Trial Outcomes & Findings for Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers (NCT NCT01552928)
NCT ID: NCT01552928
Last Updated: 2021-06-09
Results Overview
QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
COMPLETED
PHASE1
60 participants
Over 12 hours post-dose
2021-06-09
Participant Flow
Participant milestones
| Measure |
Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg
A single oral dose of 0.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of placebo on Day 1 for Period 3; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 4.
|
Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo
A single oral dose of 2.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 2; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of placebo on Day 1 for Period 4.
|
Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg
A single oral dose of 400 mg of moxifloxacin on Day 1 for Period 1; then a single oral dose of placebo on Day 1 for Period 2; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 4.
|
Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg
A single oral dose of placebo on Day 1 for Period 1; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 3; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 4.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
14
|
15
|
15
|
16
|
|
Period 1
COMPLETED
|
14
|
15
|
15
|
16
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
14
|
15
|
15
|
16
|
|
Period 2
COMPLETED
|
14
|
15
|
15
|
16
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
14
|
15
|
15
|
16
|
|
Period 3
COMPLETED
|
14
|
15
|
14
|
16
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Period 4
STARTED
|
14
|
15
|
14
|
16
|
|
Period 4
COMPLETED
|
14
|
15
|
14
|
16
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg
A single oral dose of 0.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of placebo on Day 1 for Period 3; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 4.
|
Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo
A single oral dose of 2.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 2; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of placebo on Day 1 for Period 4.
|
Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg
A single oral dose of 400 mg of moxifloxacin on Day 1 for Period 1; then a single oral dose of placebo on Day 1 for Period 2; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 4.
|
Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg
A single oral dose of placebo on Day 1 for Period 1; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 3; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 4.
|
|---|---|---|---|---|
|
Period 3
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg
n=14 Participants
A single oral dose of 0.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of placebo on Day 1 for Period 3; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 4.
|
Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo
n=15 Participants
A single oral dose of 2.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 2; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of placebo on Day 1 for Period 4.
|
Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg
n=15 Participants
A single oral dose of 400 mg of moxifloxacin on Day 1 for Period 1; then a single oral dose of placebo on Day 1 for Period 2; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 4.
|
Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg
n=16 Participants
A single oral dose of placebo on Day 1 for Period 1; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 3; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 4.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Age, Continuous
|
28.1 Years
STANDARD_DEVIATION 6.44 • n=5 Participants
|
28.4 Years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
29.5 Years
STANDARD_DEVIATION 5.83 • n=5 Participants
|
30.4 Years
STANDARD_DEVIATION 8.02 • n=4 Participants
|
29.2 Years
STANDARD_DEVIATION 6.96 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Region of Enrollment
FRANCE
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Over 12 hours post-dosePopulation: Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
Outcome measures
| Measure |
Anagrelide 0.5 mg
n=50 Participants
A single oral dose of 0.5 mg of anagrelide
|
Anagrelide 2.5 mg
n=55 Participants
A single oral dose of 2.5 mg of anagrelide
|
Moxifloxacin 400 mg
n=53 Participants
A single oral dose of 400 mg of moxifloxacin
|
|---|---|---|---|
|
Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals From Time-Matched Analysis by Largest Time Point
|
7.0 msec
Interval 4.2 to 9.8
|
13.0 msec
Interval 10.3 to 15.7
|
12.6 msec
Interval 9.9 to 15.2
|
PRIMARY outcome
Timeframe: Over 12 hours post-dosePopulation: Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
Outcome measures
| Measure |
Anagrelide 0.5 mg
n=50 Participants
