site reader. The analysis was based on participants (per patient).
The lesion visualization (per patient) was based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed on the images performed with gadopiclenol and images performed with gadobutrol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor \[internal morphology\] or none \[border delineation, contrast enhancement\], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each of the 3 lesion visualization co-criteria was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between gadopiclenol scores mean and gadobutrol scores mean was calculated for each of the 3 co-primary criteria and for each reader.
Outcome measures
| Measure |
Patients With Gadopiclenol Paired Images
n=260 Participants
The analysis included a total of 278 patients on marching lesions who had both gadopiclenol Paired images and gadopiclonol Pre images:
145 patients of Arm 1 for whom gadopiclenol-enhanced MRI was performed as first MRI, and 133 patients of Arm 2 for whom gadopiclenol-enhanced MRI was performed as second MRI.
The analysis was based on participants (at patient level).
Therefore, the 278 patients with gadopiclenol Paired images are the same patients with gadopiclenol Pre images.
|
Patients With Gadopiclenol Pre Images
n=260 Participants
The analysis included a total of 278 patients on marching lesions who had both gadopiclenol Paired images and gadopiclonol Pre images:
145 patients of Arm 1 for whom gadopiclenol-enhanced MRI was performed as first MRI, and 133 patients of Arm 2 for whom gadopiclenol-enhanced MRI was performed as second MRI.
The analysis was based on participants (at patient level).
Therefore, the 278 patients with gadopiclenol Pre images are the same patients with gadopiclenol Paired images.
|
|---|---|---|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI
Internal morphology - Reader 2
|
3.75 mean of a score (on a scale) per patient
Standard Error 0.04
|
3.75 mean of a score (on a scale) per patient
Standard Error 0.04
|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI
Contrast enhancement - Reader 2
|
2.88 mean of a score (on a scale) per patient
Standard Error 0.07
|
2.86 mean of a score (on a scale) per patient
Standard Error 0.07
|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI
Border delineation - Reader 1
|
3.82 mean of a score (on a scale) per patient
Standard Error 0.02
|
3.81 mean of a score (on a scale) per patient
Standard Error 0.02
|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI
Border delineation - Reader 2
|
3.56 mean of a score (on a scale) per patient
Standard Error 0.05
|
3.53 mean of a score (on a scale) per patient
Standard Error 0.05
|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI
Border delineation - Reader 3
|
3.53 mean of a score (on a scale) per patient
Standard Error 0.03
|
3.57 mean of a score (on a scale) per patient
Standard Error 0.03
|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI
Internal morphology - Reader 1
|
3.83 mean of a score (on a scale) per patient
Standard Error 0.02
|
3.83 mean of a score (on a scale) per patient
Standard Error 0.02
|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI
Internal morphology - Reader 3
|
3.74 mean of a score (on a scale) per patient
Standard Error 0.03
|
3.77 mean of a score (on a scale) per patient
Standard Error 0.03
|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI
Contrast enhancement - Reader 1
|
3.69 mean of a score (on a scale) per patient
Standard Error 0.04
|
3.68 mean of a score (on a scale) per patient
Standard Error 0.04
|
|
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI
Contrast enhancement - Reader 3
|
3.35 mean of a score (on a scale) per patient
Standard Error 0.04
|
3.37 mean of a score (on a scale) per patient
Standard Error 0.04
|
Adverse Events
Gadopiclenol
Serious events: 3 serious events
Other events: 50 other events
Deaths: 0 deaths
Gadobutrol
Serious events: 0 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gadopiclenol
n=288 participants at risk
AEs reported after MRI with gadopiclenol
|
Gadobutrol
n=290 participants at risk
AEs reported after MRI with gadobutrol
|
|---|---|---|
|
General disorders
Condition Aggravated
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Infections and infestations
Covid-19
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
Other adverse events
| Measure |
Gadopiclenol
n=288 participants at risk
AEs reported after MRI with gadopiclenol
|
Gadobutrol
n=290 participants at risk
AEs reported after MRI with gadobutrol
|
|---|---|---|
|
General disorders
Injection site pain
|
1.7%
5/288 • Number of events 5 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
2.4%
7/290 • Number of events 7 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Injection site bruising
|
1.0%
3/288 • Number of events 3 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Fatigue
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Injection site discomfort
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Injection site erythema
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.69%
2/290 • Number of events 2 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.69%
2/290 • Number of events 2 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Pain
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.69%
2/290 • Number of events 2 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Asthenia
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Chest pain
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Extravasation
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Infusion site pain
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Injection site haematoma
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Injection site inflammation
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Injection site pruritus
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Injection site warmth
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Oedema peripheral
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Pyrexia
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
General disorders
Swelling
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Nervous system disorders
Headache
|
5.6%
16/288 • Number of events 17 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
1.4%
4/290 • Number of events 4 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Nervous system disorders
Dizziness
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Gastrointestinal disorders
Nausea
|
1.7%
5/288 • Number of events 5 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
1.4%
4/290 • Number of events 4 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Gastrointestinal disorders
Dry mouth
|
1.0%
3/288 • Number of events 3 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
1.0%
3/290 • Number of events 3 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.69%
2/288 • Number of events 2 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.69%
2/290 • Number of events 2 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Gastrointestinal disorders
Vomiting
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.69%
2/290 • Number of events 2 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.69%
2/288 • Number of events 2 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
1.0%
3/290 • Number of events 3 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
1.4%
4/290 • Number of events 4 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
1.0%
3/290 • Number of events 3 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
1.0%
3/290 • Number of events 3 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Blood and lymphatic system disorders
Monocytopenia
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Investigations
Blood pressure increased
|
0.69%
2/288 • Number of events 2 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.69%
2/290 • Number of events 2 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Investigations
Cystatin c increased
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Investigations
Neutrophil count increased
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Investigations
Paracentesis
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Investigations
White blood cell count increased
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.69%
2/288 • Number of events 2 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
1.0%
3/290 • Number of events 3 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Renal and urinary disorders
Nephropathy
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.69%
2/290 • Number of events 2 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Renal and urinary disorders
Renal failure
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.69%
2/288 • Number of events 2 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.69%
2/290 • Number of events 2 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Injury, poisoning and procedural complications
Incorrect dosage administered
|
1.7%
5/288 • Number of events 5 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
1.4%
4/290 • Number of events 4 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Ear and labyrinth disorders
Ear pain
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Immune system disorders
Drug hypersensitivity
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Infections and infestations
Nasopharyngitis
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Product Issues
Device malfunction
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.69%
2/290 • Number of events 2 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/288 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.34%
1/290 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Eye disorders
Swelling of eyelid
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
|
Surgical and medical procedures
Central venous catheterisation
|
0.35%
1/288 • Number of events 1 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
0.00%
0/290 • Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
|
Additional Information
Frantz Hebert, Global Head of Clinical Development
Guerbet
Phone: +33 (0)6 80 24 93 34
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER