Trial Outcomes & Findings for Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis (NCT NCT01006265)
NCT ID: NCT01006265
Last Updated: 2025-03-30
Results Overview
Cumulative Number of new T1 gadolinium-enhancing (Gd+) lesions per year on magnetic resonance imaging (MRI) scan from Week 12 to Week 24 were reported. Negative binomial (NB) regression analysis on Per protocol analysis set and imputation was applied for the missing data. Here, MS signifies multiple sclerosis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
464 participants
Primary outcome timeframe
From Week 12 to 24
Results posted on
2025-03-30
Participant Flow
Participant milestones
| Measure |
Ponesimod 40 mg
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24.
|
Ponesimod 20 mg
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24.
|
Ponesimod 10 mg
Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24.
|
Placebo
Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
119
|
116
|
108
|
121
|
|
Overall Study
Treated
|
119
|
114
|
108
|
121
|
|
Overall Study
COMPLETED
|
113
|
107
|
99
|
116
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
9
|
5
|
Reasons for withdrawal
| Measure |
Ponesimod 40 mg
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24.
|
Ponesimod 20 mg
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24.
|
Ponesimod 10 mg
Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24.
|
Placebo
Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
7
|
5
|
5
|
|
Overall Study
Administrative reason
|
1
|
2
|
3
|
0
|
Baseline Characteristics
Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Ponesimod 40 mg
n=119 Participants
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24.
|
Ponesimod 20 mg
n=116 Participants
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24.
|
Ponesimod 10 mg
n=108 Participants
Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24.
|
Placebo
n=121 Participants
Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
|
Total
n=464 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Age ( years )
|
36.5 years
STANDARD_DEVIATION 8.52 • n=93 Participants
|
35.3 years
STANDARD_DEVIATION 8.52 • n=4 Participants
|
36.9 years
STANDARD_DEVIATION 9.24 • n=27 Participants
|
36.6 years
STANDARD_DEVIATION 8.58 • n=483 Participants
|
36.3 years
STANDARD_DEVIATION 8.7 • n=36 Participants
|
|
Sex: Female, Male
Gender · Female
|
79 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
85 Participants
n=483 Participants
|
313 Participants
n=36 Participants
|
|
Sex: Female, Male
Gender · Male
|
40 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
151 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
117 Participants
n=93 Participants
|
116 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
121 Participants
n=483 Participants
|
462 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
114 Participants
n=93 Participants
|
114 Participants
n=4 Participants
|
105 Participants
n=27 Participants
|
114 Participants
n=483 Participants
|
447 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Region of Enrollment
Austria
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Region of Enrollment
Belgium
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Region of Enrollment
Bulgaria
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
19 Participants
n=36 Participants
|
|
Region of Enrollment
Canada
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Region of Enrollment
Finland
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
20 Participants
n=36 Participants
|
|
Region of Enrollment
Czech Republic
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
52 Participants
n=36 Participants
|
|
Region of Enrollment
France
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Region of Enrollment
Hungary
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
19 Participants
n=36 Participants
|
|
Region of Enrollment
Israel
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Region of Enrollment
Italy
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
28 Participants
n=36 Participants
|
|
Region of Enrollment
Netherlands
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Region of Enrollment
Poland
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
37 Participants
n=36 Participants
|
|
Region of Enrollment
Romania
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Region of Enrollment
Russia
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
33 Participants
n=36 Participants
|
|
Region of Enrollment
Spain
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Region of Enrollment
Serbia
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
42 Participants
n=36 Participants
|
|
Region of Enrollment
Sweden
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
|
Region of Enrollment
Switzerland
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Region of Enrollment
United Kingdom
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
|
Region of Enrollment
Ukraine
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
75 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: From Week 12 to 24Population: Per protocol analysis set included participants of mITT set (randomized participants who received at least one dose of study drug, and had at least one valid post-baseline MRI) who met the criteria for evaluable participants for the analysis of MRI data (participants with Relapsing-remitting multiple sclerosis (RRMS) received study drug until 168 days, two post-baseline MRIs b/w Week 12-24, no forbidden treatment for MS).
Cumulative Number of new T1 gadolinium-enhancing (Gd+) lesions per year on magnetic resonance imaging (MRI) scan from Week 12 to Week 24 were reported. Negative binomial (NB) regression analysis on Per protocol analysis set and imputation was applied for the missing data. Here, MS signifies multiple sclerosis.
Outcome measures
| Measure |
Ponesimod 40 mg
n=93 Participants
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24.
|
Ponesimod 20 mg
n=98 Participants
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24.
|
Ponesimod 10 mg
n=88 Participants
Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24.
|
Placebo
n=110 Participants
Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
|
|---|---|---|---|---|
|
Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24
|
1.4 Lesions
Standard Deviation 3.24
|
1.1 Lesions
Standard Deviation 1.96
|
3.5 Lesions
Standard Deviation 7.27
|
6.2 Lesions
Standard Deviation 13.42
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: All treated analysis set included all randomized participants who received at least one dose of study drug.
Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of Multiple Sclerosis (MS), not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicating overall functional impairment assessing Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS with information concerning gait and use of assistance. EDSS is ordinal clinical scale ranges 0 (normal neurological examination) to 10(death due to MS)
Outcome measures
| Measure |
Ponesimod 40 mg
n=119 Participants
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24.
|
Ponesimod 20 mg
n=114 Participants
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24.
|
Ponesimod 10 mg
n=108 Participants
Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24.
|
Placebo
n=121 Participants
Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
|
|---|---|---|---|---|
|
Annualized Confirmed Relapse Rate
|
0.224 Relapse per year
Standard Deviation 0.7834
|
0.396 Relapse per year
Standard Deviation 1.0169
|
0.297 Relapse per year
Standard Deviation 0.7987
|
0.601 Relapse per year
Standard Deviation 1.6626
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: All treated analysis set included all randomized participants who received at least one dose of study drug. Here 'N' (number of participants analyzed) included all participants who were evaluated for this outcome measure.
Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of MS, not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicating overall functional impairment assessing Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS with information concerning gait and use of assistance. EDSS is ordinal clinical scale ranges 0 (normal neurological examination) to 10(death due to MS). Kaplan-Meier estimate used for Outcome Measure analysis.
Outcome measures
| Measure |
Ponesimod 40 mg
n=66 Participants
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24.
|
Ponesimod 20 mg
n=71 Participants
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24.
|
Ponesimod 10 mg
n=60 Participants
Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24.
|
Placebo
n=65 Participants
Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
|
|---|---|---|---|---|
|
Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From Baseline to Week 24
|
10 Participants
|
17 Participants
|
14 Participants
|
25 Participants
|
Adverse Events
Ponesimod 40 mg
Serious events: 3 serious events
Other events: 83 other events
Deaths: 0 deaths
Ponesimod 20 mg
Serious events: 7 serious events
Other events: 73 other events
Deaths: 0 deaths
Ponesimod 10 mg
Serious events: 7 serious events
Other events: 69 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ponesimod 40 mg
n=119 participants at risk
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24.
|
Ponesimod 20 mg
n=114 participants at risk
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24.
|
Ponesimod 10 mg
n=108 participants at risk
Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24.
|
Placebo
n=121 participants at risk
Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.88%
1/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.9%
2/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Macular Oedema
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.8%
2/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Papilloedema
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.88%
1/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.88%
1/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Immune system disorders
Anaphylactoid Reaction
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.83%
1/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.84%
1/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.88%
1/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.84%
1/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Measles
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.83%
1/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.83%
1/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Electrocardiogram QT Prolonged
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Nuclear Magnetic Resonance Imaging Abnormal
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.88%
1/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.83%
1/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Postmenopausal Haemorrhage
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.83%
1/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.84%
1/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.84%
1/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.88%
1/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Ponesimod 40 mg
n=119 participants at risk
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 milligram (mg) ponesimod on Days 1 to 7 followed by first up-titration dose of 20 mg ponesimod on Days 8 to 14 and lastly received 40 mg ponesimod as second up-titration dose on Day 15 to Week 24.
|
Ponesimod 20 mg
n=114 participants at risk
Participants received ponesimod capsules once daily as per up-titration schedule with an initial dose of 10 mg ponesimod on Days 1 to 7 followed by 20 mg ponesimod on Day 8 to Week 24.
|
Ponesimod 10 mg
n=108 participants at risk
Participants received ponesimod capsules once daily as per up-titration schedule with a dose of 10 mg ponesimod on Day 1 to Week 24.
|
Placebo
n=121 participants at risk
Participants received the ponesimod matching placebo tablets once daily for up to Week 24 as per up-titration schedule.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
2.5%
3/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.88%
1/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.83%
1/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.84%
1/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.8%
3/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.5%
3/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.84%
1/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.8%
2/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
4.1%
5/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.84%
1/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.6%
3/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
1.7%
2/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
4.4%
5/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
1.7%
2/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.88%
1/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.8%
3/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.5%
3/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.88%
1/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.5%
3/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Eye Pain
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.8%
3/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.7%
2/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.84%
1/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.5%
3/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.5%
3/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.88%
1/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.83%
1/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
3/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.6%
3/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.8%
3/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
6.6%
8/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.6%
3/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.83%
1/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.84%
1/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.6%
3/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.7%
2/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
3.4%
4/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.6%
3/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.9%
2/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
5.0%
6/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
2/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.88%
1/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.8%
3/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
2.5%
3/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.88%
1/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
3.3%
4/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Chest Discomfort
|
3.4%
4/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
4.4%
5/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.5%
3/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Disease Progression
|
9.2%
11/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
7.9%
9/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
9.3%
10/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
5.0%
6/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
5.0%
6/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
7.9%
9/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
6.5%
7/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
5.8%
7/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Oedema Peripheral
|
10.9%
13/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.6%
3/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.9%
2/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.7%
2/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.5%
3/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
4.2%
5/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
3.5%
4/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
3.7%
4/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.5%
3/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.84%
1/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.6%
3/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
4.6%
5/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
3.3%
4/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
4.2%
5/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.6%
3/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.8%
3/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.7%
2/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
10.9%
13/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
10.5%
12/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
14.8%
16/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
14.0%
17/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral Herpes
|
1.7%
2/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.9%
2/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
5.0%
6/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
3.5%
4/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.8%
3/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.83%
1/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
5.0%
6/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
4.4%
5/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
3.7%
4/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
4.1%
5/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.2%
11/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
7.9%
9/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
3.7%
4/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
9.1%
11/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
2.5%
3/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.88%
1/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.9%
2/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
5.0%
6/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.84%
1/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.88%
1/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.8%
3/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.88%
1/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.8%
3/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
5.9%
7/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
6.1%
7/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
3.7%
4/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.83%
1/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood Cholesterol Increased
|
1.7%
2/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.6%
3/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.8%
3/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.83%
1/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Forced Expiratory Volume Decreased
|
2.5%
3/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.8%
2/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.9%
2/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Hepatic Enzyme Increased
|
0.84%
1/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.8%
3/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Pulmonary Function Test Decreased
|
4.2%
5/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.9%
2/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.5%
3/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.6%
3/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.9%
2/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.7%
2/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.84%
1/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.88%
1/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.9%
2/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
5.8%
7/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.0%
6/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
4.4%
5/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.9%
2/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
5.0%
6/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.84%
1/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
3.5%
4/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.5%
3/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
4.1%
5/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.7%
2/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.6%
3/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.83%
1/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
9.2%
11/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
6.1%
7/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
7.4%
8/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.5%
3/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
12.6%
15/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
14.0%
16/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
13.9%
15/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
14.9%
18/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
2.5%
3/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.8%
2/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.9%
2/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.7%
2/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
4.2%
5/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.6%
3/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.84%
1/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.8%
2/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.8%
3/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.83%
1/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Affect Lability
|
0.00%
0/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.5%
3/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
3.4%
4/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.6%
3/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
4.6%
5/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
3.4%
4/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.6%
3/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.83%
1/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
1.7%
2/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
3.5%
4/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
3.7%
4/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.83%
1/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
8/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
2.6%
3/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
0.93%
1/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.7%
2/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.4%
16/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
6.1%
7/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
4.6%
5/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
3.3%
4/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
4.2%
5/119 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
1.8%
2/114 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
3.7%
4/108 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
3.3%
4/121 • Up to 29 weeks (AEs for Treatment duration (24 weeks) and follow up (5 Weeks) on Day 7 and Day 30 after last dose)
All Treated Analysis set included all randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER