Trial Outcomes & Findings for A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis (NCT NCT04527380)
NCT ID: NCT04527380
Last Updated: 2026-03-19
Results Overview
JIA ACR, is comprised of 6 variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]). A JIA ACR30 response is defined as at least 30% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
101 participants
Primary outcome timeframe
Week 16
Results posted on
2026-03-19
Participant Flow
The results reported are for the primary outcome up to Week 16 (OLT period); data beyond Week 16 will be reported after study completion, at the time of final results reporting.
The study was designed to be conducted in four periods: Open Label Treatment (OLT) Period (Week 0-16), Open Label Extension (OLE) Period (Week 16-104), Long Term Extension (LTE) Period (Week 104-264), and a 12-week Post Treatment Follow-Up (PTFU) Period.
Participant milestones
| Measure |
Ixekizumab - OLT Period
Participants received subcutaneous (SC) ixekizumab from week 0 to week 16, following dosing regimens based on body weight:
* Greater than (\>) 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC every 4 weeks (Q4W) from week 2 to week 16.
* 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16.
* 10.0 to less than (\<) 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.
|
Adalimumab - OLT Period
Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight:
* Greater than or equal to (≥) 30.0 kg: 40 mg SC every 2 weeks (Q2W).
* 10.0 to \<30.0 kg: 20 mg SC Q2W.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
20
|
|
Overall Study
Received at Least One Dose of Study Drug
|
81
|
20
|
|
Overall Study
COMPLETED
|
80
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Ixekizumab - OLT Period
Participants received subcutaneous (SC) ixekizumab from week 0 to week 16, following dosing regimens based on body weight:
* Greater than (\>) 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC every 4 weeks (Q4W) from week 2 to week 16.
* 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16.
* 10.0 to less than (\<) 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.
|
Adalimumab - OLT Period
Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight:
* Greater than or equal to (≥) 30.0 kg: 40 mg SC every 2 weeks (Q2W).
* 10.0 to \<30.0 kg: 20 mg SC Q2W.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
Ixekizumab - OLT Period
n=81 Participants
Participants received SC ixekizumab from week 0 to week 16, following dosing regimens based on body weight:
* \> 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC Q4W from week 2 to week 16.
* 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16.
* 10.0 to \< 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.
|
Adalimumab - OLT Period
n=20 Participants
Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight:
* ≥ 30.0 kg: 40 mg SC Q2W.
* 10.0 to \<30.0 kg: 20 mg SC Q2W.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.10 years
STANDARD_DEVIATION 3.07 • n=110 Participants
|
13.30 years
STANDARD_DEVIATION 3.16 • n=114 Participants
|
13.10 years
STANDARD_DEVIATION 3.08 • n=224 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=110 Participants
|
8 Participants
n=114 Participants
|
44 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=110 Participants
|
12 Participants
n=114 Participants
|
57 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=110 Participants
|
4 Participants
n=114 Participants
|
30 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=110 Participants
|
5 Participants
n=114 Participants
|
31 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=110 Participants
|
11 Participants
n=114 Participants
|
40 Participants
n=224 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
11 Participants
n=110 Participants
|
4 Participants
n=114 Participants
|
15 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=110 Participants
|
1 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=110 Participants
|
15 Participants
n=114 Participants
|
84 Participants
n=224 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Region of Enrollment
Argentina
|
8 Participants
n=110 Participants
|
1 Participants
n=114 Participants
|
9 Participants
n=224 Participants
|
|
Region of Enrollment
Belgium
|
2 Participants
n=110 Participants
|
1 Participants
n=114 Participants
|
3 Participants
n=224 Participants
|
|
Region of Enrollment
Czechia
|
3 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
3 Participants
n=224 Participants
|
|
Region of Enrollment
France
|
3 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
3 Participants
n=224 Participants
|
|
Region of Enrollment
Germany
|
21 Participants
n=110 Participants
|
10 Participants
n=114 Participants
|
31 Participants
n=224 Participants
|
|
Region of Enrollment
Italy
|
7 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
7 Participants
n=224 Participants
|
|
Region of Enrollment
Mexico
|
17 Participants
n=110 Participants
|
4 Participants
n=114 Participants
|
21 Participants
n=224 Participants
|
|
Region of Enrollment
Netherlands
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
|
Region of Enrollment
Spain
|
5 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
5 Participants
n=224 Participants
|
|
Region of Enrollment
Switzerland
|
1 Participants
n=110 Participants
|
1 Participants
n=114 Participants
|
2 Participants
n=224 Participants
|
|
Region of Enrollment
United Kingdom
|
13 Participants
n=110 Participants
|
3 Participants
n=114 Participants
|
16 Participants
n=224 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: All randomized participants who received at least one dose of study drug. Non responder Imputation (NRI) is applied for inadequate responders and participants who had missing data at Week 16 for any reason including discontinuation. As per the pre-specified statistical analysis plan, outcomes were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups.
JIA ACR, is comprised of 6 variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]). A JIA ACR30 response is defined as at least 30% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.
Outcome measures
| Measure |
Ixekizumab - OLT Period
n=81 Participants
Participants received SC ixekizumab from week 0 to week 16, following dosing regimens based on body weight:
* \> 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC Q4W from week 2 to week 16.
* 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16.
* 10.0 to\< 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.
|
Adalimumab - OLT Period
Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight:
* ≥ 30.0 kg: 40 mg SC Q2W.
* 10.0 to \<30.0 kg: 20 mg SC Q2W.
|
Ixekizumab - OLT Period (10 to <25 kg Group)
Participants weighing 10.0 to \<25.0 kg who received a starting dose of 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16 were included in this arm.
|
|---|---|---|---|
|
Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (Ixekizumab - OLT Period)
|
88.9 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants who received at least one dose of study drug. Non responder Imputation (NRI) is applied for inadequate responders and participants who had missing data at Week 16 for any reason including discontinuation. As per the pre-specified statistical analysis plan, outcomes were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups.
JIA ACR, is comprised of 6 variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]). A JIA ACR30 response is defined as at least 30% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.
Outcome measures
| Measure |
Ixekizumab - OLT Period
n=20 Participants
Participants received SC ixekizumab from week 0 to week 16, following dosing regimens based on body weight:
* \> 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC Q4W from week 2 to week 16.
* 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16.
* 10.0 to\< 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.
|
Adalimumab - OLT Period
Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight:
* ≥ 30.0 kg: 40 mg SC Q2W.
* 10.0 to \<30.0 kg: 20 mg SC Q2W.
|
Ixekizumab - OLT Period (10 to <25 kg Group)
Participants weighing 10.0 to \<25.0 kg who received a starting dose of 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16 were included in this arm.
|
|---|---|---|---|
|
Percentage of Participants Achieving JIA ACR 30 (Adalimumab - OLT Period)
|
95.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants who received at least one dose of study drug. Non responder Imputation (NRI) is applied for inadequate responders and participants who had missing data at Week 16 for any reason including discontinuation. As per the pre-specified statistical analysis plan, outcomes were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups.
JIA ACR, is comprised of 6 core set variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]). A JIA ACR 50/70/90 response is defined as a greater than or equal to (≥) 50/70/90/100% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.
Outcome measures
| Measure |
Ixekizumab - OLT Period
n=81 Participants
Participants received SC ixekizumab from week 0 to week 16, following dosing regimens based on body weight:
* \> 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC Q4W from week 2 to week 16.
* 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16.
* 10.0 to\< 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.
|
Adalimumab - OLT Period
n=20 Participants
Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight:
* ≥ 30.0 kg: 40 mg SC Q2W.
* 10.0 to \<30.0 kg: 20 mg SC Q2W.
|
Ixekizumab - OLT Period (10 to <25 kg Group)
Participants weighing 10.0 to \<25.0 kg who received a starting dose of 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16 were included in this arm.
|
|---|---|---|---|
|
Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period)
ACR100 response
|
18.5 Percentage of participants
|
35.0 Percentage of participants
|
—
|
|
Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period)
ACR50 response
|
79 Percentage of participants
|
90.0 Percentage of participants
|
—
|
|
Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period)
ACR70 response
|
64.2 Percentage of participants
|
65.0 Percentage of participants
|
—
|
|
Percentage of Participants Achieving JIA ACR 50/70/90/100 (OLT Period)
ACR90 response
|
29.6 Percentage of participants
|
40.0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 104JIA ACR, is comprised of 6 core set variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]). A JIA ACR 30/50/70/90 response is defined as a greater than or equal to (≥) 30/50/70/90/100% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who received at least one dose of study drug with baseline psoriatic lesion(s) involving ≥3% BSA. For missing post-baseline values for subjects who discontinued the study drug due to adverse events, imputation was performed using the Modified Baseline Observation Carried Forward (mBOCF) method. As per the pre-specified statistical analysis plan, outcomes were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups.
