Trial Outcomes & Findings for Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus (NCT NCT03742037)
NCT ID: NCT03742037
Last Updated: 2025-10-03
Results Overview
The primary endpoint is the absolute change from baseline in the modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) score. The SLEDAI-2K is a cumulative index of lupus disease activity scored by the physician. It is calculated from 24 individual descriptors across 9 organ systems, with weighted scores of 2-8, and measures disease activity within the last 10 days. 0 points indicates inactive disease, and 105 points is the maximum possible score. In this study the SLEDAI-2K was modified, to exclude leucopenia (minus 1 point), due to the mechanism of action of cenerimod. Improvement in systemic lupus erythematosus disease activity is defined as a reduction in SLEDAI-2K score of greater than or equal to 4. A decreased score, i.e., a negative change, indicates an improvement in systemic lupus erythematosus disease activity from baseline to Month 6.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
427 participants
Primary outcome timeframe
Baseline (Day 1) and Month 6
Results posted on
2025-10-03
Participant Flow
The study was done from 21 December 2018 to 25 August 2022.
427 participants are considered to be enrolled in the study and were randomized to study treatment. This represents the Full Analysis Set (treatment as assigned). 810 adult subjects with SLE have been screened and 427 subjects randomized in a 1:1:1:1:1 ratio to placebo, 0.5, 1, 2, or 4 mg once daily (o.d.) of cenerimod, in addition to background SLE therapy.
Participant milestones
| Measure |
Cenerimod 0.5 mg
Participants were randomized to receive cenerimod 0.5 mg once daily in addition to background SLE therapy for up to 6-months in Treatment Period 1. Participants completing Treatment Period 1 continued to receive cenerimod 0.5 mg once daily in addition to background SLE therapy during Treatment Period 2 for up to an additional 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 1 mg
Participants were randomized to receive cenerimod 1 mg once daily in addition to background SLE therapy for up to 6-months in Treatment Period 1. Participants completing Treatment Period 1 continued to receive cenerimod 1 mg once daily in addition to background SLE therapy during Treatment Period 2 for up to an additional 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 2 mg
Participants were randomized to receive cenerimod 2 mg once daily in addition to background SLE therapy for up to 6-months in Treatment Period 1. Participants completing Treatment Period 1 continued to receive cenerimod 2 mg once daily in addition to background SLE therapy during Treatment Period 2 for up to an additional 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 2 mg (Ex-4 mg)
Half the participants completing treatment with cenerimod 4 mg for up to 6-months in Treatment Period 1 were re-randomized to cenerimod 2 mg once daily in addition to background SLE therapy during Treatment Period 2. Participants received cenerimod 2 mg for up to 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Placebo (Ex-4 mg)
Half the participants completing treatment with cenerimod 4 mg for up to 6-months in Treatment Period 1 were re-randomized to placebo once daily in addition to background SLE therapy during Treatment Period 2. Participants received placebo for up to 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 4 mg
Participants were randomized to receive cenerimod 4 mg once daily in addition to background SLE therapy for up to 6-months in Treatment Period 1. Participants randomized to the 4 mg treatment who were still on treatment at the end of Month 6 were re-randomized in a 1:1 ratio to placebo or cenerimod 2 mg to enter Treatment Period 2. After end of treatment, participants entered a 6-month follow-up period.
|
Placebo
Participants were randomized to receive placebo once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1. Participants completing Treatment Period 1 continued with placebo once daily in addition to background SLE therapy during Treatment Period 2 for up to an additional 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
|---|---|---|---|---|---|---|---|
|
Treatment Period 1 (1st Dose - Month 6)
STARTED
|
85
|
85
|
86
|
0
|
0
|
85
|
86
|
|
Treatment Period 1 (1st Dose - Month 6)
COMPLETED
|
78
|
78
|
71
|
0
|
0
|
70
|
77
|
|
Treatment Period 1 (1st Dose - Month 6)
NOT COMPLETED
|
7
|
7
|
15
|
0
|
0
|
15
|
9
|
|
Treatment Period 2 (Month 6 - Month 12)
STARTED
|
78
|
78
|
72
|
35
|
35
|
0
|
77
|
|
Treatment Period 2 (Month 6 - Month 12)
COMPLETED
|
74
|
74
|
59
|
30
|
35
|
0
|
68
|
|
Treatment Period 2 (Month 6 - Month 12)
NOT COMPLETED
|
4
|
4
|
13
|
5
|
0
|
0
|
9
|
Reasons for withdrawal
| Measure |
Cenerimod 0.5 mg
Participants were randomized to receive cenerimod 0.5 mg once daily in addition to background SLE therapy for up to 6-months in Treatment Period 1. Participants completing Treatment Period 1 continued to receive cenerimod 0.5 mg once daily in addition to background SLE therapy during Treatment Period 2 for up to an additional 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 1 mg
Participants were randomized to receive cenerimod 1 mg once daily in addition to background SLE therapy for up to 6-months in Treatment Period 1. Participants completing Treatment Period 1 continued to receive cenerimod 1 mg once daily in addition to background SLE therapy during Treatment Period 2 for up to an additional 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 2 mg
Participants were randomized to receive cenerimod 2 mg once daily in addition to background SLE therapy for up to 6-months in Treatment Period 1. Participants completing Treatment Period 1 continued to receive cenerimod 2 mg once daily in addition to background SLE therapy during Treatment Period 2 for up to an additional 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 2 mg (Ex-4 mg)
Half the participants completing treatment with cenerimod 4 mg for up to 6-months in Treatment Period 1 were re-randomized to cenerimod 2 mg once daily in addition to background SLE therapy during Treatment Period 2. Participants received cenerimod 2 mg for up to 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Placebo (Ex-4 mg)
Half the participants completing treatment with cenerimod 4 mg for up to 6-months in Treatment Period 1 were re-randomized to placebo once daily in addition to background SLE therapy during Treatment Period 2. Participants received placebo for up to 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 4 mg
Participants were randomized to receive cenerimod 4 mg once daily in addition to background SLE therapy for up to 6-months in Treatment Period 1. Participants randomized to the 4 mg treatment who were still on treatment at the end of Month 6 were re-randomized in a 1:1 ratio to placebo or cenerimod 2 mg to enter Treatment Period 2. After end of treatment, participants entered a 6-month follow-up period.
|
Placebo
Participants were randomized to receive placebo once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1. Participants completing Treatment Period 1 continued with placebo once daily in addition to background SLE therapy during Treatment Period 2 for up to an additional 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
|---|---|---|---|---|---|---|---|
|
Treatment Period 1 (1st Dose - Month 6)
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1 (1st Dose - Month 6)
Adverse Event
|
0
|
1
|
4
|
0
|
0
|
3
|
2
|
|
Treatment Period 1 (1st Dose - Month 6)
Withdrawal by Subject
|
4
|
1
|
2
|
0
|
0
|
2
|
4
|
|
Treatment Period 1 (1st Dose - Month 6)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 1 (1st Dose - Month 6)
pre-specified criteria
|
1
|
3
|
7
|
0
|
0
|
6
|
1
|
|
Treatment Period 1 (1st Dose - Month 6)
Randomized but no study treatment taken
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 1 (1st Dose - Month 6)
Other reasons
|
2
|
0
|
2
|
0
|
0
|
2
|
1
|
|
Treatment Period 1 (1st Dose - Month 6)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 2 (Month 6 - Month 12)
Adverse Event
|
1
|
2
|
3
|
1
|
0
|
0
|
4
|
|
Treatment Period 2 (Month 6 - Month 12)
Withdrawal by Subject
|
0
|
0
|
2
|
2
|
0
|
0
|
1
|
|
Treatment Period 2 (Month 6 - Month 12)
Lost to Follow-up
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (Month 6 - Month 12)
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 2 (Month 6 - Month 12)
pre-specified criteria
|
0
|
1
|
3
|
2
|
0
|
0
|
2
|
|
Treatment Period 2 (Month 6 - Month 12)
Other reasons
|
2
|
0
|
2
|
0
|
0
|
0
|
1
|
|
Treatment Period 2 (Month 6 - Month 12)
Discontinued study treatment in Treatment Period 1, re-randomized in error
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Cenerimod 0.5 mg
n=85 Participants
Participants were randomized to receive cenerimod 0.5 mg once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1.
|
Cenerimod 1 mg
n=85 Participants
Participants were randomized to receive cenerimod 1 mg once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1.
|
Cenerimod 2 mg
n=86 Participants
Participants were randomized to receive cenerimod 2 mg once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1.
|
Cenerimod 4 mg
n=85 Participants
Participants were randomized to receive cenerimod 4 mg once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1.
|
Placebo
n=86 Participants
Participants were randomized to receive placebo once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1.
|
Total
n=427 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 12.41 • n=5 Participants
|
40.0 years
STANDARD_DEVIATION 12.77 • n=7 Participants
|
42.2 years
STANDARD_DEVIATION 12.06 • n=5 Participants
|
42.1 years
STANDARD_DEVIATION 10.44 • n=4 Participants
|
41.0 years
STANDARD_DEVIATION 11.94 • n=21 Participants
|
41.6 years
STANDARD_DEVIATION 11.94 • n=8 Participants
|
|
Age, Customized
Between 18 and 45 years
|
49 years
n=5 Participants
|
54 years
n=7 Participants
|
49 years
n=5 Participants
|
50 years
n=4 Participants
|
57 years
n=21 Participants
|
259 years
n=8 Participants
|
|
Age, Customized
Between 45 and 64 years
|
31 years
n=5 Participants
|
29 years
n=7 Participants
|
36 years
n=5 Participants
|
33 years
n=4 Participants
|
27 years
n=21 Participants
|
156 years
n=8 Participants
|
|
Age, Customized
Between 64 and 75 years
|
5 years
n=5 Participants
|
2 years
n=7 Participants
|
1 years
n=5 Participants
|
2 years
n=4 Participants
|
2 years
n=21 Participants
|
12 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
406 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
89 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
336 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
337 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Region of Enrollment
Bulgaria
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
2 participants
n=21 Participants
|
13 participants
n=8 Participants
|
|
Region of Enrollment
Chile
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
7 participants
n=21 Participants
|
18 participants
n=8 Participants
|
|
Region of Enrollment
Czechia
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
7 participants
n=8 Participants
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Region of Enrollment
Georgia
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
2 participants
n=21 Participants
|
15 participants
n=8 Participants
|
|
Region of Enrollment
Greece
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Region of Enrollment
Israel
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
4 participants
n=8 Participants
|
|
Region of Enrollment
Mexico
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
6 participants
n=4 Participants
|
7 participants
n=21 Participants
|
39 participants
n=8 Participants
|
|
Region of Enrollment
Philippines
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
5 participants
n=21 Participants
|
27 participants
n=8 Participants
|
|
Region of Enrollment
Poland
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
7 participants
n=21 Participants
|
21 participants
n=8 Participants
|
|
Region of Enrollment
Romania
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Region of Enrollment
Russia
|
2 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
5 participants
n=4 Participants
|
2 participants
n=21 Participants
|
24 participants
n=8 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
7 participants
n=8 Participants
|
|
Region of Enrollment
Taiwan
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Region of Enrollment
Thailand
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Region of Enrollment
Turkey
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Region of Enrollment
Ukraine
|
36 participants
n=5 Participants
|
29 participants
n=7 Participants
|
29 participants
n=5 Participants
|
27 participants
n=4 Participants
|
29 participants
n=21 Participants
|
150 participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
1 participants
n=21 Participants
|
3 participants
n=8 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
17 participants
n=7 Participants
|
21 participants
n=5 Participants
|
21 participants
n=4 Participants
|
18 participants
n=21 Participants
|
88 participants
n=8 Participants
|
|
Body Mass Index
|
25.67 kilograms/square meter
STANDARD_DEVIATION 5.67 • n=5 Participants
|
25.55 kilograms/square meter
STANDARD_DEVIATION 5.95 • n=7 Participants
|
26.16 kilograms/square meter
STANDARD_DEVIATION 6.6 • n=5 Participants
|
26.82 kilograms/square meter
STANDARD_DEVIATION 7.15 • n=4 Participants
|
26.49 kilograms/square meter
STANDARD_DEVIATION 6.24 • n=21 Participants
|
26.14 kilograms/square meter
STANDARD_DEVIATION 6.33 • n=8 Participants
|
|
modified SLEDAI at baseline
|
9.8 units on a scale
STANDARD_DEVIATION 2.69 • n=5 Participants
|
10.1 units on a scale
STANDARD_DEVIATION 3.71 • n=7 Participants
|
9.5 units on a scale
STANDARD_DEVIATION 2.88 • n=5 Participants
|
10.0 units on a scale
STANDARD_DEVIATION 2.50 • n=4 Participants
|
10.2 units on a scale
STANDARD_DEVIATION 3.05 • n=21 Participants
|
9.9 units on a scale
STANDARD_DEVIATION 2.99 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Month 6Population: Full Analysis Set (FAS).
