Trial Outcomes & Findings for Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis (NCT NCT02425644)
NCT ID: NCT02425644
Last Updated: 2025-03-30
Results Overview
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 indicates overall functional impairment assessing Visual,Brain Stem,Pyramidal,Cerebellar,Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS in conjunction with observations and information concerning gait and use of assistance. EDSS is ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10(death due to MS).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1133 participants
Primary outcome timeframe
From randomization to end of study (Week 108)
Results posted on
2025-03-30
Participant Flow
As planned, Placebo was not a separate arm as this was included for double dummy design study part (up to Day 14).
Participant milestones
| Measure |
Ponesimod 20 mg
Participants were up-titrated during Days 1 to 14 from 2 to 10 mg of ponesimod once daily (one ponesimod tablet and one matching placebo capsule per day). From Day 15 to Week 108 participants received ponesimod 20 mg once daily up to Week 108
|
Teriflunomide 14 mg
Participants received teriflunomide 14 mg capsule once daily from Day 1 up to Week 108. During Days 1 to 14 (mock uptitration period), participants received in addition one tablet of matching placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
567
|
566
|
|
Overall Study
Treated
|
565
|
566
|
|
Overall Study
COMPLETED
|
490
|
495
|
|
Overall Study
NOT COMPLETED
|
77
|
71
|
Reasons for withdrawal
| Measure |
Ponesimod 20 mg
Participants were up-titrated during Days 1 to 14 from 2 to 10 mg of ponesimod once daily (one ponesimod tablet and one matching placebo capsule per day). From Day 15 to Week 108 participants received ponesimod 20 mg once daily up to Week 108
|
Teriflunomide 14 mg
Participants received teriflunomide 14 mg capsule once daily from Day 1 up to Week 108. During Days 1 to 14 (mock uptitration period), participants received in addition one tablet of matching placebo.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
41
|
36
|
|
Overall Study
Lack of Efficacy
|
3
|
10
|
|
Overall Study
Adverse Event
|
13
|
3
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Other
|
18
|
17
|
Baseline Characteristics
Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis
Baseline characteristics by cohort
| Measure |
Ponesimod 20 mg
n=567 Participants
Participants were up-titrated during Days 1 to 14 from 2 to 10 mg of ponesimod once daily (one ponesimod tablet and one matching placebo capsule per day). From Day 15 to Week 108 participants received ponesimod 20 mg once daily up to Week 108
|
Teriflunomide 14 mg
n=566 Participants
Participants received teriflunomide 14 mg capsule once daily from Day 1 up to Week 108. During Days 1 to 14 (mock uptitration period), participants received in addition one tablet of matching placebo.
|
Total
n=1133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 8.74 • n=93 Participants
|
36.8 years
STANDARD_DEVIATION 8.74 • n=4 Participants
|
36.7 years
STANDARD_DEVIATION 8.74 • n=27 Participants
|
|
Sex: Female, Male
Female
|
363 Participants
n=93 Participants
|
372 Participants
n=4 Participants
|
735 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
204 Participants
n=93 Participants
|
194 Participants
n=4 Participants
|
398 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
551 Participants
n=93 Participants
|
553 Participants
n=4 Participants
|
1104 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Region of Enrollment
BELARUS
|
21 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Region of Enrollment
BULGARIA
|
18 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Region of Enrollment
CANADA
|
10 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Region of Enrollment
CROATIA
|
14 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Region of Enrollment
CZECH REPUBLIC
|
55 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
101 Participants
n=27 Participants
|
|
Region of Enrollment
FINLAND
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Region of Enrollment
FRANCE
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Region of Enrollment
GEORGIA
|
24 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Region of Enrollment
GERMANY
|
9 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Region of Enrollment
GREECE
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Region of Enrollment
HUNGARY
|
7 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Region of Enrollment
ISRAEL
|
4 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Region of Enrollment
ITALY
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Region of Enrollment
LATVIA
|
11 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Region of Enrollment
LITHUANIA
|
3 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Region of Enrollment
MEXICO
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Region of Enrollment
POLAND
|
80 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
151 Participants
n=27 Participants
|
|
Region of Enrollment
PORTUGAL
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Region of Enrollment
ROMANIA
|
10 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
116 Participants
n=93 Participants
|
111 Participants
n=4 Participants
|
227 Participants
n=27 Participants
|
|
Region of Enrollment
SPAIN
|
34 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Region of Enrollment
SWEDEN
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Region of Enrollment
TURKEY
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
UKRAINE
|
57 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
123 Participants
n=27 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Region of Enrollment
UNITED STATES
|
22 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Region of Enrollment
Serbia
|
14 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Region of Enrollment
Bosnia
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From randomization to end of study (Week 108)Population: Full analysis set (FAS) included all participants randomized in the study.
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 indicates overall functional impairment assessing Visual,Brain Stem,Pyramidal,Cerebellar,Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS in conjunction with observations and information concerning gait and use of assistance. EDSS is ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10(death due to MS).
Outcome measures
| Measure |
Ponesimod 20 mg
n=567 Participants
Participants were up-titrated during Days 1 to 14 from 2 to 10 mg of ponesimod once daily (one ponesimod tablet and one matching placebo capsule per day). From Day 15 to Week 108 participants received ponesimod 20 mg once daily up to Week 108
|
Teriflunomide 14 mg
n=566 Participants
Participants received teriflunomide 14 mg capsule once daily from Day 1 up to Week 108. During Days 1 to 14 (mock uptitration period), participants received in addition one tablet of matching placebo.
|
|---|---|---|
|
Annualized Confirmed Relapse Rate
|
0.202 relapses per year
Interval 0.165 to 0.246
|
0.290 relapses per year
Interval 0.244 to 0.345
|
SECONDARY outcome
Timeframe: Baseline to Week 108Population: FAS included all participants randomized in the study. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure with available baseline and at least one post-baseline assessment.
The FSIQ-RMS is a 20-item Patient Reported Outcomes (PRO) measure to evaluate fatigue-related symptoms and the impacts of those symptoms on the lives of people. The FSIQ-RMS symptom domain (FSIQ-RMS-S) consists of seven items assessing fatigue-related symptoms daily with a recall period of 24 hours measured on an 11-point numeric rating scale; the (normalized) symptom domain score ranges from 0 to 100 with a higher score indicating greater fatigue. This domain was completed on 7 consecutive days. A negative change from baseline indicates an improvement in fatigue symptoms.
Outcome measures
| Measure |
Ponesimod 20 mg
n=449 Participants
Participants were up-titrated during Days 1 to 14 from 2 to 10 mg of ponesimod once daily (one ponesimod tablet and one matching placebo capsule per day). From Day 15 to Week 108 participants received ponesimod 20 mg once daily up to Week 108
|
Teriflunomide 14 mg
n=458 Participants
Participants received teriflunomide 14 mg capsule once daily from Day 1 up to Week 108. During Days 1 to 14 (mock uptitration period), participants received in addition one tablet of matching placebo.
|
|---|---|---|
|
Change From Baseline in Fatigue-related Symptoms as Measured by the Symptoms Domain of the Fatigue Symptom and Impact Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS) Score to Week 108
|
-0.01 score on scale
Interval -1.6 to 1.58
|
3.56 score on scale
Interval 1.96 to 5.16
|
SECONDARY outcome
Timeframe: Baseline to Week 108Population: FAS included all participants randomized in the study. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
CUALs was calculated as sum of new Gadolinium-enhanced (Gd+) T1 lesions plus new or enlarging T2 lesions (without double-counting of lesions) from baseline based on the Magnetic resonance imaging (MRI) scans up to Week 108. Average number of lesions per year were reported.
Outcome measures
| Measure |
Ponesimod 20 mg
n=539 Participants
Participants were up-titrated during Days 1 to 14 from 2 to 10 mg of ponesimod once daily (one ponesimod tablet and one matching placebo capsule per day). From Day 15 to Week 108 participants received ponesimod 20 mg once daily up to Week 108
|
Teriflunomide 14 mg
n=536 Participants
Participants received teriflunomide 14 mg capsule once daily from Day 1 up to Week 108. During Days 1 to 14 (mock uptitration period), participants received in addition one tablet of matching placebo.
|
|---|---|---|
|
Cumulative Number of Combined Unique Active Lesions (CUAL) Per Year From Baseline to Week 108
|
1.405 lesions per year
Interval 1.215 to 1.624
|
3.164 lesions per year
Interval 2.757 to 3.631
|
SECONDARY outcome
Timeframe: Baseline to Week 60 and 108 WeeksPopulation: FAS included all participants randomized in this study.
A 12-week CDA was defined as an increase of at least 1.5 in Expanded Disability Status Scale (EDSS) for participants with a baseline EDSS score of 0.0 or an increase of at least 1.0 in EDSS for participants with a baseline EDSS score of 1.0 to 5.0, or an increase of at least 0.5 in EDSS for participants with a baseline EDSS score greater than or equal to (\>=) 5.5, which was confirmed after 12 weeks. Baseline EDSS was defined as the last EDSS score recorded prior to randomization. EDSS is an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to MS).
Outcome measures
| Measure |
Ponesimod 20 mg
n=567 Participants
Participants were up-titrated during Days 1 to 14 from 2 to 10 mg of ponesimod once daily (one ponesimod tablet and one matching placebo capsule per day). From Day 15 to Week 108 participants received ponesimod 20 mg once daily up to Week 108
|
Teriflunomide 14 mg
n=566 Participants
Participants received teriflunomide 14 mg capsule once daily from Day 1 up to Week 108. During Days 1 to 14 (mock uptitration period), participants received in addition one tablet of matching placebo.
|
|---|---|---|
|
12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS
60 Weeks- from Kaplan Meier estimates
|
7.6 Percentage of Participants
Interval 5.7 to 10.2
|
8.3 Percentage of Participants
Interval 6.3 to 11.0
|
|
12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS
108 Weeks- from Kaplan Meier estimates
|
10.8 Percentage of Participants
Interval 8.4 to 13.7
|
13.2 Percentage of Participants
Interval 10.6 to 16.3
|
SECONDARY outcome
Timeframe: Baseline to 60 Weeks and 108 WeeksPopulation: FAS included all participants randomized in this study.
A 24-week CDA was defined as an increase of at least 1.5 in EDSS for participants with a baseline EDSS score of 0.0 or an increase of at least 1.0 in EDSS for participants with a baseline EDSS score of 1.0 to 5.0, or an increase of at least 0.5 in EDSS for participants with a baseline EDSS score \>= 5.5, which was confirmed after 24 weeks. Baseline EDSS was defined as the last EDSS score recorded prior to randomization. The EDSS is an ordinal scale ranging from 0 (normal neurological exam) to 10 (death to MS).
Outcome measures
| Measure |
Ponesimod 20 mg
n=567 Participants
Participants were up-titrated during Days 1 to 14 from 2 to 10 mg of ponesimod once daily (one ponesimod tablet and one matching placebo capsule per day). From Day 15 to Week 108 participants received ponesimod 20 mg once daily up to Week 108
|
Teriflunomide 14 mg
n=566 Participants
Participants received teriflunomide 14 mg capsule once daily from Day 1 up to Week 108. During Days 1 to 14 (mock uptitration period), participants received in addition one tablet of matching placebo.
|
|---|---|---|
|
24-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS
60 Weeks- from Kaplan Meier estimates
|
6.3 Percentage of Participants
Interval 4.6 to 8.7
|
6.9 Percentage of Participants
Interval 5.0 to 9.3
|
|
24-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS
108 Weeks- from Kaplan Meier estimates
|
8.7 Percentage of Participants
Interval 6.6 to 11.4
|
10.5 Percentage of Participants
Interval 8.2 to 13.4
|
Adverse Events
Ponesimod 20 mg
Serious events: 49 serious events
Other events: 434 other events
Deaths: 0 deaths
Teriflunomide 14 mg
Serious events: 46 serious events
Other events: 422 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Ponesimod 20 mg
n=565 participants at risk
Participants were up-titrated during Days 1 to 14 from 2 to 10 mg of ponesimod once daily (one ponesimod tablet and one matching placebo capsule per day). From Day 15 to Week 108 participants received ponesimod 20 mg once daily up to Week 108
|
Teriflunomide 14 mg
n=566 participants at risk
Participants received teriflunomide 14 mg capsule once daily from Day 1 up to Week 108. During Days 1 to 14 (mock uptitration period), participants received in addition one tablet of matching placebo.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Coronary Artery Insufficiency
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.53%
3/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Bowel Movement Irregularity
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal Haemorrhage
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Biliary Colic
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.53%
3/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Drug-Induced Liver Injury
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatitis Toxic
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Abdominal Infection
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Appendicitis
|
0.53%
3/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Herpes Zoster
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Lymph Node Abscess
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Meningitis
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Meningitis Enteroviral
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pilonidal Cyst
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Salpingitis
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Vestibular Neuronitis
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.35%
2/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Jaw Fracture
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Multiple Injuries
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.35%
2/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Investigations
Hepatic Enzyme Increased
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Investigations
Transaminases Increased
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Investigations
Weight Decreased
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myofascial Pain Syndrome
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eyelid Haemangioma
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary Tumour Benign
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of the Cervix
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.35%
2/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Clonic Convulsion
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Epilepsy
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.35%
2/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Multiple Sclerosis
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Partial Seizures with Secondary Generalisation
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Trigeminal Neuralgia
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Conversion Disorder
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Panic Attack
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal Colic
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Tubulointerstitial Nephritis
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Breast Cyst
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Endometrial Hyperplasia
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.35%
2/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Pelvic Adhesions
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Abortion Induced
|
0.35%
2/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Haemorrhoid Operation
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Hysterectomy
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Ligament Operation
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Uterine Dilation and Curettage
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertensive Crisis
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Raynaud's Phenomenon
|
0.00%
0/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.18%
1/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.18%
1/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.00%
0/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Ponesimod 20 mg
n=565 participants at risk
Participants were up-titrated during Days 1 to 14 from 2 to 10 mg of ponesimod once daily (one ponesimod tablet and one matching placebo capsule per day). From Day 15 to Week 108 participants received ponesimod 20 mg once daily up to Week 108
|
Teriflunomide 14 mg
n=566 participants at risk
Participants received teriflunomide 14 mg capsule once daily from Day 1 up to Week 108. During Days 1 to 14 (mock uptitration period), participants received in addition one tablet of matching placebo.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
6/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
2.3%
13/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
2.3%
13/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
1.2%
7/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.6%
9/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
3.2%
18/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
3.4%
19/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
4.2%
24/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
2.8%
16/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
3.7%
21/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
20/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
7.8%
44/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.3%
13/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
2.3%
13/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
7.6%
43/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
8.3%
47/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
11/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
3.2%
18/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
1.9%
11/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
3.2%
18/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
6.0%
34/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
6.5%
37/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
2.1%
12/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
1.2%
7/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
4.6%
26/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
4.2%
24/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
2.1%
12/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
3.2%
18/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
4.2%
24/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
4.1%
23/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
19.3%
109/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
16.8%
95/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Oral Herpes
|
3.0%
17/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
3.7%
21/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pharyngitis
|
2.5%
14/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
2.5%
14/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Respiratory Tract Infection
|
3.0%
17/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
2.8%
16/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
3.2%
18/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
1.8%
10/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Rhinitis
|
2.1%
12/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
3.0%
17/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
1.4%
8/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
2.8%
16/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Tonsillitis
|
1.4%
8/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
2.5%
14/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.6%
60/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
10.4%
59/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
5.5%
31/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
5.1%
29/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
19.5%
110/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
9.0%
51/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.4%
36/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
3.4%
19/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Investigations
C-Reactive Protein Increased
|
2.1%
12/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
1.2%
7/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Investigations
Hepatic Enzyme Increased
|
2.3%
13/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
1.4%
8/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Investigations
Weight Decreased
|
1.1%
6/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
2.5%
14/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.3%
13/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
0.53%
3/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
17/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
2.7%
15/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.8%
33/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
6.7%
38/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.5%
20/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
3.0%
17/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
5.0%
28/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
2.7%
15/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
11.3%
64/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
12.7%
72/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
2.5%
14/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
2.5%
14/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
3.0%
17/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
4.9%
28/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Somnolence
|
3.2%
18/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
1.6%
9/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
3.2%
18/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
2.8%
16/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
3.7%
21/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
4.9%
28/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
1.9%
11/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
2.8%
16/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.5%
20/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
2.5%
14/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
30/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
1.2%
7/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.2%
18/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
12.7%
72/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
8/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
2.5%
14/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
8.0%
45/565 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
7.8%
44/566 • Up to 111 Weeks (From treatment start [Day 1] to end of treatment [Week 108] plus 15 days)
Safety analysis set included all participants who received at least one dose of study treatment.
|
Additional Information
Senior Director Clinical Leader
Actelion Pharmaceuticals Ltd (a Janssen Pharmaceutical Company of Johnson & Johnson)
Phone: 844-434-4210
Email: [email protected]
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