Trial Outcomes & Findings for Pharmacokinetics, Safety and Efficacy of P03277 in Pediatric Patients Undergoing Central Nervous System Contrast-enhanced MRI (NCT NCT03749252)
NCT ID: NCT03749252
Last Updated: 2022-06-01
Results Overview
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours
Results posted on
2022-06-01
Participant Flow
Participant milestones
| Measure |
CNS & Body Cohorts 2-6 Years
Pediatric patients aged 2-6 years undergoing CNS or Body contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS & Body Cohorts 7-11 Years
Pediatric patients aged 7-11 years undergoing CNS or Body contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS & Body Cohorts 12-17 Years
Pediatric patients aged 12-17 years undergoing CNS or Body contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
23
|
31
|
|
Overall Study
COMPLETED
|
26
|
23
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics, Safety and Efficacy of P03277 in Pediatric Patients Undergoing Central Nervous System Contrast-enhanced MRI
Baseline characteristics by cohort
| Measure |
CNS & Body Cohorts 2-6 Years
n=26 Participants
Pediatric patients aged 2-6 years undergoing CNS or Body contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS & Body Cohorts 7-11 Years
n=23 Participants
Pediatric patients aged 7-11 years undergoing CNS or Body contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS & Body Cohorts 12-17 Years
n=31 Participants
Pediatric patients aged 12-17 years undergoing CNS or Body contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
3.8 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
8.8 years
STANDARD_DEVIATION 1.2 • n=7 Participants
|
14.3 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
9.3 years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hoursPopulation: All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Outcome measures
| Measure |
CNS Cohort 2-6 Years
n=20 Participants
Pediatric patients aged 2-6 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS Cohort 7-11 Years
n=20 Participants
Pediatric patients aged 7-11 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS Cohort 12-17 Years
n=19 Participants
Pediatric patients aged 12-17 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
|---|---|---|---|
|
Elimination Half-life
|
1.29 hours
Interval 0.69 to 3.38
|
1.48 hours
Interval 0.83 to 3.2
|
1.77 hours
Interval 1.0 to 3.57
|
PRIMARY outcome
Timeframe: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hoursPopulation: All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Outcome measures
| Measure |
CNS Cohort 2-6 Years
n=20 Participants
Pediatric patients aged 2-6 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS Cohort 7-11 Years
n=20 Participants
Pediatric patients aged 7-11 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS Cohort 12-17 Years
n=19 Participants
Pediatric patients aged 12-17 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
|---|---|---|---|
|
Total Clearance
|
0.12 L/h/kg
Interval 0.05 to 0.28
|
0.10 L/h/kg
Interval 0.04 to 0.24
|
0.08 L/h/kg
Interval 0.04 to 0.2
|
PRIMARY outcome
Timeframe: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hoursPopulation: All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Outcome measures
| Measure |
CNS Cohort 2-6 Years
n=20 Participants
Pediatric patients aged 2-6 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS Cohort 7-11 Years
n=20 Participants
Pediatric patients aged 7-11 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS Cohort 12-17 Years
n=19 Participants
Pediatric patients aged 12-17 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
|---|---|---|---|
|
Central Volume of Distribution
|
0.12 L/kg
Interval 0.06 to 0.26
|
0.12 L/kg
Interval 0.06 to 0.24
|
0.11 L/kg
Interval 0.05 to 0.24
|
PRIMARY outcome
Timeframe: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hoursPopulation: All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Outcome measures
| Measure |
CNS Cohort 2-6 Years
n=20 Participants
Pediatric patients aged 2-6 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS Cohort 7-11 Years
n=20 Participants
Pediatric patients aged 7-11 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS Cohort 12-17 Years
n=19 Participants
Pediatric patients aged 12-17 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
|---|---|---|---|
|
Peripheral Volume of Distribution
|
0.06 L/kg
Interval 0.06 to 0.06
|
0.06 L/kg
Interval 0.06 to 0.06
|
0.06 L/kg
Interval 0.06 to 0.06
|
PRIMARY outcome
Timeframe: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hoursPopulation: All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Outcome measures
| Measure |
CNS Cohort 2-6 Years
n=20 Participants
Pediatric patients aged 2-6 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS Cohort 7-11 Years
n=20 Participants
Pediatric patients aged 7-11 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS Cohort 12-17 Years
n=19 Participants
Pediatric patients aged 12-17 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
|---|---|---|---|
|
Area Under the Curve
|
403.16 mg.h/L
Standard Deviation 93.35
|
477.25 mg.h/L
Standard Deviation 105.71
|
582.30 mg.h/L
Standard Deviation 122.08
|
PRIMARY outcome
Timeframe: 10 minutes post-injectionPopulation: All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Outcome measures
| Measure |
CNS Cohort 2-6 Years
n=20 Participants
Pediatric patients aged 2-6 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS Cohort 7-11 Years
n=20 Participants
Pediatric patients aged 7-11 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS Cohort 12-17 Years
n=19 Participants
Pediatric patients aged 12-17 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
|---|---|---|---|
|
Simulated Concentrations 10 Minutes Post-injection
|
302.11 mg/L
Standard Deviation 44.68
|
327.20 mg/L
Standard Deviation 47.95
|
349.15 mg/L
Standard Deviation 52.59
|
PRIMARY outcome
Timeframe: 20 minutes post-injectionPopulation: All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Outcome measures
| Measure |
CNS Cohort 2-6 Years
n=20 Participants
Pediatric patients aged 2-6 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS Cohort 7-11 Years
n=20 Participants
Pediatric patients aged 7-11 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS Cohort 12-17 Years
n=19 Participants
Pediatric patients aged 12-17 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
|---|---|---|---|
|
Simulated Concentrations 20 Minutes Post-injection
|
234.88 mg/L
Standard Deviation 30.18
|
259.67 mg/L
Standard Deviation 32.02
|
285.16 mg/L
Standard Deviation 35.35
|
PRIMARY outcome
Timeframe: 30 minutes post-injectionPopulation: All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Outcome measures
| Measure |
CNS Cohort 2-6 Years
n=20 Participants
Pediatric patients aged 2-6 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS Cohort 7-11 Years
n=20 Participants
Pediatric patients aged 7-11 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS Cohort 12-17 Years
n=19 Participants
Pediatric patients aged 12-17 years undergoing CNS contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
|---|---|---|---|
|
Simulated Concentrations 30 Minutes Post-injection
|
188.26 mg/L
Standard Deviation 25.10
|
211.20 mg/L
Standard Deviation 25.82
|
237.25 mg/L
Standard Deviation 26.97
|
Adverse Events
CNS & Body Cohorts 2-6 Years
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
CNS & Body Cohorts 7-11 Years
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
CNS & Body Cohorts 12-17 Years
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CNS & Body Cohorts 2-6 Years
n=26 participants at risk
Pediatric patients aged 2-6 years undergoing CNS or Body contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS & Body Cohorts 7-11 Years
n=23 participants at risk
Pediatric patients aged 7-11 years undergoing CNS or Body contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS & Body Cohorts 12-17 Years
n=31 participants at risk
Pediatric patients aged 12-17 years undergoing CNS or Body contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Head injury
|
3.8%
1/26 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Nervous system disorders
Epilepsy
|
3.8%
1/26 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Nervous system disorders
Coma
|
3.8%
1/26 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
General disorders
Condition aggravated
|
3.8%
1/26 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
3.2%
1/31 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
3.2%
1/31 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
3.2%
1/31 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
Other adverse events
| Measure |
CNS & Body Cohorts 2-6 Years
n=26 participants at risk
Pediatric patients aged 2-6 years undergoing CNS or Body contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS & Body Cohorts 7-11 Years
n=23 participants at risk
Pediatric patients aged 7-11 years undergoing CNS or Body contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
CNS & Body Cohorts 12-17 Years
n=31 participants at risk
Pediatric patients aged 12-17 years undergoing CNS or Body contrast-enhanced MRI
P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
|
|---|---|---|---|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
3.2%
1/31 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
1/26 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
4.3%
1/23 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Infections and infestations
Respiratory tract infection viral
|
3.8%
1/26 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Infections and infestations
Tracheobronchitis mycoplasmal
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
4.3%
1/23 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
4.3%
1/23 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
3.2%
1/31 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
General disorders
Condition aggravated
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
4.3%
1/23 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
General disorders
Application site erythema
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
3.2%
1/31 • Number of events 2 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Investigations
Blood pressure increased
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
4.3%
1/23 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Investigations
Electrocardiogram QT prolonged
|
3.8%
1/26 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
4.3%
1/23 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
4.3%
1/23 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
4.3%
1/23 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
4.3%
1/23 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.8%
1/26 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
4.3%
1/23 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
4.3%
1/23 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Cardiac disorders
Long QT syndrome
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
3.2%
1/31 • Number of events 2 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
3.2%
1/31 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
3.2%
1/31 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
3.2%
1/31 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Eye disorders
Glaucoma
|
0.00%
0/26 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
3.2%
1/31 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
|
Injury, poisoning and procedural complications
Procedural Anxiety
|
3.8%
1/26 • Number of events 1 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/23 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
0.00%
0/31 • Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
|
Additional Information
Global Head of Medical Affairs & Clinical Development
Guerbet
Phone: +33 (0) 1 45 91 50 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place