The primary endpoint is the absolute change from baseline in the modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) score. The SLEDAI-2K is a cumulative index of lupus disease activity scored by the physician. It is calculated from 24 individual descriptors across 9 organ systems, with weighted scores of 2-8, and measures disease activity within the last 10 days. 0 points indicates inactive disease, and 105 points is the maximum possible score. In this study the SLEDAI-2K was modified, to exclude leucopenia (minus 1 point), due to the mechanism of action of cenerimod. Improvement in systemic lupus erythematosus disease activity is defined as a reduction in SLEDAI-2K score of greater than or equal to 4. A decreased score, i.e., a negative change, indicates an improvement in systemic lupus erythematosus disease activity from baseline to Month 6.
Outcome measures
| Measure |
Cenerimod 0.5 mg
n=85 Participants
Participants received cenerimod 0.5 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.
|
Cenerimod 1 mg
n=85 Participants
Participants received cenerimod 1 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.
|
Cenerimod 2 mg
n=86 Participants
Participants received cenerimod 2 mg once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1.
|
Cenerimod 4 mg
n=85 Participants
Participants received cenerimod 4 mg once daily in addition to background SLE therapy for up to 6-months in Treatment Period 1.
|
Placebo
n=86 Participants
Participants received placebo, matching cenerimod, once daily in addition to SLE therapy for up to 6 months in Treatment Period 1.
|
|---|---|---|---|---|---|
|
Change From Baseline to Month 6 in the Modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) Score
|
-3.2 score on a scale
Interval -3.98 to -2.49
|
-3.41 score on a scale
Interval -4.16 to -2.67
|
-2.84 score on a scale
Interval -3.58 to -2.09
|
-4.04 score on a scale
Interval -4.79 to -3.28
|
-2.85 score on a scale
Interval -3.6 to -2.1
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Month 6Population: Full Analysis Set (FAS)
A responder could only be assessed if the full information of all body systems was available. A participant was defined as a responder based on the Systemic Lupus Erythematosus Responder Index 4 (SRI-4) was a composite, binary endpoint based on three variables: * mSLEDAI-2K score had to have a reduction from baseline greater than or equal to 4, * Physician Global Assessment (PGA) had to have an increase from baseline less than or equal to 0.3. The PGA is a 100 mm visual analog scale used by the physician to assess disease activity ranging for 0 to 3. The scale is anchored with values from 0 = "none" and 3 = "severe"), and * BILAG-2004 (no new BILAG A organ domain score and at most one new BILAG B organ domain score) compared with baseline. If one of the SRI-4 mSLEDAI-2K, PGA and BILAG variables were not met the subject was scored a non-responder. Participants that did not fit at least one of the above criteria were assigned to the missing group.
