Trial Outcomes & Findings for Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) (NCT NCT03138655)
NCT ID: NCT03138655
Last Updated: 2020-12-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
89 participants
Primary outcome timeframe
From Day 43 (Week 6) post-dose up to pre-dose Day 99 (Week 14)
Results posted on
2020-12-21
Participant Flow
Participants took part in the study at 72 investigative sites in United States, Belgium, Canada, France, Germany, Hungary, Israel, Netherlands, Poland, Ukraine, United Kingdom and European Union from 8 November 2017 to 26 March 2020.
Pediatric participants who weighed \>10 kg with a diagnosis of moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) were enrolled in 1:1 ratio to receive vedolizumab low or high dose groups per weight (\<30 kg and \>=30 kg).
Participant milestones
| Measure |
UC: <30 kg Participants, Vedolizumab 100 mg
Participants with UC having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: <30 kg Participants, Vedolizumab 200 mg
Participants with UC having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: <30 kg Participants, Vedolizumab 100 mg
Participants with CD having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: <30 kg Participants, Vedolizumab 200 mg
Participants with CD having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: >=30 kg Participants, Vedolizumab 150 mg
Participants with UC having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: >=30 kg Participants, Vedolizumab 300 mg
Participants with UC having baseline weight of \>=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: >=30 kg Participants, Vedolizumab 150 mg
Participants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: >=30 kg Participants, Vedolizumab 300 mg
Participants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
11
|
10
|
13
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
7
|
7
|
9
|
7
|
11
|
7
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
2
|
3
|
2
|
5
|
3
|
2
|
Reasons for withdrawal
| Measure |
UC: <30 kg Participants, Vedolizumab 100 mg
Participants with UC having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: <30 kg Participants, Vedolizumab 200 mg
Participants with UC having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: <30 kg Participants, Vedolizumab 100 mg
Participants with CD having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: <30 kg Participants, Vedolizumab 200 mg
Participants with CD having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: >=30 kg Participants, Vedolizumab 150 mg
Participants with UC having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: >=30 kg Participants, Vedolizumab 300 mg
Participants with UC having baseline weight of \>=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: >=30 kg Participants, Vedolizumab 150 mg
Participants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: >=30 kg Participants, Vedolizumab 300 mg
Participants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
1
|
1
|
4
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Reason not Specified
|
1
|
0
|
0
|
2
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Baseline characteristics by cohort
| Measure |
UC: <30 kg Participants, Vedolizumab 100 mg
n=10 Participants
Participants with UC having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: <30 kg Participants, Vedolizumab 200 mg
n=9 Participants
Participants with UC having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: <30 kg Participants, Vedolizumab 100 mg
n=11 Participants
Participants with CD having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: <30 kg Participants, Vedolizumab 200 mg
n=10 Participants
Participants with CD having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: >=30 kg Participants, Vedolizumab 150 mg
n=13 Participants
Participants with UC having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: >=30 kg Participants, Vedolizumab 300 mg
n=12 Participants
Participants with UC having baseline weight of \>=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: >=30 kg Participants, Vedolizumab 150 mg
n=12 Participants
Participants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: >=30 kg Participants, Vedolizumab 300 mg
n=12 Participants
Participants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
7.0 years
n=5 Participants
|
8.0 years
n=7 Participants
|
7.4 years
n=5 Participants
|
8.1 years
n=4 Participants
|
12.4 years
n=21 Participants
|
13.9 years
n=10 Participants
|
13.4 years
n=115 Participants
|
14.3 years
n=24 Participants
|
10.56 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
39 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
9 Participants
n=24 Participants
|
50 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
12 Participants
n=24 Participants
|
78 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
11 Participants
n=24 Participants
|
71 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Region of Enrollment
Belgium
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Region of Enrollment
Hungary
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
|
Region of Enrollment
Poland
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Region of Enrollment
Ukraine
|
1 Participants
n=5 Participants
|
1 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
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Region of Enrollment
Israel
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Region of Enrollment
Canada
|
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
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
29 Participants
n=42 Participants
|
|
Height
|
119.59 cm
n=5 Participants
|
122.39 cm
n=7 Participants
|
120.58 cm
n=5 Participants
|
124.67 cm
n=4 Participants
|
153.11 cm
n=21 Participants
|
160.03 cm
n=10 Participants
|
157.85 cm
n=115 Participants
|
157.98 cm
n=24 Participants
|
139.53 cm
n=42 Participants
|
|
Weight
|
22.38 kg
n=5 Participants
|
23.23 kg
n=7 Participants
|
22.06 kg
n=5 Participants
|
23.37 kg
n=4 Participants
|
46.22 kg
n=21 Participants
|
53.98 kg
n=10 Participants
|
51.53 kg
n=115 Participants
|
45.89 kg
n=24 Participants
|
36.08 kg
n=42 Participants
|
|
Body Mass Index (BMI)
|
15.63 kg/m^2
n=5 Participants
|
15.29 kg/m^2
n=7 Participants
|
15.04 kg/m^2
n=5 Participants
|
14.93 kg/m^2
n=4 Participants
|
19.51 kg/m^2
n=21 Participants
|
20.76 kg/m^2
n=10 Participants
|
20.50 kg/m^2
n=115 Participants
|
18.26 kg/m^2
n=24 Participants
|
17.49 kg/m^2
n=42 Participants
|
PRIMARY outcome
Timeframe: From Day 43 (Week 6) post-dose up to pre-dose Day 99 (Week 14)Population: Pharmacokinetic (PK) Analysis Set included all participants who received at least 1 dose of study drug and had at least 1 measurable concentration of vedolizumab. Overall number analyzed is the number of participants with data available for analyses.
Outcome measures
| Measure |
UC: <30 kg Participants, Vedolizumab 100 mg
n=8 Participants
Participants with UC having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: <30 kg Participants, Vedolizumab 200 mg
n=7 Participants
Participants with UC having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: <30 kg Participants, Vedolizumab 100 mg
n=7 Participants
Participants with CD having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: <30 kg Participants, Vedolizumab 200 mg
n=8 Participants
Participants with CD having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: >=30 kg Participants, Vedolizumab 150 mg
n=11 Participants
Participants with UC having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: >=30 kg Participants, Vedolizumab 300 mg
n=10 Participants
Participants with UC having baseline weight of \>=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: >=30 kg Participants, Vedolizumab 150 mg
n=9 Participants
Participants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: >=30 kg Participants, Vedolizumab 300 mg
n=10 Participants
Participants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
|---|---|---|---|---|---|---|---|---|
|
AUCWeek 14: Area Under the Serum Concentration-time Curve at Week 14
|
1933.5076 h*ng/mL
Standard Deviation 1184.36284
|
3231.1001 h*ng/mL
Standard Deviation 1152.06628
|
2344.4204 h*ng/mL
Standard Deviation 1216.58345
|
3091.7957 h*ng/mL
Standard Deviation 1732.34795
|
2449.9433 h*ng/mL
Standard Deviation 772.66677
|
4182.4869 h*ng/mL
Standard Deviation 1751.87940
|
1865.0004 h*ng/mL
Standard Deviation 509.68268
|
3176.6971 h*ng/mL
Standard Deviation 928.32630
|
PRIMARY outcome
Timeframe: From Day 43 (week 6) post-dose up to pre-dose Day 99 (Week 14)Population: PK Analysis Set included all participants who received at least 1 dose of study drug and had at least 1 measurable concentration of vedolizumab. Overall number analyzed is the number of participants with data available for analyses.
Outcome measures
| Measure |
UC: <30 kg Participants, Vedolizumab 100 mg
n=9 Participants
Participants with UC having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: <30 kg Participants, Vedolizumab 200 mg
n=8 Participants
Participants with UC having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: <30 kg Participants, Vedolizumab 100 mg
n=7 Participants
Participants with CD having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: <30 kg Participants, Vedolizumab 200 mg
n=8 Participants
Participants with CD having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: >=30 kg Participants, Vedolizumab 150 mg
n=11 Participants
Participants with UC having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: >=30 kg Participants, Vedolizumab 300 mg
n=10 Participants
Participants with UC having baseline weight of \>=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: >=30 kg Participants, Vedolizumab 150 mg
n=9 Participants
Participants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: >=30 kg Participants, Vedolizumab 300 mg
n=10 Participants
Participants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
|---|---|---|---|---|---|---|---|---|
|
Cav,Week 14: Average Serum Concentration During a Dosing Interval at Week 14
|
39.3143 ng/mL
Standard Deviation 21.34097
|
61.2934 ng/mL
Standard Deviation 18.14446
|
46.8716 ng/mL
Standard Deviation 23.07334
|
63.6275 ng/mL
Standard Deviation 28.29116
|
44.6465 ng/mL
Standard Deviation 11.48500
|
77.2452 ng/mL
Standard Deviation 28.49511
|
37.4752 ng/mL
Standard Deviation 18.26528
|
63.1734 ng/mL
Standard Deviation 15.08119
|
PRIMARY outcome
Timeframe: At the end of a dosing interval at Week 14Population: PK Analysis Set included all participants who received at least 1 dose of study drug and had at least 1 measurable concentration of vedolizumab. Overall number analyzed is the number of participants with data available for analyses.
Outcome measures
| Measure |
UC: <30 kg Participants, Vedolizumab 100 mg
n=8 Participants
Participants with UC having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: <30 kg Participants, Vedolizumab 200 mg
n=7 Participants
Participants with UC having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: <30 kg Participants, Vedolizumab 100 mg
n=8 Participants
Participants with CD having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: <30 kg Participants, Vedolizumab 200 mg
n=8 Participants
Participants with CD having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: >=30 kg Participants, Vedolizumab 150 mg
n=11 Participants
Participants with UC having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: >=30 kg Participants, Vedolizumab 300 mg
n=10 Participants
Participants with UC having baseline weight of \>=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: >=30 kg Participants, Vedolizumab 150 mg
n=10 Participants
Participants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: >=30 kg Participants, Vedolizumab 300 mg
n=10 Participants
Participants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
|---|---|---|---|---|---|---|---|---|
|
Ctrough,Week 14: Observed Serum Concentration at the End of a Dosing Interval at Week 14
|
9.3100 ng/mL
Standard Deviation 9.48045
|
10.7226 ng/mL
Standard Deviation 10.35423
|
8.7395 ng/mL
Standard Deviation 7.77386
|
10.3685 ng/mL
Standard Deviation 11.30124
|
16.3645 ng/mL
Standard Deviation 16.93869
|
21.4860 ng/mL
Standard Deviation 18.01872
|
3.9006 ng/mL
Standard Deviation 3.62991
|
7.8310 ng/mL
Standard Deviation 9.44044
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 14Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Overall number analyzed is the number of participants with data available for analyses.
Clinical response was defined as a reduction in complete Mayo score of \>= 3 points and \>=30 % from Baseline with an accompanying decrease in rectal bleeding sub-score of \>=1 point(s) or absolute rectal bleeding sub-score of \<= 1 point. Mayo score was used in to assess UC disease activity. It consisted of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale was scored on a scale of 0 to 3, where 0= normal condition and 3 = severe disease condition. The total Mayo score ranged from 0 to 12, with higher scores indicating more severe disease.
Outcome measures
| Measure |
UC: <30 kg Participants, Vedolizumab 100 mg
n=10 Participants
Participants with UC having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: <30 kg Participants, Vedolizumab 200 mg
n=9 Participants
Participants with UC having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: <30 kg Participants, Vedolizumab 100 mg
n=13 Participants
Participants with CD having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: <30 kg Participants, Vedolizumab 200 mg
n=12 Participants
Participants with CD having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: >=30 kg Participants, Vedolizumab 150 mg
Participants with UC having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: >=30 kg Participants, Vedolizumab 300 mg
Participants with UC having baseline weight of \>=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: >=30 kg Participants, Vedolizumab 150 mg
Participants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: >=30 kg Participants, Vedolizumab 300 mg
Participants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of UC Participants Who Achieve Clinical Response Based on Complete Mayo Score
|
40.0 percentage of participants
Interval 12.2 to 73.8
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
69.2 percentage of participants
Interval 38.6 to 90.9
|
41.7 percentage of participants
Interval 15.2 to 72.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 14Population: FAS included all randomized participants who received at least 1 dose of study drug. Overall number analyzed is the number of participants with data available for analyses.
Clinical response was defined as \>=70 points decrease from Baseline in CDAI score at Week 14. The CDAI evaluated severity of signs and symptoms of CD. Information was collected on number of liquid stools, intensity of abdominal pain, general well-being, presence of comorbid conditions, use of medications for diarrhea, physical examination, and laboratory, yielding 8 items that were combined with data from a 7-day diary to obtain total CDAI score. Index values of 150 and below were associated with quiescent disease; values above that indicated active disease, values \>=220 indicated moderate to severe disease, and values above 450 were seen with extremely severe disease.
Outcome measures
| Measure |
UC: <30 kg Participants, Vedolizumab 100 mg
n=11 Participants
Participants with UC having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: <30 kg Participants, Vedolizumab 200 mg
n=10 Participants
Participants with UC having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: <30 kg Participants, Vedolizumab 100 mg
n=11 Participants
Participants with CD having baseline weight of \<30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: <30 kg Participants, Vedolizumab 200 mg
n=12 Participants
Participants with CD having baseline weight of \<30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: >=30 kg Participants, Vedolizumab 150 mg
Participants with UC having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
UC: >=30 kg Participants, Vedolizumab 300 mg
Participants with UC having baseline weight of \>=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: >=30 kg Participants, Vedolizumab 150 mg
Participants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
CD: >=30 kg Participants, Vedolizumab 300 mg
Participants with CD having baseline weight of \>=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of CD Participants Who Achieve Clinical Response Based on Crohn's Disease Activity Index (CDAI)
|
63.6 percentage of participants
Interval 30.8 to 89.1
|
40.0 percentage of participants
Interval 12.2 to 73.8
|
45.5 percentage of participants
Interval 16.7 to 76.6
|
33.3 percentage of participants
Interval 9.9 to 65.1
|
—
|
—
|
—
|
—
|
Adverse Events
<30 kg Participants, Vedolizumab 100 mg
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
<30 kg Participants, Vedolizumab 200 mg
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
<30 kg Participants, Vedolizumab 100 mg to 200 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
>=30 kg Participants, Vedolizumab 150 mg
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
>=30 kg Participants, Vedolizumab 300 mg
Serious events: 8 serious events
Other events: 20 other events
Deaths: 0 deaths
>=30 kg Participants, Vedolizumab 150 mg to 300 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
<30 kg Participants, Vedolizumab 100 mg
n=17 participants at risk
Participants with UC or CD having baseline weight of \<30 kg, were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
<30 kg Participants, Vedolizumab 200 mg
n=19 participants at risk
Participants with UC or CD having baseline weight of \<30 kg, were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
<30 kg Participants, Vedolizumab 100 mg to 200 mg
n=4 participants at risk
Participants from '\<30 kg Participants, Vedolizumab 100 mg' low dose group who did not achieve Clinical Response at Week 14 were escalated to receive vedolizumab 200 mg IV infusion at Week 14.
|
>=30 kg Participants, Vedolizumab 150 mg
n=18 participants at risk
Participants with UC or CD having baseline weight of \>=30 kg, were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
>=30 kg Participants, Vedolizumab 300 mg
n=24 participants at risk
Participants with UC or CD having baseline weight of \>=30 kg, were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
>=30 kg Participants, Vedolizumab 150 mg to 300 mg
n=6 participants at risk
Participants from '\>=30 kg Participants, Vedolizumab 150 mg' low dose group who did not achieve Clinical Response at Week 14 were escalated to receive vedolizumab 300 mg IV infusion at Week 14.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Varicella
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
10.5%
2/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
12.5%
3/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
15.8%
3/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
8.3%
2/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Clostridium difficile infection
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Pelvic abscess
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Septic shock
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Viral infection
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Injury, poisoning and procedural complications
Stoma site inflammation
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Musculoskeletal and connective tissue disorders
Pleural mass
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
Other adverse events
| Measure |
<30 kg Participants, Vedolizumab 100 mg
n=17 participants at risk
Participants with UC or CD having baseline weight of \<30 kg, were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
<30 kg Participants, Vedolizumab 200 mg
n=19 participants at risk
Participants with UC or CD having baseline weight of \<30 kg, were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
<30 kg Participants, Vedolizumab 100 mg to 200 mg
n=4 participants at risk
Participants from '\<30 kg Participants, Vedolizumab 100 mg' low dose group who did not achieve Clinical Response at Week 14 were escalated to receive vedolizumab 200 mg IV infusion at Week 14.
|
>=30 kg Participants, Vedolizumab 150 mg
n=18 participants at risk
Participants with UC or CD having baseline weight of \>=30 kg, were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
>=30 kg Participants, Vedolizumab 300 mg
n=24 participants at risk
Participants with UC or CD having baseline weight of \>=30 kg, were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
|
>=30 kg Participants, Vedolizumab 150 mg to 300 mg
n=6 participants at risk
Participants from '\>=30 kg Participants, Vedolizumab 150 mg' low dose group who did not achieve Clinical Response at Week 14 were escalated to receive vedolizumab 300 mg IV infusion at Week 14.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
15.8%
3/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
8.3%
2/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Eye disorders
Swelling of eyelid
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Eye disorders
Eye swelling
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Abdominal pain
|
29.4%
5/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
15.8%
3/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
50.0%
2/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Crohn's disease
|
11.8%
2/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
8.3%
2/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
50.0%
2/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Gastritis
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
33.3%
2/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
8.3%
2/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
General disorders
Pyrexia
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
10.5%
2/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
12.5%
3/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
General disorders
Face oedema
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
General disorders
Influenza like illness
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
General disorders
Infusion site irritation
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
General disorders
Asthenia
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
General disorders
Chest pain
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
General disorders
Fatigue
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
General disorders
Malaise
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Investigations
C-reactive protein increased
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Investigations
Blood albumin decreased
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Investigations
Blood bicarbonate decreased
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Investigations
Blood glucose increased
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Investigations
Body temperature increased
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Immune system disorders
Allergy to arthropod sting
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Respiratory tract infection viral
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Viral infection
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
8.3%
2/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Investigations
Clostridium test positive
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
11.1%
2/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Investigations
Haematocrit decreased
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Investigations
Haemoglobin decreased
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
8.3%
2/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Investigations
Weight decreased
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Ear infection
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
3/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Gastroenteritis norovirus
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Investigations
Amylase increased
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Hordeolum
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Influenza
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Investigations
Liver function test increased
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
8.3%
2/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
12.5%
3/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Pneumonia
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
11.1%
2/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Investigations
Blood calcium decreased
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Gastrointestinal candidiasis
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Infected bite
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Otitis externa
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Peritonitis
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
2/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
8.3%
2/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Injury, poisoning and procedural complications
Torus fracture
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Injury, poisoning and procedural complications
Limb injury
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Vascular disorders
Hot flush
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Vascular disorders
Pallor
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Vascular disorders
Haematoma
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Musculoskeletal and connective tissue disorders
Fistula discharge
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
25.0%
1/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
10.5%
2/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
11.1%
2/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
12.5%
3/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
33.3%
2/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
33.3%
2/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Psychiatric disorders
Depression
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Psychiatric disorders
Fear of injection
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
15.8%
3/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
10.5%
2/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
33.3%
2/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
16.7%
1/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.9%
1/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.3%
1/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
5.6%
1/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
|
Reproductive system and breast disorders
Vulvovaginal swelling
|
0.00%
0/17 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/19 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/4 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/18 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
4.2%
1/24 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
0.00%
0/6 • From first dose of study drug up to Week 32
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for \>30 kg group and v23.0 for \<30 kg group).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER