Trial Outcomes & Findings for Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®) (NCT NCT02907177)
NCT ID: NCT02907177
Last Updated: 2021-05-18
Results Overview
Relapse: occurrence of acute episode of one or more new 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
TERMINATED
Study phase
PHASE3
Target enrollment
136 participants
Primary outcome timeframe
Through study completion, an average of 68 weeks
Results posted on
2021-05-18
Participant Flow
Total 136 participants were randomized,68 in both arms (ponesimod 20mg plus DMF \[dimethyl fumarate\] \& placebo plus DMF). Of 136 participants,107 (50 in ponesimod 20mg plus DMF; 57 in placebo plus DMF) completed study till early termination.This study was discontinued due to sponsor's decision.
Participant milestones
| Measure |
Ponesimod Plus Dimethyl Fumarate (DMF)
Participants were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
Placebo Plus Dimethyl Fumarate (DMF)
Participants received matching placebo once daily during Days 1 to 14 and maintenance dose from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
68
|
|
Overall Study
Treated
|
67
|
68
|
|
Overall Study
Randomized Analysis Set
|
68
|
68
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
68
|
68
|
Reasons for withdrawal
| Measure |
Ponesimod Plus Dimethyl Fumarate (DMF)
Participants were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
Placebo Plus Dimethyl Fumarate (DMF)
Participants received matching placebo once daily during Days 1 to 14 and maintenance dose from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Physician Decision
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
15
|
7
|
|
Overall Study
Sponsor's Decision
|
50
|
57
|
Baseline Characteristics
Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
Baseline characteristics by cohort
| Measure |
Ponesimod Plus Dimethyl Fumarate (DMF)
n=68 Participants
Participants were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
Placebo Plus Dimethyl Fumarate (DMF)
n=68 Participants
Participants received matching placebo once daily during Days 1 to 14 and maintenance dose from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
38.1 years
STANDARD_DEVIATION 9.1 • n=107 Participants
|
37.9 years
STANDARD_DEVIATION 9.07 • n=206 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
64 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
Region of Enrollment
AUSTRIA
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
BELGIUM
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
BULGARIA
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
CANADA
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
CZECH REPUBLIC
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Region of Enrollment
FRANCE
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
GERMANY
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
GREECE
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
HUNGARY
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
ITALY
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
MEXICO
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
POLAND
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
PORTUGAL
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
SPAIN
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
UNITED STATES
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 68 weeksPopulation: Full Analysis Set (FAS) included all randomized participants who were treated with at least one dose of study treatment and had at least one post baseline efficacy assessment. Participants were analyzed according to randomized treatment.
Relapse: occurrence of acute episode of one or more new 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 Plus Dimethyl Fumarate (DMF)
n=66 Participants
Participants were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
Placebo Plus Dimethyl Fumarate (DMF)
n=67 Participants
Participants received matching placebo once daily during Days 1 to 14 and maintenance dose from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
|---|---|---|
|
Annualized Confirmed Relapse Rate (ARR)
|
0.237 Relapses per year
Interval 0.144 to 0.391
|
0.187 Relapses per year
Interval 0.109 to 0.322
|
SECONDARY outcome
Timeframe: Week 96Population: FAS included all randomized participants who were treated with at least one dose of study treatment and had at least one post baseline efficacy assessment. Participants were analyzed according to randomized treatment.
Percentage of participants with 12-week CDA as assessed by Kaplan Meier estimate at week 96 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 Plus Dimethyl Fumarate (DMF)
n=66 Participants
Participants were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
Placebo Plus Dimethyl Fumarate (DMF)
n=67 Participants
Participants received matching placebo once daily during Days 1 to 14 and maintenance dose from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
|---|---|---|
|
Percentage of Participants With 12-Week Confirmed Disability Accumulation (CDA) as Assessed by Kaplan Meier Estimate at Week 96
|
18.7 Percentage of participants with a CDA.
Interval 8.7 to 37.6
|
11.9 Percentage of participants with a CDA.
Interval 4.6 to 28.8
|
SECONDARY outcome
Timeframe: Week 96Population: FAS included all randomized participants who were treated with at least one dose of study treatment and had at least one post baseline efficacy assessment. Participants were analyzed according to randomized treatment.
Percentage of participants experiencing a confirmed relapse as assessed by Kaplan Meier estimate at week 96 was reported. The time to first confirmed relapse (in days) is defined as \[Date of first confirmed relapse minus Date of randomization plus 1\] in days. Relapse: Occurrence of acute episode of one or more new symptoms or worsened symptoms of Multiple sclerosis (MS), not related with fever/infection and lasting 24 hours after 30 days stable period.
Outcome measures
| Measure |
Ponesimod Plus Dimethyl Fumarate (DMF)
n=66 Participants
Participants were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
Placebo Plus Dimethyl Fumarate (DMF)
n=67 Participants
Participants received matching placebo once daily during Days 1 to 14 and maintenance dose from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
|---|---|---|
|
Percentage of Participants Experiencing a Confirmed Relapse as Assessed by Kaplan Meier Estimate at Week 96
|
33.6 Percentage of Participants
Interval 19.5 to 53.8
|
25.7 Percentage of Participants
Interval 13.4 to 46.1
|
SECONDARY outcome
Timeframe: Up to 147 WeeksPopulation: Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Outcome measures
| Measure |
Ponesimod Plus Dimethyl Fumarate (DMF)
n=67 Participants
Participants were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
Placebo Plus Dimethyl Fumarate (DMF)
n=68 Participants
Participants received matching placebo once daily during Days 1 to 14 and maintenance dose from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
|
48 Participants
|
53 Participants
|
Adverse Events
Ponesimod Plus Dimethyl Fumarate (DMF)
Serious events: 6 serious events
Other events: 45 other events
Deaths: 0 deaths
Placebo Plus Dimethyl Fumarate (DMF)
Serious events: 7 serious events
Other events: 41 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Ponesimod Plus Dimethyl Fumarate (DMF)
n=67 participants at risk
Participants were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
Placebo Plus Dimethyl Fumarate (DMF)
n=68 participants at risk
Participants received matching placebo once daily during Days 1 to 14 and maintenance dose from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
|---|---|---|
|
Cardiac disorders
Right Ventricular Failure
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis Bacterial
|
1.5%
1/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia Influenzal
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia Pseudomonal
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Multiple Injuries
|
1.5%
1/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
1.5%
1/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
1.5%
1/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicle Adenoma
|
1.5%
1/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Seizure
|
1.5%
1/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Status Epilepticus
|
1.5%
1/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary Retention
|
1.5%
1/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Ponesimod Plus Dimethyl Fumarate (DMF)
n=67 participants at risk
Participants were up-titrated during Days 1 to 14 with 2 to 10 mg of ponesimod once daily and maintenance dose of 20 mg ponesimod tablets once daily from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
Placebo Plus Dimethyl Fumarate (DMF)
n=68 participants at risk
Participants received matching placebo once daily during Days 1 to 14 and maintenance dose from Day 15 to end of treatment. In addition, participants also continued receiving DMF capsules, orally, as background therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Ear Pain
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Diplopia
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Dry Eye
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Eye disorders
Eye Pain
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
3/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
3/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
4.5%
3/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
6.0%
4/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
5.9%
4/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders
Influenza Like Illness
|
1.5%
1/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders
Non-Cardiac Chest Pain
|
4.5%
3/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
7.5%
5/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
4.4%
3/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Conjunctivitis
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Folliculitis
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
1.5%
1/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
1.5%
1/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
9.0%
6/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
19.1%
13/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Oral Herpes
|
4.5%
3/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Otitis Externa
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Rhinitis
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Tinea Versicolour
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.5%
3/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
10.3%
7/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
6.0%
4/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
7.4%
5/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Viral Infection
|
1.5%
1/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
4.4%
3/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.5%
1/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
6.0%
4/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
4.5%
3/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Investigations
Hepatic Enzyme Increased
|
4.5%
3/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
4/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
10.3%
7/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
8.8%
6/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
1.5%
1/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
4.4%
3/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.0%
4/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
5.9%
4/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of Skin
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic Naevus
|
4.5%
3/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
10.4%
7/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
9.0%
6/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
8.8%
6/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
4.4%
3/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Migraine
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
8.8%
6/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
1.5%
1/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
3/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
4.4%
3/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
4.5%
3/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Airways Disorder
|
4.5%
3/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
0.00%
0/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Burning Sensation
|
0.00%
0/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
3.0%
2/67 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
2.9%
2/68 • Up to End of treatment + 15 days (maximum up to 147 Weeks)
Treatment-Emergent Adverse Events (TEAEs) included deaths, Serious Adverse Events (SAEs), Adverse Events (AEs) leading to premature treatment discontinuation, and Adverse Events of Special Interest (AESIs) were summarized. Safety Analysis Set (SAF) includes all participants who received at least one dose of study treatment.
|
Additional Information
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 Any study-related publication written independently by investigators must be submitted to Actelion for review at least 30 days prior to submission for publication or presentation. Upon review, Actelion may provide comments and may also request alterations and/or deletions for the sole purpose of protecting its confidential information and/or patent rights. Neither the institution nor the investigator should permit publication during such a review period.
- Publication restrictions are in place
Restriction type: OTHER