Outcome measures
| Measure |
Cenerimod 0.5 mg
n=85 Participants
Participants received cenerimod 0.5 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.
|
Cenerimod 1 mg
n=85 Participants
Participants received cenerimod 1 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.
|
Cenerimod 2 mg
n=86 Participants
Participants received cenerimod 2 mg once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1.
|
Cenerimod 4 mg
n=85 Participants
Participants received cenerimod 4 mg once daily in addition to background SLE therapy for up to 6-months in Treatment Period 1.
|
Placebo
n=86 Participants
Participants received placebo, matching cenerimod, once daily in addition to SLE therapy for up to 6 months in Treatment Period 1.
|
|---|---|---|---|---|---|
|
Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 6 as Compared to Baseline
Responder
|
36 participants
|
41 participants
|
38 participants
|
41 participants
|
34 participants
|
|
Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 6 as Compared to Baseline
Non-responder
|
45 participants
|
38 participants
|
41 participants
|
36 participants
|
43 participants
|
|
Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 6 as Compared to Baseline
Missing
|
4 participants
|
6 participants
|
7 participants
|
8 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Month 6Population: Full analysis set (FAS).
The British Isles Lupus Assessment Group-2004 (BILAG) is a comprehensive tool used by the physician to assess disease activity and is sensitive to small changes over time. Response (no worsening) at Month 6 on BILAG-2004 disease activity index was defined as no new BILAG A organ domain score and no more than one new BILAG B organ domain score compared with baseline. No analysis is reported because the model did not meet the convergence criteria.
Outcome measures
| Measure |
Cenerimod 0.5 mg
n=81 Participants
Participants received cenerimod 0.5 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.
|
Cenerimod 1 mg
n=79 Participants
Participants received cenerimod 1 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1.
|
Cenerimod 2 mg
n=79 Participants
Participants received cenerimod 2 mg once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1.
|
Cenerimod 4 mg
n=77 Participants
Participants received cenerimod 4 mg once daily in addition to background SLE therapy for up to 6-months in Treatment Period 1.
|
Placebo
n=77 Participants
Participants received placebo, matching cenerimod, once daily in addition to SLE therapy for up to 6 months in Treatment Period 1.
|
|---|---|---|---|---|---|
|
British Isles Lupus Assessment Group-2004 (BILAG) Disease Activity Index Response at Month 6
|
98.8 percentage of participants
|
98.7 percentage of participants
|
97.5 percentage of participants
|
98.7 percentage of participants
|
97.4 percentage of participants
|
Adverse Events
Cenerimod 0.5 mg (Treatment Period 1 & 2)
Serious events: 4 serious events
Other events: 37 other events
Deaths: 0 deaths
Cenerimod 1 mg (Treatment Period 1 & 2)
Serious events: 12 serious events
Other events: 54 other events
Deaths: 2 deaths
Cenerimod 2 mg (Treatment Period 1 & 2)
Serious events: 4 serious events
Other events: 53 other events
Deaths: 0 deaths
Cenerimod 4 mg (Treatment Period 1) & Cenerimod 2 mg (Ex-4 mg; Treatment Period 2)
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Cenerimod 4 mg (Treatment Period 1) & Placebo (Ex-4 mg; Treatment Period 2)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Cenerimod 4 mg (Treatment Period 1) & Not Re-randomized (Ex-4 mg; Treatment Period 2)
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo (Treatment Period 1 & 2)
Serious events: 6 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cenerimod 0.5 mg (Treatment Period 1 & 2)
n=84 participants at risk
Participants received cenerimod 0.5 mg once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1. Participants completing Treatment Period 1 continued with cenerimod 0.5 mg once daily in addition to background SLE therapy during treatment period 2 for up to an additional 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 1 mg (Treatment Period 1 & 2)
n=85 participants at risk
Participants received cenerimod 1 mg once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1. Participants completing Treatment Period 1 continued to receive cenerimod 1 mg once daily in addition to background SLE therapy during Treatment Period 2 for up to an additional 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 2 mg (Treatment Period 1 & 2)
n=87 participants at risk
Participants received cenerimod 2 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1. Participants completing Treatment Period 1 continued to receive cenerimod 2 mg once daily in addition to background SLE therapy during Treatment Period 2 for up to an additional 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 4 mg (Treatment Period 1) & Cenerimod 2 mg (Ex-4 mg; Treatment Period 2)
n=35 participants at risk
Half the participants completing treatment with cenerimod 4 mg in Treatment Period 1 were re-randomized to cenerimod 2 mg once daily in addition to background SLE therapy during Treatment Period 2. Participants received cenerimod 2 mg for up to 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 4 mg (Treatment Period 1) & Placebo (Ex-4 mg; Treatment Period 2)
n=35 participants at risk
Half the participants completing treatment with cenerimod 4 mg in Treatment Period 1 were re-randomized to placebo once daily in addition to background SLE therapy during Treatment Period 2. Participants received placebo for up to 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 4 mg (Treatment Period 1) & Not Re-randomized (Ex-4 mg; Treatment Period 2)
n=14 participants at risk
Participants were not re-randomized and did not receive treatment in Treatment Period 2. (These participants previously received cenerimod 4 mg once daily in addition to background SLE therapy for 6 months in treatment period 1). After end of treatment, participants entered a 6-month follow-up period.
|
Placebo (Treatment Period 1 & 2)
n=86 participants at risk
Participants received placebo once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1. Participants completing Treatment Period 1 continued with placebo once daily in addition to background SLE therapy during Treatment Period 2 for up to an additional 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.4%
2/85 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.2%
1/84 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
COVID-19
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.4%
2/85 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.2%
1/84 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.4%
2/85 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
Pneumonia
|
1.2%
1/84 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
1/84 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.4%
2/85 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
Other adverse events
| Measure |
Cenerimod 0.5 mg (Treatment Period 1 & 2)
n=84 participants at risk
Participants received cenerimod 0.5 mg once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1. Participants completing Treatment Period 1 continued with cenerimod 0.5 mg once daily in addition to background SLE therapy during treatment period 2 for up to an additional 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 1 mg (Treatment Period 1 & 2)
n=85 participants at risk
Participants received cenerimod 1 mg once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1. Participants completing Treatment Period 1 continued to receive cenerimod 1 mg once daily in addition to background SLE therapy during Treatment Period 2 for up to an additional 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 2 mg (Treatment Period 1 & 2)
n=87 participants at risk
Participants received cenerimod 2 mg once daily in addition to background SLE therapy for up to 6 months in treatment period 1. Participants completing Treatment Period 1 continued to receive cenerimod 2 mg once daily in addition to background SLE therapy during Treatment Period 2 for up to an additional 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 4 mg (Treatment Period 1) & Cenerimod 2 mg (Ex-4 mg; Treatment Period 2)
n=35 participants at risk
Half the participants completing treatment with cenerimod 4 mg in Treatment Period 1 were re-randomized to cenerimod 2 mg once daily in addition to background SLE therapy during Treatment Period 2. Participants received cenerimod 2 mg for up to 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 4 mg (Treatment Period 1) & Placebo (Ex-4 mg; Treatment Period 2)
n=35 participants at risk
Half the participants completing treatment with cenerimod 4 mg in Treatment Period 1 were re-randomized to placebo once daily in addition to background SLE therapy during Treatment Period 2. Participants received placebo for up to 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
Cenerimod 4 mg (Treatment Period 1) & Not Re-randomized (Ex-4 mg; Treatment Period 2)
n=14 participants at risk
Participants were not re-randomized and did not receive treatment in Treatment Period 2. (These participants previously received cenerimod 4 mg once daily in addition to background SLE therapy for 6 months in treatment period 1). After end of treatment, participants entered a 6-month follow-up period.
|
Placebo (Treatment Period 1 & 2)
n=86 participants at risk
Participants received placebo once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1. Participants completing Treatment Period 1 continued with placebo once daily in addition to background SLE therapy during Treatment Period 2 for up to an additional 6 months. After end of treatment, participants entered a 6-month follow-up period.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.8%
4/84 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
11.8%
10/85 • Number of events 12 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
13.8%
12/87 • Number of events 18 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
20.0%
7/35 • Number of events 12 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
11.4%
4/35 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
35.7%
5/14 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
2/84 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
4.7%
4/85 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
2/35 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.3%
2/87 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Eye disorders
Cataract subcapsular
|
1.2%
1/84 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Eye disorders
Dry eye
|
3.6%
3/84 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.4%
2/85 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
10.3%
9/87 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
3.5%
3/86 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Eye disorders
Eye irritation
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Eye disorders
Eye pain
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Eye disorders
Vision blurred
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/84 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
6/85 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.3%
2/86 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.4%
2/85 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Gastrointestinal disorders
Acid peptic disease
|
1.2%
1/84 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
4/84 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
4.7%
4/85 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
3.4%
3/87 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
8.6%
3/35 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
3.5%
3/86 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.2%
1/84 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.4%
2/85 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/84 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Gastrointestinal disorders
Nausea
|
3.6%
3/84 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.3%
2/86 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/84 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
General disorders
Pyrexia
|
1.2%
1/84 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
3.5%
3/85 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.3%
2/87 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
COVID-19
|
9.5%
8/84 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
9.4%
8/85 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
11.5%
10/87 • Number of events 10 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
14.3%
2/14 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
12.8%
11/86 • Number of events 11 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
Eyelid infection
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
5/84 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
6.9%
6/87 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
8.6%
3/35 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.8%
5/86 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
Ophthalmic herpes simplex
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
Oral herpes
|
1.2%
1/84 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
2/35 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
Pharyngitis
|
2.4%
2/84 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.4%
2/85 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
5/87 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.3%
2/86 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
2/35 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
7/84 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
4.7%
4/85 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
5/87 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
11.4%
4/35 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Infections and infestations
Urinary tract infection
|
2.4%
2/84 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.4%
2/85 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.3%
2/87 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
11.4%
4/35 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
10.5%
9/86 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
1/84 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.9%
5/85 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
3.4%
3/87 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Investigations
Forced expiratory volume decreased
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.3%
2/86 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
5/87 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
14.3%
2/14 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.4%
2/85 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
3.4%
3/87 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.2%
1/84 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.4%
2/85 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
4.6%
4/87 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/86 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
3.5%
3/85 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.3%
2/86 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
1/84 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.4%
2/85 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.9%
5/85 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
4.7%
4/86 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Nervous system disorders
Headache
|
13.1%
11/84 • Number of events 12 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
14.1%
12/85 • Number of events 13 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
9.2%
8/87 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
22.9%
8/35 • Number of events 10 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
4.7%
4/86 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.2%
1/85 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
1/84 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
1.1%
1/87 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
2.3%
2/86 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Skin and subcutaneous tissue disorders
Brachioradial pruritus
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/85 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/87 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/86 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
|
Vascular disorders
Hypertension
|
2.4%
2/84 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
9.4%
8/85 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
3.4%
3/87 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
22.9%
8/35 • Number of events 10 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/35 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
|
0.00%
0/14 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
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2.3%
2/86 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) are reported. TEAEs are defined as adverse events with onset on or after the date of first intake of double-blind study treatment up to end of treatment plus 6 months (i.e., maximum of 18 months: Treatment Period 1 + Treatment Period 2 + 6-month safety follow-up period). Subjects who received cenerimod 4 mg and completed Treatment Period 1 were re-randomized to cenerimod 2 mg or placebo in Treatment Period 2.
TEAEs are reported for the Safety Analysis Set, i.e., according to the actual treatment received, which may have differed from the assigned study treatment (see Participant Flow, above). Note that 1 subject was randomized to the cenerimod 0.5 mg arm/group but received cenerimod 2 mg during Treatment Period 2. This subject is thus included in the 'at risk' population of the cenerimod 2 mg arm/group (n = 87) and not in the cenerimod 0.5 mg arm/group (n = 84) for the reporting of TEAEs.
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Additional Information
Viatris Innovation Clinical Trial Information
Viatris Innovation GmbH
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Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any study-related publication written independently by investigators must be submitted to the sponsor for review at least 30 days prior to submission for publication or presentation. Upon review, the sponsor 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