Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) (NCT NCT03439670)
NCT ID: NCT03439670
Last Updated: 2023-03-09
Results Overview
Vamorolone at 6.0mg/kg/day vs. placebo group in change from baseline to the Week 24 assessment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
24 weeks
Results posted on
2023-03-09
Participant Flow
Participant milestones
| Measure |
Treatment Group 1
Patients enrolled in Treatment Group 1 (experimental group) will receive vamorolone 2.0 mg/kg/day for 24 weeks followed by vamorolone 2.0mg/kg/day for 20 weeks.
|
Treatment Group 2
Patients enrolled in Treatment Group 2 (experimental group) will receive vamorolone 6.0 mg/kg/day for 24 weeks followed by vamorolone 6.0mg/kg/day for 20 weeks.
|
Treatment Group 3
Patients enrolled in Treatment Group 3 (active comparator group) will receive prednisone 0.75 mg/kg/day for 24 weeks followed by vamorolone 2.0mg/kg/day for 20 weeks.
|
Treatment Group 4
Patients enrolled in Treatment Group 4 (active comparator group) will receive prednisone 0.75 mg/kg/day for 24 weeks followed by vamorolone 6.0mg/kg/day for 20 weeks.
|
Treatment Group 5
Patients enrolled in Treatment Group 5 will receive placebo for 24 weeks followed by vamorolone 2mg/kg/day for 20 weeks.
|
Treatment Group 6
Patients enrolled in Treatment Group 6 will receive placebo for 24 weeks followed by vamorolone 6mg/kg/day for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
15
|
16
|
15
|
15
|
|
Overall Study
COMPLETED
|
28
|
26
|
15
|
15
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
0
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
Baseline characteristics by cohort
| Measure |
Treatment Group 1
n=28 Participants
Patients enrolled in Treatment Group 1 (experimental group) will receive vamorolone 2.0 mg/kg/day for 24 weeks followed by vamorolone 2.0mg/kg/day for 20 weeks.
|
Treatment Group 2
n=28 Participants
Patients enrolled in Treatment Group 2 (experimental group) will receive vamorolone 6.0 mg/kg/day for 24 weeks followed by vamorolone 6.0mg/kg/day for 20 weeks.
|
Treatment Group 3
n=15 Participants
Patients enrolled in Treatment Group 3 (active comparator group) will receive prednisone 0.75 mg/kg/day for 24 weeks followed by vamorolone 2.0mg/kg/day for 20 weeks.
|
Treatment Group 4
n=15 Participants
Patients enrolled in Treatment Group 4 (active comparator group) will receive prednisone 0.75 mg/kg/day for 24 weeks followed by vamorolone 6.0mg/kg/day for 20 weeks.
|
Treatment Group 5
n=14 Participants
Patients enrolled in Treatment Group 5 will receive placebo for 24 weeks followed by vamorolone 2mg/kg/day for 20 weeks.
|
Treatment Group 6
n=14 Participants
Patients enrolled in Treatment Group 6 will receive placebo for 24 weeks followed by vamorolone 6mg/kg/day for 20 weeks.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
114 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
114 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
13 Participants
n=30 Participants
|
94 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
TTSTAND (seconds)
|
6.01 Seconds
STANDARD_DEVIATION 2.406 • n=99 Participants
|
5.97 Seconds
STANDARD_DEVIATION 1.991 • n=107 Participants
|
5.36 Seconds
STANDARD_DEVIATION 1.948 • n=206 Participants
|
4.53 Seconds
STANDARD_DEVIATION 0.808 • n=7 Participants
|
5.51 Seconds
STANDARD_DEVIATION 1.578 • n=31 Participants
|
5.58 Seconds
STANDARD_DEVIATION 2.288 • n=30 Participants
|
5.560 Seconds
STANDARD_DEVIATION 1.9498 • n=3 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Per the protocol, the primary clinical efficacy endpoint was "comparison of the vamorolone 6.0 mg/kg/day dose level group versus the placebo group in change from baseline to the Week 24 assessment."
Vamorolone at 6.0mg/kg/day vs. placebo group in change from baseline to the Week 24 assessment
Outcome measures
| Measure |
Treatment Group 1
n=28 Participants
Patients enrolled in Treatment Group 1 (placebo comparator group) will receive placebo for 24 weeks.
|
Treatment Group 2
n=27 Participants
Patients enrolled in Treatment Group 2 (experimental group) will receive vamorolone 6.0 mg/kg/day for 24 weeks
|
|---|---|---|
|
Efficacy Measured by Time to Stand Test (TTSTAND) Velocity in Rises/Second Change From Baseline
|
-.007 Rises/Seconds
Standard Deviation 0.0628
|
0.054 Rises/Seconds
Standard Deviation 0.0666
|
Adverse Events
Treatment Group 1
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Treatment Group 2
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Treatment Group 3
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Treatment Group 4
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Treatment Group 5
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Treatment Group 6
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group 1
n=28 participants at risk
Patients enrolled in Treatment Group 1 (experimental group) will receive vamorolone 2.0 mg/kg/day for 24 weeks followed by vamorolone 2.0mg/kg/day for 20 weeks.
|
Treatment Group 2
n=28 participants at risk
Patients enrolled in Treatment Group 2 (experimental group) will receive vamorolone 6.0 mg/kg/day for 24 weeks followed by vamorolone 6.0mg/kg/day for 20 weeks.
|
Treatment Group 3
n=15 participants at risk
Patients enrolled in Treatment Group 3 (active comparator group) will receive prednisone 0.75 mg/kg/day for 24 weeks followed by vamorolone 2.0mg/kg/day for 20 weeks
|
Treatment Group 4
n=15 participants at risk
Patients enrolled in Treatment Group 4 (active comparator group) will receive prednisone 0.75 mg/kg/day for 24 weeks followed by vamorolone 6.0mg/kg/day for 20 weeks.
|
Treatment Group 5
n=14 participants at risk
Patients enrolled in Treatment Group 5 will receive placebo for 24 weeks followed by vamorolone 2mg/kg/day for 20 weeks.
|
Treatment Group 6
n=14 participants at risk
Patients enrolled in Treatment Group 6 will receive placebo for 24 weeks followed by vamorolone 6mg/kg/day for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis viral/viral gasteroenteritis
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
Other adverse events
| Measure |
Treatment Group 1
n=28 participants at risk
Patients enrolled in Treatment Group 1 (experimental group) will receive vamorolone 2.0 mg/kg/day for 24 weeks followed by vamorolone 2.0mg/kg/day for 20 weeks.
|
Treatment Group 2
n=28 participants at risk
Patients enrolled in Treatment Group 2 (experimental group) will receive vamorolone 6.0 mg/kg/day for 24 weeks followed by vamorolone 6.0mg/kg/day for 20 weeks.
|
Treatment Group 3
n=15 participants at risk
Patients enrolled in Treatment Group 3 (active comparator group) will receive prednisone 0.75 mg/kg/day for 24 weeks followed by vamorolone 2.0mg/kg/day for 20 weeks
|
Treatment Group 4
n=15 participants at risk
Patients enrolled in Treatment Group 4 (active comparator group) will receive prednisone 0.75 mg/kg/day for 24 weeks followed by vamorolone 6.0mg/kg/day for 20 weeks.
|
Treatment Group 5
n=14 participants at risk
Patients enrolled in Treatment Group 5 will receive placebo for 24 weeks followed by vamorolone 2mg/kg/day for 20 weeks.
|
Treatment Group 6
n=14 participants at risk
Patients enrolled in Treatment Group 6 will receive placebo for 24 weeks followed by vamorolone 6mg/kg/day for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Vascular disorders
Hot flush
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.7%
3/28 • Up to 48 weeks
|
10.7%
3/28 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
14.3%
2/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Gastrointestinal disorders
Abdominal Pain upper
|
3.6%
1/28 • Up to 48 weeks
|
10.7%
3/28 • Up to 48 weeks
|
20.0%
3/15 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Gastrointestinal disorders
Constipation
|
10.7%
3/28 • Up to 48 weeks
|
10.7%
3/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
10.7%
3/28 • Up to 48 weeks
|
17.9%
5/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Gastrointestinal disorders
Vomiting
|
21.4%
6/28 • Up to 48 weeks
|
21.4%
6/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
21.4%
3/14 • Up to 48 weeks
|
|
General disorders
Pyrexia
|
25.0%
7/28 • Up to 48 weeks
|
10.7%
3/28 • Up to 48 weeks
|
20.0%
3/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
21.4%
3/14 • Up to 48 weeks
|
21.4%
3/14 • Up to 48 weeks
|
|
Infections and infestations
Gasteroenteritis
|
0.00%
0/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
2/28 • Up to 48 weeks
|
14.3%
4/28 • Up to 48 weeks
|
20.0%
3/15 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
14.3%
2/14 • Up to 48 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
35.7%
10/28 • Up to 48 weeks
|
14.3%
4/28 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
20.0%
3/15 • Up to 48 weeks
|
21.4%
3/14 • Up to 48 weeks
|
14.3%
2/14 • Up to 48 weeks
|
|
Infections and infestations
Rhinitis
|
7.1%
2/28 • Up to 48 weeks
|
14.3%
4/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
14.3%
2/14 • Up to 48 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.6%
1/28 • Up to 48 weeks
|
7.1%
2/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
2/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
2/28 • Up to 48 weeks
|
14.3%
4/28 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
20.0%
3/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Investigations
Blood uric acid increased
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Investigations
Protein Urine Present
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
20.0%
3/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Investigations
Weight increased
|
3.6%
1/28 • Up to 48 weeks
|
10.7%
3/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Metabolism and nutrition disorders
Increased appetite
|
3.6%
1/28 • Up to 48 weeks
|
7.1%
2/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
7.1%
2/28 • Up to 48 weeks
|
10.7%
3/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
2/28 • Up to 48 weeks
|
10.7%
3/28 • Up to 48 weeks
|
26.7%
4/15 • Up to 48 weeks
|
26.7%
4/15 • Up to 48 weeks
|
14.3%
2/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Nervous system disorders
Headache
|
10.7%
3/28 • Up to 48 weeks
|
7.1%
2/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
21.4%
3/14 • Up to 48 weeks
|
|
Nervous system disorders
Psychomotor hyperactivity
|
7.1%
2/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Psychiatric disorders
Abnormal behaviour
|
7.1%
2/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Psychiatric disorders
Aggression
|
7.1%
2/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Psychiatric disorders
Irritability
|
0.00%
0/28 • Up to 48 weeks
|
10.7%
3/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.9%
5/28 • Up to 48 weeks
|
10.7%
3/28 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
26.7%
4/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
14.3%
2/14 • Up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/28 • Up to 48 weeks
|
7.1%
2/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
3.6%
1/28 • Up to 48 weeks
|
10.7%
3/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
2/28 • Up to 48 weeks
|
7.1%
2/28 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
14.3%
2/14 • Up to 48 weeks
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/28 • Up to 48 weeks
|
7.1%
2/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Gastrointestinal disorders
Toothache
|
3.6%
1/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Gastrointestinal disorders
Flatulance
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Infections and infestations
Enterobiasis
|
3.6%
1/28 • Up to 48 weeks
|
7.1%
2/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Infections and infestations
Ear Infection
|
3.6%
1/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Infections and infestations
Tonsilitis
|
3.6%
1/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
14.3%
2/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Infections and infestations
Viral Infection
|
0.00%
0/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Infections and infestations
Gastroenteritis viral/viral gasteroenteritis
|
10.7%
3/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Infections and infestations
Impetigo
|
7.1%
2/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Infections and infestations
Influenza
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
14.3%
2/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Infections and infestations
Moluscum contagiosum
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Infections and infestations
Otitis media bacterial
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Infections and infestations
Pneumonia
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Infections and infestations
Respiratory track infection viral
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Infections and infestations
Steptococcal infection
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Endocrine disorders
Cushingoid
|
14.3%
4/28 • Up to 48 weeks
|
32.1%
9/28 • Up to 48 weeks
|
26.7%
4/15 • Up to 48 weeks
|
26.7%
4/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Endocrine disorders
Growth hormone deficiency
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Injury, poisoning and procedural complications
Ligament strain
|
3.6%
1/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
1/28 • Up to 48 weeks
|
7.1%
2/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
3.6%
1/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Costrochondritis
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Vertebral wedging
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Agitation
|
0.00%
0/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Psychiatric disorders
Anger
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Psychiatric disorders
Dysphemia
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Psychiatric disorders
Enuresis
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Psychiatric disorders
Oppositional defiant disorder
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Psychiatric disorders
Personality change
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Psychiatric disorders
Trichotillomania
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Psychiatric disorders
Epistaxis
|
0.00%
0/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.6%
1/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.00%
0/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Psychiatric disorders
Night sweats
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Rash macropapular
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Skin and subcutaneous tissue disorders
Viral rash
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Investigations
Cortisol decreased
|
3.6%
1/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Investigations
Bacterial test postive
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Investigations
Blood pressure increased
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Investigations
Lipase decreased
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Metabolism and nutrition disorders
Overweight
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
General disorders
Asthenia
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
General disorders
Fatigue
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
13.3%
2/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
General disorders
Impaired healing
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
General disorders
Thirst
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/28 • Up to 48 weeks
|
3.6%
1/28 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
|
Renal and urinary disorders
Proteinuria
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
7.1%
1/14 • Up to 48 weeks
|
|
Nervous system disorders
Poor quality sleep
|
3.6%
1/28 • Up to 48 weeks
|
0.00%
0/28 • Up to 48 weeks
|
0.00%
0/15 • Up to 48 weeks
|
6.7%
1/15 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
0.00%
0/14 • Up to 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place