Trial Outcomes & Findings for An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (NCT NCT02890992)
NCT ID: NCT02890992
Last Updated: 2019-09-06
Results Overview
Percent change in calculated LDL-C was defined as 100\*(calculated LDL-C value at Week 8 - calculated LDL-C value at baseline)/calculated LDL-C value at baseline. All available baseline and post-baseline calculated LDL-C value during the OLDFI efficacy treatment period \& within one of the analysis windows up to Week 8 were used in the model. OLDFI efficacy treatment period was defined as the period from first investigational medicinal product (IMP) injection to last OLDFI IMP injection + 21 days(for Cohorts 1 \& 2) or +35 days (for Cohorts 3 \& 4). Adjusted Least-squares (LS) mean \& standard error (SE) at Week 8 were obtained from mixed-effect model with repeated measures (MMRM) analysis, with fixed categorical effects of alirocumab dose/dose regimen (30 mg Q2W \[\<50 kg\], 40 mg Q2W \[\<50 kg\], 50 mg Q2W \[\>=50 kg\], 75 mg Q2W \[\>=50 kg\], 75 mg Q4W \[\<50 kg\],150 mg Q4W \[\>=50 kg\], 150 mg Q4W \[\<50 kg\] and 300 mg Q4W (\[\>=50 kg\] dose), time point \& dose/dose regimen-by-time point interaction.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Baseline, Week 8
Results posted on
2019-09-06
Participant Flow
The study was conducted at 16 sites in 10 countries. Overall 63 participants were screened between 15 September 2016 and 13 June 2018, of whom 21 participants were screen failures. Screen failures were mainly due to exclusion criteria met.
A total of 42 participants were included in this study.
Participant milestones
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Period 1: Participants with body weight less than (\<) 50 kilograms (kg) received subcutaneous (SC) injection of alirocumab 30 milligram (mg) administered every 2 weeks (Q2W) up to 8 weeks added to lipid modifying therapy (LMT).
Period 2: Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W from Week 16 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still \< 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Period 1: Participants with body weight greater than or equal to (\>=) 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W from Week 16 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Period 1: Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W from Week 16 until switch of dosage in Cohorts 1 and 3. If body weight was still \< 50 kg, participants continued to receive SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Period 1: Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W from Week 16 until Week 130.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
Period 1: Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
Period 2: Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W from Week 14 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still \< 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
Period 1: Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
Period 2: Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 14 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Period 1: Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
Period 2: Participants with body weight \< 50 kg received SC injection of Alirocumab 150 mg administered Q4W from Week 12 until Week 48.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
Period 1: Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
Period 2: Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W from Week 12 until Week 48.
|
|---|---|---|---|---|---|---|---|---|
|
12 Weeks Open-Label Dose Finding Period
STARTED
|
4
|
6
|
4
|
6
|
6
|
5
|
6
|
5
|
|
12 Weeks Open-Label Dose Finding Period
Treated
|
4
|
6
|
4
|
6
|
6
|
5
|
6
|
5
|
|
12 Weeks Open-Label Dose Finding Period
COMPLETED
|
4
|
6
|
4
|
6
|
6
|
5
|
6
|
5
|
|
12 Weeks Open-Label Dose Finding Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
130 Weeks Open-Label Extension Period
STARTED
|
3
|
6
|
4
|
6
|
6
|
5
|
6
|
5
|
|
130 Weeks Open-Label Extension Period
Treated
|
3
|
6
|
4
|
6
|
6
|
5
|
5
|
4
|
|
130 Weeks Open-Label Extension Period
COMPLETED
|
3
|
3
|
4
|
6
|
6
|
5
|
5
|
4
|
|
130 Weeks Open-Label Extension Period
NOT COMPLETED
|
0
|
3
|
0
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Period 1: Participants with body weight less than (\<) 50 kilograms (kg) received subcutaneous (SC) injection of alirocumab 30 milligram (mg) administered every 2 weeks (Q2W) up to 8 weeks added to lipid modifying therapy (LMT).
Period 2: Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W from Week 16 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still \< 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Period 1: Participants with body weight greater than or equal to (\>=) 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W from Week 16 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Period 1: Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W from Week 16 until switch of dosage in Cohorts 1 and 3. If body weight was still \< 50 kg, participants continued to receive SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Period 1: Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W from Week 16 until Week 130.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
Period 1: Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
Period 2: Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W from Week 14 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still \< 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
Period 1: Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
Period 2: Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 14 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Period 1: Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
Period 2: Participants with body weight \< 50 kg received SC injection of Alirocumab 150 mg administered Q4W from Week 12 until Week 48.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
Period 1: Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
Period 2: Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W from Week 12 until Week 48.
|
|---|---|---|---|---|---|---|---|---|
|
130 Weeks Open-Label Extension Period
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
130 Weeks Open-Label Extension Period
Included but not treated
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
130 Weeks Open-Label Extension Period
Other than specified
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Baseline characteristics by cohort
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=4 Participants
Period 1: Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W from Week 16 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still \< 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Period 1: Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W from Week 16 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=4 Participants
Period 1: Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W from Week 16 until switch of dosage in Cohorts 1 and 3. If body weight was still \< 50 kg, participants continued to receive SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 Participants
Period 1: Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W from Week 16 until Week 130.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Period 1: Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered every 4 weeks (Q4W) up to 8 weeks added to LMT.
Period 2: Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W from Week 14 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still \< 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Period 1: Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
Period 2: Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 14 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Period 1: Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
Period 2: Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 12 until Week 48.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Period 1: Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
Period 2: Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W from Week 12 until Week 48.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
11.0 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
13.8 years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
11.3 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
14.3 years
STANDARD_DEVIATION 2.3 • n=4 Participants
|
9.8 years
STANDARD_DEVIATION 1.9 • n=21 Participants
|
13.8 years
STANDARD_DEVIATION 1.6 • n=10 Participants
|
11.3 years
STANDARD_DEVIATION 2.2 • n=115 Participants
|
13.6 years
STANDARD_DEVIATION 2.1 • n=6 Participants
|
12.4 years
STANDARD_DEVIATION 2.6 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
23 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American/White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
39 Participants
n=6 Participants
|
|
Low Density Lipoprotein Cholesterol (LDL-C)
|
5.169 millimoles per litre (mmol/L)
STANDARD_DEVIATION 0.736 • n=5 Participants
|
4.339 millimoles per litre (mmol/L)
STANDARD_DEVIATION 1.200 • n=7 Participants
|
3.596 millimoles per litre (mmol/L)
STANDARD_DEVIATION 0.630 • n=5 Participants
|
4.510 millimoles per litre (mmol/L)
STANDARD_DEVIATION 1.052 • n=4 Participants
|
4.337 millimoles per litre (mmol/L)
STANDARD_DEVIATION 1.147 • n=21 Participants
|
4.642 millimoles per litre (mmol/L)
STANDARD_DEVIATION 1.272 • n=10 Participants
|
5.100 millimoles per litre (mmol/L)
STANDARD_DEVIATION 1.136 • n=115 Participants
|
4.641 millimoles per litre (mmol/L)
STANDARD_DEVIATION 0.926 • n=6 Participants
|
4.6 millimoles per litre (mmol/L)
STANDARD_DEVIATION 1.1 • n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on modified intent-to-treat (mITT) population which included all participants who received at least one dose or partial dose of IMP injection and had an evaluable outcome measure during the open-label dose finding efficacy treatment period.
Percent change in calculated LDL-C was defined as 100\*(calculated LDL-C value at Week 8 - calculated LDL-C value at baseline)/calculated LDL-C value at baseline. All available baseline and post-baseline calculated LDL-C value during the OLDFI efficacy treatment period \& within one of the analysis windows up to Week 8 were used in the model. OLDFI efficacy treatment period was defined as the period from first investigational medicinal product (IMP) injection to last OLDFI IMP injection + 21 days(for Cohorts 1 \& 2) or +35 days (for Cohorts 3 \& 4). Adjusted Least-squares (LS) mean \& standard error (SE) at Week 8 were obtained from mixed-effect model with repeated measures (MMRM) analysis, with fixed categorical effects of alirocumab dose/dose regimen (30 mg Q2W \[\<50 kg\], 40 mg Q2W \[\<50 kg\], 50 mg Q2W \[\>=50 kg\], 75 mg Q2W \[\>=50 kg\], 75 mg Q4W \[\<50 kg\],150 mg Q4W \[\>=50 kg\], 150 mg Q4W \[\<50 kg\] and 300 mg Q4W (\[\>=50 kg\] dose), time point \& dose/dose regimen-by-time point interaction.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 8
|
-41.1 percent change
Standard Error 12.6
|
-7.9 percent change
Standard Error 10.3
|
-40.6 percent change
Standard Error 13.2
|
-49.8 percent change
Standard Error 10.6
|
-17.5 percent change
Standard Error 10.3
|
4.0 percent change
Standard Error 11.2
|
-31.9 percent change
Standard Error 10.3
|
-59.8 percent change
Standard Error 11.2
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on mITT population.
Absolute change in LDL-C was calculated by subtracting baseline value from Week 8 value. Adjusted LS means and SE were obtained using MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 8
|
-83.7 milligram per deciliter (mg/dL)
Standard Error 19.5
|
-27.6 milligram per deciliter (mg/dL)
Standard Error 15.9
|
-55.5 milligram per deciliter (mg/dL)
Standard Error 20.8
|
-88.3 milligram per deciliter (mg/dL)
Standard Error 16.5
|
-32.4 milligram per deciliter (mg/dL)
Standard Error 15.9
|
0.1 milligram per deciliter (mg/dL)
Standard Error 17.4
|
-55.9 milligram per deciliter (mg/dL)
Standard Error 15.9
|
-104.3 milligram per deciliter (mg/dL)
Standard Error 17.4
|
SECONDARY outcome
Timeframe: At Week 8Population: Analysis was performed on mITT population.
Combined estimate for percentage of participants was obtained by averaging out all the imputed percentage of participants reaching the level of interest. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively; with number of imputations = 1000. In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Calculated Low Density Lipoprotein Cholesterol (LDL-C) <130 mg/dL (3.37 mmol/L) at Week 8
|
100.0 percentage of participants
|
33.3 percentage of participants
|
97.6 percentage of participants
|
83.0 percentage of participants
|
33.3 percentage of participants
|
20.0 percentage of participants
|
66.7 percentage of participants
|
80.0 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 8Population: Analysis was performed on mITT population.
Combined estimate for percentage of participants was obtained by averaging out all the imputed percentage of participants reaching the level of interest. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively; with number of imputations = 1000. In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Calculated LDL-C <110 mg/dL (2.84 mmol/L) at Week 8
|
0.0 percentage of participants
|
0.0 percentage of participants
|
93.4 percentage of participants
|
65.7 percentage of participants
|
16.7 percentage of participants
|
20.0 percentage of participants
|
66.7 percentage of participants
|
80.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT population. Data for this outcome measure was planned to be collected for Cohort 4 only.
Adjusted LS means and standard error at Week 12 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 12: Cohort 4
|
-29.7 percent change
Standard Error 6.9
|
-49.2 percent change
Standard Error 7.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on mITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure.
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline value and post-baseline values in at least one of the analysis windows used in the model.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=3 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=3 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 8
|
-38.4 percent change
Standard Error 12.8
|
-9.7 percent change
Standard Error 9.1
|
-36.4 percent change
Standard Error 12.8
|
-40.1 percent change
Standard Error 9.9
|
-12.6 percent change
Standard Error 9.1
|
-0.9 percent change
Standard Error 9.9
|
-27.2 percent change
Standard Error 9.1
|
-51.4 percent change
Standard Error 9.9
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on mITT population.
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baselines value and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Non-High Density Lipoprotein (HDL-C) at Week 8
|
-39.6 percent change
Standard Error 11.9
|
-7.1 percent change
Standard Error 9.7
|
-39.7 percent change
Standard Error 12.5
|
-43.9 percent change
Standard Error 10.0
|
-14.4 percent change
Standard Error 9.7
|
3.2 percent change
Standard Error 10.7
|
-31.5 percent change
Standard Error 9.7
|
-54.6 percent change
Standard Error 10.7
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on mITT population.
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 8
|
-29.0 percent change
Standard Error 9.7
|
-4.1 percent change
Standard Error 7.9
|
-28.6 percent change
Standard Error 10.1
|
-34.2 percent change
Standard Error 8.1
|
-10.7 percent change
Standard Error 7.9
|
5.2 percent change
Standard Error 8.6
|
-24.0 percent change
Standard Error 7.9
|
-41.8 percent change
Standard Error 8.6
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on mITT population.
Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively (with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein(a) at Week 8
|
4.5 percent change
Standard Error 21.1
|
-26.9 percent change
Standard Error 11.6
|
1.5 percent change
Standard Error 15.1
|
-25.2 percent change
Standard Error 14.4
|
2.2 percent change
Standard Error 10.5
|
-7.7 percent change
Standard Error 11.4
|
0.1 percent change
Standard Error 10.2
|
-7.7 percent change
Standard Error 11.1
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on mITT population.
Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Triglyceride at Week 8
|
-0.4 percent change
Standard Error 19.6
|
-4.0 percent change
Standard Error 16.0
|
-7.4 percent change
Standard Error 28.4
|
14.5 percent change
Standard Error 19.0
|
19.3 percent change
Standard Error 16.0
|
-3.1 percent change
Standard Error 17.5
|
-32.1 percent change
Standard Error 16.0
|
-7.1 percent change
Standard Error 17.5
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on mITT population.
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 8
|
9.7 percent change
Standard Error 7.1
|
16.5 percent change
Standard Error 5.8
|
14.7 percent change
Standard Error 7.7
|
10.6 percent change
Standard Error 6.1
|
5.2 percent change
Standard Error 5.8
|
13.8 percent change
Standard Error 6.4
|
4.5 percent change
Standard Error 5.8
|
2.8 percent change
Standard Error 6.4
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=3 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=3 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein A-1 at Week 8
|
4.4 percent change
Standard Error 7.2
|
14.8 percent change
Standard Error 5.1
|
10.7 percent change
Standard Error 7.2
|
1.8 percent change
Standard Error 5.6
|
8.9 percent change
Standard Error 5.1
|
7.4 percent change
Standard Error 5.6
|
5.8 percent change
Standard Error 5.1
|
7.2 percent change
Standard Error 5.6
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=3 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=3 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Apolipoprotein B at Week 8
|
-51.7 mg/dL
Standard Error 15.8
|
-18.5 mg/dL
Standard Error 11.1
|
-35.3 mg/dL
Standard Error 15.8
|
-53.4 mg/dL
Standard Error 12.2
|
-15.3 mg/dL
Standard Error 11.1
|
-5.4 mg/dL
Standard Error 12.2
|
-34.2 mg/dL
Standard Error 11.1
|
-63.5 mg/dL
Standard Error 12.2
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on mITT population.
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Non-High-Density Lipoprotein (Non-HDL-C) at Week 8
|
-86.1 mg/dL
Standard Error 20.8
|
-28.7 mg/dL
Standard Error 17.0
|
-62.7 mg/dL
Standard Error 22.1
|
-88.5 mg/dL
Standard Error 17.6
|
-29.5 mg/dL
Standard Error 17.0
|
-0.6 mg/dL
Standard Error 18.6
|
-63.1 mg/dL
Standard Error 17.0
|
-106.4 mg/dL
Standard Error 18.6
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on mITT population.
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Total Cholesterol (Total-C) at Week 8
|
-80.1 mg/dL
Standard Error 21.4
|
-20.8 mg/dL
Standard Error 17.5
|
-57.1 mg/dL
Standard Error 22.8
|
-84.4 mg/dL
Standard Error 18.1
|
-27.2 mg/dL
Standard Error 17.5
|
5.3 mg/dL
Standard Error 19.1
|
-60.7 mg/dL
Standard Error 17.5
|
-105.1 mg/dL
Standard Error 19.1
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on mITT population.
Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Lipoprotein(a) at Week 8
|
0.003 gram/Liter (g/L)
Standard Error 0.022
|
-0.021 gram/Liter (g/L)
Standard Error 0.017
|
0.007 gram/Liter (g/L)
Standard Error 0.073
|
-0.025 gram/Liter (g/L)
Standard Error 0.020
|
0.023 gram/Liter (g/L)
Standard Error 0.018
|
-0.031 gram/Liter (g/L)
Standard Error 0.019
|
-0.002 gram/Liter (g/L)
Standard Error 0.017
|
-0.120 gram/Liter (g/L)
Standard Error 0.020
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on mITT population.
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in HDL-C at Week 8
|
5.9 mg/dL
Standard Error 3.4
|
7.7 mg/dL
Standard Error 2.8
|
5.5 mg/dL
Standard Error 3.7
|
4.9 mg/dL
Standard Error 2.9
|
2.4 mg/dL
Standard Error 2.8
|
5.9 mg/dL
Standard Error 3.1
|
2.2 mg/dL
Standard Error 2.8
|
1.2 mg/dL
Standard Error 3.1
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on mITT population.
Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=4 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Fasting Triglyceride at Week 8
|
-0.121 mmol/L
Standard Error 0.193
|
-0.076 mmol/L
Standard Error 0.157
|
0.168 mmol/L
Standard Error 0.226
|
0.111 mmol/L
Standard Error 0.188
|
0.117 mmol/L
Standard Error 0.157
|
-0.045 mmol/L
Standard Error 0.172
|
-0.402 mmol/L
Standard Error 0.157
|
-0.107 mmol/L
Standard Error 0.172
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=3 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=3 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Apolipoprotein A-1 at Week 8
|
4.0 mg/dL
Standard Error 9.3
|
17.7 mg/dL
Standard Error 6.5
|
11.3 mg/dL
Standard Error 9.3
|
-0.4 mg/dL
Standard Error 7.2
|
10.5 mg/dL
Standard Error 6.5
|
8.0 mg/dL
Standard Error 7.2
|
7.5 mg/dL
Standard Error 6.5
|
11.0 mg/dL
Standard Error 7.2
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Outcome measures
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=3 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=3 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 Participants
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 Participants
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
|
|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Ratio Apolipoprotein B/Apolipoprotein A-1 at Week 8
|
-0.363 ratio (Apo B/Apo A-1)
Standard Error 0.123
|
-0.262 ratio (Apo B/Apo A-1)
Standard Error 0.087
|
-0.370 ratio (Apo B/Apo A-1)
Standard Error 0.123
|
-0.402 ratio (Apo B/Apo A-1)
Standard Error 0.096
|
-0.190 ratio (Apo B/Apo A-1)
Standard Error 0.087
|
-0.086 ratio (Apo B/Apo A-1)
Standard Error 0.096
|
-0.282 ratio (Apo B/Apo A-1)
Standard Error 0.087
|
-0.473 ratio (Apo B/Apo A-1)
Standard Error 0.096
|
Adverse Events
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Alirocumab 40 Q2W Post-switch
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Alirocumab 75 Q2W Post-switch
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
n=4 participants at risk
Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to the switch of dosage added to LMT.
|
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
n=6 participants at risk
Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to the switch of dosage added to LMT.
|
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
n=4 participants at risk
Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to the switch of dosage added to LMT.
|
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
n=6 participants at risk
Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to the switch of dosage added to LMT.
|
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
n=6 participants at risk
Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to the switch of dosage added to LMT.
|
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
n=5 participants at risk
Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to the switch of dosage added to LMT.
|
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
n=6 participants at risk
Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to the end of the OLE period (up to 130 weeks) added to LMT.
|
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
n=5 participants at risk
Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to the end of the OLE period (up to 130 weeks) added to LMT.
|
Alirocumab 40 Q2W Post-switch
n=10 participants at risk
Participants with body weight \< 50 kg from cohort 1, 2 and 3 switched to dosage and received SC injection of alirocumab 40 mg administered Q2W from the switch up to the end of the OLE period (up to 130 weeks) added to LMT.
|
Alirocumab 75 Q2W Post-switch
n=18 participants at risk
Participants from Cohort 1 (7 participants), Cohort 2 and Cohort 3 (11 participants) switched to dosage and received SC injection of alirocumab 75 mg administered Q2W up to the end of the OLE period (up to 130 weeks) added to LMT.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Eye disorders
Excessive Eye Blinking
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
33.3%
2/6 • Number of events 2 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
20.0%
1/5 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 2 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
20.0%
1/5 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
General disorders
Fatigue
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
General disorders
Influenza Like Illness
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
20.0%
1/5 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
10.0%
1/10 • Number of events 2 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
General disorders
Injection Site Reaction
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
20.0%
1/5 • Number of events 2 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Immune system disorders
Food Allergy
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Cystitis Bacterial
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Cytomegalovirus Hepatitis
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Ear Infection
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
10.0%
1/10 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Gastroenteritis Viral
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
30.0%
3/10 • Number of events 3 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 2 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Infectious Mononucleosis
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
33.3%
2/6 • Number of events 5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
20.0%
1/5 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
10.0%
1/10 • Number of events 2 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
11.1%
2/18 • Number of events 2 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
10.0%
1/10 • Number of events 2 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Post Procedural Infection
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
20.0%
1/5 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 2 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
20.0%
1/5 • Number of events 2 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
20.0%
1/5 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
10.0%
1/10 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Varicella
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
10.0%
1/10 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Animal Scratch
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
11.1%
2/18 • Number of events 2 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Post-Traumatic Pain
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Investigations
Blood Follicle Stimulating Hormone Decreased
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Investigations
Blood Luteinising Hormone Decreased
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Investigations
Low Density Lipoprotein Decreased
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Type 1 Diabetes Mellitus
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
20.0%
1/5 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
10.0%
1/10 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Tendon Pain
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic Granuloma
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
20.0%
1/5 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
10.0%
1/10 • Number of events 2 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Nervous system disorders
Thoracic Outlet Syndrome
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Psychiatric disorders
Alcohol Abuse
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Psychiatric disorders
Anxiety Disorder
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Premenstrual Pain
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
20.0%
1/5 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
20.0%
1/5 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
20.0%
1/5 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
|
Vascular disorders
Pallor
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
16.7%
1/6 • Number of events 1 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/4 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/5 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/10 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
0.00%
0/18 • All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER