Trial Outcomes & Findings for Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab. (NCT NCT04157348)
NCT ID: NCT04157348
Last Updated: 2026-02-03
Results Overview
Percentage of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 4 mg/day (main remission definition) at both Weeks 36 and 48.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
140 participants
Primary outcome timeframe
Week 36 and Week 48
Results posted on
2026-02-03
Participant Flow
140 participants were randomized to receive treatment in study D3253C00001 (MANDARA) with benralizumab 30 mg or mepolizumab 300 mg. Of the 140 patients randomized, 140 (100%) received treatment with study drug. 70 (50%) patients received benralizumab 30 mg and 70 (50%) patients received mepolizumab 300 mg.
All patients completed a screening period of 1-4 weeks during which inclusion/exclusion criteria was assessed, disease activity, corticosteroid medication usage and patient reported outcomes were recorded, medical history and clinical laboratory were taken. All patients who entered open label extension period received benralizumab 30 mg during open label extension period.
Participant milestones
| Measure |
Benralizumab 30 mg
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Double-blind Treatment Period
STARTED
|
70
|
70
|
|
Double-blind Treatment Period
COMPLETED
|
69
|
67
|
|
Double-blind Treatment Period
NOT COMPLETED
|
1
|
3
|
|
Open-label Extension Period
STARTED
|
66
|
62
|
|
Open-label Extension Period
COMPLETED
|
0
|
0
|
|
Open-label Extension Period
NOT COMPLETED
|
66
|
62
|
Reasons for withdrawal
| Measure |
Benralizumab 30 mg
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Double-blind Treatment Period
other reasons or due to COVID-19
|
1
|
1
|
|
Double-blind Treatment Period
Withdrawal by Subject
|
0
|
1
|
|
Double-blind Treatment Period
Adverse Event
|
0
|
1
|
|
Open-label Extension Period
Adverse Event
|
1
|
1
|
|
Open-label Extension Period
Death
|
0
|
1
|
|
Open-label Extension Period
Lack of Efficacy
|
2
|
2
|
|
Open-label Extension Period
Withdrawal by Subject
|
2
|
0
|
|
Open-label Extension Period
Ongoing
|
60
|
57
|
|
Open-label Extension Period
other reasons
|
1
|
1
|
Baseline Characteristics
Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.
Baseline characteristics by cohort
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 13.90 • n=13 Participants
|
52.7 years
STANDARD_DEVIATION 14.38 • n=15 Participants
|
52.3 years
STANDARD_DEVIATION 14.10 • n=28 Participants
|
|
Age, Customized
>= 18 to <= 65 years
|
57 participants
n=13 Participants
|
59 participants
n=15 Participants
|
116 participants
n=28 Participants
|
|
Age, Customized
> 65 years
|
13 participants
n=13 Participants
|
11 participants
n=15 Participants
|
24 participants
n=28 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=13 Participants
|
39 Participants
n=15 Participants
|
84 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=13 Participants
|
31 Participants
n=15 Participants
|
56 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
4 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=13 Participants
|
67 Participants
n=15 Participants
|
128 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=13 Participants
|
3 Participants
n=15 Participants
|
8 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
White
|
53 participants
n=13 Participants
|
57 participants
n=15 Participants
|
110 participants
n=28 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 participants
n=13 Participants
|
8 participants
n=15 Participants
|
17 participants
n=28 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=13 Participants
|
2 participants
n=15 Participants
|
5 participants
n=28 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
5 participants
n=13 Participants
|
3 participants
n=15 Participants
|
8 participants
n=28 Participants
|
|
Region of Enrollment
North America
|
16 participants
n=13 Participants
|
16 participants
n=15 Participants
|
32 participants
n=28 Participants
|
|
Region of Enrollment
Japan
|
4 participants
n=13 Participants
|
4 participants
n=15 Participants
|
8 participants
n=28 Participants
|
|
Region of Enrollment
Rest of World
|
50 participants
n=13 Participants
|
50 participants
n=15 Participants
|
100 participants
n=28 Participants
|
PRIMARY outcome
Timeframe: Week 36 and Week 48Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Percentage of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 4 mg/day (main remission definition) at both Weeks 36 and 48.
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48
|
40 Participants
|
40 Participants
|
PRIMARY outcome
Timeframe: Week 36 and Week 48Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Supportive endpoint: Proportion of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 7.5 mg/day (supportive remission definition) at both Weeks 36 and 48.
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Supportive Endpoint: Proportion of Subjects Who Achieved Supportive Remission at Both Weeks 36 and 48
|
55 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 Weeks.Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Total accrued duration of remission for the following categories: 0 week, \> 0 to \< 12 week, 12 to \< 24 week, 24 to \< 36 week, ≥ 36 week.
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Total Accrued Duration of Remission During DB Treatment Period
supportive remission · 12 to <24 weeks
|
5 Participants
|
4 Participants
|
|
Total Accrued Duration of Remission During DB Treatment Period
supportive remission · 24 to <36 weeks
|
16 Participants
|
15 Participants
|
|
Total Accrued Duration of Remission During DB Treatment Period
supportive remission · >=36 weeks
|
45 Participants
|
44 Participants
|
|
Total Accrued Duration of Remission During DB Treatment Period
main remission · 0 week
|
9 Participants
|
15 Participants
|
|
Total Accrued Duration of Remission During DB Treatment Period
main remission · >0 to <12 weeks
|
13 Participants
|
10 Participants
|
|
Total Accrued Duration of Remission During DB Treatment Period
main remission · 12 to <24 weeks
|
8 Participants
|
8 Participants
|
|
Total Accrued Duration of Remission During DB Treatment Period
main remission · 24 to <36 weeks
|
20 Participants
|
19 Participants
|
|
Total Accrued Duration of Remission During DB Treatment Period
main remission · >=36 weeks
|
20 Participants
|
18 Participants
|
|
Total Accrued Duration of Remission During DB Treatment Period
supportive remission · 0 week
|
2 Participants
|
4 Participants
|
|
Total Accrued Duration of Remission During DB Treatment Period
supportive remission · >0 to <12 weeks
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Total accrued duration of sustained remission for the following categories: 0 week, \> 0 to \< 12 week, 12 to \< 24 week, 24 to \< 36 week, ≥ 36 week.
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Total Accrued Duration of Sustained Remission During DB Treatment Period
sustained main remission · 0 week
|
9 Participants
|
15 Participants
|
|
Total Accrued Duration of Sustained Remission During DB Treatment Period
sustained main remission · >0 to <12 weeks
|
15 Participants
|
13 Participants
|
|
Total Accrued Duration of Sustained Remission During DB Treatment Period
sustained main remission · 12 to <24 weeks
|
11 Participants
|
8 Participants
|
|
Total Accrued Duration of Sustained Remission During DB Treatment Period
sustained main remission · 24 to <36 weeks
|
16 Participants
|
18 Participants
|
|
Total Accrued Duration of Sustained Remission During DB Treatment Period
sustained main remission · >=36 weeks
|
19 Participants
|
16 Participants
|
|
Total Accrued Duration of Sustained Remission During DB Treatment Period
sustained supportive remission · 0 week
|
2 Participants
|
4 Participants
|
|
Total Accrued Duration of Sustained Remission During DB Treatment Period
sustained supportive remission · >0 to <12 weeks
|
5 Participants
|
6 Participants
|
|
Total Accrued Duration of Sustained Remission During DB Treatment Period
sustained supportive remission · 12 to <24 weeks
|
8 Participants
|
10 Participants
|
|
Total Accrued Duration of Sustained Remission During DB Treatment Period
sustained supportive remission · >=36 weeks
|
37 Participants
|
36 Participants
|
|
Total Accrued Duration of Sustained Remission During DB Treatment Period
sustained supportive remission · 24 to <36 weeks
|
18 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Time from randomization to first Eosinophilic Granulomatosis with Polyangiitis (EGPA) relapse, where relapse is defined as any of the following: * Active vasculitis (BVAS \> 0); OR * Active asthma symptoms and/or signs with a corresponding worsening in ACQ-6 score; OR * Active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions; warranting any of the following: * An increased dose of OCS therapy to \> 4 mg/day prednisolone total daily dose; OR * An increased dose or addition of immunosuppressive therapy; OR * Hospitalization related to EGPA worsening Calculated using the Kaplan-Meier technique.