A single oral dose of 0.5 mg of anagrelide
|
Anagrelide 2.5 mg
n=54 Participants
A single oral dose of 2.5 mg of anagrelide
|
Moxifloxacin 400 mg
n=53 Participants
A single oral dose of 400 mg of moxifloxacin
|
|---|---|---|---|
|
Mean Difference Changes From Baseline Versus Placebo in Heart Rate From Time-Matched Analysis by Largest Time Point
|
7.8 beats per minute
Interval 5.3 to 10.4
|
29.1 beats per minute
Interval 26.6 to 31.6
|
4.3 beats per minute
Interval 1.8 to 6.7
|
PRIMARY outcome
Timeframe: Over 12 hours post-dosePopulation: Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
Outcome measures
| Measure |
Anagrelide 0.5 mg
n=50 Participants
A single oral dose of 0.5 mg of anagrelide
|
Anagrelide 2.5 mg
n=55 Participants
A single oral dose of 2.5 mg of anagrelide
|
Moxifloxacin 400 mg
n=53 Participants
A single oral dose of 400 mg of moxifloxacin
|
|---|---|---|---|
|
Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals From Time-Matched Analysis by Largest Time Point
|
5.0 msec
Interval 2.1 to 8.0
|
10.0 msec
Interval 7.3 to 12.7
|
11.8 msec
Interval 8.9 to 14.8
|
PRIMARY outcome
Timeframe: Over 12 hours post-dosePopulation: Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
Outcome measures
| Measure |
Anagrelide 0.5 mg
n=50 Participants
A single oral dose of 0.5 mg of anagrelide
|
Anagrelide 2.5 mg
n=56 Participants
A single oral dose of 2.5 mg of anagrelide
|
Moxifloxacin 400 mg
n=55 Participants
A single oral dose of 400 mg of moxifloxacin
|
|---|---|---|---|
|
Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals From Time-Matched Analysis by Largest Time Point
|
-2.9 msec
Interval -5.6 to -0.2
|
-18.1 msec
Interval -20.7 to -15.4
|
-2.3 msec
Interval -5.0 to 0.4
|
PRIMARY outcome
Timeframe: Over 12 hours post-dosePopulation: Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
Outcome measures
| Measure |
Anagrelide 0.5 mg
n=49 Participants
A single oral dose of 0.5 mg of anagrelide
|
Anagrelide 2.5 mg
n=54 Participants
A single oral dose of 2.5 mg of anagrelide
|
Moxifloxacin 400 mg
n=56 Participants
A single oral dose of 400 mg of moxifloxacin
|
|---|---|---|---|
|
Mean Difference Changes From Baseline Versus Placebo in QT Intervals From Time-Matched Analysis by Largest Time Point
|
1.7 msec
Interval -2.0 to 5.4
|
-2.4 msec
Interval -6.0 to 1.2
|
9.6 msec
Interval 5.2 to 14.1
|
SECONDARY outcome
Timeframe: Over 12 hours post-dosePopulation: Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.
Outcome measures
| Measure |
Anagrelide 0.5 mg
n=51 Participants
A single oral dose of 0.5 mg of anagrelide
|
Anagrelide 2.5 mg
n=55 Participants
A single oral dose of 2.5 mg of anagrelide
|
Moxifloxacin 400 mg
n=55 Participants
A single oral dose of 400 mg of moxifloxacin
|
|---|---|---|---|
|
Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals at Subject-Specific Time of Maximum Plasma Concentration (Tmax)
|
4.4 msec
Interval 2.0 to 6.8
|
8.2 msec
Interval 4.9 to 11.6
|
11.3 msec
Interval 9.0 to 13.7
|
SECONDARY outcome
Timeframe: Over 12 hours post-dosePopulation: Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Outcome measures
| Measure |
Anagrelide 0.5 mg
n=51 Participants
A single oral dose of 0.5 mg of anagrelide
|
Anagrelide 2.5 mg
n=55 Participants
A single oral dose of 2.5 mg of anagrelide
|
Moxifloxacin 400 mg
n=55 Participants
A single oral dose of 400 mg of moxifloxacin
|
|---|---|---|---|
|
Mean Difference Changes From Baseline Versus Placebo in Heart Rate at Subject-Specific Tmax
|
4.5 beats per minute
Interval 2.7 to 6.2
|
21.8 beats per minute
Interval 18.3 to 25.4
|
2.9 beats per minute
Interval 1.5 to 4.3
|
SECONDARY outcome
Timeframe: Over 12 hours post-dosePopulation: Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.
Outcome measures
| Measure |
Anagrelide 0.5 mg
n=51 Participants
A single oral dose of 0.5 mg of anagrelide
|
Anagrelide 2.5 mg
n=55 Participants
A single oral dose of 2.5 mg of anagrelide
|
Moxifloxacin 400 mg
n=55 Participants
A single oral dose of 400 mg of moxifloxacin
|
|---|---|---|---|
|
Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals at Subject-Specific Tmax
|
3.7 msec
Interval 1.3 to 6.1
|
4.5 msec
Interval 0.8 to 8.1
|
10.8 msec
Interval 8.5 to 13.1
|
SECONDARY outcome
Timeframe: Over 12 hours post-dosePopulation: Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.
Outcome measures
| Measure |
Anagrelide 0.5 mg
n=51 Participants
A single oral dose of 0.5 mg of anagrelide
|
Anagrelide 2.5 mg
n=55 Participants
A single oral dose of 2.5 mg of anagrelide
|
Moxifloxacin 400 mg
n=55 Participants
A single oral dose of 400 mg of moxifloxacin
|
|---|---|---|---|
|
Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals at Subject-Specific Tmax
|
8.5 msec
Interval 4.9 to 12.0
|
25.5 msec
Interval 20.3 to 30.6
|
14.0 msec
Interval 11.0 to 17.1
|
SECONDARY outcome
Timeframe: Over 12 hours post-dosePopulation: Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.
