Trial Outcomes & Findings for Cardiac Safety Evaluation of P03277 (NCT NCT03657264)
NCT ID: NCT03657264
Last Updated: 2022-07-18
Results Overview
Each subject was monitored with a 12-lead Holter electrocardiogram (ECG). The study had to show that both 0.1 and 0.3 mmol/kg doses of P03277 do not increase the QT interval corrected by Fridericia formula (QTcF). The study is successful if the difference between each of the two doses of P03277 and placebo for the largest mean change from baseline for the QTcF is lower than 10 milliseconds. The baseline was defined as the mean of the 3 triplicates ECG measured within 1 hour before each product administration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
from 1 hour before any administration until 24 hours post-administration at the following timepoints: -1 hour, 5 min, 10 min, 20 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 24 hours.
Results posted on
2022-07-18
Participant Flow
Participant milestones
| Measure |
Sequence 1
The sequence of administration is: P/ScD/PC/CD
Where:
* P = Placebo (Nacl 0.9%)
* CD = P03277 tested at 0.1 mmol/kg
* ScD = P03277 tested at 0.3 mmol/kg
* PC = Positive control (moxifloxacin 400 mg - per os).
|
Sequence 2
The sequence of administration is: CD/PC/ScD/P
Where:
* P = Placebo (Nacl 0.9%)
* CD = P03277 tested at 0.1 mmol/kg
* ScD = P03277 tested at 0.3 mmol/kg
* PC = Positive control (moxifloxacin 400 mg - per os).
|
Sequence 3
The sequence of administration is: ScD/CD/P/PC
Where:
* P = Placebo (Nacl 0.9%)
* CD = P03277 tested at 0.1 mmol/kg
* ScD = P03277 tested at 0.3 mmol/kg
* PC = Positive control (moxifloxacin 400 mg - per os).
|
Sequence 4
The sequence of administration is: PC/P/CD/ScD
Where:
* P = Placebo (Nacl 0.9%)
* CD = P03277 tested at 0.1 mmol/kg
* ScD = P03277 tested at 0.3 mmol/kg
* PC = Positive control (moxifloxacin 400 mg - per os).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cardiac Safety Evaluation of P03277
Baseline characteristics by cohort
| Measure |
Sequence 1
n=12 Participants
The sequence of administration is: P/ScD/PC/CD
Where:
* P = Placebo (Nacl 0.9%)
* CD = P03277 tested at 0.1 mmol/kg
* ScD = P03277 tested at 0.3 mmol/kg
* PC = Positive control (moxifloxacin 400 mg - per os).
|
Sequence 2
n=12 Participants
The sequence of administration is: CD/PC/ScD/P
Where:
* P = Placebo (Nacl 0.9%)
* CD = P03277 tested at 0.1 mmol/kg
* ScD = P03277 tested at 0.3 mmol/kg
* PC = Positive control (moxifloxacin 400 mg - per os).
|
Sequence 3
n=12 Participants
The sequence of administration is: ScD/CD/P/PC
Where:
* P = Placebo (Nacl 0.9%)
* CD = P03277 tested at 0.1 mmol/kg
* ScD = P03277 tested at 0.3 mmol/kg
* PC = Positive control (moxifloxacin 400 mg - per os).
|
Sequence 4
n=12 Participants
The sequence of administration is: PC/P/CD/ScD
Where:
* P = Placebo (Nacl 0.9%)
* CD = P03277 tested at 0.1 mmol/kg
* ScD = P03277 tested at 0.3 mmol/kg
* PC = Positive control (moxifloxacin 400 mg - per os).
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.8 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
39.8 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
40.5 years
STANDARD_DEVIATION 11.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
47 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Weight
|
76.3 kg
STANDARD_DEVIATION 10.4 • n=5 Participants
|
77.6 kg
STANDARD_DEVIATION 11.1 • n=7 Participants
|
75.9 kg
STANDARD_DEVIATION 8.3 • n=5 Participants
|
71.3 kg
STANDARD_DEVIATION 9.8 • n=4 Participants
|
75.3 kg
STANDARD_DEVIATION 9.9 • n=21 Participants
|
PRIMARY outcome
Timeframe: from 1 hour before any administration until 24 hours post-administration at the following timepoints: -1 hour, 5 min, 10 min, 20 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 24 hours.Population: The primary analysis was performed using the per protocol set which included subjects who had no major protocol deviations throughout their whole study period.
Each subject was monitored with a 12-lead Holter electrocardiogram (ECG). The study had to show that both 0.1 and 0.3 mmol/kg doses of P03277 do not increase the QT interval corrected by Fridericia formula (QTcF). The study is successful if the difference between each of the two doses of P03277 and placebo for the largest mean change from baseline for the QTcF is lower than 10 milliseconds. The baseline was defined as the mean of the 3 triplicates ECG measured within 1 hour before each product administration.
Outcome measures
| Measure |
P03277 0.1 mmol/kg
n=47 Participants
All subjects who received P03277 at 0.1 mmol/kg.
|
P03277 0.3 mmol/kg
n=47 Participants
All subjects who received P03277 at 0.3 mmol/kg.
|
Placebo
n=47 Participants
All subjects who received placebo.
|
|---|---|---|---|
|
Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
5 min
|
0.97 milliseconds
Standard Error 0.88
|
5.05 milliseconds
Standard Error 0.89
|
0.24 milliseconds
Standard Error 0.89
|
|
Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
10 min
|
-0.11 milliseconds
Standard Error 0.86
|
1.34 milliseconds
Standard Error 0.86
|
-0.59 milliseconds
Standard Error 0.86
|
|
Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
20 min
|
-1.25 milliseconds
Standard Error 0.88
|
-1.20 milliseconds
Standard Error 0.88
|
-1.41 milliseconds
Standard Error 0.88
|
|
Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
30 min
|
-1.06 milliseconds
Standard Error 0.79
|
-1.26 milliseconds
Standard Error 0.79
|
-1.69 milliseconds
Standard Error 0.79
|
|
Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
1 hour
|
-2.72 milliseconds
Standard Error 0.92
|
-2.44 milliseconds
Standard Error 0.92
|
-2.90 milliseconds
Standard Error 0.92
|
|
Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
1.5 hours
|
-3.08 milliseconds
Standard Error 0.89
|
-4.64 milliseconds
Standard Error 0.89
|
-3.53 milliseconds
Standard Error 0.89
|
|
Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
2 hours
|
-2.08 milliseconds
Standard Error 0.99
|
-3.22 milliseconds
Standard Error 0.99
|
-2.05 milliseconds
Standard Error 0.99
|
|
Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
3 hours
|
2.34 milliseconds
Standard Error 0.98
|
-1.38 milliseconds
Standard Error 0.98
|
-0.05 milliseconds
Standard Error 0.98
|
|
Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
4 hours
|
0.61 milliseconds
Standard Error 0.97
|
-0.51 milliseconds
Standard Error 0.97
|
0.33 milliseconds
Standard Error 0.97
|
|
Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
8 hours
|
-2.55 milliseconds
Standard Error 1.17
|
-5.59 milliseconds
Standard Error 1.17
|
-3.66 milliseconds
Standard Error 1.17
|
|
Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
24 hours
|
-3.18 milliseconds
Standard Error 0.92
|
-3.28 milliseconds
Standard Error 0.92
|
-3.49 milliseconds
Standard Error 0.93
|
SECONDARY outcome
Timeframe: from 1 hour before any administration until 4 hours post-administration at the following timepoints: -1 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours.Population: Analysis of secondary criteria was performed using the full analysis set which included all randomized subjects.
Each subject was monitored with a 12-lead Holter electrocardiogram (ECG). The assay sensitivity was assessed through this outcome. The difference between the positive control (moxifloxacin) and placebo for the largest mean change from baseline for the QTcF had to be greater than 5 milliseconds for at least one time point. The baseline was defined as the mean of the 3 triplicates ECG measured within 1 hour before each product administration.
Outcome measures
| Measure |
P03277 0.1 mmol/kg
n=48 Participants
All subjects who received P03277 at 0.1 mmol/kg.
|
P03277 0.3 mmol/kg
n=48 Participants
All subjects who received P03277 at 0.3 mmol/kg.
|
Placebo
All subjects who received placebo.
|
|---|---|---|---|
|
Change-from-baseline Mean Effect of Moxifloxacin on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
1 hour
|
1.73 milliseconds
Standard Error 0.91
|
-2.89 milliseconds
Standard Error 0.91
|
—
|
|
Change-from-baseline Mean Effect of Moxifloxacin on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
1.5 hours
|
6.13 milliseconds
Standard Error 0.88
|
-3.27 milliseconds
Standard Error 0.88
|
—
|
|
Change-from-baseline Mean Effect of Moxifloxacin on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
2 hours
|
8.60 milliseconds
Standard Error 0.97
|
-1.95 milliseconds
Standard Error 0.97
|
—
|
|
Change-from-baseline Mean Effect of Moxifloxacin on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
3 hours
|
10.50 milliseconds
Standard Error 0.97
|
0.17 milliseconds
Standard Error 0.97
|
—
|
|
Change-from-baseline Mean Effect of Moxifloxacin on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
4 hours
|
11.28 milliseconds
Standard Error 0.95
|
0.63 milliseconds
Standard Error 0.95
|
—
|
SECONDARY outcome
Timeframe: from 1 hour before any administration until 24 hours post-administration.Concentration-response relationship was investigated between ∆QTc and P03277 concentrations using a mixed model approach. Plasma concentration of P03277 was measured at the same timepoints as ECG measurements.
Outcome measures
| Measure |
P03277 0.1 mmol/kg
n=48 Participants
All subjects who received P03277 at 0.1 mmol/kg.
|
P03277 0.3 mmol/kg
n=48 Participants
All subjects who received P03277 at 0.3 mmol/kg.
|
Placebo
All subjects who received placebo.
|
|---|---|---|---|
|
Predicted Value of ∆∆QTc at Cmax
|
0.41 milliseconds
Interval -0.08 to 0.9
|
2.23 milliseconds
Interval 1.19 to 3.26
|
—
|
Adverse Events
P03277 0.1 mmol/kg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
P03277 0.3 mmol/kg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Positive Control (Moxifloxacin)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
P03277 0.1 mmol/kg
n=48 participants at risk
All subjects who received P03277 at 0.1 mmol/kg.
|
P03277 0.3 mmol/kg
n=48 participants at risk
All subjects who received P03277 at 0.3 mmol/kg.
|
Positive Control (Moxifloxacin)
n=48 participants at risk
All subjects who received Moxifloxacin.
|
Placebo
n=48 participants at risk
All subjects who received placebo.
|
|---|---|---|---|---|
|
General disorders
Application site irritation
|
12.5%
6/48 • Number of events 7 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
14.6%
7/48 • Number of events 8 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
10.4%
5/48 • Number of events 5 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
12.5%
6/48 • Number of events 6 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
General disorders
Injection site haematoma
|
8.3%
4/48 • Number of events 4 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
6.2%
3/48 • Number of events 3 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
General disorders
Injection site erythema
|
4.2%
2/48 • Number of events 2 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
General disorders
Catheter site haematoma
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
General disorders
Injection site inflammation
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
General disorders
Injection site rash
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
General disorders
Injection site reaction
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
General disorders
Catheter site erythema
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
General disorders
Catheter site pain
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
General disorders
Catheter site swelling
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
General disorders
Feeling hot
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
General disorders
Influenza like illness
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
General disorders
Injection site discomfort
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
General disorders
Injection site extravasation
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Nervous system disorders
Headache
|
12.5%
6/48 • Number of events 6 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
10.4%
5/48 • Number of events 6 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
8.3%
4/48 • Number of events 4 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
8.3%
4/48 • Number of events 4 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Nervous system disorders
Dysgeusia
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
4.2%
2/48 • Number of events 2 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Nervous system disorders
Dizziness
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
4.2%
2/48 • Number of events 2 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
6.2%
3/48 • Number of events 3 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
4.2%
2/48 • Number of events 2 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
4.2%
2/48 • Number of events 2 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
4.2%
2/48 • Number of events 2 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Psychiatric disorders
Nightmare
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
General disorders
Injection site pain
|
4.2%
2/48 • Number of events 2 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
8.3%
4/48 • Number of events 4 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
General disorders
Asthenia
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
2.1%
1/48 • Number of events 1 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
0.00%
0/48 • From informed consent signature until the end of the confinement period, i.e. a period ranging from 32 to 41 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER