Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of MNK-1411 in Duchenne Muscular Dystrophy (NCT NCT03400852)
NCT ID: NCT03400852
Last Updated: 2021-03-16
Results Overview
10 Meter Walk/Run is a motor function test to measure the functional capability in patients with DMD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2021-03-16
Participant Flow
Twenty-four participants with Duchenne Muscular Dystrophy (DMD) who chose to discontinue the double-blind period prior to Week 24 entered the open label extension (OLE, Period 2). Participants who did not enter OLE Period were followed up to Week 28.
After screening, 44 participants from 8 countries were enrolled into Period 1
Participant milestones
| Measure |
Period 1: MNK-1411
Participants receive MNK-1411 at a dosing volume appropriate to body weight during Period 1
|
Period 1: Placebo
Participants receive placebo at a volume appropriate to body weight during Period 1
|
Period 2: MNK-1411
All participants receive MNK-1411 at a dosing volume appropriate to body weight during Period 2
|
|---|---|---|---|
|
Blinded Treatment Period
STARTED
|
29
|
15
|
0
|
|
Blinded Treatment Period
COMPLETED
|
20
|
9
|
0
|
|
Blinded Treatment Period
NOT COMPLETED
|
9
|
6
|
0
|
|
Open Label Period
STARTED
|
0
|
0
|
24
|
|
Open Label Period
COMPLETED
|
0
|
0
|
2
|
|
Open Label Period
NOT COMPLETED
|
0
|
0
|
22
|
Reasons for withdrawal
| Measure |
Period 1: MNK-1411
Participants receive MNK-1411 at a dosing volume appropriate to body weight during Period 1
|
Period 1: Placebo
Participants receive placebo at a volume appropriate to body weight during Period 1
|
Period 2: MNK-1411
All participants receive MNK-1411 at a dosing volume appropriate to body weight during Period 2
|
|---|---|---|---|
|
Blinded Treatment Period
Physician Decision
|
0
|
1
|
0
|
|
Blinded Treatment Period
Adverse Event
|
1
|
1
|
0
|
|
Blinded Treatment Period
Study terminated by sponsor
|
8
|
4
|
0
|
|
Open Label Period
Physician Decision
|
0
|
0
|
1
|
|
Open Label Period
Study terminated by sponsor
|
0
|
0
|
21
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Period 1: MNK-1411
n=29 Participants
All participants who received any dose of MNK-1411 in Period 1
|
Period 1: Placebo
n=15 Participants
All patients who received placebo in Period 1
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Children (2-11 Years)
|
29 Participants
n=29 Participants
|
15 Participants
n=15 Participants
|
44 Participants
n=44 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=29 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=29 Participants
|
15 Participants
n=15 Participants
|
44 Participants
n=44 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
0 participants
n=29 Participants
|
0 participants
n=15 Participants
|
3 participants
n=44 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=29 Participants
|
0 participants
n=15 Participants
|
10 participants
n=44 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=29 Participants
|
0 participants
n=15 Participants
|
2 participants
n=44 Participants
|
|
Region of Enrollment
Mexico
|
0 participants
n=29 Participants
|
0 participants
n=15 Participants
|
18 participants
n=44 Participants
|
|
Region of Enrollment
Israel
|
0 participants
n=29 Participants
|
0 participants
n=15 Participants
|
1 participants
n=44 Participants
|
|
Region of Enrollment
Bulgaria
|
0 participants
n=29 Participants
|
0 participants
n=15 Participants
|
2 participants
n=44 Participants
|
|
Region of Enrollment
Serbia
|
0 participants
n=29 Participants
|
0 participants
n=15 Participants
|
2 participants
n=44 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=29 Participants
|
0 participants
n=15 Participants
|
6 participants
n=44 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Summary aggregate results for all participants enrolled into Period 1 and with a score at Week 24
10 Meter Walk/Run is a motor function test to measure the functional capability in patients with DMD.
Outcome measures
| Measure |
Period 1: MNK-1411
n=29 Participants
All participants who received any dose of MNK-1411 in Period 1
|
Period 1: Placebo
n=15 Participants
All patients who received placebo in Period 1
|
|---|---|---|
|
Time to Complete 10 Meter Walk/Run[
at Baseline
|
5.9 seconds
Interval 4.7 to 22.3
|
7.8 seconds
Interval 3.9 to 13.0
|
|
Time to Complete 10 Meter Walk/Run[
at Week 24
|
5.4 seconds
Interval 4.1 to 8.9
|
8.7 seconds
Interval 3.3 to 18.3
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Summary aggregate results for all participants enrolled into Period 1 and with a score at Week 24
The NSAA is comprised of 17 items, each of which is graded using the standard scorecard. Each assessment is rated as 0 - unable to achieve independently, 1 - modified method but achieves goal independent of physical assistance from another, or 2 - normal with no obvious modification of activity. The subscale scores are summed for a total score ranging from 0 to 34. The higher the total score, the better the outcome.
Outcome measures
| Measure |
Period 1: MNK-1411
n=29 Participants
All participants who received any dose of MNK-1411 in Period 1
|
Period 1: Placebo
n=15 Participants
All patients who received placebo in Period 1
|
|---|---|---|
|
North Star Ambulatory Assessment (NSAA) Score
at Baseline
|
17.9 score on a scale
Standard Deviation 6.80
|
17.1 score on a scale
Standard Deviation 6.40
|
|
North Star Ambulatory Assessment (NSAA) Score
at Week 24
|
20.5 score on a scale
Standard Deviation 7.94
|
16.6 score on a scale
Standard Deviation 8.82
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Summary aggregate results for all participants enrolled into Period 1 and with a score at Week 24
Time to Climb 4 Standardized Stairs is a motor performance test
Outcome measures
| Measure |
Period 1: MNK-1411
n=29 Participants
All participants who received any dose of MNK-1411 in Period 1
|
Period 1: Placebo
n=15 Participants
All patients who received placebo in Period 1
|
|---|---|---|
|
Time to Climb 4 Standardized Stairs
at Baseline
|
8.52 seconds
Standard Deviation 8.88
|
8.47 seconds
Standard Deviation 4.34
|
|
Time to Climb 4 Standardized Stairs
at Week 24
|
4.71 seconds
Standard Deviation 2.45
|
15.09 seconds
Standard Deviation 13.84
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Summary aggregate results for all participants who enrolled into Period 1 with a score for this measure at the given time point
Time to stand from a supine position is a motor function test to measure the functional capability in subjects with DMD.
Outcome measures
| Measure |
Period 1: MNK-1411
n=23 Participants
All participants who received any dose of MNK-1411 in Period 1
|
Period 1: Placebo
n=13 Participants
All patients who received placebo in Period 1
|
|---|---|---|
|
Time to Stand From a Supine Position
at Baseline
|
11.14 seconds
Standard Deviation 9.08
|
15.03 seconds
Standard Deviation 12.45
|
|
Time to Stand From a Supine Position
at Week 24
|
7.65 seconds
Standard Deviation 4.99
|
24.89 seconds
Standard Deviation 26.48
|
SECONDARY outcome
Timeframe: BaselinePopulation: Summary aggregate results for all participants enrolled into Period 1 with a score at baseline.
Quantitative muscle testing measured strength-knee flexion and extension measured in Newtons, using a dynamometer
Outcome measures
| Measure |
Period 1: MNK-1411
n=25 Participants
All participants who received any dose of MNK-1411 in Period 1
|
Period 1: Placebo
n=15 Participants
All patients who received placebo in Period 1
|
|---|---|---|
|
Quantitative Muscle Testing Scores at Baseline
Knee flexion
|
26.61 Newtons
Standard Deviation 14.17
|
29.87 Newtons
Standard Deviation 14.17
|
|
Quantitative Muscle Testing Scores at Baseline
Knee extension
|
28.99 Newtons
Standard Deviation 16.24
|
26.64 Newtons
Standard Deviation 15.27
|
SECONDARY outcome
Timeframe: Week 24Population: Summary aggregate results for all participants enrolled into Period 1 with a score at Week 24
Quantitative muscle testing measured strength-knee flexion and extension measured in Newtons, using a dynamometer
Outcome measures
| Measure |
Period 1: MNK-1411
n=18 Participants
All participants who received any dose of MNK-1411 in Period 1
|
Period 1: Placebo
n=9 Participants
All patients who received placebo in Period 1
|
|---|---|---|
|
Quantitative Muscle Testing Scores at Week 24
Knee flexion
|
33.64 Newtons
Standard Deviation 1578
|
25.27 Newtons
Standard Deviation 13.35
|
|
Quantitative Muscle Testing Scores at Week 24
Knee extension
|
26.61 Newtons
Standard Deviation 14.17
|
29.87 Newtons
Standard Deviation 15.13
|
SECONDARY outcome
Timeframe: within 28 weeksPopulation: Summary aggregate results for all participants enrolled into Period 1
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessments were reported as adverse events (AEs)
Outcome measures
| Measure |
Period 1: MNK-1411
n=29 Participants
All participants who received any dose of MNK-1411 in Period 1
|
Period 1: Placebo
n=15 Participants
All patients who received placebo in Period 1
|
|---|---|---|
|
Summary of Adverse Events in the Blinded Treatment Period
Exposed
|
29 Participants
|
15 Participants
|
|
Summary of Adverse Events in the Blinded Treatment Period
Affected by serious adverse events
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events in the Blinded Treatment Period
Affected by non-serious adverse events
|
22 Participants
|
15 Participants
|
|
Summary of Adverse Events in the Blinded Treatment Period
Died from any cause
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 28 weeksPopulation: Summary aggregate results for all participants enrolled into Period 2
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessments were reported as adverse events (AEs)
Outcome measures
| Measure |
Period 1: MNK-1411
n=24 Participants
All participants who received any dose of MNK-1411 in Period 1
|
Period 1: Placebo
All patients who received placebo in Period 1
|
|---|---|---|
|
Summary of Adverse Events in the Open Label Period
Exposed
|
24 Participants
|
—
|
|
Summary of Adverse Events in the Open Label Period
Affected by serious adverse events
|
2 Participants
|
—
|
|
Summary of Adverse Events in the Open Label Period
Affected by non-serious adverse events
|
11 Participants
|
—
|
|
Summary of Adverse Events in the Open Label Period
Died from any cause
|
0 Participants
|
—
|
Adverse Events
Period 1: MNK-1411
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Period 1: Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Period 2: MNK-1411
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1: MNK-1411
n=29 participants at risk
Participants receive MNK-1411 at a dosing volume appropriate to body weight during Period 1
|
Period 1: Placebo
n=15 participants at risk
Participants receive placebo at a volume appropriate to body weight during Period 1
|
Period 2: MNK-1411
n=24 participants at risk
Participants receive MNK-1411 at a dosing volume appropriate to body weight during Period 2
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
nary tract infection
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
Other adverse events
| Measure |
Period 1: MNK-1411
n=29 participants at risk
Participants receive MNK-1411 at a dosing volume appropriate to body weight during Period 1
|
Period 1: Placebo
n=15 participants at risk
Participants receive placebo at a volume appropriate to body weight during Period 1
|
Period 2: MNK-1411
n=24 participants at risk
Participants receive MNK-1411 at a dosing volume appropriate to body weight during Period 2
|
|---|---|---|---|
|
Vascular disorders
Haematoma
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Vascular disorders
Hypertension
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
General disorders
Face oedema
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
13.3%
2/15 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
General disorders
Fatigue
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
General disorders
Injection site bruising
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
General disorders
Injection site erythema
|
13.8%
4/29 • Number of events 4 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
General disorders
Injection site haematoma
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
General disorders
Injection site induration
|
13.8%
4/29 • Number of events 4 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
8.3%
2/24 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
General disorders
Injection site irritation
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
General disorders
Injection site mass
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
20.0%
3/15 • Number of events 3 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
General disorders
Injection site pain
|
6.9%
2/29 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
General disorders
Injection site swelling
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
General disorders
Pyrexia
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
13.3%
2/15 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
General disorders
Swelling face
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Psychiatric disorders
Affect lability
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Psychiatric disorders
Depression
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Psychiatric disorders
Mood swings
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Psychiatric disorders
Separation anxiety disorder
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Investigations
Weight increased
|
24.1%
7/29 • Number of events 9 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
12.5%
3/24 • Number of events 3 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Investigations
Nerve stimulation test abnormal
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
2/29 • Number of events 3 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
13.3%
2/15 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Nervous system disorders
Headache
|
6.9%
2/29 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Nervous system disorders
Motor dysfunction
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Gastrointestinal disorders
Abdominal distension
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
2/29 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Gastrointestinal disorders
Aphthous ulcer
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Gastrointestinal disorders
Food poisoning
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Renal and urinary disorders
Proteinuria
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 3 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
6.9%
2/29 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.4%
1/29 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Endocrine disorders
Cushing's syndrome
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Endocrine disorders
Cushingoid
|
6.9%
2/29 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Metabolism and nutrition disorders
Hyperphagia
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Metabolism and nutrition disorders
Increased appetite
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Bronchitis
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Ear infection
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
20.0%
3/15 • Number of events 4 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
2/29 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Gastroenteritis viral
|
6.9%
2/29 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Influenza
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
13.3%
2/15 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Pharyngotonsillitis
|
10.3%
3/29 • Number of events 3 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Tonsillitis bacterial
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Tooth abscess
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
13.3%
2/15 • Number of events 2 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Urinary tract infection
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Viral infection
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
6.7%
1/15 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Viral pharyngitis
|
3.4%
1/29 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/24 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Oral herpes
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Otitis media
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/29 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
0.00%
0/15 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
4.2%
1/24 • Number of events 1 • within 28 weeks
Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessment were reported as AEs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place