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse
relapse-percent subject with at least 1 relapse by week 16
|
5.71 percentage of subjects
Interval 2.18 to 14.51
|
4.29 percentage of subjects
Interval 1.4 to 12.7
|
|
Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse
relapse-percent subject with at least 1 relapse by week 32
|
17.14 percentage of subjects
Interval 10.12 to 28.21
|
20.24 percentage of subjects
Interval 12.52 to 31.77
|
|
Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse
relapse-percent subject with at least 1 relapse by week 52
|
30.00 percentage of subjects
Interval 20.71 to 42.21
|
29.10 percentage of subjects
Interval 19.85 to 41.4
|
|
Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse
major relapse-percent subject with at least 1 relapse by week 16
|
0 percentage of subjects
Interval 0.0 to 0.0
|
0 percentage of subjects
Interval 0.0 to 0.0
|
|
Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse
major relapse-percent subject with at least 1 relapse by week 32
|
0 percentage of subjects
Interval 0.0 to 0.0
|
0 percentage of subjects
Interval 0.0 to 0.0
|
|
Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse
major relapse-percent subject with at least 1 relapse by week 52
|
0 percentage of subjects
Interval 0.0 to 0.0
|
2.94 percentage of subjects
Interval 0.74 to 11.25
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Annualized Eosinophilic Granulomatosis with Polyangiitis (EGPA) relapse rate through end of DB treatment period. The estimate of annualized relapse rate (relapses per year) and the corresponding 95% CIs were calculated using a negative binomial model. The response variable in the model is the number of relapses experienced by a subject up to Week 52. The logarithm of the subject's corresponding follow-up time up to Week 52 was used as an offset variable to adjust for subjects having different follow-up times during which the events occur. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Annualized Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse Rate
|
0.50 relapses per year
Interval 0.3 to 0.83
|
0.49 relapses per year
Interval 0.28 to 0.86
|
SECONDARY outcome
Timeframe: last 4 weeks of DB periodPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Average daily dose of prednisolone/prednisone and change from baseline during Week 48 through 52, or last 28 days prior to last double-blind assessment for those that withdrew
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Average Daily Dose of Prednisolone/Prednisone and Change From Baseline During Week 48 Through 52
average daily dose
|
3.01 mg
Standard Deviation 3.776
|
3.43 mg
Standard Deviation 4.124
|
|
Average Daily Dose of Prednisolone/Prednisone and Change From Baseline During Week 48 Through 52
change from baseline of average daily dose
|
-8.08 mg
Standard Deviation 4.575
|
-7.52 mg
Standard Deviation 7.070
|
SECONDARY outcome
Timeframe: last 4 weeks of DB periodPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Proportion of patients with average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: 0 mg; \>0 to ≤ 4 mg; \> 4 to ≤ 7.5 mg and \> 7.5 mg
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
>0 to <=4.0 mg
|
19 Participants
|
30 Participants
|
|
Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
>4.0 to <=7.5 mg
|
15 Participants
|
13 Participants
|
|
Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
>7.5 mg
|
7 Participants
|
8 Participants
|
|
Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
0
|
29 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: last 4 weeks of DB periodPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Percentage reduction from baseline in average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: no reduction or withdrawal from treatment; \< 25% reduction; 25 to \< 50% reduction; 50 to \<75% reduction; 75 to \< 100% reduction; 100% reduction.
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
no reduction or withdrawal from IP before week 48
|
3 Participants
|
7 Participants
|
|
Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
<25% reduction
|
0 Participants
|
2 Participants
|
|
Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
25 to <50% reduction
|
8 Participants
|
9 Participants
|
|
Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
50 to <75% reduction
|
19 Participants
|
17 Participants
|
|
Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
75 to <100% reduction
|
11 Participants
|
17 Participants
|
|
Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
100% reduction
|
29 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: last 4 weeks of DB periodPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Proportion of subjects with reduction from baseline in average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: \>= 50% reduction; 100% reduction; OCS dose \<= 4 mg/day.
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Proportion of Subjects With Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
>=50% reduction
|
59 Participants
|
52 Participants
|
|
Proportion of Subjects With Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
100% reduction
|
29 Participants
|
18 Participants
|
|
Proportion of Subjects With Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
OCS dose <=4 mg/day
|
48 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Proportion of subjects who achieved any clinical benefit definition 1 (defined as any of the following: * Main remission at any time in DB period * \>= 50% reduction in OCS dose in Weeks 48 to 52 * EGPA relapse free in DB period) and subjects who achieved complete response definition 1 (defined as meeting all the definition 1 criteria above.)
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Proportion of Subjects Who Achieve Clinical Benefit
Complete response - definition 1
|
43 Participants
|
39 Participants
|
|
Proportion of Subjects Who Achieve Clinical Benefit
any clinical benefit-definition 1
|
66 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Proportion of patients who have achieved remission within the first 24 weeks and remained in remission for remainder of the double-blind treatment period
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Proportion of Patients Who Have Achieved Remission Within the First 24 Weeks and Remained in Remission for Remainder of the Double-blind Treatment Period
main remission
|
28 Participants
|
27 Participants
|
|
Proportion of Patients Who Have Achieved Remission Within the First 24 Weeks and Remained in Remission for Remainder of the Double-blind Treatment Period
supportive remission
|
41 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Birmingham Vasculitis Activity Score (BVAS) change from baseline by timepoint up to week 52. The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The total score on all 9 organ systems gives an indication of the disease activity of each patient at the time of scoring. Total scores range from 0 to 63, with higher scores indicating more active vasculitis.
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in Birmingham Vasculitis Activity Score (BVAS)
week 4
|
-1.19 scores on a scale
Interval -1.62 to -0.76
|
-1.14 scores on a scale
Interval -1.57 to -0.7
|
|
Change From Baseline in Birmingham Vasculitis Activity Score (BVAS)
week 8
|
-1.33 scores on a scale
Interval -1.75 to -0.9
|
-1.74 scores on a scale
Interval -2.16 to -1.31
|
|
Change From Baseline in Birmingham Vasculitis Activity Score (BVAS)
week 12
|
-1.79 scores on a scale
Interval -2.03 to -1.55
|
-1.66 scores on a scale
Interval -1.9 to -1.42
|
|
Change From Baseline in Birmingham Vasculitis Activity Score (BVAS)
week 16
|
-1.85 scores on a scale
Interval -2.04 to -1.65
|
-1.80 scores on a scale
Interval -2.0 to -1.59
|
|
Change From Baseline in Birmingham Vasculitis Activity Score (BVAS)
week 20
|
-1.73 scores on a scale
Interval -2.01 to -1.44
|
-1.82 scores on a scale
Interval -2.1 to -1.53
|
|
Change From Baseline in Birmingham Vasculitis Activity Score (BVAS)
week 24
|
-1.59 scores on a scale
Interval -1.88 to -1.31
|
-1.74 scores on a scale
Interval -2.02 to -1.45
|
|
Change From Baseline in Birmingham Vasculitis Activity Score (BVAS)
week 28
|
-1.94 scores on a scale
Interval -2.09 to -1.79
|
-1.95 scores on a scale
Interval -2.1 to -1.8
|
|
Change From Baseline in Birmingham Vasculitis Activity Score (BVAS)
week 32
|
-1.92 scores on a scale
Interval -2.04 to -1.8
|
-1.93 scores on a scale
Interval -2.05 to -1.81
|
|
Change From Baseline in Birmingham Vasculitis Activity Score (BVAS)
week 36
|
-1.98 scores on a scale
Interval -2.29 to -1.66
|
-1.65 scores on a scale
Interval -1.98 to -1.33
|
|
Change From Baseline in Birmingham Vasculitis Activity Score (BVAS)
week 40
|
-1.84 scores on a scale
Interval -2.01 to -1.67
|
-1.89 scores on a scale
Interval -2.07 to -1.72
|
|
Change From Baseline in Birmingham Vasculitis Activity Score (BVAS)
week 44
|
-1.84 scores on a scale
Interval -2.0 to -1.68
|
-1.96 scores on a scale
Interval -2.13 to -1.8
|
|
Change From Baseline in Birmingham Vasculitis Activity Score (BVAS)
week 48
|
-1.80 scores on a scale
Interval -2.04 to -1.56
|
-1.92 scores on a scale
Interval -2.17 to -1.66
|
|
Change From Baseline in Birmingham Vasculitis Activity Score (BVAS)
week 52
|
-1.85 scores on a scale
Interval -2.37 to -1.34
|
-1.32 scores on a scale
Interval -1.84 to -0.8
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Pre-bronchodilator (BD) Forced Expiratory Volume during first second (FEV1) change from baseline by timepoint up to week 52
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L)
week 48
|
0.03 L
Interval -0.1 to 0.1
|
0.06 L
Interval 0.0 to 0.2
|
|
Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L)
week 52
|
0.06 L
Interval 0.0 to 0.2
|
0.01 L
Interval -0.1 to 0.1
|
|
Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L)
week 36
|
0.10 L
Interval 0.0 to 0.2
|
0.11 L
Interval 0.0 to 0.2
|
|
Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L)
week 12
|
0.13 L
Interval 0.0 to 0.2
|
0.11 L
Interval 0.0 to 0.2
|
|
Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L)
week 24
|
0.11 L
Interval 0.0 to 0.2
|
0.13 L
Interval 0.0 to 0.2
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Pre-bronchodilator (BD) Forced vital capacity (FVC) change from baseline by timepoint up to week 52
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L)
week 12
|
0.13 L
Interval 0.0 to 0.2
|
0.05 L
Interval 0.0 to 0.2
|
|
Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L)
week 24
|
0.09 L
Interval 0.0 to 0.2
|
0.04 L
Interval -0.1 to 0.1
|
|
Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L)
week 36
|
0.05 L
Interval 0.0 to 0.1
|
0.03 L
Interval -0.1 to 0.1
|
|
Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L)
week 48
|
0.03 L
Interval -0.1 to 0.1
|
0.00 L
Interval -0.1 to 0.1
|
|
Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L)
week 52
|
0.01 L
Interval -0.1 to 0.1
|
-0.04 L
Interval -0.2 to 0.1
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Vasculitis Damage Index (VDI) change from baseline by timepoint up to week 52. The VDI is divided into 11 organ systems and records items of damage, due to vasculitis, treatment or unrelated, that have occurred since the onset of vasculitis. Completion of the form provides a numerical score, ranging from 0 to 64, with a higher score indicating more damage.
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in Vasculitis Damage Index (VDI)
week 24
|
0.06 score
Interval 0.0 to 0.12
|
0.04 score
Interval -0.02 to 0.1
|
|
Change From Baseline in Vasculitis Damage Index (VDI)
week 52
|
0.13 score
Interval 0.04 to 0.22
|
0.10 score
Interval 0.01 to 0.2
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Asthma Control Questionnaire (6-item version) (ACQ-6) change from baseline by timepoint up to week 52. The ACQ-6 score is calculated by taking the mean of 6 equally weighted domains, with a range of 0 (well controlled) to 6 (extremely poorly controlled).
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6)
week 1-4
|
-0.34 score
Interval -0.47 to -0.21
|
-0.31 score
Interval -0.44 to -0.18
|
|
Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6)
week 5-8
|
-0.56 score
Interval -0.68 to -0.43
|
-0.49 score
Interval -0.61 to -0.36
|
|
Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6)
week 9-12
|
-0.55 score
Interval -0.68 to -0.42
|
-0.52 score
Interval -0.65 to -0.39
|
|
Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6)
week 13-16
|
-0.62 score
Interval -0.76 to -0.48
|
-0.48 score
Interval -0.62 to -0.33
|
|
Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6)
week 17-20
|
-0.59 score
Interval -0.75 to -0.43
|
-0.47 score
Interval -0.63 to -0.31
|
|
Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6)
week 21-24
|
-0.59 score
Interval -0.76 to -0.43
|
-0.53 score
Interval -0.7 to -0.37
|
|
Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6)
week 25-28
|
-0.65 score
Interval -0.8 to -0.49
|
-0.49 score
Interval -0.64 to -0.33
|
|
Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6)
week 29-32
|
-0.56 score
Interval -0.73 to -0.39
|
-0.50 score
Interval -0.67 to -0.33
|
|
Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6)
week 33-36
|
-0.57 score
Interval -0.73 to -0.41
|
-0.55 score
Interval -0.71 to -0.39
|
|
Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6)
week 37-40
|
-0.57 score
Interval -0.72 to -0.42
|
-0.54 score
Interval -0.69 to -0.39
|
|
Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6)
week 41-44
|
-0.58 score
Interval -0.73 to -0.43
|
-0.60 score
Interval -0.75 to -0.45
|
|
Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6)
week 45-48
|
-0.61 score
Interval -0.76 to -0.45
|
-0.64 score
Interval -0.79 to -0.48
|
|
Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6)
week 49-52
|
-0.57 score
Interval -0.72 to -0.41
|
-0.61 score
Interval -0.77 to -0.46
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Short Form 36-item health survey (version 2, acute recall) (SF-36v2) component Physical Component Summary (PCS) change from baseline by timepoint up to week 52. PCS score ranges from 10.8 to 75.5, where a higher score indicates better health.
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS)
week 1
|
0.68 score
Interval -0.4 to 1.7
|
0.88 score
Interval -0.2 to 1.9
|
|
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS)
week 4
|
1.18 score
Interval -0.1 to 2.5
|
1.11 score
Interval -0.2 to 2.4
|
|
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS)
week 8
|
1.56 score
Interval 0.3 to 2.8
|
1.46 score
Interval 0.2 to 2.7
|
|
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS)
week 12
|
1.30 score
Interval 0.0 to 2.6
|
1.31 score
Interval 0.0 to 2.6
|
|
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS)
week 16
|
1.24 score
Interval -0.2 to 2.7
|
1.85 score
Interval 0.4 to 3.3
|
|
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS)
week 28
|
1.54 score
Interval 0.0 to 3.1
|
2.12 score
Interval 0.6 to 3.7
|
|
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS)
week 40
|
1.73 score
Interval 0.4 to 3.1
|
2.28 score
Interval 0.9 to 3.6
|
|
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS)
week 52
|
0.29 score
Interval -1.3 to 1.9
|
2.45 score
Interval 0.8 to 4.0
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Short Form 36-item health survey (version 2, acute recall) (SF-36v2) component Mental Component Summary (MCS) change from baseline by timepoint up to week 52. MCS score ranges from 5.6 to 69.7, where a higher score indicates better health.
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS)
week 1
|
0.90 score
Interval -0.7 to 2.5
|
-0.13 score
Interval -1.7 to 1.5
|
|
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS)
week 4
|
0.06 score
Interval -1.8 to 1.9
|
0.58 score
Interval -1.2 to 2.4
|
|
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS)
week 8
|
0.64 score
Interval -1.3 to 2.6
|
1.05 score
Interval -0.9 to 3.0
|
|
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS)
week 12
|
0.04 score
Interval -1.9 to 2.0
|
1.44 score
Interval -0.5 to 3.4
|
|
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS)
week 16
|
0.29 score
Interval -1.8 to 2.3
|
2.18 score
Interval 0.1 to 4.2
|
|
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS)
week 28
|
-0.03 score
Interval -2.0 to 1.9
|
2.03 score
Interval 0.1 to 4.0
|
|
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS)
week 40
|
0.77 score
Interval -1.5 to 3.0
|
2.39 score
Interval 0.2 to 4.6
|
|
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS)
week 52
|
1.13 score
Interval -1.1 to 3.4
|
2.19 score
Interval -0.1 to 4.4
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Sino-nasal Outcome Test-22 (SNOT-22) total score change from baseline by timepoint up to week 52. Patient reported symptom severity and symptom impact over the previous 2 weeks on 22 items are captured via a 6-point scale (0 = no problem to 5 = problem as bad as it can be). The total score is the sum of item scores and ranges from 0 to 110 (higher scores indicate poorer outcomes).
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score
week 4
|
-4.34 score
Interval -7.2 to -1.5
|
-4.32 score
Interval -7.2 to -1.5
|
|
Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score
week 8
|
-5.79 score
Interval -8.8 to -2.8
|
-6.42 score
Interval -9.4 to -3.4
|
|
Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score
week 12
|
-5.30 score
Interval -8.5 to -2.1
|
-6.35 score
Interval -9.5 to -3.2
|
|
Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score
week 16
|
-6.04 score
Interval -9.2 to -2.9
|
-6.04 score
Interval -9.2 to -2.9
|
|
Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score
week 28
|
-7.89 score
Interval -11.0 to -4.8
|
-7.59 score
Interval -10.7 to -4.5
|
|
Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score
week 40
|
-5.05 score
Interval -8.2 to -1.9
|
-8.33 score
Interval -11.6 to -5.1
|
|
Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score
week 52
|
-5.98 score
Interval -9.3 to -2.7
|
-6.35 score
Interval -9.7 to -3.0
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Sino-nasal Symptoms Questionnaire (SSQ) scores : symptom runny nose by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe).
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose
week 25-28
|
1.1 score
Standard Deviation 0.95
|
1.2 score
Standard Deviation 0.90
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose
week 29-32
|
1.2 score
Standard Deviation 0.90
|
1.1 score
Standard Deviation 0.99
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose
baseline
|
1.0 score
Standard Deviation 0.85
|
1.2 score
Standard Deviation 1.00
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose
week 1-4
|
1.4 score
Standard Deviation 0.95
|
1.2 score
Standard Deviation 0.97
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose
week 5-8
|
1.3 score
Standard Deviation 0.92
|
1.0 score
Standard Deviation 0.86
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose
week 9-12
|
1.4 score
Standard Deviation 1.00
|
1.0 score
Standard Deviation 0.88
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose
week 13-16
|
1.4 score
Standard Deviation 0.99
|
1.2 score
Standard Deviation 0.92
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose
week 17-20
|
1.3 score
Standard Deviation 0.98
|
1.1 score
Standard Deviation 0.96
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose
week 21-24
|
1.3 score
Standard Deviation 0.88
|
1.2 score
Standard Deviation 0.86
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose
week 33-36
|
1.3 score
Standard Deviation 0.87
|
1.0 score
Standard Deviation 0.90
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose
week 37-40
|
1.3 score
Standard Deviation 0.96
|
1.0 score
Standard Deviation 0.87
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose
week 41-44
|
1.1 score
Standard Deviation 0.86
|
0.9 score
Standard Deviation 0.76
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose
week 45-48
|
1.3 score
Standard Deviation 0.98
|
0.9 score
Standard Deviation 0.87
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose
week 49-52
|
1.2 score
Standard Deviation 0.98
|
1.0 score
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Sino-nasal Symptoms Questionnaire (SSQ) scores : symptom Post-nasal discharge by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe).
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge
baseline
|
1.1 score
Standard Deviation 1.00
|
1.2 score
Standard Deviation 1.06
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge
week 1-4
|
1.4 score
Standard Deviation 0.88
|
1.3 score
Standard Deviation 1.00
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge
week 5-8
|
1.2 score
Standard Deviation 0.94
|
1.2 score
Standard Deviation 0.85
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge
week 9-12
|
1.2 score
Standard Deviation 1.01
|
1.2 score
Standard Deviation 0.98
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge
week 13-16
|
1.2 score
Standard Deviation 0.96
|
1.2 score
Standard Deviation 0.94
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge
week 17-20
|
1.2 score
Standard Deviation 0.99
|
1.3 score
Standard Deviation 0.99
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge
week 21-24
|
1.2 score
Standard Deviation 0.93
|
1.2 score
Standard Deviation 0.98
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge
week 25-28
|
1.1 score
Standard Deviation 1.05
|
1.1 score
Standard Deviation 0.88
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge
week 29-32
|
1.1 score
Standard Deviation 0.97
|
1.1 score
Standard Deviation 0.99
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge
week 33-36
|
1.1 score
Standard Deviation 0.88
|
1.0 score
Standard Deviation 0.95
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge
week 37-40
|
1.2 score
Standard Deviation 0.96
|
0.9 score
Standard Deviation 0.81
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge
week 41-44
|
1.1 score
Standard Deviation 1.05
|
0.9 score
Standard Deviation 0.83
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge
week 45-48
|
1.1 score
Standard Deviation 1.03
|
1.0 score
Standard Deviation 0.89
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge
week 49-52
|
1.1 score
Standard Deviation 0.96
|
1.0 score
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Sino-nasal Symptoms Questionnaire (SSQ) scores: symptom Facial pain/pressure by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe).
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure
baseline
|
0.7 score
Standard Deviation 0.95
|
0.6 score
Standard Deviation 0.94
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure
week 1-4
|
0.9 score
Standard Deviation 0.97
|
0.8 score
Standard Deviation 0.99
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure
week 5-8
|
0.9 score
Standard Deviation 1.08
|
0.8 score
Standard Deviation 0.93
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure
week 9-12
|
0.9 score
Standard Deviation 1.01
|
0.8 score
Standard Deviation 0.88
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure
week 13-16
|
0.8 score
Standard Deviation 0.93
|
0.6 score
Standard Deviation 0.80
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure
week 17-20
|
0.9 score
Standard Deviation 0.97
|
0.7 score
Standard Deviation 0.93
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure
week 21-24
|
0.8 score
Standard Deviation 0.88
|
0.6 score
Standard Deviation 0.81
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure
week 25-28
|
0.7 score
Standard Deviation 0.95
|
0.6 score
Standard Deviation 0.89
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure
week 29-32
|
0.7 score
Standard Deviation 0.89
|
0.6 score
Standard Deviation 0.90
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure
week 33-36
|
0.6 score
Standard Deviation 0.86
|
0.6 score
Standard Deviation 0.89
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure
week 37-40
|
0.8 score
Standard Deviation 1.01
|
0.6 score
Standard Deviation 0.82
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure
week 41-44
|
0.7 score
Standard Deviation 0.92
|
0.6 score
Standard Deviation 0.82
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure
week 45-48
|
0.7 score
Standard Deviation 0.90
|
0.7 score
Standard Deviation 0.98
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure
week 49-52
|
0.7 score
Standard Deviation 0.90
|
0.6 score
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Sino-nasal Symptoms Questionnaire (SSQ) scores: symptom Loss or reduction in sense of taste/smell by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe).
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell
baseline
|
1.3 score
Standard Deviation 1.32
|
1.2 score
Standard Deviation 1.43
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell
week 1-4
|
1.3 score
Standard Deviation 1.36
|
1.2 score
Standard Deviation 1.45
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell
week 5-8
|
1.2 score
Standard Deviation 1.28
|
1.1 score
Standard Deviation 1.35
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell
week 9-12
|
1.2 score
Standard Deviation 1.29
|
1.0 score
Standard Deviation 1.36
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell
week 13-16
|
1.3 score
Standard Deviation 1.32
|
1.1 score
Standard Deviation 1.41
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell
week 17-20
|
1.3 score
Standard Deviation 1.36
|
1.1 score
Standard Deviation 1.32
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell
week 21-24
|
1.4 score
Standard Deviation 1.44
|
1.2 score
Standard Deviation 1.33
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell
week 25-28
|
1.3 score
Standard Deviation 1.39
|
1.1 score
Standard Deviation 1.37
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell
week 29-32
|
1.4 score
Standard Deviation 1.34
|
1.0 score
Standard Deviation 1.38
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell
week 33-36
|
1.4 score
Standard Deviation 1.39
|
1.1 score
Standard Deviation 1.35
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell
week 37-40
|
1.5 score
Standard Deviation 1.38
|
1.1 score
Standard Deviation 1.31
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell
week 41-44
|
1.5 score
Standard Deviation 1.43
|
1.0 score
Standard Deviation 1.29
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell
week 45-48
|
1.5 score
Standard Deviation 1.44
|
1.1 score
Standard Deviation 1.36
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell
week 49-52
|
1.5 score
Standard Deviation 1.40
|
1.1 score
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Sino-nasal Symptoms Questionnaire (SSQ) scores: symptom Blockage/congestion of nose by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe).
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose
baseline
|
1.3 score
Standard Deviation 1.07
|
1.4 score
Standard Deviation 1.15
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose
week 1-4
|
1.5 score
Standard Deviation 0.99
|
1.4 score
Standard Deviation 0.96
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose
week 5-8
|
1.5 score
Standard Deviation 0.96
|
1.4 score
Standard Deviation 1.03
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose
week 9-12
|
1.5 score
Standard Deviation 0.90
|
1.3 score
Standard Deviation 1.00
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose
week 13-16
|
1.6 score
Standard Deviation 1.14
|
1.4 score
Standard Deviation 1.09
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose
week 17-20
|
1.7 score
Standard Deviation 1.12
|
1.4 score
Standard Deviation 1.04
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose
week 21-24
|
1.6 score
Standard Deviation 1.06
|
1.3 score
Standard Deviation 1.05
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose
week 25-28
|
1.4 score
Standard Deviation 1.03
|
1.4 score
Standard Deviation 1.03
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose
week 29-32
|
1.5 score
Standard Deviation 0.99
|
1.4 score
Standard Deviation 1.13
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose
week 33-36
|
1.5 score
Standard Deviation 0.92
|
1.3 score
Standard Deviation 1.09
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose
week 37-40
|
1.6 score
Standard Deviation 1.01
|
1.3 score
Standard Deviation 1.14
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose
week 41-44
|
1.5 score
Standard Deviation 1.08
|
1.2 score
Standard Deviation 0.96
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose
week 45-48
|
1.5 score
Standard Deviation 1.13
|
1.3 score
Standard Deviation 1.11
|
|
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose
week 49-52
|
1.5 score
Standard Deviation 1.07
|
1.3 score
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Patient Global Impression of Severity (PGIS) category by timepoint
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Patient Global Impression of Severity (PGIS) Category
week 1 · Very mild
|
15 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 1 · Mild
|
21 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 1 · Moderate
|
24 Participants
|
26 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 1 · Severe
|
4 Participants
|
6 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 1 · Very severe
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 1 · Missing
|
1 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 2 · No symptoms
|
12 Participants
|
5 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 2 · Very mild
|
14 Participants
|
27 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 2 · Mild
|
21 Participants
|
11 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 2 · Moderate
|
20 Participants
|
18 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 2 · Severe
|
1 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 2 · Very severe
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 2 · Missing
|
2 Participants
|
5 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 3 · No symptoms
|
9 Participants
|
8 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 3 · Very mild
|
23 Participants
|
24 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 3 · Mild
|
16 Participants
|
19 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 3 · Moderate
|
18 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 3 · Severe
|
2 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 3 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 3 · Missing
|
2 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 4 · No symptoms
|
6 Participants
|
8 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 4 · Very mild
|
17 Participants
|
20 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 4 · Mild
|
15 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 4 · Moderate
|
26 Participants
|
23 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 4 · Severe
|
3 Participants
|
5 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 4 · Very severe
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 4 · Missing
|
2 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 5 · No symptoms
|
12 Participants
|
6 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 5 · Very mild
|
20 Participants
|
31 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 5 · Mild
|
24 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 5 · Moderate
|
12 Participants
|
14 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 5 · Severe
|
0 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 5 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 5 · Missing
|
2 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 6 · No symptoms
|
8 Participants
|
9 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 6 · Very mild
|
29 Participants
|
33 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 6 · Mild
|
18 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 6 · Moderate
|
13 Participants
|
9 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 6 · Severe
|
1 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 6 · Very severe
|
0 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 6 · Missing
|
1 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 7 · No symptoms
|
8 Participants
|
12 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 7 · Very mild
|
25 Participants
|
23 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 7 · Mild
|
18 Participants
|
20 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 7 · Moderate
|
14 Participants
|
10 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 7 · Severe
|
3 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 7 · Very severe
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 7 · Missing
|
2 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 8 · No symptoms
|
4 Participants
|
5 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 8 · Very mild
|
18 Participants
|
24 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 8 · Mild
|
18 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 8 · Moderate
|
21 Participants
|
20 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 8 · Severe
|
6 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 8 · Very severe
|
1 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 8 · Missing
|
2 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 9 · No symptoms
|
7 Participants
|
14 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 9 · Very mild
|
26 Participants
|
22 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 9 · Mild
|
17 Participants
|
17 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 9 · Moderate
|
14 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 9 · Severe
|
4 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 9 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 9 · Missing
|
2 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 10 · No symptoms
|
7 Participants
|
11 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 10 · Very mild
|
21 Participants
|
24 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 10 · Mild
|
24 Participants
|
22 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 10 · Moderate
|
13 Participants
|
7 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 10 · Severe
|
1 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 10 · Very severe
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 10 · Missing
|
2 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 11 · No symptoms
|
7 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 11 · Very mild
|
27 Participants
|
24 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 11 · Mild
|
17 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 11 · Moderate
|
14 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 11 · Severe
|
2 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 11 · Very severe
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 11 · Missing
|
2 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 12 · No symptoms
|
6 Participants
|
8 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 12 · Very mild
|
18 Participants
|
20 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 12 · Mild
|
19 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 12 · Moderate
|
17 Participants
|
20 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 12 · Severe
|
6 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 12 · Very severe
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 12 · Missing
|
2 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 13 · No symptoms
|
6 Participants
|
9 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 13 · Very mild
|
26 Participants
|
24 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 13 · Mild
|
22 Participants
|
18 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 13 · Moderate
|
11 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 13 · Severe
|
2 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 13 · Very severe
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 13 · Missing
|
2 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 14 · No symptoms
|
6 Participants
|
11 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 14 · Very mild
|
29 Participants
|
24 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 14 · Mild
|
15 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 14 · Moderate
|
15 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 14 · Severe
|
2 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 14 · Very severe
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 14 · Missing
|
3 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 15 · No symptoms
|
6 Participants
|
11 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 15 · Very mild
|
31 Participants
|
23 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 15 · Mild
|
12 Participants
|
17 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 15 · Moderate
|
16 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 15 · Severe
|
3 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 15 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 15 · Missing
|
2 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 16 · No symptoms
|
3 Participants
|
5 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 16 · Very mild
|
23 Participants
|
21 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 16 · Mild
|
17 Participants
|
26 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 16 · Moderate
|
19 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 16 · Severe
|
5 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 16 · Very severe
|
1 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 16 · Missing
|
2 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 17 · No symptoms
|
13 Participants
|
6 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 17 · Very mild
|
23 Participants
|
28 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 17 · Mild
|
14 Participants
|
19 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 17 · Moderate
|
19 Participants
|
11 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 17 · Severe
|
1 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 17 · Very severe
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 17 · Missing
|
0 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 18 · No symptoms
|
7 Participants
|
7 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 18 · Very mild
|
27 Participants
|
28 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 18 · Mild
|
14 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 18 · Moderate
|
18 Participants
|
18 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 18 · Severe
|
0 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 18 · Very severe
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 18 · Missing
|
2 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 19 · No symptoms
|
7 Participants
|
11 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 19 · Very mild
|
27 Participants
|
25 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 19 · Mild
|
14 Participants
|
17 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 19 · Moderate
|
14 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 19 · Severe
|
5 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 19 · Very severe
|
2 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 19 · Missing
|
1 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 20 · No symptoms
|
8 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 20 · Very mild
|
22 Participants
|
20 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 20 · Mild
|
18 Participants
|
21 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 20 · Moderate
|
14 Participants
|
11 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 20 · Severe
|
7 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 20 · Very severe
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 20 · Missing
|
1 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 21 · No symptoms
|
7 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 21 · Very mild
|
26 Participants
|
24 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 21 · Mild
|
13 Participants
|
12 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 21 · Moderate
|
17 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 21 · Severe
|
5 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 21 · Very severe
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 21 · Missing
|
1 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 22 · No symptoms
|
13 Participants
|
12 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 22 · Very mild
|
19 Participants
|
24 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 22 · Mild
|
19 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 22 · Moderate
|
16 Participants
|
12 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 22 · Severe
|
3 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 22 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 22 · Missing
|
0 Participants
|
5 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 23 · No symptoms
|
8 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 23 · Very mild
|
24 Participants
|
24 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 23 · Mild
|
20 Participants
|
19 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 23 · Moderate
|
14 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 23 · Severe
|
1 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 23 · Very severe
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 23 · Missing
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 24 · No symptoms
|
7 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 24 · Very mild
|
25 Participants
|
22 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 24 · Mild
|
20 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 24 · Moderate
|
14 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 24 · Severe
|
3 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 24 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 24 · Missing
|
1 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 25 · No symptoms
|
11 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 25 · Very mild
|
25 Participants
|
22 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 25 · Mild
|
19 Participants
|
17 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 25 · Moderate
|
10 Participants
|
14 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 25 · Severe
|
4 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 25 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 25 · Missing
|
1 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 26 · No symptoms
|
12 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 26 · Very mild
|
25 Participants
|
22 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 26 · Mild
|
17 Participants
|
14 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 26 · Moderate
|
11 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 26 · Severe
|
3 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 26 · Very severe
|
1 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 26 · Missing
|
1 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 27 · No symptoms
|
10 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 27 · Very mild
|
28 Participants
|
21 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 27 · Mild
|
16 Participants
|
17 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 27 · Moderate
|
15 Participants
|
10 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 27 · Severe
|
0 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 27 · Very severe
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 27 · Missing
|
0 Participants
|
5 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 28 · No symptoms
|
6 Participants
|
9 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 28 · Very mild
|
21 Participants
|
21 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 28 · Mild
|
23 Participants
|
18 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 28 · Moderate
|
14 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 28 · Severe
|
4 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 28 · Very severe
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 28 · Missing
|
1 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 29 · No symptoms
|
6 Participants
|
12 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 29 · Very mild
|
28 Participants
|
21 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 29 · Mild
|
17 Participants
|
19 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 29 · Moderate
|
15 Participants
|
10 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 29 · Severe
|
2 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 29 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 29 · Missing
|
2 Participants
|
5 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 30 · No symptoms
|
7 Participants
|
18 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 30 · Very mild
|
22 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 30 · Mild
|
25 Participants
|
18 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 30 · Moderate
|
11 Participants
|
9 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 30 · Severe
|
3 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 30 · Very severe
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 30 · Missing
|
2 Participants
|
6 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 31 · No symptoms
|
8 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 31 · Very mild
|
22 Participants
|
20 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 31 · Mild
|
18 Participants
|
17 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 31 · Moderate
|
16 Participants
|
11 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 31 · Severe
|
3 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 31 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 31 · Missing
|
3 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 32 · No symptoms
|
6 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 32 · Very mild
|
25 Participants
|
20 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 32 · Mild
|
17 Participants
|
20 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 32 · Moderate
|
16 Participants
|
8 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 32 · Severe
|
3 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 32 · Very severe
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 32 · Missing
|
2 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 33 · No symptoms
|
6 Participants
|
17 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 33 · Very mild
|
23 Participants
|
20 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 33 · Mild
|
22 Participants
|
14 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 33 · Moderate
|
14 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 33 · Severe
|
2 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 33 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 33 · Missing
|
3 Participants
|
5 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 34 · No symptoms
|
8 Participants
|
14 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 34 · Very mild
|
27 Participants
|
18 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 34 · Mild
|
17 Participants
|
20 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 34 · Moderate
|
13 Participants
|
11 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 34 · Severe
|
2 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 34 · Very severe
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 34 · Missing
|
2 Participants
|
5 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 35 · No symptoms
|
10 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 35 · Very mild
|
25 Participants
|
20 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 35 · Mild
|
16 Participants
|
18 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 35 · Moderate
|
13 Participants
|
10 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 35 · Severe
|
2 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 35 · Very severe
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 35 · Missing
|
3 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 36 · No symptoms
|
7 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 36 · Very mild
|
26 Participants
|
22 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 36 · Mild
|
15 Participants
|
17 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 36 · Moderate
|
18 Participants
|
12 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 36 · Severe
|
1 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 36 · Very severe
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 36 · Missing
|
2 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 37 · No symptoms
|
5 Participants
|
17 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 37 · Very mild
|
28 Participants
|
21 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 37 · Mild
|
18 Participants
|
14 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 37 · Moderate
|
15 Participants
|
11 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 37 · Severe
|
1 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 37 · Very severe
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 37 · Missing
|
3 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 38 · No symptoms
|
7 Participants
|
17 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 38 · Very mild
|
25 Participants
|
24 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 38 · Mild
|
16 Participants
|
10 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 38 · Moderate
|
16 Participants
|
12 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 38 · Severe
|
1 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 38 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 38 · Missing
|
5 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 39 · No symptoms
|
5 Participants
|
19 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 39 · Very mild
|
30 Participants
|
23 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 39 · Mild
|
14 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 39 · Moderate
|
16 Participants
|
9 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 39 · Severe
|
1 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 39 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 39 · Missing
|
4 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 40 · No symptoms
|
2 Participants
|
10 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 40 · Very mild
|
20 Participants
|
18 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 40 · Mild
|
24 Participants
|
18 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 40 · Moderate
|
18 Participants
|
14 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 40 · Severe
|
2 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 40 · Very severe
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 40 · Missing
|
4 Participants
|
6 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 41 · No symptoms
|
6 Participants
|
17 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 41 · Very mild
|
25 Participants
|
23 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 41 · Mild
|
20 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 41 · Moderate
|
13 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 41 · Severe
|
1 Participants
|
5 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 41 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 41 · Missing
|
5 Participants
|
5 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 42 · No symptoms
|
7 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 42 · Very mild
|
23 Participants
|
26 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 42 · Mild
|
18 Participants
|
17 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 42 · Moderate
|
15 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 42 · Severe
|
2 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 42 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 42 · Missing
|
5 Participants
|
5 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 43 · No symptoms
|
9 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 43 · Very mild
|
17 Participants
|
27 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 43 · Mild
|
21 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 43 · Moderate
|
13 Participants
|
6 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 43 · Severe
|
1 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 43 · Very severe
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 43 · Missing
|
7 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 44 · No symptoms
|
6 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 44 · Very mild
|
24 Participants
|
23 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 44 · Mild
|
19 Participants
|
17 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 44 · Moderate
|
14 Participants
|
6 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 44 · Severe
|
2 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 44 · Very severe
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 44 · Missing
|
4 Participants
|
5 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 45 · No symptoms
|
8 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 45 · Very mild
|
21 Participants
|
26 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 45 · Mild
|
22 Participants
|
14 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 45 · Moderate
|
13 Participants
|
8 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 45 · Severe
|
2 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 45 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 45 · Missing
|
4 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 46 · No symptoms
|
9 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 46 · Very mild
|
23 Participants
|
27 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 46 · Mild
|
13 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 46 · Moderate
|
17 Participants
|
7 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 46 · Severe
|
3 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 46 · Very severe
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 46 · Missing
|
4 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 47 · No symptoms
|
6 Participants
|
17 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 47 · Very mild
|
25 Participants
|
27 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 47 · Mild
|
16 Participants
|
11 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 47 · Moderate
|
16 Participants
|
7 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 47 · Severe
|
2 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 47 · Very severe
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 47 · Missing
|
4 Participants
|
6 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 48 · No symptoms
|
11 Participants
|
17 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 48 · Very mild
|
26 Participants
|
23 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 48 · Mild
|
14 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 48 · Moderate
|
15 Participants
|
9 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 48 · Severe
|
1 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 48 · Very severe
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 48 · Missing
|
1 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 49 · No symptoms
|
12 Participants
|
14 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 49 · Very mild
|
20 Participants
|
25 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 49 · Mild
|
18 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 49 · Moderate
|
15 Participants
|
10 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 49 · Severe
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 49 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 49 · Missing
|
3 Participants
|
5 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 50 · No symptoms
|
10 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 50 · Very mild
|
29 Participants
|
26 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 50 · Mild
|
12 Participants
|
13 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 50 · Moderate
|
15 Participants
|
8 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 50 · Severe
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 50 · Very severe
|
1 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 50 · Missing
|
2 Participants
|
6 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 51 · No symptoms
|
12 Participants
|
15 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 51 · Very mild
|
18 Participants
|
25 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 51 · Mild
|
16 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 51 · Moderate
|
16 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 51 · Severe
|
2 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 51 · Very severe
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 51 · Missing
|
6 Participants
|
9 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 52 · No symptoms
|
4 Participants
|
11 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 52 · Very mild
|
20 Participants
|
18 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 52 · Mild
|
14 Participants
|
19 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 52 · Moderate
|
16 Participants
|
12 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 52 · Severe
|
5 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 52 · Very severe
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 52 · Missing
|
9 Participants
|
9 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
baseline · Severe
|
7 Participants
|
5 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
baseline · Very severe
|
1 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
baseline · Missing
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
week 1 · No symptoms
|
4 Participants
|
4 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
baseline · Very mild
|
8 Participants
|
19 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
baseline · Mild
|
18 Participants
|
16 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
baseline · Moderate
|
28 Participants
|
26 Participants
|
|
Patient Global Impression of Severity (PGIS) Category
baseline · No symptoms
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: from baseline to week 4Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Patient Global Impression of Change (PGIC) category by timepoint
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Patient Global Impression of Change (PGIC) Category
week 1 · Much better
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 1 · Moderately better
|
4 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 1 · A little better
|
15 Participants
|
21 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 1 · About the same
|
45 Participants
|
39 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 1 · A little worse
|
2 Participants
|
5 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 1 · Moderately worse
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 1 · Much worse
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 1 · Missing
|
1 Participants
|
4 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 2 · Much better
|
7 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 2 · Moderately better
|
7 Participants
|
6 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 2 · A little better
|
14 Participants
|
22 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 2 · About the same
|
38 Participants
|
33 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 2 · A little worse
|
2 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 2 · Moderately worse
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 2 · Much worse
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 2 · Missing
|
2 Participants
|
5 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 3 · Much better
|
7 Participants
|
3 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 3 · Moderately better
|
7 Participants
|
7 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 3 · A little better
|
15 Participants
|
27 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 3 · About the same
|
36 Participants
|
27 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 3 · A little worse
|
2 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 3 · Moderately worse
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 3 · Much worse
|
0 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 3 · Missing
|
2 Participants
|
3 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 4 · Much better
|
6 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 4 · Moderately better
|
5 Participants
|
12 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 4 · A little better
|
17 Participants
|
20 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 4 · About the same
|
35 Participants
|
31 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 4 · A little worse
|
4 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 4 · Moderately worse
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 4 · Much worse
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC) Category
week 4 · Missing
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
The Work Productivity and Activity Impairment questionnaire (WPAI-GH) has 6 questions which address absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (a higher percentage indicating greater impairment and less productivity). Subscale: Absenteeism (work time missed) (%) score, range 0-100.
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%)
week 4
|
-1.24 score
Standard Deviation 22.167
|
-5.46 score
Standard Deviation 25.387
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%)
week 8
|
0.71 score
Standard Deviation 21.429
|
-7.75 score
Standard Deviation 28.680
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%)
week 12
|
6.59 score
Standard Deviation 23.328
|
-8.88 score
Standard Deviation 30.513
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%)
week 16
|
12.43 score
Standard Deviation 28.205
|
-7.94 score
Standard Deviation 36.950
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%)
week 28
|
4.16 score
Standard Deviation 17.279
|
-3.59 score
Standard Deviation 40.441
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%)
week 40
|
-1.29 score
Standard Deviation 17.181
|
-5.02 score
Standard Deviation 35.641
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%)
week 52
|
9.02 score
Standard Deviation 23.971
|
-10.99 score
Standard Deviation 40.272
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
The Work Productivity and Activity Impairment questionnaire (WPAI-GH) has 6 questions which address absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (a higher percentage indicating greater impairment and less productivity). Presenteeism (%) score.
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100.
week 4
|
-7.42 score
Standard Deviation 15.268
|
0.36 score
Standard Deviation 16.439
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100.
week 8
|
-2.58 score
Standard Deviation 15.485
|
6.43 score
Standard Deviation 14.457
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100.
week 12
|
-2.00 score
Standard Deviation 12.247
|
3.20 score
Standard Deviation 20.355
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100.
week 16
|
2.59 score
Standard Deviation 22.290
|
2.31 score
Standard Deviation 17.043
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100.
week 28
|
-2.41 score
Standard Deviation 19.022
|
3.46 score
Standard Deviation 22.793
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100.
week 40
|
-3.91 score
Standard Deviation 17.252
|
0.43 score
Standard Deviation 10.215
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100.
week 52
|
4.80 score
Standard Deviation 34.535
|
-6.19 score
Standard Deviation 18.568
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
The Work Productivity and Activity Impairment questionnaire (WPAI-GH) has 6 questions which address absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (a higher percentage indicating greater impairment and less productivity). Work productivity loss (%) score, range 0-100.
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%)
week 4
|
-7.35 score
Standard Deviation 22.397
|
2.14 score
Standard Deviation 14.775
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%)
week 8
|
-0.53 score
Standard Deviation 23.935
|
6.26 score
Standard Deviation 19.154
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%)
week 12
|
1.47 score
Standard Deviation 19.235
|
1.24 score
Standard Deviation 24.149
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%)
week 16
|
8.09 score
Standard Deviation 31.026
|
5.31 score
Standard Deviation 23.864
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%)
week 28
|
0.05 score
Standard Deviation 25.844
|
6.87 score
Standard Deviation 24.114
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%)
week 40
|
-3.02 score
Standard Deviation 23.350
|
0.67 score
Standard Deviation 14.140
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%)
week 52
|
5.82 score
Standard Deviation 33.761
|
-4.47 score
Standard Deviation 27.803
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
The Work Productivity and Activity Impairment questionnaire (WPAI-GH) has 6 questions which address absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (a higher percentage indicating greater impairment and less productivity). Activity impairment (%) score, range 0-100.
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%)
week 4
|
-3.97 score
Standard Deviation 20.815
|
-3.38 score
Standard Deviation 19.745
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%)
week 8
|
-3.53 score
Standard Deviation 21.144
|
-4.71 score
Standard Deviation 23.466
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%)
week 12
|
-4.56 score
Standard Deviation 20.620
|
-3.97 score
Standard Deviation 20.453
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%)
week 16
|
-3.24 score
Standard Deviation 21.402
|
-6.42 score
Standard Deviation 25.268
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%)
week 28
|
-4.41 score
Standard Deviation 22.419
|
-6.31 score
Standard Deviation 27.419
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%)
week 40
|
-7.58 score
Standard Deviation 20.234
|
-4.46 score
Standard Deviation 20.235
|
|
WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%)
week 52
|
-3.28 score
Standard Deviation 27.083
|
-7.78 score
Standard Deviation 25.492
|
SECONDARY outcome
Timeframe: from baseline to end of DB period, 52 WeeksPopulation: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
Absolute eosinophil count, change from baseline by timepoint up to week 52
Outcome measures
| Measure |
Benralizumab 30 mg
n=70 Participants
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks
|
Mepolizumab 300 mg
n=70 Participants
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks
|
|---|---|---|
|
Absolute Eosinophil Count, Change From Baseline
week 32
|
0.12 cells*10^9/L
Interval 0.1 to 0.14
|
0.22 cells*10^9/L
Interval 0.18 to 0.27
|
|
Absolute Eosinophil Count, Change From Baseline
week 48
|
0.10 cells*10^9/L
Interval 0.08 to 0.13
|
0.24 cells*10^9/L
Interval 0.19 to 0.29
|
|
Absolute Eosinophil Count, Change From Baseline
week 52
|
0.10 cells*10^9/L
Interval 0.08 to 0.12
|
0.26 cells*10^9/L
Interval 0.21 to 0.32
|
|
Absolute Eosinophil Count, Change From Baseline
week 1
|
0.15 cells*10^9/L
Interval 0.12 to 0.18
|
0.39 cells*10^9/L
Interval 0.32 to 0.47
|
|
Absolute Eosinophil Count, Change From Baseline
week 4
|
0.14 cells*10^9/L
Interval 0.12 to 0.17
|
0.30 cells*10^9/L
Interval 0.25 to 0.36
|
|
Absolute Eosinophil Count, Change From Baseline
week 8
|
0.10 cells*10^9/L
Interval 0.08 to 0.11
|
0.23 cells*10^9/L
Interval 0.2 to 0.28
|
|
Absolute Eosinophil Count, Change From Baseline
week 12
|
0.11 cells*10^9/L
Interval 0.09 to 0.13
|
0.25 cells*10^9/L
Interval 0.2 to 0.3
|
|
Absolute Eosinophil Count, Change From Baseline
week 16
|
0.11 cells*10^9/L
Interval 0.09 to 0.13
|
0.24 cells*10^9/L
Interval 0.2 to 0.29
|
|
Absolute Eosinophil Count, Change From Baseline
week 20
|
0.10 cells*10^9/L
Interval 0.08 to 0.12
|
0.23 cells*10^9/L
Interval 0.19 to 0.28
|
|
Absolute Eosinophil Count, Change From Baseline
week 24
|
0.14 cells*10^9/L
Interval 0.12 to 0.17
|
0.24 cells*10^9/L
Interval 0.2 to 0.29
|
|
Absolute Eosinophil Count, Change From Baseline
week 25
|
0.14 cells*10^9/L
Interval 0.11 to 0.17
|
0.23 cells*10^9/L
Interval 0.19 to 0.28
|
|
Absolute Eosinophil Count, Change From Baseline
week 28
|
0.10 cells*10^9/L
Interval 0.08 to 0.12
|
0.24 cells*10^9/L
Interval 0.2 to 0.29
|
|
Absolute Eosinophil Count, Change From Baseline
week 36
|
0.11 cells*10^9/L
Interval 0.09 to 0.14
|
0.26 cells*10^9/L
Interval 0.21 to 0.31
|
|
Absolute Eosinophil Count, Change From Baseline
week 40
|
0.09 cells*10^9/L
Interval 0.08 to 0.11
|
0.22 cells*10^9/L
Interval 0.18 to 0.27
|
|
Absolute Eosinophil Count, Change From Baseline
week 44
|
0.10 cells*10^9/L
Interval 0.09 to 0.13
|
0.24 cells*10^9/L
Interval 0.2 to 0.29
|
Adverse Events
Benra 30 mg - DB
Serious events: 4 serious events
Other events: 46 other events
Deaths: 0 deaths
Mepo 300 mg - DB
Serious events: 9 serious events
Other events: 56 other events
Deaths: 0 deaths
Benra 30 mg - OLE
Serious events: 10 serious events
Other events: 43 other events
Deaths: 0 deaths
Mepo 300 mg Switched to Benra 30 mg - OLE
Serious events: 13 serious events
Other events: 46 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Benra 30 mg - DB
n=70 participants at risk
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks, Double-blind period
|
Mepo 300 mg - DB
n=70 participants at risk
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks, Double-blind period
|
Benra 30 mg - OLE
n=66 participants at risk
Benralizumab injections delivered subcutaneously every 4 weeks, Open-label extension period (Participants who took Double-blind benralizumab previously)
|
Mepo 300 mg Switched to Benra 30 mg - OLE
n=62 participants at risk
Benralizumab injections delivered subcutaneously every 4 weeks, Open-label extension period (Participants who took Double-blind mepolizumab previously)
|
|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Immune system disorders
Eosinophilic granulomatosis with polyangiitis
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
3.2%
2/62 • Number of events 2 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Bronchitis
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
COVID-19
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Influenza
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Streptococcal urinary tract infection
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Wound infection
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
3.2%
2/62 • Number of events 2 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 2 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Investigations
Liver function test increased
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Investigations
Weight decreased
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
2.9%
2/70 • Number of events 2 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Nervous system disorders
Headache
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Nervous system disorders
Syncope
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
General disorders
Malaise
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Hepatobiliary disorders
Hepatic infiltration eosinophilic
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
Other adverse events
| Measure |
Benra 30 mg - DB
n=70 participants at risk
Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks, Double-blind period
|
Mepo 300 mg - DB
n=70 participants at risk
Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks, Double-blind period
|
Benra 30 mg - OLE
n=66 participants at risk
Benralizumab injections delivered subcutaneously every 4 weeks, Open-label extension period (Participants who took Double-blind benralizumab previously)
|
Mepo 300 mg Switched to Benra 30 mg - OLE
n=62 participants at risk
Benralizumab injections delivered subcutaneously every 4 weeks, Open-label extension period (Participants who took Double-blind mepolizumab previously)
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
7.1%
5/70 • Number of events 5 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
8.6%
6/70 • Number of events 7 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
5.7%
4/70 • Number of events 4 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
4.5%
3/66 • Number of events 3 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
3.2%
2/62 • Number of events 3 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.1%
12/70 • Number of events 16 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
11.4%
8/70 • Number of events 8 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
4.5%
3/66 • Number of events 3 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
4/70 • Number of events 4 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
5.7%
4/70 • Number of events 4 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
4.5%
3/66 • Number of events 3 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
4.8%
3/62 • Number of events 3 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
8.6%
6/70 • Number of events 8 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Nervous system disorders
Headache
|
17.1%
12/70 • Number of events 16 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
15.7%
11/70 • Number of events 14 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
6.5%
4/62 • Number of events 4 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
4.3%
3/70 • Number of events 3 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
7.6%
5/66 • Number of events 13 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
4.8%
3/62 • Number of events 3 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
2.9%
2/70 • Number of events 2 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
6.5%
4/62 • Number of events 4 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
General disorders
Asthenia
|
8.6%
6/70 • Number of events 9 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/70 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
5.7%
4/70 • Number of events 4 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
4/70 • Number of events 5 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
2.9%
2/70 • Number of events 2 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
8.1%
5/62 • Number of events 5 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Vascular disorders
Hypertension
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
7.1%
5/70 • Number of events 5 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/66 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.6%
1/62 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Conjunctivitis
|
2.9%
2/70 • Number of events 2 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
6.5%
4/62 • Number of events 4 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Bronchitis
|
5.7%
4/70 • Number of events 4 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
7.1%
5/70 • Number of events 8 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
10.6%
7/66 • Number of events 9 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
3.2%
2/62 • Number of events 3 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
COVID-19
|
20.0%
14/70 • Number of events 14 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
25.7%
18/70 • Number of events 18 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
33.3%
22/66 • Number of events 25 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
43.5%
27/62 • Number of events 30 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
6/70 • Number of events 6 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
14.3%
10/70 • Number of events 12 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
9.1%
6/66 • Number of events 7 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
17.7%
11/62 • Number of events 19 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Oral candidiasis
|
2.9%
2/70 • Number of events 2 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
5.7%
4/70 • Number of events 4 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
3.0%
2/66 • Number of events 2 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
3.2%
2/62 • Number of events 2 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Sinusitis
|
7.1%
5/70 • Number of events 5 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
11.4%
8/70 • Number of events 9 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
21.2%
14/66 • Number of events 20 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
6.5%
4/62 • Number of events 4 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Sinusitis bacterial
|
7.1%
5/70 • Number of events 5 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
4.3%
3/70 • Number of events 4 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
4.8%
3/62 • Number of events 3 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
4/70 • Number of events 5 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
5.7%
4/70 • Number of events 4 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
3.0%
2/66 • Number of events 4 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
8.1%
5/62 • Number of events 5 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
5/70 • Number of events 6 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
3.0%
2/66 • Number of events 2 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
3.2%
2/62 • Number of events 2 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.4%
1/70 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
8.6%
6/70 • Number of events 6 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
3.2%
2/62 • Number of events 2 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
General disorders
Influenza like illness
|
5.7%
4/70 • Number of events 4 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
4.3%
3/70 • Number of events 3 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
10.6%
7/66 • Number of events 10 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
6.5%
4/62 • Number of events 6 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
|
General disorders
Injection site bruising
|
2.9%
2/70 • Number of events 3 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
5.7%
4/70 • Number of events 6 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
1.5%
1/66 • Number of events 1 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
0.00%
0/62 • Double-blind Treatment Period: From first dose of study drug until end of Double-blind period, up to 52 weeks. Open-label Extension Period: From the end of the Double-blind period (week 53) to the data cut-off date (10AUG2023), up to 138 weeks.
For analysis of Adverse Events during Double-blind period, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of Investigational Product (IP). For analysis of Adverse Events during Open-label Extension (OLE) period, OLE Analysis Set is used. OLE Analysis Set: All subjects who entered the OLE part of the study and who received at least 1 dose of IP during the OLE treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee ≥ 60 days prior to submission of material for publication/presentation, Institution and PI shall jointly provide AZ with material for review. No publication/presentation may include any of AZ's Confidential Information without AZ's written approval. AZ can request Inst. and PI to withhold material from submission for publication/presentation for an additional 90 days to allow AZ to establish and preserve its proprietary rights in the material being submitted for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER