Trial Outcomes & Findings for Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children (NCT NCT06010173)
NCT ID: NCT06010173
Last Updated: 2026-06-25
Results Overview
The lesion visualization criterion (per patient) was based on 3 co-primary criteria (border delineation, internal morphology and degree of contrast enhancement) assessed by 3 independent off-site blinded readers. The IBR recorded each of the 3 co-primary criteria for up to 10 largest and most enhancing lesions on Paired (pre+post) images performed with gadopiclenol and Paired (pre+post) images performed with gadobutrol. Delineation of the lesion border was defined as the distinction of lesion from surrounding tissues, structures, or edema, and the detection of extent of the lesion. This criterion was assessed through the following scale: 1. = None 2. = Moderate 3. = Good 4. = Excellent: For this co-primary criterion, a mean of scores for each patient and for each reader was calculated and ranged from 1 to 4.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
240 participants
Primary outcome timeframe
At each MRI exam: the first MRI at Day 1 and the second MRI performed after a wash out period of 2 to 14 days (adult cohort)
Results posted on
2026-06-25
Participant Flow
Among the 209 screened adult patients, 9 were screen failure. 200 patients were randomized (100 in each arm), of whom 197 (99 in Arm 1 and 98 in Arm 2) received the first contrast agent and underwent the first MRI. After a washout period of 2-14 days, 192 patients (96 in each arm) received the second contrast agent and underwent the second MRI (cross over study with 3 periods). All the 40 screened pediatric patients received the gadopiclenol injection and underwent an MRI (Overall period).
Participant milestones
| Measure |
Adult Cohort Arm 1: First MRI With Gadopiclenol and Second MRI With Gadobutrol
Cross-over study. For each patient in this arm, he (she) performed the first contrast-enhanced MRI with gadopiclenol as contrast agent. After a washout period of 2-14 days, the patient performed the second contrast-enhanced MRI with gadobutrol as contrast agent.
Gadopiclenol: at a dose of 0.05 mmol/kg of patient's body weight
Gadobutrol: at a dose of 0.1 mmol/kg of patient's body weight
|
Adult Cohort Arm 2: First MRI With Gadobutrol and Second MRI With Gadopiclenol
Cross-over study. For each patient in this arm, he (she) performed the first contrast-enhanced MRI with gadobutrol as contrast agent. After a washout period of 2-14 days, the patient performed the second contrast-enhanced MRI with gadopiclenol as contrast agent.
Gadopiclenol: at a dose of 0.05 mmol/kg of patient's body weight
Gadobutrol: at a dose of 0.1 mmol/kg of patient's body weight
|
Pediatric Cohort: One MRI With Gadopiclenol
Pediatric cohort was a prospective, multi-center, non-randomized, open-label and single arm study which was independent of the adult cohort and with a different study design.
For each patient included in this pediatric cohort, he (she) underwent one contrast-enhanced MRI with gadopiclenol as contrast agent.
Note: There was a single period (overall period) for this pediatric cohort. The participant flow was registered by adapting to that of adult cohort which had 3 periods.
Gadopiclenol: at a dose of 0.05 mmol/kg of patient's body weight
|
|---|---|---|---|
|
First MRI Examination
STARTED
|
100
|
100
|
40
|
|
First MRI Examination
COMPLETED
|
99
|
98
|
40
|
|
First MRI Examination
NOT COMPLETED
|
1
|
2
|
0
|
|
Washout
STARTED
|
99
|
98
|
0
|
|
Washout
COMPLETED
|
96
|
96
|
0
|
|
Washout
NOT COMPLETED
|
3
|
2
|
0
|
|
Second MRI Examination
STARTED
|
96
|
96
|
0
|
|
Second MRI Examination
COMPLETED
|
96
|
96
|
0
|
|
Second MRI Examination
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Adult Cohort Arm 1: First MRI With Gadopiclenol and Second MRI With Gadobutrol
Cross-over study. For each patient in this arm, he (she) performed the first contrast-enhanced MRI with gadopiclenol as contrast agent. After a washout period of 2-14 days, the patient performed the second contrast-enhanced MRI with gadobutrol as contrast agent.
Gadopiclenol: at a dose of 0.05 mmol/kg of patient's body weight
Gadobutrol: at a dose of 0.1 mmol/kg of patient's body weight
|
Adult Cohort Arm 2: First MRI With Gadobutrol and Second MRI With Gadopiclenol
Cross-over study. For each patient in this arm, he (she) performed the first contrast-enhanced MRI with gadobutrol as contrast agent. After a washout period of 2-14 days, the patient performed the second contrast-enhanced MRI with gadopiclenol as contrast agent.
Gadopiclenol: at a dose of 0.05 mmol/kg of patient's body weight
Gadobutrol: at a dose of 0.1 mmol/kg of patient's body weight
|
Pediatric Cohort: One MRI With Gadopiclenol
Pediatric cohort was a prospective, multi-center, non-randomized, open-label and single arm study which was independent of the adult cohort and with a different study design.
For each patient included in this pediatric cohort, he (she) underwent one contrast-enhanced MRI with gadopiclenol as contrast agent.
Note: There was a single period (overall period) for this pediatric cohort. The participant flow was registered by adapting to that of adult cohort which had 3 periods.
Gadopiclenol: at a dose of 0.05 mmol/kg of patient's body weight
|
|---|---|---|---|
|
First MRI Examination
Inclusion criteria not met
|
1
|
0
|
0
|
|
First MRI Examination
Other reason
|
0
|
2
|
0
|
|
Washout
Adverse Event
|
3
|
0
|
0
|
|
Washout
Withdrawal by Subject
|
0
|
1
|
0
|
|
Washout
Other reason
|
0
|
1
|
0
|
Baseline Characteristics
Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children
Baseline characteristics by cohort
| Measure |
Adult Cohort Arm 1: First MRI With Gadopiclenol and Second MRI With Gadobutrol
n=92 Participants
Cross-over study. For each patient in this arm, he (she) performed the first contrast-enhanced MRI with gadopiclenol as contrast agent. After a washout period of 2-14 days, the patient performed the second contrast-enhanced MRI with gadobutrol as contrast agent.
Gadopiclenol: at a dose of 0.05 mmol/kg of patient's body weight
Gadobutrol: at a dose of 0.1 mmol/kg of patient's body weight
|
Adult Cohort Arm 2: First MRI With Gadobutrol and Second MRI With Gadopiclenol
n=96 Participants
Cross-over study. For each patient in this arm, he (she) performed the first contrast-enhanced MRI with gadobutrol as contrast agent. After a washout period of 2-14 days, the patient performed the second contrast-enhanced MRI with gadopiclenol as contrast agent.
Gadobutrol: at a dose of 0.1 mmol/kg of patient's body weight
Gadopiclenol: at a dose of 0.05 mmol/kg of patient's body weight
|
Pediatric Cohort: One MRI With Gadopiclenol
n=40 Participants
Pediatric cohort was a prospective, multi-center, non-randomized, open-label and single arm study which was independent of the adult cohort and with a different study design.
For each patient included in this pediatric cohort, he (she) underwent one contrast-enhanced MRI with gadopiclenol as contrast agent.
There was a single period (overall period) for this pediatric cohort.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 11.9 • n=20 Participants
|
63.8 years
STANDARD_DEVIATION 14.5 • n=20 Participants
|
8.43 years
STANDARD_DEVIATION 5.26 • n=40 Participants
|
65.4 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=20 Participants
|
43 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=20 Participants
|
53 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
128 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
92 Participants
n=20 Participants
|
96 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
228 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At each MRI exam: the first MRI at Day 1 and the second MRI performed after a wash out period of 2 to 14 days (adult cohort)Population: The per protocol analysis included a total of 188 patients who had matched lesions on gadopiclenol Paired images and gadobutrol Paired images: 92 patients performed gadopiclenol-enhanced MRI as first MRI and 96 patients performed gadobutrol-enhanced MRI as first MRI. The analysis was based on participants (at patient level).
The lesion visualization criterion (per patient) was based on 3 co-primary criteria (border delineation, internal morphology and degree of contrast enhancement) assessed by 3 independent off-site blinded readers. The IBR recorded each of the 3 co-primary criteria for up to 10 largest and most enhancing lesions on Paired (pre+post) images performed with gadopiclenol and Paired (pre+post) images performed with gadobutrol. Delineation of the lesion border was defined as the distinction of lesion from surrounding tissues, structures, or edema, and the detection of extent of the lesion. This criterion was assessed through the following scale: 1. = None 2. = Moderate 3. = Good 4. = Excellent: For this co-primary criterion, a mean of scores for each patient and for each reader was calculated and ranged from 1 to 4.
Outcome measures
| Measure |
Pediatric Cohort: Patients With Paired Images
n=188 Participants
Pediatric cohort was a prospective, multi-center, non-randomized, open-label and single arm study which was independent of the adult cohort and with a different study design.
For each patient included in this pediatric cohort, he (she) underwent one contrast-enhanced MRI with gadopiclenol as contrast agent.
A single period (overall period) for this pediatric cohort.
Patients with paired images and pre-images were the same patients (paired images compared with pre-images on matching lesions within the same patient).
|
Patients With Gadobutrol Paired Images
n=188 Participants
Patients of Arm 2 for whom gadobutrol-enhanced MRI was performed as first MRI and patients of Arm 1 for whom gadobutrol-enhanced MRI was performed as second MRI.
Patients with gadobutrol Paired images are the same patients with gadopiclenol Paired images.
|
|---|---|---|
|
Lesion Visualization on Paired Images: Border Delineation
Border delineation - Reader A
|
3.81 score on a scale
Standard Error 0.04
|
3.75 score on a scale
Standard Error 0.04
|
|
Lesion Visualization on Paired Images: Border Delineation
Border delineation - Reader B
|
3.34 score on a scale
Standard Error 0.05
|
3.24 score on a scale
Standard Error 0.05
|
|
Lesion Visualization on Paired Images: Border Delineation
Border delineation - Reader C
|
3.07 score on a scale
Standard Error 0.05
|
3.00 score on a scale
Standard Error 0.05
|
PRIMARY outcome
Timeframe: At each MRI exam: the first MRI at Day 1 and the second MRI performed after a wash out period of 2 to 14 days (adult cohort)Population: Baseline Analysis Population Description The analysis was based on participants. For the primary analysis to demonstrate the non-inferiority of gadopiclenol-enhanced MRI at 0.05 mmol/kg compared to gadobutrol-enhanced MRI at 0.1 mmol/kg, the analysis population was patients who had matching lesions on Paired (combined unenhanced and contrast-enhanced) images performed with gadopiclenol and Paired images performed with gadobutrol.
The lesion visualization criterion (per patient) was based on 3 co-primary criteria (border delineation, internal morphology and degree of contrast enhancement) assessed by 3 independent off-site blinded readers. The IBR recorded each of the 3 co-primary criteria for up to 10 largest and most enhancing lesions on Paired (pre+post) images performed with gadopiclenol and Paired (pre+post) images performed with gadobutrol. Internal morphology of the lesion included an identification of lesion architecture and the intra-lesion features such as necrosis, hemorrhage, and vascularity. This criterion was assessed through the following scale: 1. = Poor 2. = Moderate 3. = Good 4. = Excellent For this co-primary criterion "internal morphology", a mean of scores for each patient and for each reader was calculated and ranged from 1 to 4.
Outcome measures
| Measure |
Pediatric Cohort: Patients With Paired Images
n=188 Participants
Pediatric cohort was a prospective, multi-center, non-randomized, open-label and single arm study which was independent of the adult cohort and with a different study design.
For each patient included in this pediatric cohort, he (she) underwent one contrast-enhanced MRI with gadopiclenol as contrast agent.
A single period (overall period) for this pediatric cohort.
Patients with paired images and pre-images were the same patients (paired images compared with pre-images on matching lesions within the same patient).
|
Patients With Gadobutrol Paired Images
n=188 Participants
Patients of Arm 2 for whom gadobutrol-enhanced MRI was performed as first MRI and patients of Arm 1 for whom gadobutrol-enhanced MRI was performed as second MRI.
Patients with gadobutrol Paired images are the same patients with gadopiclenol Paired images.
|
|---|---|---|
|
Lesion Visualization on Paired Images: Internal Morphology
Internal morphology - Reader A
|
3.71 score on a scale
Standard Error 0.04
|
3.65 score on a scale
Standard Error 0.04
|
|
Lesion Visualization on Paired Images: Internal Morphology
Internal morphology - Reader B
|
3.20 score on a scale
Standard Error 0.07
|
3.17 score on a scale
Standard Error 0.07
|
|
Lesion Visualization on Paired Images: Internal Morphology
Internal morphology - Reader C
|
3.24 score on a scale
Standard Error 0.05
|
3.14 score on a scale
Standard Error 0.05
|
PRIMARY outcome
Timeframe: At each MRI exam: the first MRI at Day 1 and the second MRI performed after a wash out period of 2 to 14 days (adult cohort)Population: The analysis was based on participants. For the primary analysis to demonstrate the non-inferiority of gadopiclenol-enhanced MRI at 0.05 mmol/kg compared to gadobutrol-enhanced MRI at 0.1 mmol/kg, the analysis population was patients who had matching lesions on Paired (combined unenhanced and contrast-enhanced) images performed with gadopiclenol and Paired images performed with gadobutrol.
The lesion visualization criterion (per patient) was based on 3 co-primary criteria (border delineation, internal morphology and degree of contrast enhancement) assessed by 3 independent off-site blinded readers. The IBR recorded each of the 3 co-primary criteria for up to 10 largest and most enhancing lesions on Paired (pre+post) images performed with gadopiclenol and Paired (pre+post) images performed with gadobutrol. The criterion "degree of contrast enhancement" was a qualitative assessment (not based on signal intensity measurement) according to the following scale: 1. = No: no enhancement 2. = Moderate: weakly enhanced 3. = Good: clearly enhanced 4. = Excellent: clearly and brightly enhanced For each co-primary criterion, a mean of scores for each patient and for each reader was calculated and ranged from 1 to 4.
Outcome measures
| Measure |
Pediatric Cohort: Patients With Paired Images
n=188 Participants
Pediatric cohort was a prospective, multi-center, non-randomized, open-label and single arm study which was independent of the adult cohort and with a different study design.
For each patient included in this pediatric cohort, he (she) underwent one contrast-enhanced MRI with gadopiclenol as contrast agent.
A single period (overall period) for this pediatric cohort.
Patients with paired images and pre-images were the same patients (paired images compared with pre-images on matching lesions within the same patient).
|
Patients With Gadobutrol Paired Images
n=188 Participants
Patients of Arm 2 for whom gadobutrol-enhanced MRI was performed as first MRI and patients of Arm 1 for whom gadobutrol-enhanced MRI was performed as second MRI.
Patients with gadobutrol Paired images are the same patients with gadopiclenol Paired images.
|
|---|---|---|
|
Lesion Visualization on Paired Images: Degree of Contrast Enhancement
Degree of contrast enhancement - Reader A
|
3.70 score on a scale
Standard Error 0.07
|
3.59 score on a scale
Standard Error 0.07
|
|
Lesion Visualization on Paired Images: Degree of Contrast Enhancement
Degree of contrast enhancement - Reader B
|
3.18 score on a scale
Standard Error 0.07
|
3.06 score on a scale
Standard Error 0.07
|
|
Lesion Visualization on Paired Images: Degree of Contrast Enhancement
Degree of contrast enhancement - Reader C
|
3.04 score on a scale
Standard Error 0.07
|
3.03 score on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: At MRI exam, Day 1 (pediatric cohort)Population: In pediatric cohort, the full analysis set (FAS) included a total of 40 pediatric patients who had matched lesions on gadopiclenol Paired images and pre images performed with gadopiclenol as contrast agent. The analysis was based on participants (at patient level).
The lesion visualization criterion based on 3 co-criteria: border delineation, internal morphology and degree of contrast enhancement assessed on the images acquired during the MRI performed with gadopiclenol assessed by 3 independent off-site blinded readers (IBR). The IBR recorded each of the 3 co-criteria for up to 10 largest and most enhancing lesions on Paired (pre+post) images and Pre images performed with gadopiclenol as contrast agent. Definitions of each co-criteria and score calculation were provided in the section for primary outcome measure.
Outcome measures
| Measure |
Pediatric Cohort: Patients With Paired Images
n=40 Participants
Pediatric cohort was a prospective, multi-center, non-randomized, open-label and single arm study which was independent of the adult cohort and with a different study design.
For each patient included in this pediatric cohort, he (she) underwent one contrast-enhanced MRI with gadopiclenol as contrast agent.
A single period (overall period) for this pediatric cohort.
Patients with paired images and pre-images were the same patients (paired images compared with pre-images on matching lesions within the same patient).
|
Patients With Gadobutrol Paired Images
n=40 Participants
Patients of Arm 2 for whom gadobutrol-enhanced MRI was performed as first MRI and patients of Arm 1 for whom gadobutrol-enhanced MRI was performed as second MRI.
Patients with gadobutrol Paired images are the same patients with gadopiclenol Paired images.
|
|---|---|---|
|
Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Border Delineation
Border delineation - Reader A
|
3.72 mean of a score (on a scale) per patient
Standard Error 0.13
|
1.88 mean of a score (on a scale) per patient
Standard Error 0.13
|
|
Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Border Delineation
Border delineation - Reader B
|
3.33 mean of a score (on a scale) per patient
Standard Error 0.13
|
2.57 mean of a score (on a scale) per patient
Standard Error 0.13
|
|
Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Border Delineation
Border delineation - Reader C
|
3.07 mean of a score (on a scale) per patient
Standard Error 0.14
|
2.34 mean of a score (on a scale) per patient
Standard Error 0.14
|
SECONDARY outcome
Timeframe: At MRI exam, Day 1 (pediatric cohort)Population: In pediatric cohort, the full analysis set (FAS) included a total of 40 pediatric patients who had matched lesions on gadopiclenol Paired images and pre images performed with gadopiclenol as contrast agent. The analysis was based on participants (at patient level).
The lesion visualization criterion based on 3 co-criteria: border delineation, internal morphology and degree of contrast enhancement assessed on the images acquired during the MRI performed with gadopiclenol assessed by 3 independent off-site blinded readers (IBR). The IBR recorded each of the 3 co-criteria for up to 10 largest and most enhancing lesions on Paired (pre+post) images and Pre images performed with gadopiclenol. Definitions of each co-criteria and score calculation were provided in the section for primary outcome measure.
Outcome measures
| Measure |
Pediatric Cohort: Patients With Paired Images
n=40 Participants
Pediatric cohort was a prospective, multi-center, non-randomized, open-label and single arm study which was independent of the adult cohort and with a different study design.
For each patient included in this pediatric cohort, he (she) underwent one contrast-enhanced MRI with gadopiclenol as contrast agent.
A single period (overall period) for this pediatric cohort.
Patients with paired images and pre-images were the same patients (paired images compared with pre-images on matching lesions within the same patient).
|
Patients With Gadobutrol Paired Images
n=40 Participants
Patients of Arm 2 for whom gadobutrol-enhanced MRI was performed as first MRI and patients of Arm 1 for whom gadobutrol-enhanced MRI was performed as second MRI.
Patients with gadobutrol Paired images are the same patients with gadopiclenol Paired images.
|
|---|---|---|
|
Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Internal Morphology
Internal morphology - Reader A
|
3.76 mean of a score (on a scale) per patient
Standard Error 0.12
|
1.60 mean of a score (on a scale) per patient
Standard Error 0.12
|
|
Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Internal Morphology
Internal morphology - Reader B
|
3.33 mean of a score (on a scale) per patient
Standard Error 0.14
|
2.26 mean of a score (on a scale) per patient
Standard Error 0.14
|
|
Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Internal Morphology
Internal morphology - Reader C
|
3.15 mean of a score (on a scale) per patient
Standard Error 0.17
|
2.43 mean of a score (on a scale) per patient
Standard Error 0.17
|
SECONDARY outcome
Timeframe: At MRI exam, day 1 (pediatric cohort)Population: In pediatric cohort, the full analysis set (FAS) included a total of 40 pediatric patients who had matched lesions on gadopiclenol Paired images and pre images performed with gadopiclenol as contrast agent. The analysis was based on participants (at patient level).
The lesion visualization criterion based on 3 co-criteria: border delineation, internal morphology and degree of contrast enhancement assessed on the images acquired during the MRI performed with gadopiclenol assessed by 3 independent off-site blinded readers (IBR). The IBR recorded each of the 3 co-criteria for up to 10 largest and most enhancing lesions on Paired (pre+post) images and Pre images performed with gadopiclenol. Definitions of each co-criteria and score calculation were provided in the section for primary outcome measure.
Outcome measures
| Measure |
Pediatric Cohort: Patients With Paired Images
n=40 Participants
Pediatric cohort was a prospective, multi-center, non-randomized, open-label and single arm study which was independent of the adult cohort and with a different study design.
For each patient included in this pediatric cohort, he (she) underwent one contrast-enhanced MRI with gadopiclenol as contrast agent.
A single period (overall period) for this pediatric cohort.
Patients with paired images and pre-images were the same patients (paired images compared with pre-images on matching lesions within the same patient).
|
Patients With Gadobutrol Paired Images
n=40 Participants
Patients of Arm 2 for whom gadobutrol-enhanced MRI was performed as first MRI and patients of Arm 1 for whom gadobutrol-enhanced MRI was performed as second MRI.
Patients with gadobutrol Paired images are the same patients with gadopiclenol Paired images.
|
|---|---|---|
|
Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Degree of Contrast Enhancement
Degree of contrast enhancement - Reader A
|
3.68 Mean of a score (on a scale) per patient
Standard Error 0.09
|
1.00 Mean of a score (on a scale) per patient
Standard Error 0.09
|
|
Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Degree of Contrast Enhancement
Degree of contrast enhancement - Reader B
|
3.30 Mean of a score (on a scale) per patient
Standard Error 0.11
|
1.00 Mean of a score (on a scale) per patient
Standard Error 0.11
|
|
Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Degree of Contrast Enhancement
Degree of contrast enhancement - Reader C
|
3.27 Mean of a score (on a scale) per patient
Standard Error 0.12
|
1.00 Mean of a score (on a scale) per patient
Standard Error 0.12
|
Adverse Events
Adult Cohort: TEAEs Occurring During and or After Gadopiclenol Administration
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Adult Cohort: TEAEs Occurring During and or After Gadobutrol Administration
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Pediatric Cohort: TEAEs Occurring During and or After Gadopiclenol Administration
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adult Cohort: TEAEs Occurring During and or After Gadopiclenol Administration
n=195 participants at risk
A total of 195 patients received gadopiclenol administration as the first or second contrast agent for enhanced MRI examination.
29 TEAEs occurring after gadopiclenol administration in a total of 27 patients were reported, including 1 serious TEAE in 1 patient and 28 non-serious TEAEs in 26 patients.
|
Adult Cohort: TEAEs Occurring During and or After Gadobutrol Administration
n=194 participants at risk
A total of 194 patients received gadobutrol administration as the first or second contrast agent for enhanced MRI examination.
34 TEAEs occurring after gadobutrol administration in a total of 25 patients were reported, including 4 serious TEAEs in 3 patients and 30 non-serious TEAEs in 24 patients.
|
Pediatric Cohort: TEAEs Occurring During and or After Gadopiclenol Administration
n=40 participants at risk
A total of 40 pediatric patients received gadopiclenol administration for enhanced MRI examination.
A total of 8 non-serious TEAEs were reported in 4 pediatric patients: 3 patients each experienced a single TEAE and 1 patient experienced 5 TEAEs.
|
|---|---|---|---|
|
Nervous system disorders
Cerebral Infarction
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Nervous system disorders
Intracranial Tumour Haemorrhage
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
Other adverse events
| Measure |
Adult Cohort: TEAEs Occurring During and or After Gadopiclenol Administration
n=195 participants at risk
A total of 195 patients received gadopiclenol administration as the first or second contrast agent for enhanced MRI examination.
29 TEAEs occurring after gadopiclenol administration in a total of 27 patients were reported, including 1 serious TEAE in 1 patient and 28 non-serious TEAEs in 26 patients.
|
Adult Cohort: TEAEs Occurring During and or After Gadobutrol Administration
n=194 participants at risk
A total of 194 patients received gadobutrol administration as the first or second contrast agent for enhanced MRI examination.
34 TEAEs occurring after gadobutrol administration in a total of 25 patients were reported, including 4 serious TEAEs in 3 patients and 30 non-serious TEAEs in 24 patients.
|
Pediatric Cohort: TEAEs Occurring During and or After Gadopiclenol Administration
n=40 participants at risk
A total of 40 pediatric patients received gadopiclenol administration for enhanced MRI examination.
A total of 8 non-serious TEAEs were reported in 4 pediatric patients: 3 patients each experienced a single TEAE and 1 patient experienced 5 TEAEs.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
1.0%
2/194 • Number of events 2 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.0%
2/195 • Number of events 2 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Gastrointestinal disorders
Constipation
|
1.0%
2/195 • Number of events 2 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
1.0%
2/194 • Number of events 2 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Gastrointestinal disorders
Anal paraesthesia
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Gastrointestinal disorders
Duodenitis
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
General disorders
Pyrexia
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
2.6%
5/194 • Number of events 5 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
General disorders
Administration site warmth
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Gastrointestinal disorders
Fatigue
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
General disorders
Feeling cold
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
General disorders
Infusion site erythema
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
General disorders
Injection site pain
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
General disorders
Oedema peripheral
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Nervous system disorders
Headache
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
1.0%
2/194 • Number of events 2 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
1.0%
2/194 • Number of events 2 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Nervous system disorders
Presyncope
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.0%
2/195 • Number of events 2 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
2/195 • Number of events 2 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Infections and infestations
Nasopharyngitis
|
1.0%
2/195 • Number of events 2 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Infections and infestations
Pneumonia aspiration
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain stem glioma
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Eye disorders
Eyelid oedema
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.51%
1/195 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.52%
1/194 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/40 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
2.5%
1/40 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
2.5%
1/40 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
2.5%
1/40 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
2.5%
1/40 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
2.5%
1/40 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
2.5%
1/40 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
2.5%
1/40 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
|
Vascular disorders
Hypertension
|
0.00%
0/195 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
0.00%
0/194 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
2.5%
1/40 • Number of events 1 • For adult cohort, adverse event (AE) data were collected from informed consent signature to one day after the second MRI examination. For pediatric cohort, AE data were collected from informed consent signature to one day after the only MRI examination.
For adult cohort: Safety population (SS) included 197 patients who received at least one contrast agent of the study. For pediatric cohort, SS included 40 patients who received gadopiclenol injection. Treatment Emergent Adverse Events (TEAEs) were AEs occurring during and/or after contrast agent administration. TEAEs for SS were registered below according to TEAEs occurring during \& after gadopiclenol or gadobutrol administration whatever the arm (for adult cohort) or pediatric cohort.
|
Additional Information
Frantz Hebert, Global Head of Clinical Development
Guerbet
Phone: +33 680249334
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place