Outcome measures
| Measure |
Anagrelide 0.5 mg
n=51 Participants
A single oral dose of 0.5 mg of anagrelide
|
Anagrelide 2.5 mg
n=55 Participants
A single oral dose of 2.5 mg of anagrelide
|
Moxifloxacin 400 mg
n=55 Participants
A single oral dose of 400 mg of moxifloxacin
|
|---|---|---|---|
|
Mean Difference Changes From Baseline Versus Placebo in QT Intervals at Subject-Specific Tmax
|
-6.1 msec
Interval -9.5 to -2.8
|
-34.3 msec
Interval -40.5 to -28.1
|
4.3 msec
Interval 0.8 to 7.7
|
SECONDARY outcome
Timeframe: Over 12 hours post-dosePopulation: Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.
Outcome measures
| Measure |
Anagrelide 0.5 mg
n=34 Participants
A single oral dose of 0.5 mg of anagrelide
|
Anagrelide 2.5 mg
n=25 Participants
A single oral dose of 2.5 mg of anagrelide
|
Moxifloxacin 400 mg
A single oral dose of 400 mg of moxifloxacin
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of 0.5 mg Anagrelide in Males and Females
|
2.083 ng/ml
Standard Deviation 0.975
|
3.64 ng/ml
Standard Deviation 1.959
|
—
|
SECONDARY outcome
Timeframe: Over 12 hours post-dosePopulation: Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.
Outcome measures
| Measure |
Anagrelide 0.5 mg
n=35 Participants
A single oral dose of 0.5 mg of anagrelide
|
Anagrelide 2.5 mg
n=25 Participants
A single oral dose of 2.5 mg of anagrelide
|
Moxifloxacin 400 mg
A single oral dose of 400 mg of moxifloxacin
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of 2.5 mg Anagrelide in Males and Females
|
10.592 ng/ml
Standard Deviation 4.871
|
16.378 ng/ml
Standard Deviation 10.224
|
—
|
SECONDARY outcome
Timeframe: Over 12 hours post-dosePopulation: Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.
Outcome measures
| Measure |
Anagrelide 0.5 mg
n=34 Participants
A single oral dose of 0.5 mg of anagrelide
|
Anagrelide 2.5 mg
n=25 Participants
A single oral dose of 2.5 mg of anagrelide
|
Moxifloxacin 400 mg
A single oral dose of 400 mg of moxifloxacin
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Metabolite of 0.5 mg Anagrelide (BCH24426) in Males and Females
|
3.731 ng/ml
Standard Deviation 1.257
|
4.534 ng/ml
Standard Deviation 1.405
|
—
|
SECONDARY outcome
Timeframe: Over 12 hours post-dosePopulation: Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.
Outcome measures
| Measure |
Anagrelide 0.5 mg
n=35 Participants
A single oral dose of 0.5 mg of anagrelide
|
Anagrelide 2.5 mg
n=25 Participants
A single oral dose of 2.5 mg of anagrelide
|
Moxifloxacin 400 mg
A single oral dose of 400 mg of moxifloxacin
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Metabolite of 2.5 mg Anagrelide (BCH24426) in Males and Females
|
18.927 ng/ml
Standard Deviation 6.016
|
23.785 ng/ml
Standard Deviation 7.952
|
—
|
Adverse Events
Anagrelide 0.5mg
Anagrelide 2.5mg
Moxifloxacin 400mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Anagrelide 0.5mg
n=59 participants at risk
|
Anagrelide 2.5mg
n=60 participants at risk
|
Moxifloxacin 400mg
n=60 participants at risk
|
Placebo
n=60 participants at risk
|
|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/59
|
5.0%
3/60 • Number of events 3
|
0.00%
0/60
|
0.00%
0/60
|
|
Gastrointestinal disorders
Constipation
|
5.1%
3/59 • Number of events 3
|
1.7%
1/60 • Number of events 1
|
0.00%
0/60
|
0.00%
0/60
|
|
Gastrointestinal disorders
Nausea
|
3.4%
2/59 • Number of events 2
|
28.3%
17/60 • Number of events 17
|
1.7%
1/60 • Number of events 1
|
0.00%
0/60
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/59
|
8.3%
5/60 • Number of events 5
|
0.00%
0/60
|
0.00%
0/60
|
|
Nervous system disorders
Dizziness
|
3.4%
2/59 • Number of events 2
|
23.3%
14/60 • Number of events 14
|
0.00%
0/60
|
0.00%
0/60
|
|
Nervous system disorders
Headache
|
20.3%
12/59 • Number of events 13
|
73.3%
44/60 • Number of events 44
|
1.7%
1/60 • Number of events 1
|
0.00%
0/60
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/59
|
8.3%
5/60 • Number of events 5
|
0.00%
0/60
|
0.00%
0/60
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER