Trial Outcomes & Findings for A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC) (NCT NCT04004611)
NCT ID: NCT04004611
Last Updated: 2024-03-26
Results Overview
Clearance of mirikizumab was evaluated. The PK of mirikizumab is characterized at interim analysis points using mixed-effect (population PK) modelling approaches using the available induction and maintenance mirikizumab concentration data.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8
Results posted on
2024-03-26
Participant Flow
Mirikizumab (Miri) dose groups to which pediatric participants are assigned at week (wk) 0 (for induction period) and at wk 12 (for maintenance period) are dependent on participant' s weight and their clinical response status at wk 12 for maintenance period. All participants who achieved a modified Mayo score (MMS) clinical response at wk 12 or wk 24 \[non-responders (NR) at wk 12 who received extended intravenous (IV) induction dosing for 12 more wks\] were eligible for the maintenance period.
Participant milestones
| Measure |
Open Label (OL) Induction Period: 5 Milligram Per Kilogram (mg/kg) Miri IV
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion every 4 weeks (Q4W) on weeks 0, 4, 8 for 12 weeks.
|
OL Induction Period: 10 mg/kg Miri IV
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
|
OL Induction Period: 300 mg Miri IV
Participants (\>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
|
OL Maintenance Period: 50 mg Miri Subcutaneous (SC)
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
OL Maintenance Period: 100 mg Miri SC
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
OL Maintenance Period: 200 mg Miri SC
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
OL Maintenance Period: NR: 10 mg/kg Miri IV/50 mg Miri SC
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
OL Maintenance Period: NR: 10 mg/kg Miri IV/100 mg Miri SC
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
OL Maintenance Period: NR: 300 mg Miri IV /200 mg Miri SC
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|---|---|---|
|
OL Induction Period (Wk 0-12)
STARTED
|
10
|
5
|
11
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OL Induction Period (Wk 0-12)
COMPLETED
|
10
|
5
|
11
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OL Induction Period (Wk 0-12)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OL Maintenance Period (Wk 12-52)
STARTED
|
0
|
0
|
0
|
1
|
8
|
9
|
1
|
1
|
6
|
|
OL Maintenance Period (Wk 12-52)
COMPLETED
|
0
|
0
|
0
|
1
|
7
|
8
|
0
|
1
|
2
|
|
OL Maintenance Period (Wk 12-52)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
4
|
|
OL Induction and Maintenance Period
STARTED
|
10
|
5
|
11
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OL Induction and Maintenance Period
COMPLETED
|
9
|
4
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OL Induction and Maintenance Period
NOT COMPLETED
|
1
|
1
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Open Label (OL) Induction Period: 5 Milligram Per Kilogram (mg/kg) Miri IV
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion every 4 weeks (Q4W) on weeks 0, 4, 8 for 12 weeks.
|
OL Induction Period: 10 mg/kg Miri IV
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
|
OL Induction Period: 300 mg Miri IV
Participants (\>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
|
OL Maintenance Period: 50 mg Miri Subcutaneous (SC)
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
OL Maintenance Period: 100 mg Miri SC
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
OL Maintenance Period: 200 mg Miri SC
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
OL Maintenance Period: NR: 10 mg/kg Miri IV/50 mg Miri SC
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
OL Maintenance Period: NR: 10 mg/kg Miri IV/100 mg Miri SC
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
OL Maintenance Period: NR: 300 mg Miri IV /200 mg Miri SC
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|---|---|---|
|
OL Maintenance Period (Wk 12-52)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
OL Maintenance Period (Wk 12-52)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
3
|
|
OL Maintenance Period (Wk 12-52)
Withdrawal by Parent or Guardian
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
OL Induction and Maintenance Period
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OL Induction and Maintenance Period
Lack of Efficacy
|
1
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OL Induction and Maintenance Period
Withdrawal by Parent or Guardian
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
Baseline characteristics by cohort
| Measure |
OL Induction Period: 5 mg/kg Miri IV
n=10 Participants
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
|
OL Induction Period: 10 mg/kg Miri IV
n=5 Participants
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
|
OL Induction Period: 300 mg Miri IV
n=11 Participants
Participants (\>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
9.6 years
STANDARD_DEVIATION 4.22 • n=5 Participants
|
11.6 years
STANDARD_DEVIATION 1.14 • n=7 Participants
|
14.0 years
STANDARD_DEVIATION 1.26 • n=5 Participants
|
11.80 years
STANDARD_DEVIATION 3.37 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Clearance of mirikizumab was evaluated. The PK of mirikizumab is characterized at interim analysis points using mixed-effect (population PK) modelling approaches using the available induction and maintenance mirikizumab concentration data.
Outcome measures
| Measure |
Mirikizumab
n=26 Participants
Participants weighing \>40 kg received a mirikizumab induction dose of 300 mg via IV infusion and participants weighing ≤40 kg received induction doses of 5 or 10 mg/kg via IV infusion at weeks 0, 4, and 8 for 12 weeks.
|
Maintenance Period: 100 mg Miri SC Q4W
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 200 mg Miri SC Q4W
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/50 mg Miri SC
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/100 mg Miri SC
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Clearance of Mirikizumab
|
0.000190 Liters per hour per kilogram (L/hr/kg)
Geometric Coefficient of Variation 59.74
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the clinical remission measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Clinical remission at week 52 is defined as achieving a 9-point modified Mayo score (MMS) for rectal bleeding (RB) = 0, stool frequency (SF) = 0 or 1 and endoscopy (ES) = 0 or 1 (excluding friability). The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: SF subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); RB subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); ES subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding,ulceration.
Outcome measures
| Measure |
Mirikizumab
n=1 Participants
Participants weighing \>40 kg received a mirikizumab induction dose of 300 mg via IV infusion and participants weighing ≤40 kg received induction doses of 5 or 10 mg/kg via IV infusion at weeks 0, 4, and 8 for 12 weeks.
|
Maintenance Period: 100 mg Miri SC Q4W
n=8 Participants
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 200 mg Miri SC Q4W
n=9 Participants
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/50 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/100 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
n=6 Participants
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants in Clinical Remission
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
62.5 percentage of participants
Interval 30.6 to 86.3
|
55.6 percentage of participants
Interval 26.7 to 81.1
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 39.0
|
SECONDARY outcome
Timeframe: Week 52Population: mITT: All randomized participants who received at least one dose of study drug and who had the clinical response measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Clinical response at week 52 is defined as a decrease in the 9-point modified Mayo score (MMS) \[rectal bleeding, stool frequency and the endoscopic findings\] inclusive of ≥2 points and ≥30% from baseline with either a decrease of rectal bleeding subscore of ≥1 or rectal bleeding subscore of 0 or 1. The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: SF subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); RB subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); ES subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
Outcome measures
| Measure |
Mirikizumab
n=1 Participants
Participants weighing \>40 kg received a mirikizumab induction dose of 300 mg via IV infusion and participants weighing ≤40 kg received induction doses of 5 or 10 mg/kg via IV infusion at weeks 0, 4, and 8 for 12 weeks.
|
Maintenance Period: 100 mg Miri SC Q4W
n=8 Participants
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 200 mg Miri SC Q4W
n=9 Participants
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/50 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/100 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
n=6 Participants
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants in Clinical Response
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
75.0 percentage of participants
Interval 40.9 to 92.9
|
88.9 percentage of participants
Interval 56.5 to 98.0
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 39.0
|
SECONDARY outcome
Timeframe: Week 52Population: mITT: All randomized participants who received at least one dose of study drug and who had the modified mayo score clinical remission without the use of corticosteroids measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Corticosteroid-free clinical remission was defined as an SF subscore = 0 or 1, RB subscore = 0, ES ≤ 1 (excluding friability), and have not received corticosteroids for ≥ 12 weeks in the 52-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Mirikizumab
n=1 Participants
Participants weighing \>40 kg received a mirikizumab induction dose of 300 mg via IV infusion and participants weighing ≤40 kg received induction doses of 5 or 10 mg/kg via IV infusion at weeks 0, 4, and 8 for 12 weeks.
|
Maintenance Period: 100 mg Miri SC Q4W
n=8 Participants
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 200 mg Miri SC Q4W
n=9 Participants
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/50 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/100 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
n=6 Participants
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Are in MMS Clinical Remission Without the Use of Corticosteroids
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
62.5 percentage of participants
Interval 30.6 to 86.3
|
55.6 percentage of participants
Interval 26.7 to 81.1
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 39.0
|
SECONDARY outcome
Timeframe: Week 52Population: mITT: All randomized participants who received at least one dose of study drug and who had the clinical remission based on the PUCAI measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
The PUCAI is a clinician-administered, 6-item questionnaire that measures: abdominal pain; RB; stool consistency; number of stools; nocturnal stools; and activity level. For PUCAI score all items are answered as an average over the 'past 2 days'. A total disease activity score is calculated from 0 to 85, with Severe 65-85; Moderate:35-60; Mild:10-30, and None:\<10. The clinician will record the participant or caregiver/legal guardian responses for the PUCAI electronically as source data in the tablet device at appropriate visits. PUCAI clinical remission is defined as a PUCAI score of \<10 points.
Outcome measures
| Measure |
Mirikizumab
n=1 Participants
Participants weighing \>40 kg received a mirikizumab induction dose of 300 mg via IV infusion and participants weighing ≤40 kg received induction doses of 5 or 10 mg/kg via IV infusion at weeks 0, 4, and 8 for 12 weeks.
|
Maintenance Period: 100 mg Miri SC Q4W
n=8 Participants
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 200 mg Miri SC Q4W
n=9 Participants
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/50 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/100 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
n=6 Participants
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants in Clinical Remission Based on the Pediatric Ulcerative Colitis Activity Index (PUCAI)
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
75.0 percentage of participants
Interval 40.9 to 92.9
|
77.8 percentage of participants
Interval 45.3 to 93.7
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 39.0
|
SECONDARY outcome
Timeframe: Week 52Population: mITT: All randomized participants who received at least one dose of study drug and who had the clinical response based on the PUCAI measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
PUCAI clinical response is defined as a reduction in baseline PUCAI score of ≥20 points.
Outcome measures
| Measure |
Mirikizumab
n=1 Participants
Participants weighing \>40 kg received a mirikizumab induction dose of 300 mg via IV infusion and participants weighing ≤40 kg received induction doses of 5 or 10 mg/kg via IV infusion at weeks 0, 4, and 8 for 12 weeks.
|
Maintenance Period: 100 mg Miri SC Q4W
n=8 Participants
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 200 mg Miri SC Q4W
n=9 Participants
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/50 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/100 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
n=6 Participants
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants in Clinical Response Based on the PUCAI
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
75.0 percentage of participants
Interval 40.9 to 92.9
|
88.9 percentage of participants
Interval 56.5 to 98.0
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 39.0
|
SECONDARY outcome
Timeframe: Week 52Population: mITT: All randomized participants who received at least one dose of study drug and who had the endoscopic remission measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Endoscopic remission at week 52 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 52. ES subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
Outcome measures
| Measure |
Mirikizumab
n=1 Participants
Participants weighing \>40 kg received a mirikizumab induction dose of 300 mg via IV infusion and participants weighing ≤40 kg received induction doses of 5 or 10 mg/kg via IV infusion at weeks 0, 4, and 8 for 12 weeks.
|
Maintenance Period: 100 mg Miri SC Q4W
n=8 Participants
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 200 mg Miri SC Q4W
n=9 Participants
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/50 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/100 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
n=6 Participants
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants in Endoscopic Remission
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
62.5 percentage of participants
Interval 30.6 to 86.3
|
55.6 percentage of participants
Interval 26.7 to 81.1
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 39.0
|
SECONDARY outcome
Timeframe: Week 52Population: mITT: All randomized participants who received at least one dose of study drug and who had the symptomatic remission measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Symptomatic remission at week 52 is defined as a Mayo score for RB=0, SF=0 or 1 with ≥ 1 point decrease from baseline. SF subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal). RB subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed).
Outcome measures
| Measure |
Mirikizumab
n=1 Participants
Participants weighing \>40 kg received a mirikizumab induction dose of 300 mg via IV infusion and participants weighing ≤40 kg received induction doses of 5 or 10 mg/kg via IV infusion at weeks 0, 4, and 8 for 12 weeks.
|
Maintenance Period: 100 mg Miri SC Q4W
n=8 Participants
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 200 mg Miri SC Q4W
n=9 Participants
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/50 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/100 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
n=6 Participants
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants in Symptomatic Remission
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
75.0 percentage of participants
Interval 40.9 to 92.9
|
66.7 percentage of participants
Interval 35.4 to 87.9
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 39.0
|
SECONDARY outcome
Timeframe: Week 52Population: mITT: All randomized participants who received at least one dose of study drug and who had the height velocity measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Observed height velocity by gender and age group was calculated. Age groups for which this was summarized were 2 to \<8, 8 to \<12, and 12 to \<18. Observed height velocity by gender and age group was calculated at baseline according to the following formula: (Present Height \[cm\] - Previous Height \[cm\])/Interval (months) Between Measurements × 12.
Outcome measures
| Measure |
Mirikizumab
n=10 Participants
Participants weighing \>40 kg received a mirikizumab induction dose of 300 mg via IV infusion and participants weighing ≤40 kg received induction doses of 5 or 10 mg/kg via IV infusion at weeks 0, 4, and 8 for 12 weeks.
|
Maintenance Period: 100 mg Miri SC Q4W
n=5 Participants
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 200 mg Miri SC Q4W
n=11 Participants
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/50 mg Miri SC
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/100 mg Miri SC
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|
|
Height Velocity (in Centimeters/Year)
Female: 2 - <8 years
|
NA centimeter per year (cm/year)
Standard Deviation NA
Individual value = 7.85
|
—
|
—
|
—
|
—
|
—
|
|
Height Velocity (in Centimeters/Year)
Female: 8 - <12 years
|
8.65 centimeter per year (cm/year)
Standard Deviation 3.2
|
—
|
—
|
—
|
—
|
—
|
|
Height Velocity (in Centimeters/Year)
Female: 12 - <18 years
|
4.54 centimeter per year (cm/year)
Standard Deviation 4.2
|
4.14 centimeter per year (cm/year)
Standard Deviation 1.3
|
2.97 centimeter per year (cm/year)
Standard Deviation 0.2
|
—
|
—
|
—
|
|
Height Velocity (in Centimeters/Year)
Male: 2 - <8 years
|
NA centimeter per year (cm/year)
Standard Deviation NA
Individual value = 7.72
|
—
|
—
|
—
|
—
|
—
|
|
Height Velocity (in Centimeters/Year)
Male: 8 - <12 years
|
—
|
NA centimeter per year (cm/year)
Standard Deviation NA
Individual value = 3.64
|
—
|
—
|
—
|
—
|
|
Height Velocity (in Centimeters/Year)
Male: 12 - <18 years
|
12.67 centimeter per year (cm/year)
Standard Deviation 1.0
|
NA centimeter per year (cm/year)
Standard Deviation NA
Individual value = 3.64
|
3.65 centimeter per year (cm/year)
Standard Deviation 4.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: mITT: All randomized participants who received at least one dose of study drug and who had the body weight measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Change from Baseline in body weight by gender and age group was calculated.
Outcome measures
| Measure |
Mirikizumab
n=10 Participants
Participants weighing \>40 kg received a mirikizumab induction dose of 300 mg via IV infusion and participants weighing ≤40 kg received induction doses of 5 or 10 mg/kg via IV infusion at weeks 0, 4, and 8 for 12 weeks.
|
Maintenance Period: 100 mg Miri SC Q4W
n=5 Participants
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 200 mg Miri SC Q4W
n=11 Participants
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/50 mg Miri SC
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/100 mg Miri SC
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight
Female: 2 - <8 years
|
NA kg
Standard Deviation NA
Individual value = 5.1
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight
Female: 8 - <12 years
|
8 kg
Standard Deviation 1.1
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight
Female: 12 - <18 years
|
9 kg
Standard Deviation 7.1
|
9 kg
Standard Deviation 3.5
|
8 kg
Standard Deviation 2.7
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight
Male: 2 - <8 years
|
NA kg
Standard Deviation NA
Individual value = 1.3
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight
Male: 8 - <12 years
|
—
|
NA kg
Standard Deviation NA
Individual value = 3
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight
Male: 12 - <18 years
|
13 kg
Standard Deviation 11.6
|
NA kg
Standard Deviation NA
Individual value = 3.6
|
2 kg
Standard Deviation 3.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: mITT: All randomized participants who received at least one dose of study drug and who had the histologic-endoscopic mucosal remission measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Histologic-endoscopic mucosal remission is defined as achieving both histologic remission and endoscopic remission. Histologic remission is defined as Geboes histological subscores of 0 for parameters: 2B (neutrophils in lamina propria), 3 (neutrophils in epithelium), 4 (crypt destruction), and 5 (erosion or ulceration).
Outcome measures
| Measure |
Mirikizumab
n=1 Participants
Participants weighing \>40 kg received a mirikizumab induction dose of 300 mg via IV infusion and participants weighing ≤40 kg received induction doses of 5 or 10 mg/kg via IV infusion at weeks 0, 4, and 8 for 12 weeks.
|
Maintenance Period: 100 mg Miri SC Q4W
n=8 Participants
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 200 mg Miri SC Q4W
n=9 Participants
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/50 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/100 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
n=6 Participants
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Histologic-Endoscopic Mucosal Remission
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
62.5 percentage of participants
Interval 30.6 to 86.3
|
44.4 percentage of participants
Interval 18.9 to 73.3
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 79.3
|
0.0 percentage of participants
Interval 0.0 to 39.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT: All randomized participants who received at least one dose of study drug and who had the 7-day average of Abdominal Pain NRS measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
The Abdominal Pain NRS is a single participant-reported item that measures the "worst abdominal pain in the past 24 hours" using a 6-point scale ranging from 0 (no pain) to 5 (worst possible pain) for 8-11 years old, and 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) for children \< 8 years old as completed by a caregiver and those 12-17 years old. Abdominal Pain NRS Score is calculated by averaging data from all available daily diary entries of abdominal pain NRS for a 7 day period. A negative change from baseline indicates improvement in the participant's Abdominal Pain NRS.
Outcome measures
| Measure |
Mirikizumab
n=10 Participants
Participants weighing \>40 kg received a mirikizumab induction dose of 300 mg via IV infusion and participants weighing ≤40 kg received induction doses of 5 or 10 mg/kg via IV infusion at weeks 0, 4, and 8 for 12 weeks.
|
Maintenance Period: 100 mg Miri SC Q4W
n=5 Participants
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 200 mg Miri SC Q4W
n=11 Participants
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/50 mg Miri SC
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/100 mg Miri SC
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in 7-day Average of Abdominal Pain Numeric Rating Scale (NRS) Score at Week 12
2 - <8 years
|
-3 score on a scale
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 7-day Average of Abdominal Pain Numeric Rating Scale (NRS) Score at Week 12
8 - <12 years
|
-3 score on a scale
Standard Deviation 2.1
|
NA score on a scale
Standard Deviation NA
Individual value = -2
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 7-day Average of Abdominal Pain Numeric Rating Scale (NRS) Score at Week 12
12- <18 years
|
-4 score on a scale
Standard Deviation 2.7
|
-2 score on a scale
Standard Deviation 1.5
|
-1 score on a scale
Standard Deviation 2.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: mITT: All randomized participants who received at least one dose of study drug and who had the 7-day average of Abdominal Pain NRS measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
The Abdominal Pain NRS is a single participant-reported item that measures the "worst abdominal pain in the past 24 hours" using a 6-point scale ranging from 0 (no pain) to 5 (worst possible pain) for 8-11 years old, and 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) for children \< 8 years old as completed by a caregiver and those 12-17 years old. Abdominal Pain NRS Score is calculated by averaging data from all available daily diary entries of abdominal pain NRS for a 7 day period. A negative change from baseline indicates improvement in the participant's Abdominal Pain NRS.
Outcome measures
| Measure |
Mirikizumab
n=1 Participants
Participants weighing \>40 kg received a mirikizumab induction dose of 300 mg via IV infusion and participants weighing ≤40 kg received induction doses of 5 or 10 mg/kg via IV infusion at weeks 0, 4, and 8 for 12 weeks.
|
Maintenance Period: 100 mg Miri SC Q4W
n=8 Participants
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 200 mg Miri SC Q4W
n=9 Participants
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/50 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 10 mg/kg Miri IV/100 mg Miri SC
n=1 Participants
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
|
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
n=6 Participants
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in 7-day Average of Abdominal Pain NRS Score at Week 52
2 - <8 years
|
NA score on a scale
Standard Deviation NA
Individual value = -2
|
NA score on a scale
Standard Deviation NA
Individual value = -6
|
—
|
0 score on a scale
Standard Deviation 0
|
—
|
—
|
|
Change From Baseline in 7-day Average of Abdominal Pain NRS Score at Week 52
8 - <12 years
|
—
|
-2 score on a scale
Standard Deviation 1.0
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 7-day Average of Abdominal Pain NRS Score at Week 52
12- <18 years
|
—
|
-5 score on a scale
Standard Deviation 3.1
|
-4 score on a scale
Standard Deviation 2.4
|
—
|
NA score on a scale
Standard Deviation NA
Individual value = -3
|
0 score on a scale
Standard Deviation 2.6
|
Adverse Events
OL Induction Period: 5 mg/kg Miri IV
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
OL Induction Period: 10 mg/kg Miri IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
OL Induction Period: 300 mg Miri IV
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
OL Induction and Maintenance Period: 5 mg/kg Miri IV
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
OL Induction and Maintenance Period: 10 mg/kg Miri IV
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
OL Induction and Maintenance Period: 300 mg Miri IV
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OL Induction Period: 5 mg/kg Miri IV
n=10 participants at risk
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion every 4 Q4W on weeks 0, 4, 8 for 12 weeks.
|
OL Induction Period: 10 mg/kg Miri IV
n=5 participants at risk
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
|
OL Induction Period: 300 mg Miri IV
n=11 participants at risk
Participants (\>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
|
OL Induction and Maintenance Period: 5 mg/kg Miri IV
n=10 participants at risk
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks followed by IV or SC mirikizumab based on their week 12 response status and weight through week 48 or until loss of response was confirmed.
|
OL Induction and Maintenance Period: 10 mg/kg Miri IV
n=5 participants at risk
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks followed by IV or SC mirikizumab based on their week 12 response status and weight through week 48 or until loss of response was confirmed.
|
OL Induction and Maintenance Period: 300 mg Miri IV
n=11 participants at risk
Participants (\>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks followed by IV or SC mirikizumab based on their week 12 response status and weight through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Appendicitis noninfective
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
Other adverse events
| Measure |
OL Induction Period: 5 mg/kg Miri IV
n=10 participants at risk
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion every 4 Q4W on weeks 0, 4, 8 for 12 weeks.
|
OL Induction Period: 10 mg/kg Miri IV
n=5 participants at risk
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
|
OL Induction Period: 300 mg Miri IV
n=11 participants at risk
Participants (\>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
|
OL Induction and Maintenance Period: 5 mg/kg Miri IV
n=10 participants at risk
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks followed by IV or SC mirikizumab based on their week 12 response status and weight through week 48 or until loss of response was confirmed.
|
OL Induction and Maintenance Period: 10 mg/kg Miri IV
n=5 participants at risk
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks followed by IV or SC mirikizumab based on their week 12 response status and weight through week 48 or until loss of response was confirmed.
|
OL Induction and Maintenance Period: 300 mg Miri IV
n=11 participants at risk
Participants (\>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks followed by IV or SC mirikizumab based on their week 12 response status and weight through week 48 or until loss of response was confirmed.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Endocrine disorders
Growth hormone deficiency
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Gastrointestinal disorders
Anal incontinence
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Gastrointestinal disorders
Food poisoning
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
18.2%
2/11 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
2/10 • Number of events 4 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
General disorders
Administration site oedema
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
General disorders
Catheter site induration
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
General disorders
Feeling abnormal
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
General disorders
Infusion site reaction
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
General disorders
Injection site erythema
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
General disorders
Injection site oedema
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
General disorders
Injection site pain
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
2/10 • Number of events 5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
1/5 • Number of events 7 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
27.3%
3/11 • Number of events 22 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
General disorders
Injection site pruritus
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
General disorders
Injection site reaction
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
General disorders
Puncture site oedema
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
General disorders
Puncture site pain
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
General disorders
Pyrexia
|
20.0%
2/10 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
18.2%
2/11 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Immune system disorders
Immunosuppression
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
18.2%
2/11 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Infections and infestations
COVID-19
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
18.2%
2/11 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Infections and infestations
Impetigo
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 3 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
18.2%
2/11 • Number of events 3 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Nervous system disorders
Headache
|
30.0%
3/10 • Number of events 7 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
30.0%
3/10 • Number of events 8 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
18.2%
2/11 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Nervous system disorders
Migraine
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Psychiatric disorders
Procedural anxiety
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/3 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/6 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/3 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal swelling
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/11 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
18.2%
2/11 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
18.2%
2/11 • Number of events 2 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/10 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
0.00%
0/5 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60