Trial Outcomes & Findings for A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Children With Achondroplasia (NCT NCT05598320)
NCT ID: NCT05598320
Last Updated: 2026-07-14
Results Overview
Annualized growth velocity is defined as (height - baseline height)/(date of height assessment - date of baseline) \* 365.25. Annualized growth velocity reported in terms of centimeters (cm) per year. Missing values at Week 52 were imputed by a multiple imputation method.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
84 participants
Primary outcome timeframe
At Week 52
Results posted on
2026-07-14
Participant Flow
Participant milestones
| Measure |
Navepegritide
Participants received navepegritide (TransCon CNP) 100 micrograms per kilogram (µg/kg) delivered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
|
Placebo for Navepegritide
Participants received placebo matched for navepegritide (TransCon CNP) 100 µg/kg delivered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
|
Open-Label Extension Period: Navepegritide
Participants who completed the 52-week treatment period continued into the open-label extension (OLE) period and received treatment with navepegritide (TransCon CNP) doses up to Week 104. All participants received navepegritide at a dose of 100 μg/kg/week.
|
|---|---|---|---|
|
Double-Blind Period (Up to Week 52)
STARTED
|
57
|
27
|
0
|
|
Double-Blind Period (Up to Week 52)
COMPLETED
|
55
|
27
|
0
|
|
Double-Blind Period (Up to Week 52)
NOT COMPLETED
|
2
|
0
|
0
|
|
OLE Period (From Week 52 up to Week 104)
STARTED
|
0
|
0
|
82
|
|
OLE Period (From Week 52 up to Week 104)
COMPLETED
|
0
|
0
|
80
|
|
OLE Period (From Week 52 up to Week 104)
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Navepegritide
Participants received navepegritide (TransCon CNP) 100 micrograms per kilogram (µg/kg) delivered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
|
Placebo for Navepegritide
Participants received placebo matched for navepegritide (TransCon CNP) 100 µg/kg delivered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
|
Open-Label Extension Period: Navepegritide
Participants who completed the 52-week treatment period continued into the open-label extension (OLE) period and received treatment with navepegritide (TransCon CNP) doses up to Week 104. All participants received navepegritide at a dose of 100 μg/kg/week.
|
|---|---|---|---|
|
Double-Blind Period (Up to Week 52)
Withdrawal by Parent/Guardian
|
2
|
0
|
0
|
|
OLE Period (From Week 52 up to Week 104)
Lost to Follow-up
|
0
|
0
|
1
|
|
OLE Period (From Week 52 up to Week 104)
Withdrawal by Parent/Guardian
|
0
|
0
|
1
|
Baseline Characteristics
A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Children With Achondroplasia
Baseline characteristics by cohort
| Measure |
Navepegritide
n=57 Participants
Participants received navepegritide (TransCon CNP) 100 µg/kg delivered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
|
Placebo for Navepegritide
n=27 Participants
Participants received placebo matched for navepegritide (TransCon CNP) 100 µg/kg delivered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.56 years
STANDARD_DEVIATION 2.608 • n=9 Participants
|
5.95 years
STANDARD_DEVIATION 2.748 • n=27 Participants
|
5.68 years
STANDARD_DEVIATION 2.644 • n=267 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=9 Participants
|
13 Participants
n=27 Participants
|
39 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
45 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=9 Participants
|
25 Participants
n=27 Participants
|
77 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
74 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Height
|
88.82 centimeter
STANDARD_DEVIATION 12.871 • n=9 Participants
|
89.10 centimeter
STANDARD_DEVIATION 11.450 • n=27 Participants
|
88.98 centimeter
STANDARD_DEVIATION 12.363 • n=267 Participants
|
|
CDC-Based Height Z-score
|
-4.87 Z-score
STANDARD_DEVIATION 0.976 • n=9 Participants
|
-5.24 Z-score
STANDARD_DEVIATION 0.932 • n=27 Participants
|
-5.02 Z-score
STANDARD_DEVIATION 0.968 • n=267 Participants
|
|
Achondroplasia (ACH)-specific Height Z-score
|
0.18 Z-score
STANDARD_DEVIATION 0.921 • n=9 Participants
|
-0.11 Z-score
STANDARD_DEVIATION 0.725 • n=27 Participants
|
0.09 Z-score
STANDARD_DEVIATION 0.869 • n=267 Participants
|
PRIMARY outcome
Timeframe: At Week 52Population: Analysis was performed on full analysis set.
Annualized growth velocity is defined as (height - baseline height)/(date of height assessment - date of baseline) \* 365.25. Annualized growth velocity reported in terms of centimeters (cm) per year. Missing values at Week 52 were imputed by a multiple imputation method.
Outcome measures
| Measure |
Navepegritide
n=57 Participants
Participants received navepegritide (TransCon CNP) 100 µg/kg delivered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
|
Placebo for Navepegritide
n=27 Participants
Participants received placebo matched for navepegritide (TransCon CNP) 100 µg/kg delivered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
|
|---|---|---|
|
Annualized Growth Velocity (AGV) at Week 52
|
5.89 centimeters per year
Interval 5.66 to 6.13
|
4.41 centimeters per year
Interval 4.04 to 4.77
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Analysis was performed on full analysis set.
ACH specific Z-scores of height provide a measure of growth relative to other individuals with ACH from the CLARITY database. A height Z-score is a standardized height measure after considering important factors like age and gender. Z-scores (or standard deviation scores) describe how far the measurement deviates from the mean. A height Z-score of 0 indicates that height is equal to the mean in the reference population. Negative numbers indicate values below the mean and positive numbers indicate values above the mean.
Outcome measures
| Measure |
Navepegritide
n=57 Participants
Participants received navepegritide (TransCon CNP) 100 µg/kg delivered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
|
Placebo for Navepegritide
n=27 Participants
Participants received placebo matched for navepegritide (TransCon CNP) 100 µg/kg delivered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
|
|---|---|---|
|
Change From Baseline in Height Z-score (ACH-specific) at Week 52
|
0.30 Z-score
Interval 0.24 to 0.35
|
0.01 Z-score
Interval -0.07 to 0.1
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Analysis was performed on full analysis set.
Z-scores of height are determined using Centers for Disease Control and Prevention (CDC) clinical growth charts for children. A height Z-score is a standardized height measure after considering important factors like age and gender. Z-scores (or standard deviation scores) describe how far the measurement deviates from the median. A height Z-score of 0 indicates that height is equal to the median in the reference population. Negative numbers indicate values below the median and positive numbers indicate values above the median.
Outcome measures
| Measure |
Navepegritide
n=57 Participants
Participants received navepegritide (TransCon CNP) 100 µg/kg delivered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
|
Placebo for Navepegritide
n=27 Participants
Participants received placebo matched for navepegritide (TransCon CNP) 100 µg/kg delivered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
|
|---|---|---|
|
Change From Baseline in Height Z-score (CDC-Based) at Week 52
|
0.15 Z-score
Interval 0.05 to 0.25
|
-0.15 Z-score
Interval -0.27 to -0.03
|
Adverse Events
Navepegritide
Serious events: 3 serious events
Other events: 52 other events
Deaths: 0 deaths
Placebo for Navepegritide
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Open-Label Extension Period: Navepegritide
Serious events: 0 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Navepegritide
n=57 participants at risk
Participants received navepegritide (TransCon CNP) 100 micrograms per kilogram (µg/kg) delivered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
|
Placebo for Navepegritide
n=27 participants at risk
Participants received placebo matched for navepegritide (TransCon CNP) 100 µg/kg delivered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
|
Open-Label Extension Period: Navepegritide
n=82 participants at risk
Participants who completed the 52-week treatment period continued into the OLE period and received treatment with navepegritide (TransCon CNP) doses up to Week 104. All participants received navepegritide at a dose of 100 μg/kg/week.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
1.8%
1/57 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/27 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/82 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
1.8%
1/57 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/27 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/82 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/57 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
1/27 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/82 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Infections and infestations
Localised infection
|
1.8%
1/57 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/27 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/82 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Blood and lymphatic system disorders
Mesenteric lymphadenitis
|
0.00%
0/57 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
1/27 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/82 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/57 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
1/27 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/82 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
Other adverse events
| Measure |
Navepegritide
n=57 participants at risk
Participants received navepegritide (TransCon CNP) 100 micrograms per kilogram (µg/kg) delivered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
|
Placebo for Navepegritide
n=27 participants at risk
Participants received placebo matched for navepegritide (TransCon CNP) 100 µg/kg delivered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
|
Open-Label Extension Period: Navepegritide
n=82 participants at risk
Participants who completed the 52-week treatment period continued into the OLE period and received treatment with navepegritide (TransCon CNP) doses up to Week 104. All participants received navepegritide at a dose of 100 μg/kg/week.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
31.6%
18/57 • Number of events 37 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
37.0%
10/27 • Number of events 14 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
28.0%
23/82 • Number of events 51 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Infections and infestations
Otitis media
|
24.6%
14/57 • Number of events 21 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
25.9%
7/27 • Number of events 8 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
20.7%
17/82 • Number of events 20 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Infections and infestations
Upper respiratory tract infection
|
19.3%
11/57 • Number of events 16 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
11.1%
3/27 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
13.4%
11/82 • Number of events 12 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Infections and infestations
Ear infection
|
12.3%
7/57 • Number of events 10 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
1/27 • Number of events 6 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
3/82 • Number of events 8 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Infections and infestations
Influenza
|
8.8%
5/57 • Number of events 8 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/27 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
12.2%
10/82 • Number of events 12 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Infections and infestations
Gastroenteritis viral
|
8.8%
5/57 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
1/27 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
4.9%
4/82 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Infections and infestations
Impetigo
|
8.8%
5/57 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/27 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/82 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Infections and infestations
Pharyngitis streptococcal
|
7.0%
4/57 • Number of events 6 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
1/27 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
3/82 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Infections and infestations
Viral infection
|
7.0%
4/57 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
7.4%
2/27 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
1.2%
1/82 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.3%
3/57 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
11.1%
3/27 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
1.2%
1/82 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Infections and infestations
Otitis media acute
|
5.3%
3/57 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
11.1%
3/27 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
3/82 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Infections and infestations
Gastroenteritis
|
5.3%
3/57 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
1/27 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
3/82 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Infections and infestations
Lower respiratory tract infection
|
5.3%
3/57 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
1/27 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
2.4%
2/82 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Infections and infestations
COVID-19
|
3.5%
2/57 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
11.1%
3/27 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
2.4%
2/82 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/57 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
7.4%
2/27 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/82 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Infections and infestations
Wound infection
|
0.00%
0/57 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
7.4%
2/27 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/82 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
General disorders
Pyrexia
|
35.1%
20/57 • Number of events 31 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
22.2%
6/27 • Number of events 16 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
20.7%
17/82 • Number of events 24 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
General disorders
Injection site erythema
|
8.8%
5/57 • Number of events 6 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/27 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
6.1%
5/82 • Number of events 9 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
General disorders
Injection site swelling
|
7.0%
4/57 • Number of events 7 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/27 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
4.9%
4/82 • Number of events 8 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
General disorders
Injection site bruising
|
5.3%
3/57 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
11.1%
3/27 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
2.4%
2/82 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Gastrointestinal disorders
Vomiting
|
19.3%
11/57 • Number of events 15 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
11.1%
3/27 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
8.5%
7/82 • Number of events 9 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
4/57 • Number of events 6 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
11.1%
3/27 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
1.2%
1/82 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
3/57 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
1/27 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
3/82 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
3/57 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/27 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/82 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
3/57 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/27 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
1.2%
1/82 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
14.0%
8/57 • Number of events 8 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
11.1%
3/27 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
3/82 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
6/57 • Number of events 7 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
14.8%
4/27 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
4.9%
4/82 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
3/57 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
7.4%
2/27 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
1.2%
1/82 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
5.3%
3/57 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
1/27 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
1.2%
1/82 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
6/57 • Number of events 7 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/27 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
2.4%
2/82 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.0%
4/57 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
7.4%
2/27 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
1.2%
1/82 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
3/57 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
1/27 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
6.1%
5/82 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/57 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
7.4%
2/27 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
1.2%
1/82 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Nervous system disorders
Headache
|
17.5%
10/57 • Number of events 13 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
11.1%
3/27 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
13.4%
11/82 • Number of events 20 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
10.5%
6/57 • Number of events 8 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
1/27 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
4.9%
4/82 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Ear and labyrinth disorders
Hypoacusis
|
8.8%
5/57 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/27 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
1.2%
1/82 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Ear and labyrinth disorders
Ear pain
|
3.5%
2/57 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
7.4%
2/27 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
4.9%
4/82 • Number of events 6 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Injury, poisoning and procedural complications
Fall
|
12.3%
7/57 • Number of events 8 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
11.1%
3/27 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
8.5%
7/82 • Number of events 9 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Injury, poisoning and procedural complications
Face injury
|
5.3%
3/57 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/27 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
1.2%
1/82 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.8%
1/57 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
7.4%
2/27 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
2.4%
2/82 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/57 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
7.4%
2/27 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
0.00%
0/82 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Immune system disorders
Seasonal allergy
|
3.5%
2/57 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
7.4%
2/27 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
4.9%
4/82 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/57 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
3.7%
1/27 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
8.5%
7/82 • Number of events 7 • From Week 0 to Week 52 for double-blind treatment period and from Week 52 up to Week 104 for the Open Label Extension period (OLE) period
Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of the investigational medicinal product. Participants were analyzed according to the treatment they actually received. Adverse Events were reported as per MedDRA version 26.0 for double-blind treatment period and MedDRA version 28.0 for OLE period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place