The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling (S), redness (R), and plaque induration/infiltration thickness (T) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Severity is rated for each index (R, S, T) on a 0 to 4 scale (0 for no involvement up to 4 for severe involvement): 0 = none 1. = slight 2. = moderate 3. = severe 4. = very severe The various body regions are weighted to reflect their respective proportion of BSA.
Outcome measures
| Measure |
Ixekizumab - OLT Period
n=14 Participants
Participants received SC ixekizumab from week 0 to week 16, following dosing regimens based on body weight:
* \> 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC Q4W from week 2 to week 16.
* 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16.
* 10.0 to\< 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.
|
Adalimumab - OLT Period
n=1 Participants
Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight:
* ≥ 30.0 kg: 40 mg SC Q2W.
* 10.0 to \<30.0 kg: 20 mg SC Q2W.
|
Ixekizumab - OLT Period (10 to <25 kg Group)
Participants weighing 10.0 to \<25.0 kg who received a starting dose of 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16 were included in this arm.
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) for Juvenile Psoriatic Arthritis (JPsA) Participants With at Least 3% Body Surface Area (BSA) at Baseline (OLT Period)
|
-3.80 score on a scale
Standard Deviation 3.541
|
-0.70 score on a scale
Standard Deviation NA
Standard deviation in the adalimumab arm was not estimable due to insufficient data (as only one participant was available for analysis).
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 104The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling (S), redness (R), and plaque induration/infiltration thickness (T) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Severity is rated for each index (R, S, T) on a 0 to 4 scale (0 for no involvement up to 4 for severe involvement): 0 = none 1. = slight 2. = moderate 3. = severe 4. = very severe The various body regions are weighted to reflect their respective proportion of BSA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who received at least one dose of study drug and had a baseline enthesitis (LEI \>0). For missing post-baseline values for subjects who discontinued the study drug due to adverse events, imputation was performed using the Modified Baseline Observation Carried Forward (mBOCF) method. As per the pre-specified statistical analysis plan, outcomes were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups.
The LEI was developed specifically for use in psoriatic arthritis (PsA). It measures enthesitis at 6 sites (lateral epicondyle of humerus, right/left (R/L); medial femoral condyle, (R/L); Achilles tendon insertion, (R/L)). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site are then added to produce a total score (range 0 to 6) with the higher scores indicating more severe enthesitis.
Outcome measures
| Measure |
Ixekizumab - OLT Period
n=40 Participants
Participants received SC ixekizumab from week 0 to week 16, following dosing regimens based on body weight:
* \> 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC Q4W from week 2 to week 16.
* 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16.
* 10.0 to\< 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.
|
Adalimumab - OLT Period
n=4 Participants
Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight:
* ≥ 30.0 kg: 40 mg SC Q2W.
* 10.0 to \<30.0 kg: 20 mg SC Q2W.
|
Ixekizumab - OLT Period (10 to <25 kg Group)
Participants weighing 10.0 to \<25.0 kg who received a starting dose of 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16 were included in this arm.
|
|---|---|---|---|
|
Change From Baseline in Leeds Enthesitis Index (LEI) for Participants With Enthesitis Related Arthritis (ERA) at Baseline (OLT Period)
|
-1.63 score on a scale
Standard Deviation 1.005
|
-1.50 score on a scale
Standard Deviation 0.577
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 104The LEI was developed specifically for use in psoriatic arthritis (PsA). It measures enthesitis at 6 sites (lateral epicondyle of humerus, right/left (R/L); medial femoral condyle, (R/L); Achilles tendon insertion, (R/L)). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site are then added to produce a total score (range 0 to 6) with the higher scores indicating more severe enthesitis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 2 through Week 16Population: All randomized participants, even if the participant does not take the assigned treatment. As per the pre-specified statistical analysis plan, outcomes were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups.
Disease flare is defined as worsening of ≥30% from baseline in at least 3 of the 6 JIA ACR core set criteria and an improvement of ≥30% in no more than one of the criteria. The JIA ACR, is comprised of 6 core set variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]).
Outcome measures
| Measure |
Ixekizumab - OLT Period
n=81 Participants
Participants received SC ixekizumab from week 0 to week 16, following dosing regimens based on body weight:
* \> 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC Q4W from week 2 to week 16.
* 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16.
* 10.0 to\< 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.
|
Adalimumab - OLT Period
n=20 Participants
Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight:
* ≥ 30.0 kg: 40 mg SC Q2W.
* 10.0 to \<30.0 kg: 20 mg SC Q2W.
|
Ixekizumab - OLT Period (10 to <25 kg Group)
Participants weighing 10.0 to \<25.0 kg who received a starting dose of 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16 were included in this arm.
|
|---|---|---|---|
|
Percentage of Participants With Disease Flare (OLT Period)
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 104Disease flare is defined as worsening of ≥30% from baseline in at least 3 of the 6 JIA ACR core set criteria and an improvement of ≥30% in no more than one of the criteria. The JIA ACR, is comprised of 6 core set variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4, 12 and 16 : Pre-dosePopulation: All randomized participants who received at least one dose of the study drug and had evaluable C-trough data at the specified time points. As per the pre-specified statistical analysis plan, the PK outcome was analyzed and reported for the ixekizumab treatment arm, categorized by weight.
C-trough were measured at specified time points to assess the minimum concentration of ixekizumab in the blood before the next dose was administered.
Outcome measures
| Measure |
Ixekizumab - OLT Period
n=55 Participants
Participants received SC ixekizumab from week 0 to week 16, following dosing regimens based on body weight:
* \> 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC Q4W from week 2 to week 16.
* 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16.
* 10.0 to\< 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.
|
Adalimumab - OLT Period
n=20 Participants
Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight:
* ≥ 30.0 kg: 40 mg SC Q2W.
* 10.0 to \<30.0 kg: 20 mg SC Q2W.
|
Ixekizumab - OLT Period (10 to <25 kg Group)
n=6 Participants
Participants weighing 10.0 to \<25.0 kg who received a starting dose of 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16 were included in this arm.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Trough Concentrations (C-trough) of Ixekizumab (Ixekizumab - OLT Period)
Week 4
|
4.43 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 71
|
5.09 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 38
|
3.28 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 56
|
|
Pharmacokinetics (PK): Trough Concentrations (C-trough) of Ixekizumab (Ixekizumab - OLT Period)
Week 12
|
3.25 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 68
|
3.39 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 57
|
2.95 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 41
|
|
Pharmacokinetics (PK): Trough Concentrations (C-trough) of Ixekizumab (Ixekizumab - OLT Period)
Week 16
|
3.47 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 55
|
3.32 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 37
|
2.80 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 46
|
SECONDARY outcome
Timeframe: Week 20, 32, 56, 80 and 104 : Pre-doseC-trough were measured at specified time points to assess the minimum concentration of ixekizumab in the blood before the next dose was administered.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Week 16Population: All randomized participants who received at least one dose of the study drug and had evaluable data. As per the pre-specified statistical analysis plan, outcomes were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups.
Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants \* 100%.
Outcome measures
| Measure |
Ixekizumab - OLT Period
n=80 Participants
Participants received SC ixekizumab from week 0 to week 16, following dosing regimens based on body weight:
* \> 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC Q4W from week 2 to week 16.
* 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16.
* 10.0 to\< 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.
|
Adalimumab - OLT Period
Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight:
* ≥ 30.0 kg: 40 mg SC Q2W.
* 10.0 to \<30.0 kg: 20 mg SC Q2W.
|
Ixekizumab - OLT Period (10 to <25 kg Group)
Participants weighing 10.0 to \<25.0 kg who received a starting dose of 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16 were included in this arm.
|
|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Positive Anti-ixekizumab Antibodies (Ixekizumab - OLT Period)
|
8.8 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 104Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants \* 100%.
Outcome measures
Outcome data not reported
Adverse Events
Ixekizumab - OLT Period
Serious events: 3 serious events
Other events: 66 other events
Deaths: 0 deaths
Adalimumab - OLT Period
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixekizumab - OLT Period
n=81 participants at risk
Participants received SC ixekizumab from week 0 to week 16, following dosing regimens based on body weight:
* \> 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC Q4W from week 2 to week 16.
* 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16.
* 10.0 to \< 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.
|
Adalimumab - OLT Period
n=20 participants at risk
Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight:
* ≥ 30.0 kg: 40 mg SC Q2W.
* 10.0 to \<30.0 kg: 20 mg SC Q2W.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Acute sinusitis
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tonsillitis
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Ixekizumab - OLT Period
n=81 participants at risk
Participants received SC ixekizumab from week 0 to week 16, following dosing regimens based on body weight:
* \> 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC Q4W from week 2 to week 16.
* 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16.
* 10.0 to \< 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.
|
Adalimumab - OLT Period
n=20 participants at risk
Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight:
* ≥ 30.0 kg: 40 mg SC Q2W.
* 10.0 to \<30.0 kg: 20 mg SC Q2W.
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear inflammation
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear pain
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
2.5%
2/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Chalazion
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eye haematoma
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eye pain
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eyelid oedema
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Ocular hyperaemia
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
2/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.9%
4/81 • Number of events 4 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
6/81 • Number of events 6 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
2/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
7/81 • Number of events 8 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Application site pain
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Asthenia
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest discomfort
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest pain
|
1.2%
1/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chills
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
2.5%
2/81 • Number of events 3 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Illness
|
1.2%
1/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Influenza like illness
|
2.5%
2/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site erythema
|
2.5%
2/81 • Number of events 4 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site haematoma
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site hypersensitivity
|
2.5%
2/81 • Number of events 3 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site pain
|
9.9%
8/81 • Number of events 21 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site rash
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
16.0%
13/81 • Number of events 29 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site swelling
|
2.5%
2/81 • Number of events 3 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site urticaria
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
2.5%
2/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pain
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Peripheral swelling
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Puncture site induration
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
7.4%
6/81 • Number of events 7 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Immune system disorders
Seasonal allergy
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Candida infection
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
8.6%
7/81 • Number of events 7 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Ear infection
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Enterobiasis
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Fungal foot infection
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
2.5%
2/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastrointestinal infection
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Hordeolum
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Localised infection
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
13.6%
11/81 • Number of events 13 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
4/20 • Number of events 6 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Otitis media
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Parainfluenzae virus infection
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Paronychia
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
2.5%
2/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis bacterial
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngotonsillitis
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
1/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Rhinitis
|
6.2%
5/81 • Number of events 6 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tonsillitis
|
3.7%
3/81 • Number of events 3 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.6%
7/81 • Number of events 8 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Viral infection
|
3.7%
3/81 • Number of events 3 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Viral pharyngitis
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.2%
1/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.5%
2/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Foreign body ingestion
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
2.5%
2/81 • Number of events 3 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Injury
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Sunburn
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Atypical lymphocytes increased
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood cholesterol decreased
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood parathyroid hormone increased
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood urine present
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Body temperature increased
|
2.5%
2/81 • Number of events 3 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
C-reactive protein increased
|
2.5%
2/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Cd4/cd8 ratio decreased
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Eosinophil count increased
|
4.9%
4/81 • Number of events 4 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Haematocrit decreased
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Haemoglobin decreased
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Heart rate increased
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Monocyte count decreased
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Protein urine present
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Vitamin d decreased
|
2.5%
2/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
White blood cell count decreased
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.5%
2/81 • Number of events 3 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Amplified musculoskeletal pain syndrome
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
3/81 • Number of events 4 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
2/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
3/81 • Number of events 3 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Burning sensation
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
2.5%
2/81 • Number of events 4 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
16.0%
13/81 • Number of events 20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Presyncope
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Initial insomnia
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Tearfulness
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Haematuria
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Testicular pain
|
2.2%
1/45 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic respiratory disease
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
2/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.5%
2/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.9%
8/81 • Number of events 11 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 3 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.5%
2/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
1.2%
1/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.5%
2/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.7%
3/81 • Number of events 3 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
2/81 • Number of events 2 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/81 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Endodontic procedure
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Orthostatic hypotension
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Vein disorder
|
1.2%
1/81 • Number of events 1 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 16 (until OLT period)
* All randomized participants who received at least 1 dose of the study drug. * As per the pre-specified statistical analysis plan, safety data were analyzed and reported by treatment regimen, as exposure was the same across the different treatment groups. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60